Allograft definition
Examples of Allograft in a sentence
Human Solid Organ transplant benefits are Covered for: • Kidney • Liver • Pancreas • Intestine • Heart • Lung • multi-visceral (3 or more abdominal Organs) • simultaneous multi-Organ transplants – unless investigational • pancreas islet cell infusion • Meniscal Allograft • Autologous Chondrocyte Implantation – knee only • Bone Marrow Transplant including peripheral blood bone marrow stem cell harvesting and transplantation (stem cell transplant) following high dose chemotherapy.
All Specialty Allografts and Bone Paste distributed pursuant to this Agreement shall be labeled by RTI in accordance with this Section 4.4. Any Specialty Allograft or Bone Paste which is improperly labeled shall not be deemed delivered until properly identified by MSD, and RTI shall credit MSD’s account for its reasonable costs incurred while (i) identifying Specialty Allografts and Bone Paste that were inappropriately labeled and (ii) correcting orders both to RTI and from its customers.
Once Specialty Allografts are supplied and initially packaged by RTI, MSD will not without RTI’s concurrence remove, alter or modify any Specialty Allograft Packaging Specifications of such Specialty Allografts.
RTI shall supply all packaging and labeling information and designs, including without limitation all artwork and pharmacological information, usage instructions and warnings to be applied to Specialty Allografts (the “Specialty Allograft Packaging Specifications”).
MSD shall be fully responsible for compliance with regulatory requirements with respect to all Specialty Allograft and Bone Paste distribution activities performed by MSD, including, if necessary, registration as a Tissue Bank under FDA 21 CFR 1271 and under any state licensure requirements.
The Parties will work to agree on specifications, development schedules and a budget with respect to the development of any Jointly-Developed New Allograft.
ANDF means the sum of the actual gross amounts invoiced to customers for such Specialty Allograft catalog number during such time period (excluding items placed on consignment) less discounts, rebates paid or accrued, credits, taxes, shipping, handling and other fees, and less allowances and returns, and divided by the total number of units of each such Bone Paste catalog number shipped.
Quality Procedures will be amended from time to time by RTI with the advice and comment from MSD to reflect changes in technology, laws, regulations and industry standards, provided that no party will be required to agree to any change to the Quality Procedures that, in the reasonable discretion of such party, would adversely impact the quality, safety or efficacy of any Specialty Allograft or Bone Paste.
Specialty Allografts shall meet the specifications set forth on Schedule 4.1(a) hereto (the “Specialty Allograft Specifications”).
Promptly after the Effective Date, the Parties will establish a joint steering committee (the “JSC”) to serve as a forum for consultation and decision-making with regard to certain strategic decisions regarding the marketing and commercialization of the Allograft Services, as set forth in Section 3.2 below.