Clinical Support Services Clause Samples
Clinical Support Services. During the Term, WHC and WHI may, from time to time, request that Abiomed perform certain clinical support services for WHC or WHI (the “Clinical Support Services”); provided, however, that WHC and WHI are under no obligation to request any Clinical Support Services, or to request any minimum amount of Clinical Support Services during the Term. If Abiomed agrees to perform such Clinical Support Services, the parties shall mutually agree on a written statement of work in the form of Exhibit B hereto (“Clinical Statement of Work”), provided, however, the Parties may mutually agree on variations to such form as required, on a case-by-case basis. Examples of the types of Clinical Support Services that may be provided, upon mutual agreement, include the following: Clinical Support (Clinical Field Specialist level):
(a) On-site start-up and ongoing training of a clinical center’s clinical staff responsible for the care and management of LVAS recipients or LVAS hardware.
(b) On-site clinical support to clinical centers, including but not limited to direct support at implants. This would include from time-to-time, providing urgent clinical or technical on-site support.
(c) Participation in a rotating schedule to provide 24-hour on-call clinical and technical support to clinical centers.
(d) Documenting clinical experiences per WHC/WHI’s internal business and regulatory processes. Clinical Trial Support (CRA I level):
(e) Conducting study site initiations and close-out visits in compliance with WHC/WHI Clinical Affairs operating procedures and policies. Ensuring collection of required essential documents for study start-up and throughout conduct of study.
(f) Conducting study site monitoring visits to ensure that conduct of a Clinical Trial is in compliance with the then-currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements. Conducting source data/document verification.
Clinical Support Services. From time to time during the Licensed Period, Shionogi may desire for ▇▇▇▇▇ to undertake the performance of certain clinical support activities for the Licensed Products in the Field in the Shionogi Territory in addition to those set forth in the Support Services Plan, including, without limitation, support of IT systems, data analytics, consulting services and regulatory assistance. ▇▇▇▇▇ will not be under any obligation to perform such activities unless mutually agreed by the Parties. Shionogi will bear one hundred percent (100%) of the Development Costs incurred by or on behalf of the Parties in connection with any such mutually agreed Development activities, including any internal and Out-of-Pocket Costs, and will reimburse ▇▇▇▇▇ for any Development Costs incurred by or on behalf of ▇▇▇▇▇ Territory in accordance with the invoicing and payment procedures of Section 7.9.
Clinical Support Services a) [***].
b) [***].
c) [***].
d) [***].
e) [***].
f) [***].
g) [***].
h) [***].
i) [***].
j) [***].
k) [***].
l) [***]. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
m) [***].
Clinical Support Services. If NWBT requests any services from Cognate relating to the evaluation, preparation, training, initiation and/or support of clinical trial sites for clinical trials of DCVax® Products, NWBT and Cognate will enter into separate agreements for such services (collectively, the “Clinical Support Services”), and each such separate agreement will be attached as part of Exhibit A (Exhibit A-▇, ▇-▇, etc.), and incorporated herein by reference. Such Clinical Support Services may include, without limitation, traveling to clinical sites, training various on-site staff in regard to collection, processing, shipping and handling of tumors tissues that are to be used in the production of DCVax® Products by Cognate, as well as scheduling and reserving of manufacturing slots, scheduling and management of delivery of finished DCVax® Products to the hospital’s pharmacy and to the patients, and other clinical matters. Each such separate agreement will include the scope and nature of work, and the payment and cost reimbursement provisions.