Exhibit 10.16(c)
Confidential
Amendment No. 2 to Toll Manufacturing and Packaging Agreement
THIS Amendment No. 2 to Toll Manufacturing and Packaging Agreement is
made as of this 9th day of October, 2001, by and between Cephalon, Inc.
("Cephalon") and Catalytica Pharmaceuticals, Inc. ("Catalytica").
WHEREAS, Cephalon and Catalytica have previously executed a Toll
Manufacturing and Packaging Agreement dated as of August 24, 1999, as amended by
Amendment No. 1 thereto dated July 3, 2001 (collectively, the "Agreement"); and
WHEREAS, the parties desire to establish special procedures to apply to
the formulation and packaging of [**] commercial lots of Product (the
"Launch Lots"), which provisions differ from provisions in the Agreement.
NOW THEREFORE, for and in consideration of the covenants exchanged
between the parties, including those provisions intended as inducements for
Catalytica to produce the Launch Lots, the parties hereto agree as follows:
1. The parties recognize that the Agreement contains the general
provisions for the supply of Product; however, the parties
hereto expressly recognize and agree that this Amendment No. 2
expressly supercedes any provisions of the Agreement which
directly or indirectly conflict with the provisions of this
Amendment No. 2, including by way of example and not
limitation Section 6.2, Section 8.1, Section 8.3, Section 9.1,
Section 9.3, Section 11.1, Section 11.2, Section 11.3, Section
14.3, and Section 20.1.
2. With regard to the production of the Launch Lots, the
following shall apply:
a. Cephalon shall provide free of charge and deliver to
Catalytica at Catalytica's Greenville facility and
shall retain title to the Active Drug Substance and
Compressil at all times before, during and after the
production of the Launch Lots.
b. Cephalon specifically recognizes and confirms that it
is seeking production the Launch Lots, and is
agreeing to pay for such Launch Lots, notwithstanding
any regulatory delay or non-approval (including by
way of example, actions or lack of action by the FDA)
associated with Product as or to be manufactured at
Catalytica's Greenville, North Carolina facility. No
Product shall be shipped from the facility until all
applicable regulatory approvals have been obtained.
3. On or before October 10, 2001 Cephalon agrees to pay a fifty
percent (50%) down payment of estimated costs [**] for the
Production of the Launch Lots (i.e. [**] batches at an
aggregate estimated down payment of [**]. The remainder of the
payment for the Launch Lots shall be due within thirty (30)
days of Catalytica's delivery of the applicable invoice and
the certificate of analysis with variances/incidents, if any,
for such Launch Lots.
4. Catalytica shall provide Cephalon with a certificate of
analysis with variances/ incidents, if any, as provided in
Section 9.1 of the Agreement, and Cephalon shall have the
right to inspect the Product (at Catalytica's facility and at
**Certain portions of this document have been omitted based upon a
request for confidential treatment that has been filed with the Commission.
The omitted portions have been filed separately with the Commission.
Confidential
Cephalon's cost and expense) as outlined in Section 9.2 of the
Agreement. If Cephalon properly rejects the Product within
thirty (30) days of Catalytica's delivery of certificate of
analysis with variances/incidents, if any, for the Launch
Lots, subject to agreement as to the rightfulness of such
rejection (or in the absence thereof the opinion of a mutually
acceptable, third party laboratory) Catalytica shall refund to
Cephalon all payments made hereunder as to such rejected
Product and shall reimburse Cephalon for the acquisition cost
of the applicable portion of the lost Active Ingredients.
5. The parties further recognize that Product may need to be
stored in a special area or in special containers following
production. The parties shall separately and in good faith
negotiate the charge or charges for such storage as well as
any time or space limitations that may apply thereto.
IN WITNESS WHEREOF, the undersigned parties have caused this Amendment
No. 2 to be executed as of the date first above written and further confirm by
their execution the power of the officials so shown to bind each such party.
Cephalon, Inc. Catalytica Pharmaceuticals, Inc.
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Senior Director, Technical Operations Vice President and
Business Manager, PPO
Date: October 9, 2001 Date: October 12, 2001