Genoptix Responsibilities Clause Samples

The 'Genoptix Responsibilities' clause defines the specific duties and obligations that Genoptix must fulfill under the agreement. This may include providing certain services, delivering products, maintaining compliance with applicable laws, or meeting performance standards as outlined in the contract. By clearly outlining what is expected of Genoptix, this clause ensures accountability and helps prevent misunderstandings or disputes regarding each party's roles and obligations.
Genoptix Responsibilities. Genoptix shall use Commercially Reasonable Efforts to perform the activities reasonably required for the development and regulatory submission of a PMA to CDRH for the Companion Diagnostic, including, but not limited to: (a) developing and validating the Assay as a Companion Diagnostic pursuant to the Companion Diagnostic Validation Plan; (b) allocating Genoptix resources to the Companion Diagnostic Activities in accordance with the Companion Diagnostic Validation Plan; (c) sourcing all reagents and materials (other than patient samples and genotyping data provided by Ambit) that are necessary to conduct the Companion Diagnostic Activities in accordance with the Companion Diagnostic Validation Plan; (d) managing all patient samples and genotyping data provided by Ambit to Genoptix or generated by Genoptix in connection with the Companion Diagnostic Activities in full accordance with the parameters governing informed consent, the MSA, the specifications of the Companion Diagnostic Validation Plan and all applicable Laws; (e) preparing, for timely review by the JCDC, the PMA for the Companion Diagnostic, revising the PMA to take into account reasonable comments provided by the JCDC, and upon JCDC decision to file the PMA, submitting the PMA to CDRH substantially simultaneously with, but not later than ten (10) business days after, the NDA filing for AC220; (f) leading all interactions with the CDRH division at FDA to seek PMA Approval, provided that Genoptix shall promptly provide Ambit with copies of all written communications to and from the CDRH with respect to the Companion Diagnostic, and shall provide Ambit with reasonable advance notice of any scheduled meetings with the CDRH and Ambit shall have the right to be present in any such meeting to the extent permitted by applicable Laws; and (g) granting Ambit and its development and commercialization strategic partner for AC220 (which, as of the Effective Date, is Astellas Pharma Inc. and Astellas US LLC) the authority to cross-reference the PMA for the Companion Diagnostic so that Regulatory Authorities may access data from such PMA, under confidentiality and as required, to support review of the NDA for AC220.
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Genoptix Responsibilities 
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Related to Genoptix Responsibilities

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