EXHIBIT 10.22
AMENDMENTS
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Current Clinical Trial Agreement Terms
CTA Management Module
CTA #: 0104 NCI Principal Investigator: Xxxx Xxxxxxx, M.D.
Effective Date: 6/30/94 Division: DCPC
Term (years): 5 years Laboratory: CDISB
Expiration: 6/30/99 Collaborator: Cell Pathways, Inc.
Title: FGN-1 for Chemoprevention
New CTA Terms
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The purpose of this amendment is to change certain terms of the above
referenced Clinical Trial Agreement (CTA). These changes are reflected below
and except for these changes and those of any previous amendments, all other
provisions of the original CTA remain in full force and effect.
(1) Add to Definitions: "Additional Compounds" mean CP57, CP78, CP66
(2) Add to Paragraph 2 (Planning and Conduct of Research: DCPC shall not be
obligated to cause clinical trials of Additional Compounds to be conducted, but
would be permitted to conduct mutually agreed clinical trials in accordance with
the provisions of this Paragraph. In addition, NCI agrees not to analyze any
Additional Compound to ascertain its composition, purity, utility or efficacy in
any manner other than authorized by mutual agreement of the parties in
accordance with this Agreement, or use any Additional Compound for any purpose
other than set forth in this Agreement. The NCI agrees to keep records of how
much Additional Compound is used in pre-clinical experiments and return unused
quantities to Cell Pathways upon request.
(3) Modification to Paragraph 7 (Data Rights): Replace "for its own analysis
and for its application for FDA approval" with "for any purpose subject to the
provisions of Paragraphs 12 and 14."
(4) Add to Paragraph 9 (Proprietary Data): IN accordance with the provisions
of this Paragraph, NCI shall treat in confidence any of Collaborator's written
information related to a particular Additional Compound for a period of three
(3) years subject to the same right to extend such period for two (2) additional
years measured from the date of execution of this amendment.
(5) Add to Paragraph 12 (Publications): DCPC investigators may present and
publish data regarding a particular Additional Compound upon initiation of any
clinical trial on that particular Additional Compound in accordance with the
provisions of this Paragraph. However, in no case shall any limitation on the
publication rights specified in this Paragraph exceed a period of (1) one year
measured from the date the data is made available to the Collaborator.
(6) Modification to Paragraph 14 (Patents): Replace "filings related to Agent
and its analogs (a copy of Collaborator's US Patent Application is attached as
Exhibit A)" with "filings related to Agent and Additional Compounds and their
analogs (copies of Collaborator's US Patent Applications and issued patents are
attached as Exhibits A through E).
ACCEPTED AND AGREED TO:
National Cancer Institute Cell Pathways, Inc.
/s/ Xxxxxxx X. Xxxx
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Xxxxx Xxxxxxxxx, M.D. Title: Vice President
Division Director, DCPC ------------------------------
Cell Pathways, Inc.
September 4, 1996
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Date Date
1.