EXHIBIT 10.7
AMENDMENT #5
This Amendment #5 dated August 28th, 2002 is to further amend the Development
and License Agreement between CIMA LABS INC. ("CIMA") and Aventis
Pharmaceuticals Inc. ("Aventis") dated August 1, 2001 (the "Development and
License Agreement"), as amended. The terms used in this Amendment, which are
defined in the Development and License Agreement, shall have the same meanings
as set forth therein.
CIMA and Aventis hereby agree to make the following amendments to the
Development and License Agreement:
1. Exhibit 1 attached hereto shall be added to Schedule A and
shall govern the anticipated product attributes for
fexofenadine hydrochloride [***CONFIDENTIAL TREATMENT
REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION***] and the development
plan;
2. "Development Activities, Costs and Timing" shall be deleted in
its entirety from Schedule A and Exhibit II shall be inserted
in its place;
In all other respects, the terms and conditions of the Development and License
Agreement remain in full force and effect.
IN WITNESS WHEREOF, the parties have caused this Amendment #5 to be executed by
their duly authorized representatives, effective as of the day and year first
written above.
CIMA LABS INC. AVENTIS PHARMACEUTICALS INC.
By: /s/ Xxxx X. Xxxxxxx By:_________________________________________
-----------------------------------------
28 Aug 02
Name: Xxxx X. Xxxxxxx Name:_______________________________________
Title: President & CEO Title:______________________________________
EXHIBIT I
FEXOFENADINE HYDROCHLORIDE [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] ORASOLV(R)
PROTOTYPE DEVELOPMENT FOR AVENTIS PHARMA
SCALE UP, REGULATORY SUBMISSION AND PROCESS VALIDATION
PRODUCT ATTRIBUTES:
- Active ingredient and potency
Fexofenadine Hydrochloride [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
DEVELOPMENT PLAN
----------------------------------------------------------------------------------------------------------------------
Activities Timing Cost
----------------------------------------------------------------------------------------------------------------------
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
EXHIBIT II
FEXOFENADINE HYDROCHLORIDE [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] ORASOLV(R)
PROTOTYPE DEVELOPMENT FOR AVENTIS PHARMA
DEVELOPMENT, SCALE UP, REGULATORY SUBMISSION AND PROCESS VALIDATION
PRODUCT ATTRIBUTES:
- Active ingredient and potency
Fexofenadine Hydrochloride [***CONFIDENTIAL TREATMENT REQUESTED,
PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.***]
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
EXHIBIT III
DEVELOPMENT ACTIVITIES, COSTS AND TIMING
----------------------------------------------------------------------------------------------------------------------
Phase Activity Timing Costs ($)
----------------------------------------------------------------------------------------------------------------------
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
[***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.***]
