Attached files
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| EX-10.1 - MANUFACTURING AND SUPPLY AGREEMENT BETWEEN FLEET LABORATORIES AND COLUMBIA LABORATORIES (BERMUDA), LTD., DATED DECEMBER 8, 2009. - JUNIPER PHARMACEUTICALS INC | exhibit101.htm |
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 OR 15(d) of the Securities Exchange Act of 1934
DATE OF
REPORT – December 8, 2009
(Date of
Earliest Event Reported)
COLUMBIA
LABORATORIES, INC.
(Exact
name of registrant as specified in its charter)
Commission
File No. 1-10352
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Delaware
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59-2758596
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|
|
(State
of Incorporation)
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(I.R.S.
Employer
Identification
No.)
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354
Eisenhower Parkway
Livingston,
New Jersey
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07039
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(Address
of principal
executive
offices)
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Zip
Code
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Registrant’s
telephone number, including area code: (973) 994-3999
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General Instruction A.2. below):
[ ]
Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[ ]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[ ]
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b))
[ ]
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c))
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Item
1.01 Entry into a Material Definitive Agreement.
On
December 8, 2009, Columbia Laboratories (Bermuda) Ltd., a wholly owned
subsidiary of Columbia Laboratories, Inc. (together “Columbia”), entered into a
manufacturing and supply agreement (the “Agreement”) with Fleet Laboratories
(“Fleet”), Watford Herts, United Kingdom for the manufacture of bulk
progesterone vaginal gel (“Gel”) for Columbia’s CRINONE® and PROCHIEVE®
products. The Agreement supersedes the supply agreement between Columbia and
Fleet dated July 12, 1996, that was filed as an exhibit to the Registrant’s
Annual Report on Form 10-K for the year ended December 31, 2007.
Under the
Agreement, Fleet will exclusively manufacture and supply, and Columbia will
exclusively purchase its requirements of Gel from Fleet. Columbia also granted
Fleet a non-exclusive, royalty-free license to use and practice Columbia’s
intellectual property solely and exclusively in connection with the manufacture
and supply of Gel to Columbia.
Under the
Agreement, Fleet agrees to manufacture and supply Columbia with Gel at a set
price per batch in pounds sterling pursuant to rolling monthly forecasts and
quarterly firm forecasts. The price may be adjusted annually on the anniversary
date of the Agreement to take into account any documented decrease or increase
in the cost of raw materials or any other decrease or increase in the cost of
manufacturing Gel.
The
initial term of the Agreement is five years and the Agreement automatically
renews for additional periods of two years unless either party gives to the
other party, not less than six months prior to expiration of the
Agreement, written notice of its intention not to extend the Agreement;
provided, however, that upon termination of the Agreement Fleet agrees to
perform its obligations under the Agreement for the earlier of one year or
Columbia’s engagement and qualification of an alternative manufacturer of
Gel.
Either
party may terminate the Agreement immediately for (i) breach of any material
provision that is not cured within sixty days after receipt of written notice,
or (ii) in the event that the other party is or becomes insolvent. Columbia may
terminate the Agreement upon thirty days notice to Fleet in the event: (i) Fleet
fails to maintain its regulatory authorizations to manufacture the Product,
including without limitation those from the US Food and Drug Administration and
the UK Medicines and Healthcare Products Regulatory Agency; (ii) a Change of
Control Event, as defined in the Agreement, occurs with respect to Fleet, or
(iii) Fleet cannot supply product at a competitive price, which is a price for
Gel that is no more than ten percent greater than the price of Gel available
from a comparable alternate independent third party located in North America or
Europe. Fleet may terminate the Agreement upon six months notice to Columbia in
the event that Columbia does not meet its minimum purchase obligation for Gel
over the immediately preceding 12 calendar months.
The
foregoing description of the Agreement contained in this Item 1.01 does not
purport to be complete and is qualified in its entirety by reference to the
complete text of the Agreement, which is attached hereto as Exhibit
10.1.
Item
9.01 Financial
Statements and Exhibits.
(d) Exhibits.
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Exhibit
No.
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Description
|
|
10.1
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Manufacturing
and Supply Agreement between Fleet Laboratories and Columbia Laboratories
(Bermuda), Ltd., dated December 8,
2009.
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
Date: December
9, 2009
COLUMBIA
LABORATORIES, INC.
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By: /S/ Lawrence A.
Gyenes
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Lawrence
A. Gyenes
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Senior
Vice President,
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Chief
Financial Officer,
and
Treasurer
EXHIBIT
INDEX
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Exhibit
No.
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Description
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10.1
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Manufacturing
and Supply Agreement between Fleet Laboratories and Columbia Laboratories
(Bermuda), Ltd., dated December 8,
2009.
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