Patient Samples definition
Examples of Patient Samples in a sentence
Each Party’s use of Patient Samples shall be in accordance with Applicable Law, including any informed consent and institutional review board regulations and all applicable requirements relating to the protection of human subjects.
Each Party shall access the Patient Samples, and authorize Affiliates and Third Parties to access the Patient Samples, only as determined by the JDC for activities approved by the JDC (or, following termination or expiration of this Agreement, as approved by the Parties) in advance.
Unless otherwise agreed by the Parties, all Patient Samples shall be maintained and stored at the facilities of a Third Party selected by the JDC, and the fees paid to such Third Party in connection with such maintenance and storage shall be shared as Development Costs during the Term (and after the Term, shared equally by the Parties).
Unless otherwise agreed by the Parties or otherwise set forth in this Section 4.7, all Patient Samples shall be maintained and stored at the facilities of a Third Party reasonably agreed by the Parties for the purposes of the conduct of Collaboration Program activities, and the fees paid to such Third Party in connection with such maintenance and storage shall be a Development Cost.
Without limiting Section 3.5, (i) each Party shall promptly provide the other all Data made, generated or obtained in whole or part through use of the Patient Samples, whether during or after the Term, and (ii) all Know-How made, generated or obtained in whole or part through use of the Patient Samples, whether during or after the Term, and Patent Rights in and to any inventions within such Know-How, shall be included within the definition of Collaboration Intellectual Property for purposes of Section 3.5.
Each Party shall (and shall cause its Affiliates to) reasonably cooperate with the other Party to promptly share and to provide access to all clinical Data, and other Data and Know-How, within the Collaboration Intellectual Property (other than Patient Samples), and the JDC may establish reasonable policies to effectuate such exchange of Data and Know-How within the Collaboration Intellectual Property.
Patient Samples shall be stored, maintained and accessed by the Parties as provided in Section 4.7 below.
Each Party shall access the Patient Samples, and authorize Affiliates and Third Parties to access the Patient Samples, in each case solely to the extent in accordance with the applicable GDP, GCP, GMAP or as otherwise approved by the JDC (or, following termination or expiration of this Agreement, as approved by the Parties) in advance in respect of the Licensed Product.
Without limiting the foregoing, Millennium shall ensure that the informed consents and authorizations provided by subjects participating in Clinical Trials included in the Work Plan permit the provision of Patient Samples and information to Precision for use as contemplated by this Agreement, including for purposes of developing the Products.
ARNO shall be responsible at no cost to LBS for conducting the Clinical Trials required for a Project, as applicable (including Clinical Trials for any clinical validation of the Product), and providing all Patient Samples and Patient Data necessary for the conduct of the Project, provided however, that ARNO will have the sole discretion as to whether to conduct any such Clinical Trials, and the extent of such Clinical Trials, or otherwise whether to obtain such Patient Samples and Patient Data.