Examples of MSC Product in a sentence
If a Gene Therapy Product containing transduced cells also meets the definition of an MSC Product, it shall be considered as an MSC Product for the purpose of determining milestone payments under this Agreement, and only the milestone payments appropriate for the Bone Therapy Area or the Cartilage Therapy Area, as the case may be, shall be payable by Novartis.
If Novartis gives notice of early termination of research funding for the Bone Therapy Area and/or the Cartilage Therapy Area under the provisions of Article 4.5, the Areas for which research funding has been terminated shall no longer be part of the Field, the license granted to Novartis for MSC Product in each such Area shall be terminated and Novartis shall have no further rights in respect of such Area.
If a Gene Therapy Product containing transduced cells also meets the definition of an MSC Product, it shall be considered as an MSC Product for the purpose of determining royalty payments under this Agreement, and the applicable royalty rates will be as set out in Art.
Such Supply Agreement shall terminate no later than the expiry of Novartis' obligation to pay royalties on sales of said MSC Product in all North American countries.
Within thirty (30) days of such notification, Osiris may at its discretion notify Novartis that Osiris wishes to supply Novartis and its Affiliates with that MSC Product for sale in North America.
Such Supply Agreement shall provide that if Osiris is unable to supply such MSC Product in accordance with the forecasting requirements set forth in such Agreement, then to the extent that Osiris cannot meet such requirements, and for the period for which Osiris cannot meet such requirements, Novartis or a Novartis Affiliate shall have the right to manufacture itself or to have a Third Party manufacture such MSC Product.
Osiris shall provide Novartis or such Third Party with sufficient technical information to enable the manufacture of such Product, all under suitable confidentiality requirements and requirements that it be used only to the extent necessary to manufacture for Novartis and its Affiliates the amount of MSC Product which Osiris cannot provide, and for the period for which Novartis is required to obligate itself to have a Third Party manufacture such MSC Product.
Manufacturing Facility: The Supply Agreement shall provide that Osiris will assume full cost and responsibility for constructing, operating and maintaining one or more United States manufacturing facilities together capable of supplying the expected commercial requirements of Novartis and its Affiliates in North America with respect to MSC Product for which an NDA has been approved in the United States.
Novartis shall notify Osiris when any MSC Product being developed by Novartis or its Affiliates enters into Clinical Phase 3.
If Osiris does not make such notification within said thirty (30) day period, then Novartis' license under this Agreement shall include a license to make and have made said MSC Product for sale in North America.