Cell Therapy Product definition

Cell Therapy Product means [***].

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 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.

Examples of Cell Therapy Product in a sentence

• Such independent test organization shall determine whether the Cell Therapy Product in a given shipment was defective, and the decision of said independent test organization shall be final and binding on Athersys and Angiotech.

• In the event that any one or more of the provisions contained in this Agreement is or are invalid, irregular or unenforceable in any respect, the validity, regularity and enforceability of the remaining provisions contained in this Agreement shall be in no way affected, prejudiced or disturbed thereby.

• 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.

• If the defective Cell Therapy Product was supplied by a Third-Party manufacturer or by Athersys, then any expenses actually incurred by Athersys in connection with such defective Cell Therapy Product shall be borne solely by Athersys, and shall not be included in Manufacturing Costs hereunder.

• Angiotech shall use Commercially Reasonable Efforts to commercialize at least one Cell Therapy Product (at its discretion) for a myocardial infarction indication and a peripheral vascular disease indication in countries of the Territory where Regulatory Approval has been obtained for such Cell Therapy Product(s); provided that Angiotech shall consider in good faith any recommendations and requests by Athersys’ representatives on the JSC regarding commercialization of Cell Therapy Products.

More Definitions of Cell Therapy Product

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

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 each of (i) human cells, tissues, and cellular- and tissue- based products as defined under 21 C.F.R. § 1271, 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 PCT 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 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 proscribed by applicable state, local, or other Non-governmental Regulatory Body.

Cell Therapy Product means a human therapy or product in which the specificity of an immune system cell is genetically modified to enable the respective cell’s recognition of a desired target antigen or peptide. Certain confidential information contained in this document, marked by [**], has been omitted because Immatics N.V. (the “Company”) has determined that the information (i) is not material and (ii) is customarily and actually treated by the Company as private or confidential.

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