EXHIBIT 10.1
AMENDMENT TO FACILITIES CONTRIBUTION AGREEMENT
THIS AMENDMENT TO FACILITIES CONTRIBUTION AGREEMENT ("AMENDMENT") is entered
into and made effective as of August 18, 2004 ("AMENDMENT EFFECTIVE DATE") by
and between DPT Laboratories, Ltd.. ("DPT") and Connetics Corporation
("CONNETICS"). Unless otherwise indicated, a capitalized term within this
Amendment shall have the same meaning as the same capitalized term within the
Facilities Agreement (defined below).
BACKGROUND
A DPT and Connetics are parties to a Confidentiality and Material Transfer
Agreement, dated April 12, 2001; a Research & Development Services
Agreement dated July 20, 2001; a Quality and Technical Agreement, dated
March 7, 2002; an Amended and Restated Manufacturing and Supply Agreement
dated August 18, 2004; and a Facilities Contribution Agreement dated
November 1, 2001 (the "FACILITIES AGREEMENT").
B. The Facilities Agreement relates to Connetics' contribution of capital
used to construct an aerosol filling/packaging operation on DPT's leased
distribution facilities, and DPT's manufacture and filling of Connetics'
aerosol products.
C. Connetics desires to make improvements to the aerosol filling/packaging
operation as well as add new equipment at DPT's facility in connection
with the manufacture of a new drug product. Connetics will contribute
capital for the improvements and additions as further set forth in this
Amendment.
D. The Parties desire to amend the Facilities Agreement to encompass the
matters set forth in this Amendment.
NOW, THEREFORE, in consideration of the above premises and the mutual covenants
set forth below, DPT and Connetics agree as follows:
AGREEMENT
1. A new section is hereby added to the Facilities Agreement as SECTION 2.4
as follows.
2.4. CONNETICS' IMPROVEMENTS AND ADDITIONS CONTRIBUTIONS. Connetics
agrees to pay the costs associated with construction of certain
improvements to the aerosol filling/packaging operation and the purchase
of production scale equipment used in the operation ("2004 IMPROVEMENTS"),
currently estimated at [**], and to pay for the purchase of new production
and laboratory scale equipment for use in the production of a new drug
product ("ADDITIONS"), currently estimated at [**], subject to all of the
terms, covenants and conditions set forth in this Agreement, provided that
references to the Architect and General Contractor in the
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** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
Facilities Agreement shall not be applicable to the 2004
Improvements or the Additions. The construction of the 2004
Improvements and adding of the Additions are collectively referred
to as the "IMPROVEMENTS AND ADDITIONS PROJECT." Connetics' cash
contributions and contribution of new Equipment are collectively
referred to as "ADDITIONAL CONTRIBUTIONS." The Additional
Contributions shall be used to purchase, install, and qualify
equipment as specified in EXHIBIT D.
The remaining provisions of ARTICLE 2 (SECTIONS 2.1 - 2.3) shall remain the same
and continue in full force and effect.
2. The Designated Representatives in SECTION 3.7 are hereby updated as
follows:
3.7.(a) Connetics' Representative. [**].
3.7.(b) DPT's Representative. [**].
3. A new section is hereby added to the Facilities Agreement as SECTION 3.8
as follows.
3.8. TIMING OF IMPROVEMENTS AND ADDITIONS PROJECT. DPT shall use its
commercially reasonable efforts to complete the Improvements and Additions
Project promptly, diligently and within the applicable time periods set
forth in the Estimated Construction Schedule attached hereto as EXHIBIT
B-1 and incorporated by this reference, as such schedule may be modified
from time to time, subject to the effects of any delays beyond the
Parties' reasonable control.
The remaining provisions of ARTICLE 3 (SECTIONS 3.1 - 3.6, and 3.7 as modified
above) shall remain the same and continue in full force and effect.
4. SECTION 5.2 (b) of the Facilities Agreement is hereby deleted and replaced
with the following.
5.2.(b) DPT shall be entitled to use the Assets and Additions to
manufacture cosmetic, over-the-counter and non-dermatological prescription
drug products for its affiliates or third parties without obtaining
Connetics' prior written consent, provided that the use does not interfere
with Connetics' capacity requirements and DPT pays to Connetics [**]. If
DPT elects to pursue development work on a cosmetic, over-the-counter or
non-dermatological prescription drug product it shall so notify Connetics
as soon as is practical providing as much detail as is reasonably
possible, subject to any applicable obligation of confidentiality.
The remaining provisions of SECTION 5.2 shall remain the same and continue in
full force and effect.
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** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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5. All of the remaining provisions of the Facilities Agreement shall continue
in full force and effect as though fully set forth in this Amendment.
IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment
Effective Date.
CONNETICS CORPORATION DPT LABORATORIES, LTD.
"CONNETICS" "DPT"
By: DFB PHARMACEUTICALS, INC.,
Its sole General Partner
Signature: /s/ THOMAS WIGGANS Signature: /s/ PAUL JOHNSON
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Name: Thomas Wiggans Name: Paul Johnson
Title: President and CEO Title: President
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EXHIBIT B-1
[**]
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** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
EXHIBIT D
[**]
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** Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.