AATB definition
Examples of AATB in a sentence
All costs associated with obtaining and/or maintaining any regulatory or governmental approval, within the United States, or accreditation with AATB as set forth in this Section 4.5 shall be borne solely by RTI insofar as those costs relate to activities performed by RTI.
All costs associated with regulatory requirements, or AATB accreditation related to distribution activities performed by MSD, shall be borne by MSD.
MSD shall be responsible for assuring that applicable AATB requirements are met with respect to MSD’s distribution activities.
Once obtained, Osiris agrees to maintain its accreditation with the AATB and should Osiris’ accreditation lapse at any time or for any reason, it shall promptly communicate to the NuVasive the reasons for such lapse and the actions taken to cure the loss of AATB accreditation.
RTI warrants that it will use its best efforts to continue its membership in good standing in the AATB and retain its AATB accreditation at all time during the term of this Agreement.
The Parties agree that Osiris is actively pursuing AATB accreditation, and that NuVasive shall continue to perform its obligations under this Agreement despite the pendency of such AATB accreditation for so long as Osiris is using reasonable commercial efforts to obtain such accreditation.
Osiris shall promptly notify NuVasive of the results of any inspection, comments, responses or notices received from the FDA, AATB, or other applicable regulatory authorities, which relate to the Processing of Product hereunder.
NuVasive represents and warrants that all Tissues will be stored, packaged, shipped, labeled and otherwise handled in accordance with all applicable federal and state laws and regulations, AATB standards applicable to human tissue, as well as the Specifications.
ATC will perform serologic, bacterial and microbiological testing on all donor tissue processed in accordance with AATB standards and/or applicable U.S. federal regulations.
The term “Product” means human nerve allografts based on AxoGen’s proprietary technology that meet Product Specifications (as defined below) and meet applicable federal, state and local regulations and in accordance with the Standards for Tissue Banking of the AATB.