Monthly Updates. Each Party shall provide the JCDC with monthly updates on its activities under this Agreement. Ambit shall provide the JCDC with monthly updates on: (i) the AC220 development program timeline; (ii) the status of the AC220-002 and AC220-003 Clinical Trials and any changes relevant to sample logistics from such trials; and (iii) feedback on interactions with CDER concerning requirements for the Companion Diagnostic. Genoptix shall provide the JCDC with monthly updates on: (1) development and validation of the Companion Diagnostic; (2) status of preparation of the PMA for the Companion Diagnostic; (3) feedback on interactions with the CDRH concerning requirements for the Companion Diagnostic; and (4) any actual variances or expected variances to the approved budget for Companion Diagnostic Activities.
Appears in 4 contracts
Samples: Collaboration Agreement (Ambit Biosciences Corp), Collaboration Agreement (Ambit Biosciences Corp), Collaboration Agreement (Ambit Biosciences Corp)
Monthly Updates. Each Party shall provide the JCDC with monthly updates on its activities under this Agreement. Ambit shall provide the JCDC with monthly updates on: (i) the AC220 development program timeline; (ii) the status of the AC220-002 and ***Confidential Treatment Requested AC220-003 Clinical Trials and any changes relevant to sample logistics from such trials; and (iii) feedback on interactions with CDER concerning requirements for the Companion Diagnostic. Genoptix shall provide the JCDC with monthly updates on: (1) development and validation of the Companion Diagnostic; (2) status of preparation of the PMA for the Companion Diagnostic; (3) feedback on interactions with the CDRH concerning requirements for the Companion Diagnostic; and (4) any actual variances or expected variances to the approved budget for Companion Diagnostic Activities.
Appears in 1 contract
Samples: Collaboration Agreement
