Note: Certain portions of this document have been marked "[C.I.]" to indicate
that confidential treatment has been requested for this confidential
information. The confidential portions have been omitted and filed separately
with the Securities and Exchange Commission.
AMENDMENT AND EXTENSION OF THE
SUPPLY AGREEMENT
This AMENDMENT AND EXTENSION OF THE SUPPLY AGREEMENT (the "Amendment"), is
made as of February 8, 2006 (the "Effective Date") by and between Sirius
Laboratories, Inc., an Illinois corporation headquartered at 000 Xxxxxxx Xxxxx,
Xxxxx 000, Xxxxxx Xxxxx, XX 00000 ("SIRIUS"), and Amide Pharmaceuticals, Inc., a
New Jersey corporation with its principal place of business at 000 Xxxx Xxxx
Xxxxxx, Xxxxxx Xxxxx, Xxx Xxxxxx 00000 ("AMIDE"). SIRIUS and AMIDE shall
hereinafter be collectively referred to as the "Parties" or individually as a
"Party" to this Amendment.
A. The Parties entered into that certain Supply Agreement dated as of May
18, 2001, as amended, (the "Original Agreement"), pursuant to which AMIDE has
been providing to SIRIUS certain manufacturing and supply services and
activities related to Nicomide; and
B. The Parties desire to amend the Original Agreement to adjust certain of
the terms and conditions of the Original Agreement, to clarify certain matters
relating to the Original Agreement and to extend the term of the Original
Agreement, as so amended, in each case pursuant to the terms and conditions set
forth in this Amendment.
NOW, THEREFORE, in consideration of the various promises and
undertakings set forth herein, the Parties agree as follows:
1. The phrase "SIRIUS shall not utilize such secondary manufacturing
facility unless and until" contained in Section 2.2(c) of the Original Agreement
shall be deleted and replaced with the phrase "without limiting any other right
or remedy available to SIRIUS at law or in equity, SIRIUS may order Product from
such secondary manufacturing facility in such quantities as necessary to
maintain such sources of supply for such period of time that Amide cannot
deliver Product, but not to exceed twelve (12) weeks beyond the time that Amide
has remedied the cause of the non-delivery (i.e., Amide can again meet Sirius'
demand or is willing to offer the Product at a Manufacturer's Fee equal to or
less than the qualified secondary manufacturing facility), in which case Sirius
shall continue to order Product from Amide as specified in Section 2.2 (d)(iii).
SIRIUS acknowledges that the manufacturing process and analytical methods
developed by Amide shall not be provided to any secondary manufacturer.
2. The phrase "[c.i.]" in the Section 2.2(e) of the Original Agreement
shall be replaced with the phrase "[c.i.]".
3. Schedule A attached hereto sets forth the Manufacturing Fees provided
for in Section 2.7(a) of the Original Agreement which have been renegotiated by
the parties and shall beginning with the Effective Date of this Amendment apply
pursuant to the terms of Section 2.7(a) of the Original Agreement.
4. Section 4.2(c) of the Original Agreement (termination if either Party
changes ownership) shall be deleted in its entirety and be of no further force
or effect.
5. Section 4.2 (d) of the Original Agreement ([c.i.]) shall be deleted in
its entirety and be of no further force or effect.
6. A new Section 10.3 shall be added to the Original Agreement which shall
read as follows:
"10.3 Ownership of Products. [C.I.] acknowledges and agrees that [C.I.]
shall own [c.i.], and any and all [c.i.]. [C.I.] acknowledges and agrees
that [c.i.] developed and owns [c.i.] hereunder and [c.i.]."
7. The following sentence shall be added to the end of Section 12.2 of the
Original Agreement which shall read as follows: "In the event of any
inconsistency between a term or a condition set forth on a Schedule to this
Agreement and a term or a condition set forth the Agreement itself, the term or
condition set forth on a Schedule to this Agreement shall govern."
8. Section 12.15 of the Original Agreement (Right to Purchase Product
Formulation) shall be deleted in its entirety and be of no further force or
effect.
9. The phrase "; provided however SIRIUS may, without the consent of AMIDE,
assign or otherwise transfer this Agreement and its rights and obligations
hereunder in whole or in part to an Affiliate or in connection with (1) a sale
of all or substantially all of SIRIUS's assets or business to which this
Agreement relates; (2) a merger, reorganization or consolidation involving
SIRIUS in which the stockholders of SIRIUS immediately prior to such transaction
cease to own collectively [c.i.] or more of the voting equity securities of a
successor entity; or (3) the acquisition of [c.i.] or more of the voting equity
securities of SIRIUS by a person or group of persons acting in concert; provided
that in each case notwithstanding the foregoing, AMIDE's consent shall be
required where assignment is to an entity which is a direct competitor of AMIDE
engaged in the manufacture of generic solid oral dose products" shall be added
and inserted into Section 12.4 of the Original Agreement (Assignment) following
the phrase "will not be unreasonably withheld".
10. Notwithstanding Section 4.1(a) of the Original Agreement, the Parties
agree that the term of the Original Agreement shall continue until three (3)
years following the Effective Date unless further extended by mutual agreement
or terminated earlier pursuant to the terms of the Original Agreement.
11. Each of the Parties represents and warrants to the other Party that the
Original Agreement is in full force and effect on the Effective Date and that,
as of the Effective Date, neither of the Parties is in default in the
performance of its obligations under the Original Agreement, nor are there any
circumstances that with the passage of time or the giving of notice, or both,
could constitute a default under the Original Agreement.
12. Except as expressly provided above, all terms and conditions of the
Original Agreement shall remain in full force and effect and shall apply to this
amendment and are incorporated herein by reference as though fully set forth.
-2-
IN WITNESS WHEREOF, the Parties have caused this agreement
to be executed by their respective duly authorized officers as of
the Effective Date, each copy of which shall for all purposes be
deemed to be an original.
Sirius Laboratories, Inc. Amide Pharmaceuticals, Inc.
By: /s/ Xxxxx X. Xxxxxxx By: /s/ Xxxxx X. Xxxxxxxx
---------------------- ----------------------
Name: Xxxxx X. Xxxxxxx Name: Xxxxx X. Xxxxxxxx
---------------------- ----------------------
Title: Vice Chairman Title: Director, Legal Affairs
---------------------- -----------------------
-3-
Schedule A
Nicomide Tablets Pricing Information
Product No.: 235 Product No.: 235
NDC: 00000-000-00 NDC: 00000-000-00
Batch Size: [c.i.] tablets Batch Size: [c.i.] tablets
Bottle Count: 5 Bottle Count: 60
Inner casepack: 6 bottles / sample carton Casepack: 12 bottles / casepack
Outer casepack: 36 cartons / casepack
Price / Bottle: [c.i.] Price / Bottle: [c.i.]
-4-
Schedule B
Formulation and Specifications
-5-
Amide Pharmaceutical, Inc.
MPR#: 27802 Rev #: 03 Effective Date: 12/01/03 Batch #:
Product Name: Nicomide with Zinc SR Tablets (278)
Batch Size: [c.i.] Tablets
MASTER FORMULA SHEE
--------------------
BATCH SIZE: [c.i.] EXP. DATE
THEO. TABLET WT.: [c.i.] AVG. WT. RANGE (10 TABS): [c.i.]
Item RAW MATERIAL NAME % EXCESS AMOUNT / QUANTITY
ID # UNIT (mg) REQUIRED (Kg)
Part - A
0102 [c.i.] [c.i.] [c.i.] [c.i.]
3089 [c.i.] [c.i.] [c.i.]
3032 [c.i.] [c.i.] [c.i.]
3153 [c.i.] [c.i.] [c.i.]
3046 [c.i.] [C.I.] [c.i.]
[c.i.]
TOTAL WEIGHT OF PART A [c.i.] [c.i.]
TOTAL NET WEIGHT OF PART A [c.i.] [c.i.]
PREPARED BY: /s/ H.B.S. DATE: APPROVED BY QA DIRECTOR: DATE:
11/25/03
/s/ K.W. 11/26/03
APPROVED BY MANUFACTURING DATE: APPROVED BY VP SCIENTIFIC DATE:
OPERATIONS DIRECTOR AFFAIRS:
/s/ M.P. 11/25/03 /s/ H.L. 11/26/03
APPROVED BY REGULATORY DATE: ISSUED TO PRODUCTION BY: DATE:
AFFAIRS DIRECTOR:
/s/ H.B.S. 11/25/03
-6-
Amide Pharmaceutical, Inc.
MPR#: 27802 Rev #: 03 Effective Date: 12/01/03 Batch #:
Product Name: Nicomide with Zinc SR Tablets (278)
Batch Size: [c.i.] Tablets
MASTER FORMULA SHEET
---------------------
BATCH SIZE: [c.i.] TABLETS EXP. DATE
THEO. TABLET WT.: [c.i.] AVG. WT. RANGE (10 TABS): [c.i.]
Item RAW MATERIAL NAME % EXCESS AMOUNT / QUANTITY
ID# UNIT (mg) REQUIRED (Kg)
Part - B
0062 [c.i.] [c.i.] [c.i.]
0043 [c.i.] [c.i.] [c.i.] [c.i.]
0029 [c.i.] [c.i.] [c.i.] [c.i.]
3059 [c.i.] [c.i.] [c.i.]
3059 [c.i.] [c.i.] [c.i.]
3053 [c.i.] [c.i.] [c.i.]
TOTAL WEIGHT OF PART B [c.i.] [c.i.]
TOTAL NET WEIGHT OF PART
A + B [c.i.] [c.i.]
PREPARED BY: /s/ H.B.S. DATE: APPROVED BY QA DIRECTOR: DATE:
11/25/03
/s/ K.W. 11/26/03
APPROVED BY MANUFACTURING DATE: APPROVED BY VP SCIENTIFIC DATE:
OPERATIONS DIRECTOR AFFAIRS:
/s/ M.P. 11/25/03 /s/ H.L. 11/26/03
APPROVED BY REGULATORY DATE: ISSUED TO PRODUCTION BY: DATE:
AFFAIRS DIRECTOR:
/s/ H.B.S. 11/25/03
-7-
Amide Pharmaceutical, Inc.
MPR#: 27802 Rev #: 03 Effective Date: 12/01/03 Batch #:
Product Name: Nicomide with Zinc SR Tablets (278)
Batch Size: [c.i.] Tablets
MASTER FORMULA SHEET
---------------------
[c.i.]
------
WEIGHT OF TABLETS/LOAD: 130.0+/-10 KG COATING SOLUTION/LOAD: [c.i.]
BATCH SIZE: [c.i.] TABLETS
Item RAW MATERIAL NAME AMOUNT / QUANTITY
ID # UNIT (mg) REQUIRED (Kg)
PART - C
3078 [c.i.] [c.i.] [c.i.]
3203 [c.i.] [c.i.] [c.i.]
3005 [c.i.] [c.i.] [c.i.]
[c.i.]
TOTAL WEIGHT OF PART C [c.i. [c.i.]
TOTAL NET WEIGHT OF
(PART A + B + C) [c.i.] [c.i.]
PREPARED BY: /s/ H.B.S. DATE: APPROVED BY QA DIRECTOR: DATE:
11/25/03
/s/ K.W. 11/26/03
APPROVED BY MANUFACTURING DATE: APPROVED BY VP SCIENTIFIC DATE:
OPERATIONS DIRECTOR AFFAIRS:
/s/ M.P. 11/25/03 /s/ H.L. 11/26/03
APPROVED BY REGULATORY DATE: ISSUED TO PRODUCTION BY: DATE:
AFFAIRS DIRECTOR:
/s/ H.B.S. 11/25/03
-8-
Amid Pharmaceutical, Inc.
Stability Specification
Product Name: Nicomide with Zinc SR Tablets
MOI: [c.i.] Revision#: 01
Description: Peach colored oval shaped [c.i.] tablet imprinted
"Sirius" on one side of the tablet in blue ink. "792"
Assay: (MOI # 278, REV #01)
[c.i.] [c.i.]
[c.i.] [c.i.]
[c.i.] [c.i.]
Dissolution: (MOI #278, REV #01)
[c.i.]
[c.i.] [c.i.]
[c.i.] [c.i.]
[C.I.] [c.i.]
[c.i.] [c.i.]
[c.i.] [c.i.]
[c.i.] [c.i.]
[c.i.]
[c.i.] [c.i.]
[c.i.] [c.i.]
[C.I.] [c.i.]
[c.i.] [c.i.]
[c.i.] [c.i.]
[c.i.] [c.i.]
[c.i.]
[c.i.] [c.i.]
[c.i.] [c.i.]
[C.I.] [c.i.]
[c.i.] [c.i.]
[c.i.] [c.i.]
[c.i.] [c.i.] [c.i.]
[c.i.] [c.i.]
[c.i.] [C.I.]
[c.i.] [C.I.]
Prepared By: Xxxxxx Xxxxx Effective Date: 6/3/03
Approved By: /s/ T.A.C. Effective Date: 6/3/03
-9-
