Adverse Event ("AE") Processing and Exchange Agreement for Collagenase Santyl(R)
Ointment
Between
Advance Biofactures Corporation ("ABC"), Xxxxx Pharmaceutical Company ("KPC")
and
Xxxxx & Nephew, Inc. ("S&N")
The following sets forth the agreement of S&N, KPC and ABC on the procedures to
be established and followed to assure the expeditious exchange of adverse event
(AE) information related to Santyl(R) Collagenase Ointment (the "Product").
(1) All reports of Product AEs received by KPC or S&N will be sent by overnight
mail to ABC, with a copy to the other party, no later than the fourth calendar
day following their receipt by KPC or S&N.
(2) All reports of Product AEs received by ABC will be sent by overnight mail to
KPC and S&N no later than the fourth calendar day following their receipt by
ABC.
(3) Each party hereto will acknowledge receipt of each report of an AE from the
other parties by providing the company identification number it assigned to that
AE report to the party originally receiving the AE and the other party hereto.
(4) In the case of a 15 day reportable event, ABC will submit the event to FDA
in accordance with all relevant regulations and will provide KPC and S&N with a
copy of the dated cover letter to FDA at the time submitted to FDA.
(5) KPC and S&N will forward to ABC and each other on a monthly basis a report
listing all AEs and follow-ups for the Product that were received during the
prior calendar month, or a statement that none was received. This will include
all follow-ups or, if not available, documentation of efforts to follow-up.
(6) ABC will review KPC's and S&N's monthly reports listing AEs and follow-ups
(as set forth in paragraph 5 above) and promptly notify the party or parties if
any of its or their listed AE reports had not been received by ABC pursuant to
paragraph 1 hereinabove.
(7) KPC and S&N will follow their respective standard operating procedures for
follow-up of Product AEs. Any information obtained on follow-up will be
forwarded to ABC, with a copy to the other party, by overnight mail no later
than the fourth calendar day following receipt of such information. If follow-up
is unavailable, KPC or S&N, or both, will provide documentation of the efforts
made to follow-up.
(8) ABC will notify KPC and S&N of any information obtained on follow-up of
Product AEs by forwarding such information to KPC and S&N by overnight mail no
later than the fourth calendar day following receipt by ABC.
(9) ABC will prepare and submit Periodic Reports for the Product in accordance
with FDA regulations. ABC will provide KPC and S&N from the Product Periodic
Report information relevant to the assessment of the safe use of the Product, no
later than 10 calendar days prior to the Periodic Reports' FDA submission due
date. KPC and S&N will review this report for accuracy and completeness, and
notify ABC of their respective conclusions no later than 5 calendar days from
receipt thereof.
(10) Each party agrees to promptly forward to the other parties hereto any
information which could potentially affect the safe use of the Product by
patients.
(11) Each party agrees to fully cooperate with the other parties' audits of its
AE collection practices and recordkeeping for the Product. The auditing party
will provide no less than two (2) weeks prior notice of its intention to conduct
such an audit; provided, such audits will be conducted no more frequently than
once annually, unless otherwise mutually agreed.
(12) With respect to ABC and KPC, this Agreement supercedes the existing Adverse
Event Processing and Exchange Agreement between the parties respecting the
Product.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed in
duplicate originals by their duly authorized representatives.
ADVANCE BIOFACTURES CORPORATION
By s/Xxxxxx Xxxxxx
------------------
Title Executive Vice President
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Date January 31, 2000
---------------------
XXXXX PHARMACEUTICAL COMPANY XXXXX & NEPHEW, INC.
By s/Xxxxxx X. Xxxxxx By s/Xxx Xxxxxx Xx.
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Title President Title President
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Date January 31, 2000 Date January 31, 2000
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