the Manufacturing Services
provided by MOVA Pharmaceutical Corporation on terms to be negotiated between
MOVA Pharmaceutical Corporation and Sepracor, which agreement shall be in the
form substantially similar to the Quality Agreement found at Schedule G with
necessary modifications to reflect the part of the Manufacturing Serviices to be
provided by MOVA Pharmaceutical Corporation (iv) if Patheon subcontracts any
part of the services hereunder to any other Affiliate of Patheon pursuant to
Section 12.6(a), the agreement to be entered into between such Affiliate and
Sepracor setting out the quality assurance standards to be applicable to the
Manufacturing Services provided by such Affiliate on terms to be negotiated
between such Affiliate and Sepracor, which agreement shall be in the form
substantially similar to that found at Schedule G with necessary modifications
to reflect the part of the Manufacturing Services to be provided by such
Affiliate;"
5.
SECTION 3.2 OF THE AGREEMENT IS DELETED
IN ITS ENTIRETY AND REPLACED WITH THE FOLLOWING:
"3.2
API.
(A)
SEPRACOR SHALL, AT ITS SOLE COST AND
EXPENSE, DELIVER THE API TO PATHEON IN SUFFICIENT QUANTITIES AND AT SUCH TIMES
TO FACILITATE THE PROVISION OF THE MANUFACTURING SERVICES BY PATHEON, WHICH API
SHALL BE HELD BY PATHEON ON BEHALF OF SEPRACOR ON THE TERMS AND SUBJECT TO THE
CONDITIONS HEREIN CONTAINED.
THE PARTIES ACKNOWLEDGE AND AGREE THAT TITLE TO
THE API SHALL AT ALL TIMES BELONG TO AND REMAIN THE PROPERTY OF SEPRACOR.
PATHEON AGREES THAT ANY API RECEIVED BY IT SHALL ONLY BE USED BY IT TO PROVIDE
THE MANUFACTURING SERVICES.
THE AGGREGATE LIABILITY OF PATHEON WITH RESPECT TO
ANY LOST OR DAMAGED API SHALL BE AS SET FORTH IN SECTION 9.2.
(B)
IF PATHEON SUBCONTRACTS ANY PART OF THE
SERVICES HEREUNDER TO ANY OTHER AFFILIATE OF PATHEON PURSUANT TO SECTION
12.6(A), PATHEON MAY DIRECT
2
SEPRACOR TO DELIVER THE API TO THE MANUFACTURING SITE OF SUCH AFFILIATE ON THE
SAME TERMS AS SET OUT IN SECTION 3.2(A)."
6.
SECTION 12.6(A) OF THE AGREEMENT IS
DELETED IN ITS ENTIRETY AND REPLACED WITH THE FOLLOWING:
"12.6
Assignment.
(A)
PATHEON MAY NOT ASSIGN THIS AGREEMENT OR
ANY OF ITS RIGHTS OR OBLIGATIONS HEREUNDER EXCEPT WITH THE WRITTEN CONSENT OF
SEPRACOR, SUCH CONSENT NOT TO BE UNREASONABLY WITHHELD.
FOR GREATER CERTAINTY,
PATHEON MAY ARRANGE FOR SUBCONTRACTORS TO PERFORM SPECIFIC SERVICES ARISING
UNDER THIS AGREEMENT PROVIDED THAT PATHEON REMAINS RESPONSIBLE TO SEPRACOR UNDER
THIS AGREEMENT.
SEPRACOR HEREBY ACKNOWLEDGES THAT PATHEON PHARMACEUTICALS INC.
AND MOVA PHARMACEUTICAL CORPORATION, AFFILIATES OF PATHEON, WILL BE APPOINTED BY
PATHEON AS SUBCONTRACTORS HEREUNDER AND PATHEON SHALL, ALLOCATE THE
MANUFACTURING SERVICES TO BE PERFORMED THEREAT; PROVIDED THAT PATHEON COVENANTS
THAT PRIOR TO SUBCONTRACTING ANY PART OF THE MANUFACTURING SERVICES TO MOVA
PHARMACEUTICAL CORPORATION, IT SHALL ENSURE THAT MOVA PHARMACEUTICAL CORPORATION
MAINTAINS THE REQUIRED LICENSES AND/OR CERTIFICATIONS, AS APPLICABLE, AND IS
AUTHORIZED TO PROVIDE THE ASSIGNED MANUFACTURING SERVICES IN THE COMMONWEALTH OF
PUERTO RICO;"
7.
THE FOLLOWING NEW SECTION 12.15 IS
ADDED IMMEDIATELY AFTER SECTION 12.14 OF THE AGREEMENT:
"12.15
Capital Requirements.
Certain capital requirements and the