Cell Therapy Product definition

Cell Therapy Product means [***].

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Cell Therapy Product means a therapeutic and/or prophylactic product for humans that (a) includes a Cell developed under this Agreement that is intended for use or used as Cell Therapy for at least one Cardiovascular Indication, and (b) has obtained Regulatory Approval in a given country or jurisdiction in the Territory.

Cell Therapy Product means a product containing human cells for administration to the patient or subject as a therapeutic agent in treatment or therapy.

Examples of Cell Therapy Product in a sentence

• The terms and procedures set forth in the manufacturing and supply agreement described in Section 9.1 may include provisions related to Cell Therapy Product orders and forecasts, Cell Therapy Product acceptance, and, subject to the provisions of this Section 9.5, Cell Therapy Product rejection and remedies for defective Cell Therapy Product.

• The specific terms and procedures by and upon which Athersys shall supply the Cell Therapy Products to Angiotech hereunder shall be reasonably mutually determined by the Parties in good faith, and shall be set forth in a separate manufacturing and supply agreement not less than twelve (12) months prior to the anticipated First Commercial Sale of a Cell Therapy Product in the Territory, such terms and procedures to be commercially reasonable and consistent with the provisions of the Transaction Agreements.

• Angiotech shall have the primary responsibility for communicating with any regulatory authority regarding any IND application or other regulatory filing pertaining to a Clinical Development Candidate that has completed a Phase I Study, and regarding any Clinical Development Candidate or Cell Therapy Product that has been submitted for, or has obtained, Regulatory Approval.

• Angiotech shall be solely responsible for responding to any Cell Therapy Product complaints.

• In the event that Athersys is materially unable, at any time, to fulfill its obligation to supply Clinical Development Candidates or Cell Therapy Products in a timely manner, as required hereunder, for any reason (a “Supply Disruption”), Athersys shall promptly notify Angiotech of such Supply Disruption and the estimated extent of such Supply Disruption (including the anticipated delay time and the quantity of Clinical Development Candidate or Cell Therapy Product involved).

More Definitions of Cell Therapy Product

Cell Therapy Product means AMR-001 and each other of (i) human cells, tissues, and cellular- and tissue- based products as defined under 21 C.F.R. § 1271, produced by Amorcyte specifically, articles, containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient, including but not limited to hematopoietic stem/progenitor cells derived from peripheral and cord blood; (ii) human cellular- and tissue-based products Amorcyte produces that are more than minimally manipulated for non-homologous use combined with at least one other article that raises new clinical safety concerns and/or has systemic effect on the metabolic activity of living cells for its primary function and are applicable to the prevention, treatment, or cure of a disease or condition of human beings; (iii) somatic cell-based products produced by Amorcyte that are procured from a donor and intended for manipulation and/or administration as it is defined by the America Association of Blood Banks; and (iv) any definition of Cell Therapy Product proscribed by applicable state, local, or other non-governmental regulatory body as such relates to a product produced by Amorcyte.

Cell Therapy Product means any cell, tissue or organ which is engineered ex vivo by a cell processing process which relies, in material part, on the use of a Licensed Product.

Cell Therapy Product means (i) any human cells, tissues, and cellular- and tissue- based products produced by CSC containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient, including cancer stem cells, dendritic cells, neurology and ocular cells, integumentary cells, and any derivatives or formulations thereof, and (ii) any definition of Cell Therapy Product proscribed by applicable state, local, or other non-governmental regulatory body as such relates to a product produced by CSC.

Cell Therapy Product means an Immune Cell based therapy product, whether or not autologous, that has been engineered [***].

Cell Therapy Product means any product developed or labeled for the prevention, treatment, cure, or mitigation of any health condition in humans, which product comprises a population of autologous, allogeneic, or xenogeneic cells that have been propagated, expanded, selected, pharmacologically treated, or otherwise altered in biological characteristics.

Cell Therapy Product means a medicinal product manufactured through physical, chemical, and/or biological manipulation, such as in vitro culture of autologous, allogeneic, or xenogeneic cells. However, this definition does not apply to the case where a medical doctor performs minimal manipulation which does not cause safety problems of autologous or allogeneic cells in the course of surgical operation or treatment at a medical center (simple separation, washing, freezing, thawing, and other manipulations, while maintaining biological properties).

Cell Therapy Product means a product that contains or comprises [**], wherein [**], to be administered to humans for diagnostic, prophylactic, or therapeutic use (e.g. that certain Immatics proprietary product referred to as of the Execution Date as IMA201).