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20-F
MESOBLAST LTD filed this Form 20-F on 08/31/2018
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or methods of isolating, preparing, culturing, purifying, proliferating, or enhancing cells other than MPC-150-IM or MPC-25-IC or preparations or populations of cells other than MPC-150-IM or MPC-25-IC.

Product Technology” means Product Patents and Product Know-How.

Proprietary Materials” means those materials or components described in the Product Memorandum, which are Controlled by MSB or its Affiliates and necessary for the Manufacture of Product hereunder.

Prosecution and Maintenance” means, with respect to a Patent, (a) the preparing, filing, prosecuting and maintenance of such Patent (including conducting all correspondence and interactions with any government office or court having jurisdiction over the same), including the right to apply for Patents pursuant to The Agreement on Trade-Related Aspects of Intellectual Property Rights or pursuant to any other convention, treaty, agreement or understanding and (b) seeking, conducting or defending re‑examinations, reissues, requests for Patent term extensions and the like with respect to such Patent, together with the conduct of interferences, inter partes reviews, post-grant reviews, the defense of oppositions and other similar proceedings with respect to the particular Patent (whether before or after issuance); and “Prosecute and Maintain” and “Prosecuting and Maintaining” have their correlative meanings.

Quarterly Period” means a three (3) month period of each calendar year ending on March 31, June 30, September 30 or December 31.

“Regulatory Approval” means, with respect to a therapeutic product in a particular jurisdiction, any Marketing Approval, pricing approval and all clearances, approvals, licenses, registrations or authorizations necessary for the Development or Manufacture of such product in such jurisdiction, including any tissue bank licenses for the Manufacture of such product.  Regulatory Approvals include approvals (or other clearance) of applications or submissions filed with or submitted to any Regulatory Authority necessary to initiate or conduct any clinical study in conformance with the requirements of such Regulatory Authority.

Regulatory Authority” means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the Development, Manufacture or Commercialization or other use or exploitation (including the granting of Regulatory Approvals) of Product in any jurisdiction, including the CFDA.

Regulatory Materials” means regulatory applications (including MAAs), submissions, notifications, communications, correspondence, registrations, Regulatory Approvals or other filings made to, received from or otherwise conducted with the CFDA or other relevant Regulatory Authority (including minutes of meeting with any Regulatory Authority) that are necessary or relate to the Development, Manufacture or Commercialization of, or conduct of the Medical Affairs Activities for, Product for the Field in the Territory.

 

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Confidential material omitted and filed separately with the Commission.



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