EXHIBIT 10.2
DISTRIBUTION AGREEMENT AMENDMENT NO. 1
This is an amendment to the Distribution Agreement ("Distribution Agreement")
made and entered into on January 22, 2002 between:
XXXXXXXX PHARMACEUTICALS LTD., a corporation duly organized and existing under
the laws of England having its place of business at Xxxxxxx Xx, Xxxxxxxxx,
Xxxxxx, Xxxxxx Xxxxxxx XX0 0XX and Xxxxxxxx Pharma Srl, a corporation duly
organized and existing under the laws of Italy having its place of business at
Xxxxx Xxxxxx, 00, 00000 Xxxxxx, Xxxxx. Xxxxxxxx Pharmaceuticals Ltd and
Xxxxxxxx Pharma Srl are hereinafter collectively referred to as "Company."
and
CELL PATHWAYS, INC., a corporation duly organized and existing under the laws
of Delaware having a place of business at 000 Xxxxxxxxxx Xxxxx, Xxxxxxx,
Xxxxxxxxxxxx, 00000 hereinafter referred to as "Distributor."
The Definitions set forth in Article 1 of the Distribution Agreement are used
in and control this Amendment No. 1.
This Amendment No. 1 is effective as of March 15, 2002.
The Company and Distributor have been working together under the Distribution
Agreement to have the Present Product manufactured on behalf of Company and
launched by Distributor in the United States. As they have been working
together, they now understand that the Distribution Agreement has to be
clarified so that the respective responsibilities of the parties are
memorialized clearly for the purposes of regulatory compliance in the United
States. Thus, the parties have agreed upon the following matters.
A. Company has designated Xxxxxxx Xxxxxxx as its U.S. agent under 21
C.F.R. Section 807.40(b), and Distributor agrees to this. Company will notify
Distributor of any proposed change in U.S. Agent within 30 days of the change,
and Distributor shall have the right to approve any such change, which approval
shall not unreasonably be withheld. Company's U.S. Agent shall comply with the
applicable F.D.A. rules and regulations and specifically shall assist F.D.A.
(upon request) in communications with Company and its foreign manufacturer,
respond to questions concerning Present Product that are imported, and
scheduling inspections of the Company and its foreign manufacturer. Company
shall ensure that its U.S. Agent shall reside or maintain a place of business
in U.S. To the extent that the U.S. Agent is contacted by the F.D.A. regarding
the Present Product , Company shall immediately notify Distributor of the
nature of the contact and provide Distributor copies of all correspondence
received. Company shall provide advance notice of any F.D.A. inspection or
audit and Distributor shall be entitled to have a representative present at any
such inspection or audit.
B. Company has listed Xxxxxx Xxxxx as its official correspondent on F.D.A.
Form 2891, and Distributor agrees to this. Company will notify Distributor of
any proposed change in official correspondent within 30 days of the change, and
Distributor shall have the right to approve any such change, which approval
shall not unreasonably be withheld.
C. Distributor is registered with FDA as a distributor of the Present
Product (F.D.A. Form 2891), and shall maintain that registration for as long as
its obligations under the Distribution Agreement remain in effect.
D. Company has listed Present Product Gelclair with F.D.A. (FDA Form 2892)
and shall maintain that listing for as long as its obligations under the
Distribution Agreement remain in effect.
E. To clarify Company's obligations under Section 1.16 not to modify
Specifications "without prior written agreement by the Parties," the parties
agree that Distributor should be notified reasonably in advance of making any
of proposed changes to Specifications, as well as any proposed changes to
manufacturing methods, processes, or procedures. All such changes proposed by
Company or its manufacturer shall be subject to advance written approval by the
Distributor, and such approval shall not unreasonably be withheld. For
clarity, such changes include, but are not limited to manufacturing location;
process, equipment, and batch size; components, suppliers, grade and/or source;
testing methods, finished product composition and specifications; and packaging
and labeling changes.
F. The parties agree that the packing specification attached (Appendix A)
shall be treated as part of Appendix A to the Distribution Agreement and be
deemed to be part of the Specifications under that agreement.
IN WITNESS WHEREOF, the Parties have executed this Amendment No. 1 in
duplicate.
Xxxxxxxx Pharmaceuticals Ltd. Cell Pathways Incorporated
Signed by: Xxxxxxx X. Xxxxx Signed by: Xxxxxx X. Xxxxxxxxxx
/s/ /s/
------------------------- -----------------------------
Position: President & CEO Position: President & C.E.O.
Date: April 17, 2002 Date: April 8, 2002
Xxxxxxxx Pharma Srl
Signed by: Xxxxxxx X. Xxxxx
Position: President
/s/
--------------------
Date: April 17, 2002
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APPENDIX A
[Description of GelclairTM Master Label Form and depiction of GelclairTM
packaging materials.]
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