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 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

• In the event the non-discontinuing Party does not exercise the Sole Development Option within the six (6) month time period set forth in Section 6.1 above, and if agreed upon in writing by the Parties, the JSC may seek, or designate one of the Parties to seek, qualified Third Party(ies) to develop the applicable Clinical Development Candidate or 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.

• At the first JSC meeting after the end of ViaCell's fiscal year, the JSC shall review and reconcile the actual Direct Development Costs for each Cell Therapy Product to the budget previously reviewed.

• 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.

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

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

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).

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 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 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.