INVESTIGATOR SPONSORED STUDIES. 14.1 The Company recognises the importance of Investigator Sponsored Studies (“ISSs”) in expanding scientific knowledge related to potential Uses of Company Products. An ISS may be conducted with Authorised or Unauthorised Company Products or Uses. All ISSs supported by the Company must be consistent with the research strategy for the relevant Company Product.
INVESTIGATOR SPONSORED STUDIES. The parties acknowledge that ALZA has agreed to provide funds and/or PRODUCT to ------------------------------ support independent Investigator Sponsored Studies ("ISS") of the PRODUCT. ALZA has used commercially reasonable efforts to identify all such studies, which are identified on a list attached hereto as Exhibit A. Upon MedImmune's request, ALZA shall provide true and complete copies of the ISS agreements, including the exhibits to the agreements and amendments, that cover the studies listed on Exhibit A. On or before September 10, 2001, MedImmune shall review the list and identify those studies it wishes to continue, and upon request and approval by MedImmune, ALZA shall assign the agreements pertaining to those ISS' to MedImmune. The ISS agreements that MedImmune does not request to have assigned to it will be terminated by ALZA. MedImmune specifically agrees that it will accept assignment of the ISS agreement between ALZA and PRN dated January 19, 1999 (the "PRN Agreement") concerning the investigation of PRODUCT in the treatment of Stage III A, III B, Non-Small Cell Lung Cancer (NSCLC) (the "PRN Study"), and the ISS agreement between ALZA and the American College of Radiology, Radiation Therapy Oncology Group, dated July 25, 1998 (the "RTOG Agreement"), also concerning the investigation of PRODUCT in NSCLC (the "RTOG Study"). ALZA shall be responsible for paying and fulfilling all costs and obligations of the PRN Agreement that result from conducting the PRN Study on or before September 30, 2001, including those associated with patient recruitment. MedImmune shall be responsible for paying all costs and obligations of the PRN Agreement that result from conducting the PRN Study on or after October 1, 2001. MedImmune shall also be responsible for paying and fulfilling all costs and obligations of the RTOG Agreement that result from conducting the RTOG Study on or after the date of this Amendment No. 3 and (notwithstanding the provisions of the letter agreement between ALZA and U.S. Bioscience dated July 25, 1998) shall be responsible for paying the milestone for (CONFIDENTIAL TREATMENT REQUESTED) in the RTOG study set forth in Section I(c) of Exhibit B of the RTOG Agreement ("Milestone (c)"), regardless of whether the obligation to pay Milestone (c) accrues before or after the date of this Amendment No. 3. If MedImmune terminates the PRN Study prior to March 31, 2002, it will pay ALZA (CONFIDENTIAL TREATMENT REQUESTED). If MedImmune terminates the ...
INVESTIGATOR SPONSORED STUDIES. (a) Before either Party authorizes or facilitates an investigator to conduct an ISS for the Product in the Field that complies with the guidelines established by the JDC pursuant to Section 3.2(a)(iv), such Party shall notify the other Party in writing, which notice shall provide a reasonably detailed description of such ISS and explanation of how it complies with such guidelines.
INVESTIGATOR SPONSORED STUDIES. 11.1 The Counterparty must recognise the importance of ISSs in expanding scientific knowledge related to potential uses of AstraZeneca products.
INVESTIGATOR SPONSORED STUDIES. Investigator-sponsored studies of the Collaboration Product with respect to which a Party or its Affiliate or its Sublicensee is providing funding or clinical supplies of Collaboration Product shall be treated as a Clinical Study Conducted by such Party for all purposes (including JDC review and approval, cost allocation and intellectual property). [***].
INVESTIGATOR SPONSORED STUDIES. (a) Before either Party authorizes or facilitates an investigator to conduct an ISS for the Product in the Field, such Party shall notify the other Party in writing, which notice shall provide a reasonably detailed description of such ISS and shall provide the other Party a reasonable opportunity to review and comment upon such ISS. Such Party shall give reasonable consideration to the other Party’s comments.
INVESTIGATOR SPONSORED STUDIES. In the event that a Party desires to facilitate an Investigator Sponsored Study in the Amgen Territory or in the KKC Territory, and such Investigator Sponsored Study is not already included in the then-current Global Development Plan, then such Party shall [***].
INVESTIGATOR SPONSORED STUDIES. The JDC shall establish and implement a policy regarding publications of investigator-sponsored trials of the Licensed Product in the Field in the Licensed Territory, which shall include the ability of the Parties to comment thereon, including without limitation with respect to study design and endpoints, and to request delays to allow the filing of patent applications on any patentable inventions disclosed therein in a manner consistent with Section 7.
INVESTIGATOR SPONSORED STUDIES. All investigator-sponsored studies shall be reviewed and approved by the JDC. Neither Party may Conduct, or otherwise support (including providing funding or clinical supplies of Collaboration Product) any investigator-sponsored studies of the Collaboration Products without first obtaining the JDC’s approval. Any such approved activities with respect to investigator-sponsored studies of the Collaboration Products shall be considered Development Activities.
INVESTIGATOR SPONSORED STUDIES. 14.1 The Company recognises the importance of Investigator Sponsored Studies (“ISSs”) in expanding scientific knowledge related to potential Uses of Company Products. [*] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed. An ISS may be conducted with Authorised or Unauthorised Company Products or Uses. All ISSs supported by the Company must be consistent with the research strategy for the relevant Company Product.
