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Alkermes - Development Agreement
DEVELOPMENT AGREEMENT
MEDISORB TECHNOLOGIES INTERNATIONAL L.P. ("Medisorb"), a Delaware limited partnership, doing business at 6954 Cornell Road, Cincinnati, Ohio 45242, and JANSSEN PHARMACEUTICA INTERNATIONAL, a division of Cilag International AG, ("Janssen"), a Swiss business corporation, doing business at Kollerstrasse 38, CH-6300 Zug 6, Switzerland, agree this 23 rd day of December, 1993 to jointly
-- -------- develop the products described herein under the following terms and conditions:
1. Background
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Janssen desires to develop a depot formulation of [ ]. Medisorb possesses
technology and expertise relating to bioabsorbable polymer technologies and
drug delivery systems for biologically active compounds based on such
polymers. In light of these facts, Medisorb and Janssen's Affiliate entered
into a preliminary Development Agreement (dated 9 June 1992) in order to
collaborate in determining the feasibility of developing a depot
formulation of [ ]. Janssen has executed the option as specified in the
said preliminary Development Agreement and both parties agree to continue
the development of Product under the terms and conditions specified
hereinafter.
2. Definitions
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A) Affiliate: shall mean any company controlling, controlled by, or under
common control with a party by ownership, directly or
indirectly, of fifty percent (50%) or more of the total
ownership or by the power to control the policies and
actions of such company.
B) Field: shall mean human [ ] products comprising
polymers of lactic and glycolic acids. In this regard [
.]
C) International Registration Dossier ("IRF"):
shall mean the Product registration file compiled by Janssen
Pharmaceutica N.V., Beerse, Belgium on behalf of Janssen, the
contents and format being such that it can be submitted as such
to national health authorities or be used as a basis for a
national application for marketing authorization for the Products
in the specific format required by such national health
authorities.
D) Patents: shall mean (i) any and all existing issued patents and patent applications or parts thereof which describe and claim a depot formulation of [ ], or any chemical analogues of [ ] with similar physiological activity, based on polymers of lactic and glycolic acids and the production and use thereof; (ii) any other patents and patent applications filed by or on behalf of Medisorb, or under which Medisorb has the rights to grant licenses, which are needed to practice the inventions; and (iii) any reissues, extensions, substitutions, confirmations, registrations, revalidations, additions, continuations, continuations-in-part, or divisions of or to any of the foregoing which are granted hereafter or any additional protection certificate granted with respect thereto.
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
JANSSEN- MEDISORB PAGE 2 DEVELOPMENT AGREEMENT
E) Products: shall mean any and all depot formulations of [ ], or any chemical analogues of [ ] with similar physiological activity, based on polymers of lactic and glycolic acids which are designed to deliver [ ], or any of its chemical analogues, over an extended period.
3. Development Program
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A) "Development Program" shall mean the development activities conducted
by the parties as contemplated hereunder. The Development Program is
to be mutually agreed upon from time to time as the parties find
necessary. Medisorb shall (i) carry out its development activities in
the Development Program to the currently accepted standards of Good
Laboratory Practice, and (ii) manufacture human clinical supplies to
cGMP standards. The Development Program is attached hereto as Exhibit
A and incorporated herein.
B) Janssen will fund Medisorb's activities under the Development Program
at a cost not to exceed the following projected development costs
without prior written authorization from Janssen:
[ ]
[ ]
[ ]
Medisorb will invoice Janssen monthly according to Medisorb's standard
rates and practices for the actual costs of work performed during the
immediately preceding month. Payment will be due 30 days from the end
of the month in which the invoice is received; a late fee of 1.5% per
month will be added to any outstanding balance not paid when due.
C) Medisorb will provide Janssen monthly brief written descriptions of
the work performed during the preceding month. Upon Janssen's request
Medisorb will promptly provide Janssen with detailed reports of the
work already undertaken, in order for Janssen and its Affiliates to
prepare the health registration applications and the IRF. Medisorb
will provide to Janssen a final detailed written report on the work
performed under the Development Program within 30 days of completion
of the Development Program.
D) Janssen will disclose to Medisorb as soon as reasonably practicable
during the term of this Agreement the following test results from
experiments employing materials supplied to Janssen by Medisorb: (i)
bioavailability and bioactivity assays from in vivo tests and (ii) any
results which reasonably suggest potential adverse consequences in
humans associated with such materials.
4. Term and Termination
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A) The initial term of this Agreement shall commence upon the date first
above written and continue thereafter until the earlier of (i) the
completion of the Development Program at the moment of finalization of
the IRF, which is expected during the [ ], or (ii) [
], unless earlier terminated pursuant to the provisions of this
Section 4 or according to the terms of Section 16 below. However, in
the event that the IRF has not been completed by [
], if Janssen can show due diligence, this Agreement shall not
terminate and will be extended for such period as Janssen requires to
finalize the IRF, provided that during such extension Janssen
continues to show due diligence. Due diligence, amongst other factors,
shall mean the timely filing of required regulatory applications,
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS BRACKETED AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
JANSSEN-MEDISORB PAGE 3
including, without limitation, a CTX (clinical trial exemption
certificate) and/or IND, and continuing to fund the Development
Program in a commercially reasonable manner.
B) Janssen may terminate this Agreement upon 30 days written notice,
provided that Janssen must fulfill all obligations to Medisorb
actually incurred prior to the notice of termination.
C) Medisorb may only terminate this Agreement upon 30 days written notice
for cause, which shall include:
1. Any material breach of this Agreement by Janssen which has not