Document:

EX-10.68

 

CONFIDENTIAL
TREATMENT REQUESTED

CONFIDENTIAL
TREATMENT REQUESTED: INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED IS OMITTED AND NOTED WITH “***.” AN
UNREDACTED VERSION OF THIS DOCUMENT HAS BEEN SUBMITTED SEPARATELY TO
THE SECURITIES AND EXCHANGE COMMISSION.

Exhibit 10.68

AGREEMENT

          THIS AGREEMENT (this “Agreement”) is entered into as of December 21, 2006, by and among Ares
Trading S.A., a company constituted and existing under the laws of Switzerland (“Ares”), Serono,
Inc., a corporation organized and existing under the laws of the State of Delaware (“Serono”),
Columbia Laboratories, Inc., a corporation organized and existing under the laws of the State of
Delaware (“Columbia”), and Columbia Laboratories (Bermuda), Ltd., a corporation organized and
existing under the laws of Bermuda (“Columbia Bermuda”). Each of Ares, Serono, Columbia and
Columbia Bermuda shall be a “Party” and are collectively referred to herein as the “Parties.”

RECITALS

WHEREAS, Ares and Columbia Bermuda are parties to that certain Amended and Restated License and
Supply Agreement (as defined herein);

WHEREAS, Ares, Serono, Columbia and Columbia Bermuda are parties to that certain Marketing License
Agreement (as defined herein);

WHEREAS, pursuant to the Amended and Restated License and Supply Agreement, Columbia Bermuda has
granted to Ares an exclusive license to market, use and sell the Product (as defined herein) in the
Territory, and has agreed to supply the Product to Ares in the Territory;

WHEREAS, pursuant to the Marketing License Agreement, Serono has granted to Columbia an exclusive
license to promote the Product in the United States to the Non-Fertility Specialist Market (as
defined in the Marketing License Agreement) and sell the Product in the United States; and

WHEREAS, the Parties wish to (1) amend the Amended and Restated License and Supply Agreement to
terminate Ares’s U.S. rights under the Amended and Restated License and Supply Agreement and (2)
terminate the Marketing License Agreement, on the terms and subject to the conditions set forth
herein.

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth in this
Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties hereto hereby agree as follows:

DEFINITIONS

	(a)	 	In addition to the terms defined above and elsewhere in this Agreement, when used in this
Agreement, the following capitalized terms have the meanings set forth in this Article 1.
	 
	1.1	 	“Adverse Event” means any serious untoward medical occurrence in a patient or subject who is
administered the Product, but only if and to the extent that such

 

 

	 	 	serious untoward medical occurrence is required under applicable laws, rules and
regulations to be reported to any Governmental Authority.
	 
	1.2	 	“Affiliate” means, with respect to a Person, any other Person that, directly or indirectly,
through one or more intermediaries, controls, is controlled by, or is under common control
with, the Person specified. For the purposes of this definition, control shall mean the
direct or indirect ownership of (a) in the case of corporate entities, securities authorized
to cast more than fifty percent (50%) of the votes in any election for directors, or (b) in
the case of non-corporate entities, more than fifty percent (50%) ownership interest with the
power to direct the management and policies of such non-corporate entity.
	 
	1.3	 	“Agreement” means this Agreement and all exhibits and schedules attached hereto.
	 
	1.4	 	“Amended and Restated License and Supply Agreement” means the Amended and Restated License
and Supply Agreement dated as of June 4, 2002 by and between Columbia Bermuda and Ares,
amending and restating that License and Supply Agreement dated as of May 20, 1999.
	 
	1.5	 	“Assigned Assets” shall mean all Inventory.
	 
	1.6	 	“Assignment and Royalty Agreement” means Section 4.2 of that Assignment and Royalty Agreement
dated as of May 27, 1999 by and between American Home Products Corporation, represented by its
Wyeth-Ayerst Laboratories Division (“AHPC”) and Ares.
	 
	1.7	 	“Business Day” means any day except a Saturday, Sunday or a day on which a commercial bank in
Geneva, Switzerland or New York City is authorized to close.
	 
	1.8	 	“BWH” means Brigham and Women’s Hospital.
	 
	1.9	 	“BWH Study” means the infertility study sponsored by Serono at the BWH.
	 
	1.10	 	“BWH Study Data” means all technical, scientific, biological, pharmacological and
toxicological data related to the Product that was or is generated by or derived from the BWH
Study, which is owned by Serono or its Affiliates.
	 
	1.11	 	“BWH Study Protocol” means the scientific protocol for the BWH Study approved by Serono or
its Affiliates.
	 
	1.12	 	“Chargebacks” shall mean credits, chargebacks, reimbursements, administrative fees and other
payments to wholesalers and other distributors, group purchasing organizations, insurers and
other institutions.
	 
	1.13	 	“Control” or “Controlled” means, with respect to any Intellectual Property or other
intangible property, the possession (whether by license or ownership, or by control over an
Affiliate having possession by license or ownership) by a Party of

 

 

	 	 	the ability to grant to the other Party access and/or a license or sublicense as provided herein.
	 
	1.14 	 	“Crinone” means the Product sold under the brand name Crinone®.
	 
	1.15	 	“Crinone NDA” means new drug application #20-701 for Crinone/Prochieve owned by Columbia and
approved by the FDA, and all amendments and supplements thereto.
	 
	1.16	 	“FDA” means the U.S. Food and Drug Administration, and any successor agency thereto.
	 
	1.17	 	“Finished Goods” means Product purchased by Ares under the License and Supply Agreement.
	 
	1.18	 	“Governmental Authority” means any federal, regional, state, provincial, local or other
government, any national, regional, state, provincial, local or other court of competent
jurisdiction, legislature, governmental, administrative or regulatory agency, department,
body, bureau, council or commission or any other national, regional, state, provincial, local
or other governmental authority or instrumentality, including the FDA Division of Drug
Marketing, Advertising and Communications (DDMAC), other FDA offices, or their foreign
equivalents.
	 
	1.19	 	“Intellectual Property” means all (a) Patents; (b) copyrights in works of authorship of any
type, including computer software and industrial designs, registrations and applications for
registration thereof; (c) trademarks (both registered and common law) and trademark
registrations, applications and renewals and domain names and all goodwill associated
therewith; and (d) trade secrets, know-how, ideas, concepts, formulas, methods, procedures,
designs, compositions, plans, documents, data, inventions, discoveries, works of authorship,
compounds and biological materials and other confidential or proprietary technical, business
and other information, and all rights in any jurisdiction to limit the use or disclosure
thereof.
	 
	1.20	 	“Inventory” or “Inventories” mean all inventories of Finished Goods held by Ares or its
Affiliates bearing lot number C06107 as of the Closing Date for sale in the U.S., whether
then in the possession of Ares or an Affiliate thereof or in the possession of, or in transit
to, any distribution center of Ares or an Affiliate thereof as of such date.
	 
	1.21	 	“Inventory Unit” shall mean a set of eighteen (18) applicators of the Product in Inventory.
	 
	1.22	 	“Law” means any applicable declaration, decree, directive, legislative enactment, order,
ordinance, law, regulation, rule, guidance or other binding restriction of or by any
Governmental Authority, as amended from time to time.

 

 

	1.23	 	“Liabilities” means any and all debts, liabilities and obligations, whether accrued or fixed,
absolute or contingent, matured or unmatured, or determined or determinable, including those
arising under any Laws, action or governmental order and those arising under any contract,
agreement, arrangement, commitment or undertaking, or otherwise.
	 
	1.24	 	“Liens” means any liens, hypothecations, mortgages, charges, security interests, pledges,
defects of title and other similar encumbrances, in each case whether absolute, contingent,
accrued or otherwise.
	 
	1.25	 	“Losses” means any and all Liabilities, damages, fines, penalties, deficiencies, losses and
expenses (including interest, court costs, amounts paid in settlement, reasonable fees of
attorneys, accountants and other experts or other reasonable expenses of litigation or other
proceedings or of any claim, default or assessment); provided, however, that the term “Losses”
shall not include any special, consequential, indirect, punitive, provisional or similar
damages, except to the extent actually paid by a Party pursuant to any Third Party Claim.
	 
	1.26	 	“Marketing License Agreement” means the Marketing License Agreement dated as of June 4, 2002
by and among Columbia Bermuda, Columbia, Ares and Serono.
	 
	1.27	 	“Patents” means all patents, patent applications, additions, reissues, renewals,
registrations, divisions, continuations, continuations-in-part, continued prosecution
applications, substitutions, extensions and reexaminations thereof.
	 
	1.28	 	“Person” means any individual, firm, corporation, partnership, limited liability company,
trust, unincorporated organization or other entity or a government agency or political
subdivision thereto, and shall include any successor (by merger or otherwise) of such Person.
	 
	1.29	 	“Product” means and collectively refers to progesterone/COL-1620 vaginal gel containing
progesterone in a concentration of four percent (4%) or eight percent (8%).
	 
	1.30	 	“Product B” shall have the meaning attributed to it in the Amended and Restated License and
Supply Agreement.
	 
	1.31	 	“Product Marketing Materials” means all marketing, advertising and promotional materials of
Ares, Serono or their respective Affiliates that are used, or held for use, solely in
connection with the Product in the U.S. and that are in existence as of the Closing Date.
	 
	1.32	 	“Regulatory Approval” means the technical, medical, scientific and other applicable licenses,
registrations, authorizations, approvals and other requirements of any Governmental Authority
necessary for the development, manufacture, distribution, marketing, promotion, offer for
sale, use, import, export or sale of the Product solely and exclusively for the U.S.

 

 

	1.33	 	“Serono Intellectual Property” means any Intellectual Property Controlled by Ares, Serono
and/or their respective Affiliates, in each case related to the Product.
	 
	1.34	 	“Serono Product Tradedress” means the current trade dress of Crinone® in the U.S., to the
extent owned, controlled or licensed by Ares and/or Serono, including, but not limited to,
product packaging associated with the sale of Crinone® in the U.S. and the lettering of
Crinone®’s trade name or brand name in the U.S.
	 
	1.35	 	“Serono Product Trademarks” means, to the extent owned, controlled or licensed by Ares and/or
Serono, the trademarks, proprietary names or designations currently used by Serono in the U.S.
for Crinone®, including registrations and applications for registration therefor (and all
renewals, modifications, and extensions thereof).
	 
	1.36	 	“Taxes” (and with correlative meaning, “Tax,” “Taxes,” and “Taxable”) shall mean all taxes of
any kind imposed by a federal, state, provincial, local or foreign Governmental Authority,
including those on, or measured by or referred to as, income, gross receipts, financial
operation, sales, use, ad valorem, value added, franchise, profits, license, excise, stamp,
premium, property, transfer (including transfer of goodwill) or windfall profits taxes,
customs, duties or similar fees, assessments or charges of any kind whatsoever, together with
any interest and any penalties, additions to tax or additional amounts imposed by such
Governmental Authority with respect to such amounts.
	 
	1.37	 	“Technology” shall have the meaning attributed to it in the Amended and Restated License and
Supply Agreement.
	 
	1.38	 	“Territory” shall have the meaning attributed to it in the Amended and Restated License and
Supply Agreement.
	 
	1.39	 	“Third Party” means any Person who is not a Party to this Agreement (or an Affiliate
thereof).
	 
	1.40	 	“Transaction Documents” means this Agreement, Amendment No. 1, and all other instruments,
agreements, certificates or other documents executed or delivered in connection with the
consummation of the transactions contemplated by this Agreement.
	 
	1.41	 	“United States” or “U.S.” means the several United States, the District of Columbia and
Puerto Rico.
	 
	1.42	 	“U.S. Patent” means United States patent 5,543,150, assigned to Columbia.
	 
	1.43	 	“U.S. Trademark” means United States trademark 2,086,161, for Crinone and owned by Columbia.

 

 

	(b)	 	Additional Definitions. Each of the following definitions is set forth in the Section of
this Agreement indicated below:

	 	 	 
	Definition

	 	Section

	Agreement

	 	Preamble
	AHPC Assumed Liabilities

	 	2.3(b)
	Amendment No. 1

	 	2.1
	Ares

	 	Preamble
	Assignment and Assumption

	 	2.6(c)
	Assumed Liabilities

	 	2.3(a)
	Closing

	 	2.7(a)
	Closing Date

	 	2.7(a)
	Columbia

	 	Preamble
	Columbia Bermuda

	 	Preamble
	Confidential Information

	 	10.4(a)
	Indemnitee

	 	6.3(a)
	Indemnitor

	 	6.3(a)
	Inventory Distribution Period

	 	3.4(a)
	Inventory Purchase Amount

	 	2.5
	Licenses

	 	2.2
	Proceeding

	 	4.1(f)
	Product Acquisition Transactions

	 	2.1
	Product Registration Transfer Date

	 	3.1
	Proposed Transaction

	 	5.7
	Proceeding

	 	4.1(e) and 4.2(e)
	Retained Liabilities

	 	2.3(c)
	Returns

	 	5.4
	Serono

	 	Preamble
	Termination Payment

	 	2.4
	Third Party Claim

	 	6.3(a)

	(c)	 	Interpretive Provisions.

          (i) The words “hereof”, “herein”, and “hereunder” and words of similar import, when used in
this Agreement, shall refer to this Agreement as a whole and not to any particular provision of
this Agreement. The word “including” means “including without limitation.”

          (ii) The terms “dollars” and “$” shall mean United States dollars.

 

 

ARTICLE 2

SALE OF ASSETS, LICENSES, CLOSING AND ASSIGNMENT AND ASSUMPTION

	2.1	 	Product Acquisition Transactions.

The Parties have agreed to terminate Ares’s right under the License and Supply Agreement to market,
use and sell the Product in the U.S., including the termination of Ares’s rights to Crinone NDA,
the Technology in the U.S., the U.S. Patent, and the U.S. Trademark, in exchange for the payment to
Ares of the Termination Payment in accordance with the terms and conditions herein. In connection
with the foregoing, the Parties have agreed to certain actions, including but not limited to the
following actions (the “Product Acquisition Transactions”), in accordance with the terms and
conditions contained herein:

	(a)	 	On the Closing Date, Ares and Columbia Bermuda shall execute Amendment No. 1 to the Amended
and Restated License and Supply Agreement in the form attached hereto as Exhibit A (“Amendment
No. 1”).
	 
	(b)	 	Effective as of the Closing Date, the Marketing License Agreement shall be terminated.
	 
	(c)	 	On the Closing Date, Columbia shall purchase from Ares and Ares shall sell to Columbia the
entire Inventory for consideration consisting of the Inventory Purchase Amount, and promptly
following the Closing, Ares shall transfer, or cause to be transferred, to Columbia, the
Inventory.
	 
	(d)	 	On the Closing Date, Columbia shall pay to Ares the Termination Payment.
	 
	2.2	 	Licenses.

Effective as of the Closing Date, subject to the terms and conditions of this Agreement, Ares
hereby grants, and agrees to cause its Affiliates to grant to Columbia the following licenses (the
“Licenses”):

	(a)	 	An irrevocable, non-exclusive, royalty-free right and license to use the Serono Product
Trademarks and Serono Product Tradedress in the U.S. during the Inventory Distribution Period,
and an irrevocable non-exclusive, royalty-free license to use the Serono Product Tradedress in
the U.S. during the period subsequent to the Inventory Distribution Period, for so long as
Columbia is selling the Product in the U.S.
	 
	(b)	 	A non-exclusive, royalty-free right and license to reference, file with the FDA and otherwise
use the Serono Intellectual Property, if any, solely for the purposes of (1) maintaining
Regulatory Approvals for the Products for sale in the U.S. and (2) subject to this Section
2.2, making product labeling changes for Products for sale in the U.S.
	 
	(c)	 	So long as the Amended and Restated License and Supply Agreement is in effect, Columbia shall
obtain the prior written approval of Ares prior to implementing any change affecting the
infertility branding, infertility product labeling and infertility product positioning of the
Crinone brand, such consent not to be unreasonably withheld or delayed.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	2.3	 	Assumed Liabilities.
	 
	(a)	 	As of the Closing Date, Columbia shall assume, be responsible for and pay, perform and
discharge when due the following (collectively, the “Assumed Liabilities”): any Liabilities
arising from (i) the use, manufacture, supply, packaging, labeling, marketing or sale of the
Product in the U.S. by or on behalf of Columbia arising out of acts, omissions or events first
occurring on or after the Closing Date, (ii) Returns, Chargebacks and Rebates and (iii) the
AHPC Assumed Liabilities. In addition, for the sake of clarity, the Parties agree that
notwithstanding anything to the contrary herein, the obligations of the Parties under the
Amended and Restated License and Supply Agreement, as amended by Amendment No.1 (including but
not limited to the respective indemnification obligations of the Parties thereunder) shall
remain in effect, other than the obligation of Columbia to supply Serono with Product for sale
in U.S. after the Closing Date. Furthermore, for the sake of clarity, the Parties agree that
notwithstanding anything to the contrary herein, the provisions of the Marketing License
Agreement that under the terms of the Marketing License Agreement continue after termination
of the Marketing License Agreement shall remain in effect as provided in the Marketing License
Agreement.
	 
	(b)	 	From the Closing Date through December 31, 2009, Columbia shall report to Ares within thirty
(30) days of the end of each calendar quarter on the number of units of Product B sold by
Columbia and its Affiliates and its sublicensees during such period. In the event that, for
any calendar year or other period, Ares is required to pay to AHPC royalties under the
Assignment and Royalty Agreement on sales of Product B in excess of $*** then
(i) Ares shall provide to Columbia a copy of the written report with regard to such calendar
year or other period furnished by Ares to AHPC under the Assignment and Royalty Agreement,
which report shall include the description and number of all units of Product B sold by Ares
and its Affiliates (including Serono) and its sublicensees and the number of all units of
Product B sold by Columbia and its Affiliates and its sublicensees during such calendar year
or other period and the royalties payable thereon by Ares to AHPC; and (ii) Columbia shall,
within thirty (30) days following receipt of such report, pay to Ares an amount calculated by
multiplying the royalties payable by Ares to AHPC for such calendar year or other period by
the fraction X/Y where X is Columbia’s Net Sales (as defined in the Amended and Restated
License and Supply Agreement) of Product B in the United States during such calendar year or
other period and Y is Columbia’s Net Sales of Product B in the United States plus Ares’s Net
Sales of Product B throughout the world during such calendar year or other period. Such
payment shall be made in immediately available funds by wire transfer to an account designated
by Ares. Columbia’s obligation to make the

 

			
	*	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment filed separately with the
Commission.

 

 

CONFIDENTIAL
TREATMENT REQUESTED

	 	 	
	 	 	payments described in this Section 2.3(b) are referred to herein as the “AHPC Assumed
Liabilities”.
	 
	(c)	 	Except (i) for the Assumed Liabilities and (ii) as otherwise provided in Section 2.3(a),
Columbia will not assume, nor will it become responsible for, nor will it be deemed to have
assumed or become responsible for, any Liability or obligation of Ares, Serono or their
respective Affiliates relating to the marketing, use or sale of Crinone prior to the Closing
Date (each, a “Retained Liability” and collectively, the “Retained Liabilities”).
	 
	2.4	 	Termination Payment. Subject to the terms and conditions set forth herein, in consideration
for (a) the amendment of the Amended and Restated License and Supply Agreement, as provided in
Amendment No. 1 and (b) the sale, transfer, assignment, conveyance, license and delivery of
the Assigned Assets (other than the Inventory) and the Licenses, at the Closing, Columbia will
pay to Ares, a non-refundable cash payment of Thirty-Three Million Dollars ($33,000,000) (the
“Termination Payment”).
	 
	2.5	 	Inventory Purchase and Transfer.
	 
	(a)	 	In addition to the Termination Payment under Section 2.4 above, at the Closing, Columbia
shall pay to Ares the non-refundable amount equal to (a) the product of (x)
$*** and (y) the number of Inventory Units as of the Closing Date less (b)
$*** (such amount, the “Inventory Purchase Amount”). The Parties agree that
the Inventory Purchase Amount includes payment to account, in full, for any and all Returns,
Chargebacks and Rebates, whether attributable to sale of Product prior or subsequent to the
Closing Date.
	 
	(b)	 	The Inventory will be transferred to Columbia or its designees in accordance with the terms
of this Section 2.5(b). Promptly following the Closing Date, Ares shall ship the Inventory to
Columbia. Upon the transfer of the Inventory to Columbia, the number of Inventory Units
shipped to Columbia will be counted and noted by Ares, and the amount received by Columbia
will be counted by Columbia. Within thirty (30) days of the Closing, the Parties will jointly
prepare a reconciliation report, accompanied by reasonable supporting documents and
calculations, which reconciles among other things: (i) the number of Inventory Units specified
in Section 2.5(a) for which payment was made at the Closing and (ii) the actual quantities
received by Columbia. Within ten (10) days after such reconciliation report is prepared and
exchanged by the Parties the net amount shown as being due either Columbia or Ares will be
paid by the Party owing such amount.

 

			
	*	 	Portions of this page have been omitted
pursuant to a request for Confidential Treatment filed separately with the
Commission.

 

 

	(c)	 	Title to the Inventory and risk of loss shall pass to Columbia on the Closing Date,
regardless of the date Columbia receives delivery of the Inventory.
	 
	(d)	 	All right, title and interest in and to accounts receivable of Serono on account of Products
existing as of the Closing Date shall continue to be the property of Serono, and such accounts
receivable shall not be transferred to Columbia.
	 
	2.6	 	Method of Payment. All payments to be made by Columbia or Ares hereunder shall be made in
United States dollars by way of wire transfer to the other Party on the date each such
payment is due and payable.
	 
	2.7	 	Closing.
	 
	(a)	 	The closing of the transactions contemplated hereby (the “Closing”) will take place at the
offices of Ares in Geneva, Switzerland on the first (1st) Business Day following
the satisfaction or waiver of the conditions to Closing set forth in Articles 7 and 8 hereof.
The actual date of the Closing is referred to as the “Closing Date.” The Closing, and the
consummation of the Product Acquisition Transactions shall be deemed to be effective at 12:01
A.M. on the Closing Date.
	 
	(b)	 	At the Closing, Columbia will (i) pay to Ares the Termination Payment and (ii) pay to Ares
the Inventory Purchase Amount, in full in cash without any deductions or offsets, by wire
transfer of immediately available funds to a bank account or accounts to be designated in
writing by Ares and Serono prior to Closing.
	 
	(c)	 	At the Closing, Ares and Serono will sell, assign, convey, transfer and deliver to Columbia
all of Ares’s, Serono’s and their respective Affiliates’ right, title and interest in, to and
under the Assigned Assets, as provided in Section 2.8 hereof.
	 
	(d)	 	At the Closing, Columbia will assume from Ares the due payment, performance and discharge of
the Assumed Liabilities, as provided in Section 2.8 hereof.
	 
	2.8	 	Assignment and Assumption.
	 
	(a)	 	Effective as of the Closing, Ares hereby grants, sells, assigns, transfers, conveys and
delivers to Columbia, its successors and assigns, all of Ares’s rights, title and interest
under, in and to the Assigned Assets.
	 
	(b)	 	Effective as of the Closing, Columbia hereby expressly assumes and agrees to pay, perform
and/or discharge the Assumed Liabilities.

 

 

ARTICLE 3

RESALE OF INVENTORY

AND PRODUCT CLINICAL DATA

	3.1	 	Adverse Event Reporting.
	 
	(a)	 	Columbia shall continue to be responsible for the adverse experience and safety reporting for
Products in the U.S. in compliance with the requirements of the FDCA, including 21 U.S.C. §
321 et seq. and the regulations promulgated thereunder.
	 
	(b)	 	Each Party shall promptly provide the other Party with Adverse Event reports related to
Products that are filed by such Party with Governmental Authorities.
	 
	(c)	 	Serono shall, as soon as practicable following the Closing Date, but no later than thirty
(30) Business Days thereafter, provide Columbia with copies of the information in its
possession relating to all investigation and reporting in the twelve (12) month period prior
to the Closing Date to Governmental Authorities of Adverse Events. The Parties agree to
cooperate following the Closing Date in Adverse Event and safety reporting for the Product in
the U.S.
	 
	(d)	 	Each Party shall promptly provide the other Party with Adverse Event reports related to the
Product that are filed by such Party with Governmental Authorities.
	 
	3.2	 	Medical and Other Inquiries. From and after the Closing Date, Columbia shall assume all
responsibility for all correspondence and communication with physicians and other health care
professionals and customers with respect to the Product in the U.S. The Parties shall
cooperate in the prompt transition of handling such communications for the Product in the U.S.
After the Closing Date, Ares shall refer all questions relating to the Product in the U.S.
raised by health care professionals and customers to Columbia for its response and handling.
	 
	3.3	 	Resale of Inventory.
	 
	(a)	 	Columbia shall have the right to resell or otherwise distribute the Inventory for a period of
up to six (6) months subsequent to the Closing Date (the “Inventory Distribution Period”).
Following such date, all remaining Inventory shall be destroyed by Columbia.
	 
	(b)	 	Upon Ares’s request, Columbia shall provide to Ares a resell exemption certificate relating
to the resale of the Inventory.
	 
	(c)	 	Columbia shall have the right to use the distribution services of Freedom Pharmacy, Serono’s
distributor of Product in the U.S. until the end of the Inventory Distribution Period, and the
Parties shall take such action, at Columbia’s cost and expense, as may be reasonably required
in connection thereof.

 

 

	(d)	 	Within fifteen (15) Business Days of the Closing Date, Serono shall send a letter of
introduction, prepared by Serono (with review by Columbia), to ten (10) physicians selected
by Columbia in the U.S.
	 
	3.4	 	Product Marketing Materials. On the Closing Date, Serono shall provide Columbia with one
sample of the Product Marketing Materials offered or used by Serono as of the Closing Date,
for Columbia’s information only. Columbia shall not be permitted to disseminate such Product
Marketing Materials to any Third Party, and shall have no rights in such Product Marketing
Materials.
	 
	3.5	 	BWH Study. Serono shall provide to Columbia a copy of each of the BWH Protocol and BWH
Clinical Data, promptly after each becomes available. Columbia shall have the right to use
the BWH Clinical Data for promotional and regulatory purposes only, to the extent permitted by
Law. All costs and expenses for Product after the Closing for the BWH Study shall be the
responsibility of Columbia.

ARTICLE 4

REPRESENTATIONS AND WARRANTIES

	4.1	 	Representations and Warranties of Ares and Serono. Each of Ares and Serono represents and
warrants, jointly and severally, to Columbia and Columbia Bermuda, as follows:
	 
	(a)	 	Organization and Standing. Such Party is a legal entity duly organized, validly existing and
in good standing under the Laws of the jurisdiction of Switzerland (in the case of Ares) or
Delaware (in the case of Serono).
	 
	(b)	 	Power and Authority; Binding Effect. Such Party has all requisite power and authority, and
has taken all other actions necessary, to execute and deliver and to perform all of its
obligations of under this Agreement and the other Transaction Documents to which it is a party
or by which it is bound and to consummate the transactions contemplated herein and therein.
Such Party has duly and properly taken all actions required by Law, its organizational
documents or otherwise to authorize the execution, delivery and performance by it of its
obligations under this Agreement and the other Transaction Documents to be executed and
delivered by it and the consummation of transactions contemplated hereby and thereby. This
Agreement has been duly and validly executed and delivered by it and constitutes the legal,
valid and binding obligation of it, enforceable against it in accordance with its terms,
except as enforcement may be affected by bankruptcy, insolvency or other similar laws and by
general principles of equity. The other Transaction Documents to be executed by it, when so
executed and delivered, will be duly and validly executed and delivered by it and will
constitute the legal, valid, and binding obligations of it, enforceable against it in
accordance with their respective terms, except as enforcement may be affected by bankruptcy,
insolvency or other similar laws and by general principles of equity.

 

 

	(c)	 	No Conflict. The execution, delivery, and performance of this Agreement and the other
Transaction Documents by such Party to which such Party is a party or by which such Party is
bound, including the granting of the Licenses, and the consummation of the transactions
contemplated hereby or thereby (i) is not prohibited by, and will not result in the breach of,
or a material default under (1) any provisions of such Party’s organizational documents, (2)
any Law applicable to such Party or its Affiliates, (3) any contract to which such Party or
its Affiliates is a party, or (4) any order, writ, injunction, judgment or decree to which
such Party or its Affiliates is bound or subject, and (ii) will not result in the creation or
imposition of any Lien upon any of the Assigned Assets.
	 
	(d)	 	Ownership of Assets. Ares and Serono have good and valid title in and to all of the Assigned
Assets and the assets, properties or rights subject to the Licenses and, at the Closing,
Columbia will receive beneficial and legal title to the Assigned Assets, free and clear of all
Liens.
	 
	(e)	 	Litigation or Disputes. There is no material claim, action, suit, proceeding, investigation,
hearing, arbitration, judgment, decree, injunction, rule or order with any Person, including
any Governmental Authority (each, a “Proceeding”), pending or, to the knowledge of such Party
and its Affiliates, threatened, with respect to the Assigned Assets, the Product in the U.S.,
or against any of or its Affiliates relating to the Assigned Assets, the Product in the U.S.
or the assets, properties or rights subject to the Licenses, or that would otherwise delay or
impair the ability of such Party and its Affiliates to consummate the transactions
contemplated by this Agreement or the other Transaction Documents or to perform such Party’s
obligations hereunder or thereunder.
	 
	4.2	 	Representations and Warranties of Columbia and Columbia Bermuda. Each of Columbia and
Columbia Bermuda represents and warrants, jointly and severally, to Ares and Serono, as
follows:
	 
	(a)	 	Organization and Standing. Such Party is a corporation duly organized, validly existing and
in good standing under the Laws of the State of Delaware (in the case of Columbia) or Bermuda
(in the case of Columbia Bermuda).
	 
	(b)	 	Power and Authority; Binding Effect. Such Party has all requisite corporate power and
authority, and has taken all other actions necessary, to execute and deliver and to perform
all of its obligations under this Agreement and the other Transaction Documents to which it is
a party or by which it is bound and to consummate the transactions contemplated herein and
therein. Such Party has duly and properly taken all actions required by Law, its
organizational documents or otherwise to authorize the execution, delivery and performance by
it of its obligations under this Agreement and the other Transaction Documents to be executed
and delivered by it and the consummation of the transactions contemplated hereby and thereby.
This Agreement has been duly and validly executed and delivered by such Party and constitutes
the legal, valid and binding obligation of such Party, enforceable against it in accordance
with its terms,

 

 

	 	 	except as enforcement may be affected by bankruptcy, insolvency or other similar laws and
by general principles of equity. The other Transaction Documents to be executed by such
Party, when so executed and delivered, will be duly and validly executed and delivered and
will constitute the legal, valid, and binding obligations of such Party, enforceable
against it in accordance with their respective terms, except as enforcement may be affected
by bankruptcy, insolvency or other similar laws and by general principles of equity.
	 
	(c)	 	No Conflict. The execution, delivery, and performance of this Agreement and the other
Transaction Documents to which such Party is a party or by which such Party is bound and the
consummation of the transactions contemplated hereby or thereby by such Party is not
prohibited or limited by, and will not result in the breach of, or a default under (1) any
provisions of such Party’s organizational documents, (2) any Law applicable to such Party, (3)
any contract to which such Party is a party, or (4) any order, writ, injunction, judgment or
decree to which such Party is bound or subject.
	 
	(d)	 	Litigation. There is no material Proceeding pending or, to the knowledge of such Party,
threatened, against such Party and, to such Buyer’s knowledge, such Party is not in violation
of or in default with any applicable Law, the result of any of which, either individually or
cumulatively, would prevent or materially delay or impair the ability of such Party to
consummate the transactions contemplated by this Agreement or the other Transaction Documents
to which such Party is to be a party or to perform such Party’s obligations hereunder or
thereunder.
	 
	4.3	 	Survival of Representations/Warranties. The representations and warranties contained in this
Article 4 shall survive the Closing Date for a period of twelve (12) months.
	 
	4.4	 	Brokers. Each Party represents that no agent, broker, investment banker, financial advisor
or other Person, is or will be entitled to any brokers’ or finder’s fee or any other
commission or similar fee in connection with any of the transactions contemplated by this
Agreement.

ARTICLE 5

COVENANTS AND ACKNOWLEDGMENT

	5.1	 	Post-Closing Orders and Payments. At the Closing, Serono will deliver to Columbia all
purchase orders for Product in the U.S. in its possession. From and after the Closing Date,
Serono shall promptly deliver to Columbia any purchase orders for Product in the U.S. received
after the Closing and any payments received from Third Parties for Products purchased from
Columbia after the Closing, and refer all inquiries it shall receive with respect to the
Product in the U.S. to Columbia or its designee.

 

 

	5.2	 	Chargebacks. Following the Closing Date, Columbia shall be responsible for all Chargebacks
for Product sold in the U.S., on account of Products sold, whether sold prior to, on or
subsequent to the Closing Date.
	 
	5.3	 	Medicare, Medicaid and State Rebates. Following the Closing Date, Columbia shall be
responsible for the processing, payment and handling of all government (federal or state)
rebate programs related to the sale of Product.
	 
	5.4	 	Returns.
	 
	(a)	 	Following the Closing Date, Columbia shall be responsible for all refunds to customers on
account of any Product in the U.S. which is returned (“Returns”), whether sold prior to, on
or, subsequent to the Closing Date.
	 
	(b)	 	In the event that any Products are returned to Serono or its Third Party processor of Returns
rather than to Columbia, Serono shall, and shall cause its Third Party processor to, forward
such returned Products to Columbia. In such event, Columbia shall reimburse Serono for all of
its costs and expenses related to Serono’s or its Third Party processor’s receipt of such
returned Product and subsequent forwarding to Columbia.
	 
	(c)	 	Columbia shall notify all parties purchasing Inventory from Columbia following the Closing
Date that all Returns should be sent to Columbia’s designated return vendor for Products.
	 
	5.5	 	Acknowledgment and Release. Columbia and Columbia Bermuda acknowledge and agree that Ares
and Serono have satisfied any and all of their respective obligations under the Amended and
Restated License and Supply Agreement, or otherwise, to market, promote and sell Product in
the United States. Further, Columbia and Columbia Bermuda hereby forever release and
discharge Ares, Serono, their predecessors, successors, Affiliates, and their respective
stockholders, officers, directors, agents, attorneys, employees, and any and all others in any
way acting or claiming on its behalf, from any and all claims, demands, liabilities, actions,
causes of action, suits, damages and complaints arising out of any breach prior to the Closing
Date by Ares or Serono of its obligations under the Amended and Restated License and Supply
Agreement, or otherwise, to market, promote and sell Product in the United States. The
foregoing shall not limit the retention by Ares and Serono of the Retained Liabilities.

ARTICLE 6

INDEMNIFICATION

	6.1	 	Indemnification by Ares and Serono. From and after the Closing Date, Ares and Serono,
jointly and severally, shall reimburse and indemnify Columbia, Columbia Bermuda, the
Affiliates of Columbia and Columbia Bermuda, and their respective officers, directors,
employees, legal representatives and agents in respect of, and hold each of them harmless from
and against, any and all Losses

 

 

	 	 	suffered, incurred or sustained by any of them or to which any of them becomes subject,
resulting from, arising out of or relating to:
	 
	(a)	 	the Retained Liabilities;
	 
	(b)	 	any misrepresentation or breach of warranty by Ares or Serono made or contained in this
Agreement; and
	 
	(c)	 	any failure of Ares or Serono to perform or observe any covenant or agreement to be performed
or observed by Ares or Serono pursuant to this Agreement.
	 
	6.2	 	Indemnification by Columbia and Columbia Bermuda. From and after the Closing Date, Columbia
and Columbia Bermuda, jointly and severally, shall reimburse and indemnify Ares, Serono,
Affiliates of Ares and Serono, and their respective officers, directors, employees and agents
in respect of, and hold each of them harmless from and against, any and all Losses suffered,
incurred or sustained by any of them or to which any of them becomes subject, resulting from,
arising out of or relating to:
	 
	(a)	 	the Assumed Liabilities;
	 
	(b)	 	any misrepresentation or breach of warranty by Columbia or Columbia Bermuda made or contained
in this Agreement; and
	 
	(c)	 	any failure by Columbia or Columbia Bermuda to duly perform or observe any covenant or
agreement to be performed or observed by Columbia or Columbia Bermuda pursuant to this
Agreement.
	 
	6.3	 	Procedures for Indemnification for Third Party Claims.
	 
	(a)	 	In the event of any claim or demand made by any Person who is not a Party to this Agreement
(or an Affiliate thereof) (“Third Party Claim”) which relates to circumstances under which, in
accordance with Section 6.1 or 6.2, a Party (the “Indemnitor”) may be obligated to provide
indemnification pursuant to this Agreement, such Party seeking indemnification hereunder
(“Indemnitee”) will notify the Indemnitor in writing of the Third Party Claim (and specifying
in reasonable detail the factual basis for the Third Party Claim and to the extent known, the
amount of the Third Party Claim) reasonably promptly after becoming aware of such Third Party
Claim; provided, however, that failure to give such notification will not affect the
indemnification provided hereunder except to the extent the Indemnitor shall have been
actually prejudiced as a result of such failure.
	 
	(b)	 	If a Third Party Claim is made against an Indemnitee, the Indemnitor will be entitled, within
sixty (60) days after receipt of written notice from the Indemnitee, under Section 6.3(a), of
the commencement or assertion of any such Third Party Claim, to assume the defense thereof (at
the expense of the Indemnitor) with counsel selected by the Indemnitor and reasonably
satisfactory to the Indemnitee,

 

 

	 	 	for so long as the Indemnitor is conducting a good faith and diligent defense. Should the
Indemnitor so elect to assume the defense of a Third Party Claim:

	 	(i)	 	the Indemnitor will not be liable to the Indemnitee for any legal or other
expenses subsequently incurred by the Indemnitee in connection with the defense
thereof; provided, that if under applicable standards of professional conduct a
conflict of interest exists between the Indemnitor and the Indemnitee in respect of
such claim, such Indemnitee shall have the right to employ separate counsel (which
shall be reasonably satisfactory to the Indemnitor) to represent such Indemnitee with
respect to the matters as to which a conflict of interest exists and in that event the
reasonable fees and expenses of such separate counsel shall be paid by such
Indemnitor; provided, further, that the Indemnitor shall only be responsible for the
reasonable fees and expenses of one separate counsel for such Indemnitee;
	 
	 	(ii)	 	the Indemnitee shall have the right to participate in the defense thereof and
to employ counsel, at its own expense, separate from the counsel employed by the
Indemnitor;
	 
	 	(iii)	 	the Indemnitor and Indemnitee will promptly supply to the other copies of
all correspondence and documents relating to or in connection with such Third Party
Claim and keep the other informed of developments relating to or in connection with
such Third Party Claim, as may be reasonably requested by the Indemnitee or
Indemnitor, as applicable (including providing to the Indemnitee or Indemnitor, as
applicable, on reasonable request updates and summaries as to the status thereof); and
	 
	 	(iv)	 	all Indemnitees shall reasonably cooperate with the Indemnitor in the
defense, and in the conduct of discussions for settlement, compromise or discharge,
thereof (such cooperation to be at the expense, including reasonable legal fees and
expenses, of the Indemnitor).

	(c)	 	If the Indemnitor does not elect to assume control of the defense thereof within the sixty
(60) day period set forth above, or if such good faith and diligent defense is not being or
ceases to be conducted by the Indemnitor, the Indemnitee shall have the right, at the expense
of the Indemnitor, after three (3) Business Days notice to the Indemnitor of its intent to do
so, to undertake the defense of the Third Party Claim (with counsel selected by the
Indemnitee), and to compromise or settle such Third Party Claim, exercising reasonable
business judgment.
	 
	(d)	 	If the Indemnitor acknowledges in writing its obligation to indemnify the Indemnitee for a
Third Party Claim, the Indemnitee will agree to any settlement, compromise or discharge of
such Third Party Claim that the Indemnitor may recommend that by its terms obligates the
Indemnitor to pay the full amount of Losses (whether through settlement, compromise or
discharge) in connection with such Third Party Claim and unconditionally and irrevocably
releases the

 

 

	 	 	Indemnitee completely from all Liability in connection with such Third Party Claim;
provided, however, that, without the Indemnitee’s prior written consent, the Indemnitor
shall not consent to any settlement, compromise or discharge (including the consent to
entry of any judgment), and the Indemnitee may refuse to agree to any such settlement,
compromise or discharge, that provides for injunctive or other equitable or other
non-monetary relief affecting the Indemnitee, the Product in the U.S. or the Assigned
Assets. If the Indemnitor acknowledges in writing its obligation to indemnify the
Indemnitee for a Third Party Claim, the Indemnitee shall not (unless required by applicable
Law) admit any liability with respect to, or settle, compromise or discharge, such Third
Party Claim without the Indemnitor’s prior written consent (which consent shall not be
unreasonably withheld or delayed).

	6.4	 	Losses That Are Not Third Party Claims. Any claim on account of Losses which does not
involve a Third Party Claim shall be asserted by reasonably prompt written notice (stating in
reasonable detail, the basis of such claim and a reasonable estimate of the amount thereof)
given by the Indemnitee to the Indemnitor from whom such indemnification is sought. For a
period of sixty (60) days from and after receipt of the written notice, the Parties shall
attempt in good faith to resolve such claim for indemnification. If the Parties are unable to
resolve such claim, the Party seeking indemnification may thereafter pursue any and all
remedies at its disposal to enforce said indemnification claim.

	6.5	 	Termination of Indemnification Obligations. The obligations of each Party to indemnify,
defend and hold harmless the other Party and other Indemnitees pursuant to Sections 6.1(b) and
6.2(b) shall terminate when the applicable representation or warranty expires pursuant to
Section 4.3; provided, however, that such obligations to indemnify, defend and hold the
Indemnitee harmless shall not terminate with respect to any individual item as to which the
Indemnitee shall have before the expiration of the survival period, made a claim by delivering
a written notice (stating in reasonable detail the basis of such claim and a reasonable
estimate of the amount thereof) to the Indemnitor.
	 
	6.6	 	Other Matters. In the event of payment in full by an Indemnitor to any Indemnitee in
connection with any Third Party Claim, such Indemnitor will be subrogated to and shall stand
in the place of such Indemnitee as to any events or circumstances in respect of which such
Indemnitee may have any right or claim relating to such Third Party Claim against any claimant
or plaintiff asserting such Third Party Claim or against any other Person. Such Indemnitee
will cooperate with such Indemnitor in a reasonable manner, and at the cost and expense of
such Indemnitor, in prosecuting any subrogated right or claim.

 

 

ARTICLE 7

CONDITIONS TO PERFORMANCE BY ARES AND SERONO

          The obligations of Ares and Serono to consummate at the Closing the transactions contemplated
by this Agreement shall be subject to the satisfaction, at or prior to the Closing, of each of the
following conditions:

	7.1	 	Compliance by Columbia and Columbia Bermuda. Each of Columbia and Columbia Bermuda shall
have complied with and performed in all material respects all of their respective agreements
and obligations under the terms, covenants and conditions of this Agreement to be complied
with or performed by each of them on or prior to the Closing Date.
	 
	7.2	 	Representations and Warranties of Columbia and Columbia Bermuda. The representations and
warranties of each of Columbia and Columbia Bermuda contained in this Agreement shall be true
and correct in all material respects as of the Closing Date, with the same force and effect as
if made as of the Closing Date.
	 
	7.3	 	No Litigation or Governmental Proceeding. Since the date of this Agreement, no action or
proceeding shall have been instituted or threatened before any court or Governmental Authority
or by any third party (a) involving any challenge to or seeking damages or other relief in
connection with, any of the transactions contemplated hereby or (b) that may have the effect
of preventing, delaying, making illegal or otherwise interfering with any of the transactions
contemplated hereby.
	 
	7.4	 	Closing Deliveries; Payment.
	 
	(a)	 	Columbia and Columbia Bermuda shall have executed and delivered to Ares and Serono, at or
prior to the Closing, this Agreement and any other documents to be delivered by them at the
Closing.
	 
	(b)	 	Columbia Bermuda shall have executed and delivered to Ares, at or prior to the Closing,
Amendment No. 1.
	 
	(c)	 	Ares shall have received the Termination Payment and the Inventory Purchase Amount.

ARTICLE 8

CONDITIONS TO PERFORMANCE

BY COLUMBIA AND COLUMBIA BERMUDA

          The obligations of Columbia and Columbia Bermuda to consummate at the Closing the transactions
contemplated by this Agreement shall be subject to the satisfaction, at or prior to the Closing, of
each of the following conditions:

 

 

	8.1	 	Financing. Columbia shall have obtained financing necessary to pay the Termination Payment
and the Inventory Purchase Amount at the Closing.
	 
	8.2	 	Compliance by Ares and Serono. Each of Ares and Serono shall have complied with and
performed in all material respects all of their respective agreements and obligations under
the terms, covenants and conditions of this Agreement to be complied with or performed by each
of them on or prior to the Closing Date.
	 
	8.3	 	Representations and Warranties of Ares and Serono. The representations and warranties of
Ares and Serono contained in this Agreement shall be true and correct in all material respects
as of the Closing Date with the same force and effect as if made as of the Closing Date.
	 
	8.4	 	No Litigation or Governmental Proceeding. Since the date of this Agreement, no action or
proceeding shall have been instituted or threatened before any court or Governmental Authority
or by any third party (a) involving any challenge to, or seeking damages or other relief in
connection with, any of the transactions contemplated hereby or (b) that may have the effect
of preventing, delaying making illegal or otherwise interfering with any of the transactions
contemplated hereby.
	 
	8.5	 	Closing Deliveries.
	 
	(a)	 	Ares and Serono shall have executed and delivered to Columbia and Columbia Bermuda, at or
prior to the Closing, this Agreement and any other documents to be delivered by them at the
Closing.
	 
	(b)	 	Ares shall have executed and delivered to Columbia Bermuda, Amendment No. 1.

ARTICLE 9

TERMINATION

          In the event that the Closing shall not have occurred on or before five (5) Business Days from
the date hereof, either Party shall have the right to terminate this Agreement at the close of
business on such date without liability of any Party to any other Party; provided,
however, that in the event that Closing shall not have occurred due to a breach of any
provision hereof by a Party, such breaching Party shall not have the right to terminate this
Agreement. Any termination of this Agreement shall not relieve any Party of liability for breach
hereof occurring prior to such termination.

ARTICLE 10

GENERAL PROVISIONS

	10.1	 	Payment of Transaction Expenses. All legal fees and other expenses incurred by Ares or
Serono in connection with the negotiation of this Agreement and the consummation of the
transactions contemplated herein will be borne by Ares or Serono, as the case may be, whether
or not the Closing shall have occurred. All legal fees and other expenses incurred by
Columbia or Columbia Bermuda in

 

 

	 	 	connection with the negotiation of this Agreement and the consummation of the transactions
contemplated herein will be borne by Columbia or Columbia Bermuda, as the case may be,
whether or not the Closing shall have occurred.
	 
	10.2	 	Notices. Except as otherwise specifically provided herein, any notice or other documents to
be delivered by a Party under this Agreement shall be in writing and shall be deemed to have
been duly given if sent by registered mail, nationally recognized overnight courier or
facsimile transmission (with confirmation of receipt) to a Party or delivered in person to a
Party at the address or facsimile number set out below for such Party or such other address as
the Party may from time to time designate by written notice to the other:
	 
	 	 	If to Columbia, to:
	 
	 	 	Columbia Laboratories, Inc.

354 Eisenhower Parkway

Plaza 1 Second Floor

Livingston, NJ 07039

Attn: General Counsel

Fax: 973-994-3001
	 
	 	 	with a copy to:
	 
	 	 	Kaye Scholer LLP

425 Park Avenue

New York, NY 10022

Attn: Adam H. Golden, Esq.

Fax: 212-836-8689
	 
	 	 	If to Columbia Bermuda, to:
	 
	 	 	Columbia Laboratories (Bermuda) Ltd.

22 Victoria Street

P.O. Box HM 1179

Hamilton HM EX

Bermuda

Attn: Secretary

Fax: 441-295-9216
	 
	 	 	with a copy to:
	 
	 	 	Columbia Laboratories, Inc.

354 Eisenhower Parkway

Plaza 1 Second Floor

Livingston, NJ 07039

Attn: General Counsel

Fax: 973-994-3001

 

 

	 	 	If to Ares, to:
	 
	 	 	Ares Trading S.A.

Zone Industrielle de l’Ouriettaz

1170 Aubonne

Switzerland

Attn: General Manager

Fax: Facsimile: 41 22 345 5081
	 
	 	 	With a copy to:
	 
	 	 	Serono International, SA

9 chemin des mines

1211 Geneva

Switzerland

Attn: General Counsel

Fax: 41 22 414 3070
	 
	 	 	If to Serono, to:
	 
	 	 	Serono, Inc.

One Technology Place

Rockland, Massachusetts 02370

U.S.A.

Fax: 781 681 2933
	 
	 	 	With a copy to :
	 
	 	 	Serono Inc.

One Technology Place

Rockland, Massachusetts 02370

U.S.A.

Attn: General Counsel

Fax: 781 681 2934
	 
	 	 	Any such notice or other document shall be deemed to have been received by the addressee
five (5) Business Days following the date of dispatch of the notice or other document by
post or, where the notice or other document is sent by overnight courier, by hand or is
given by facsimile, simultaneously with the transmission or delivery. Notwithstanding the
foregoing, any notice given by facsimile shall also be sent by another means of delivery
pursuant to this Section 10.2.
	 
	10.3	 	Entire Agreement. This Agreement and the other Transaction Documents embody and set forth
the entire agreement and understanding of the Parties with respect to the subject matter
herein and there are no promises, terms, conditions or obligations, oral or written, expressed
or implied, other than those contained in

 

 

	 	 	this Agreement or the other Transaction Documents. The terms
of the Transaction Documents shall supersede all previous
oral or written agreements which may exist or have existed
between the parties relating to the subject matter hereof and
thereof.
	 
	10.4	 	Confidentiality; Public Disclosures.
	 
	(a)	 	For the purposes of this Agreement, “Confidential Information” shall mean any information
relating to the Assigned Assets, this Agreement, the other Transaction Documents and the
transactions contemplated hereby or thereby; provided, however, that the Confidential
Information shall not include any information which is in the public domain or becomes
generally known through no wrongful act of the part of a Party. Following the Closing, each
Party shall keep confidential and not disclose to any Person or use any Confidential
Information of the other Party. This Section 10.4(a) shall not be violated by disclosure
pursuant to (i) court order or as otherwise required by Law, on condition that notice of the
requirement for such disclosure is given to the other Party prior to making any disclosure and
the Party subject to such requirement cooperates as the other may reasonably request in
resisting it or limiting the scope of disclosure, or (ii) Section 10.4(b).
	 
	(b)	 	Each party hereto agrees not to issue any press release or other public statement, whether
oral or written, disclosing the existence of this Agreement, the terms hereof or any
information relating to this Agreement without the prior written consent of the other party;
provided however, that neither party hereto will be prevented from complying
with any duty of disclosure it may have pursuant to law or governmental regulation or pursuant
to the rules of any recognized stock exchange or quotation system. A party hereto who desires
to issue a press release or make any other public disclosure relating to this Agreement shall
notify the other in writing at least four (4) Business Days (or such shorter period where
legally required) before the time of the proposed release. Such party shall provide a draft
of any of the proposed documents containing any such reference (including without limitation,
a copy of this Agreement or any excerpt hereof, proposed to be filed with any securities
regulatory authority or any securities exchange) to the other party and its counsel in
sufficient time for review of such documents. In the event such other party objects to any
such reference, the applicable document will be modified to such party’s reasonable
satisfaction.
	 
	10.5	 	Modifications and Amendments. This Agreement shall not be amended, modified, varied or
supplemented except in writing signed a duly authorized representative of each of the Parties.
	 
	10.6	 	Assignment. Neither this Agreement nor any of the rights or obligations of the Parties
hereunder may be assigned by any Party without the prior written consent of the other Party,
which consent shall not be unreasonably withheld, conditioned or delayed; provided, however,
that either Party shall be entitled, without the prior written consent of the other to assign
its rights and obligations hereunder in

 

 

	 	 	connection with a merger or similar reorganization or the sale of all or substantially all
of its assets. Any attempted assignment or delegation in contravention hereof shall be
null and void. Subject to the foregoing, this Agreement and all rights and powers granted
and obligations created hereby will bind and inure to the benefit of the Parties hereto and
their respective successors and assigns.
	 
	10.7	 	Headings, Interpretation. The headings used in this Agreement are for convenience only and
are not a part of this Agreement nor affect the interpretation of any of its provisions.
	 
	10.8	 	Independent Parties. This Agreement shall not be deemed to create any partnership, joint
venture, amalgamation or agency relationship between the Parties. Each Party shall act
hereunder as an independent contractor. Neither Party shall at any time enter into, incur, or
hold itself out to Third Parties as having authority to enter into or incur, on behalf of the
other party, any commitment, expense, or liability whatsoever.
	 
	10.9	 	Governing Law. This Agreement shall be governed by and construed under the substantive laws
of New York, without giving effect to the choice of law provisions thereof.
	 
	10.10	 	Jurisdiction; Waiver of Jury Trial. Any dispute, controversy, claim or difference arising
between the parties out of, relating to, or in connection with this Agreement shall be
submitted to the jurisdiction of the courts sitting in the State of New York. EXCEPT AS
PROHIBITED BY LAW, EACH PARTY HERETO WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN
RESPECT OF ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH
THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
	 
	10.11	 	Waiver. Neither the failure nor delay on the part of a Party to require the strict
performance of any term, covenant or condition of this Agreement or to exercise any right or
remedy available on a breach thereof shall constitute a waiver of any such breach or of any
such term or condition. The consent to, or the waiver of, any breach, or the failure to
require on any single occasion, the performance or timely performance of any term, covenant,
or condition of this Agreement shall not be construed as authorizing any subsequent or
additional breach and shall not prevent a subsequent enforcement of such term, covenant, or
condition.
	 
	10.12	 	Severability. In the event that any provision of this Agreement or the application thereof
to any Party or circumstance shall be finally determined by a court of proper jurisdiction to
be invalid or unenforceable to any extent, then (i) a suitable and equitable provision shall
be substituted therefore in order to carry out, so far as may be valid and enforceable, the
intent and purpose of such invalid and unenforceable provision and (ii) the remainder of this
Agreement and the

 

 

	 	 	application of such provision to the Parties or circumstances other than those to which it
is held invalid or unenforceable shall not be affected thereby.
	 
	10.13	 	Counterparts; Facsimile Signatures. This Agreement may be executed in counterparts, each of
which shall be deemed an original, and all of which together shall constitute a single
agreement. This Agreement may be executed by facsimile signatures, which signatures shall
have the same force and effect as original signatures.
	 
	10.14	 	No Third Party Beneficiaries. No Person other than the Parties and permitted assignees
hereunder shall be deemed an intended beneficiary hereunder or have any right to enforce any
term of this Agreement.
	 
	10.15	 	Further Assurances. Each Party shall execute and deliver (and Ares shall cause its
Affiliates to execute and deliver) such additional instruments and other documents and use
(and Ares shall cause its Affiliates to use) all reasonable efforts to take, or cause to be
taken, all actions and to do, or cause to be done, all things necessary under applicable Law
or reasonably requested by the other Party to consummate the transactions contemplated hereby
or by the other Transaction Documents and to confirm and assure the transfer of the Assigned
Assets to Columbia or the grant of the Licenses granted in Section 2.2.
	 
	10.16	 	No Strict Construction. This Agreement has been prepared jointly and shall not be strictly
construed against either Party.

 

 

  IN WITNESS WHEREOF, the Parties hereto have each caused this Agreement to be duly executed as of
the date first above written.

	 	 	 	 	 
	 	ARES TRADING S.A.

 	 
	 	By:  	/S/ Francois Naef
 	 
	 	 	Name:  	Francois Naef 	 
	 	 	Title:  	Senior Executive Vice President 	 
	 
	 	 	 
	 	By:  	          /S/ Franck Latrille
 	 
	 	 	Name:  	Franck Latrille 	 
	 	 	Title:  	Senior Executive Vice President 	 
	 
	 	SERONO, INC.

 	 
	 	By:  	/S/ Fereydoun Firouz
 	 
	 	 	Name:  	Fereydoun Firouz 	 
	 	 	Title:  	President 	 
	 
	 	COLUMBIA LABORATORIES, INC.

 	 
	 	By:  	/S/ Robert S Mills
 	 
	 	 	Name:  	Robert S Mills 	 
	 	 	Title:  	President & CEO 	 
	 
	 	COLUMBIA LABORATORIES (Bermuda), Ltd.

 	 
	 	By:  	/S/ Robert S Mills
 	 
	 	 	Name:  	Robert S Mills 	 
	 	 	Title:  	President 	 
	 

SIGNATURE PAGE TO AGREEMENT

 

 

Exhibit A

Amendment No. 1EX-10.69

 

Exhibit 10.69

AMENDMENT N° 1 TO THE AMENDED AND RESTATED LICENSE AND

SUPPLY AGREEMENT

THIS AMENDMENT N° 1 TO THE AMENDED AND RESTATED LICENSE AND SUPPLY AGREEMENT (the “Amendment”)
effective as of the Closing Date, is made and entered into by and between Columbia Laboratories
(Bermuda) Limited, a corporation organized and existing under the laws of Bermuda (“Licensor”) and
Ares Trading S.A., a corporation organized and existing under the laws of Switzerland (“Licensee”).
Licensor and Licensee may be referred to herein as a “Party” or, collectively, as “Parties.”

RECITALS:

WHEREAS, the Parties entered into an Amended and Restated License and Supply Agreement on June
4, 2002 (the “License and Supply Agreement”), amending and restating the License and Supply
Agreement entered into between the Parties on May 20, 1999;

WHEREAS, the Parties wish to enter into this Amendment as a result of the Parties, Serono Inc.
(which is an Affiliate of Licensee), and Columbia Laboratories, Inc. entering into an agreement
pursuant to which Licensee’s U.S. rights under the License and Supply Agreement are terminated (the
“U.S. Agreement”);

WHEREAS the Parties shall enter into this Amendment simultaneously with the execution of the U.S.
Agreement;

WHEREAS, capitalized terms used and not otherwise defined in this Amendment are used as defined in
the License and Supply Agreement and/or the U.S. Agreement. If a capitalized term is defined in
both the License and Supply Agreement and the U.S. Agreement, then for the purposes of this
Amendment, the definition in the License and Supply Agreement shall apply.

NOW, THEREFORE, in consideration of the various promises and undertakings set forth herein, the
Parties agree to amend the License and Supply Agreement as follows:

	 	1.	 	Section 1 (f) is deleted and not replaced.
	 
	 	2.	 	The following phrase of Section 1 (h) is deleted and not replaced:
	 
	 	 	 	“(i) the United States or (ii)”
	 
	 	3.	 	The following wording is inserted to the first sentence of Section 1 (s), between the
phrases “or sublicensees” and “from or on account of”:
	 
	 	 	 	“(for the sake of clarity, the definition of Net Sales hereunder shall not include any
sales of Product by the Licensor)”
	 
	 	4.	 	 The last two sentences of Section 1 (s) are deleted and not replaced.
	 
	 	5.	 	Section 1 (z) (bb) is amended to read as follows:

“Territory” shall mean all countries and territories of the world except for the United States
and for Sub-Saharan Africa. “Sub-Saharan Africa” shall mean the following countries: the
Republic of South Africa, Lesotho, Botswana, Zimbabwe, Namibia,

 

 

Mozambique, Zaire, Kenya,
Malawi, Mauritius, Seychelles, Madagascar, Zambia and Swaziland.”

	 	6.	 	Section 2 (g) is amended to read as follows:

“Licensor shall make reasonable efforts to obtain from its licensee in Sub-Saharan Africa any
right such licensee may have to market, use, sell, make or have made the Product and to use the
Trademarks. Upon Licensor obtaining such rights, “Territory” under this Agreement shall be
automatically redefined to mean “all the countries in the world, excluding the United States”.
Any incidental out-of-pocket costs incurred by Licensor in obtaining such rights shall be for
the account of Licensee, when prior approved by Licensee.”

	 	7.	 	Section 2 (h) is deleted and not replaced.
	 
	 	8.	 	Sections 3 (a), (b) and (c ) are deleted and not replaced.
	 
	 	9.	 	The last sentence of the first paragraph of Section 4 (m) (which, for the avoidance
of doubt, begins with “Licensor may manufacture..” and ends with “..shearing cycles.” is
deleted and not replaced.
	 
	 	10.	 	The last paragraph Section 4 (m) (which is the last sentence of Section 4 (m)) is
amended by deleting the phrase “under the Marketing Agreement”.
	 
	 	11.	 	Section 4 (s) is amended in its entirety to read as follows:

“Each Party shall be responsible for receiving and responding to complaints and requests for
information from patients and others regarding the Product sold by it and each Party shall
provide reasonable assistance to the other Party in responding to such complaints and requests
for information and shall be responsible for investigating and resolving any complaints. Within
thirty (30) days following the end of each calendar month during the term of the Agreement,
each Party shall provide the other Party with a written report detailing complaints regarding
the Product received during such month, provided that each Party shall notify the other Party
of any serious adverse events within two (2) days following notice to either Party of such
serious adverse event. During the term of this Agreement, each Party shall make available to
the other Party information about the Product as may be necessary to carry out the provisions
and purposes of this Agreement and the U.S. Agreement, including without limitation general
medical information relating to the Product’s storage, use and safety. Each Party shall provide
prompt written notice to the other Party, including relevant references, of any information
which the Party giving notice believes in its reasonable judgment is material for medical
information services. Material information shall include, but not be limited to, published or
unpublished reports or other clinical or laboratory data received by either Party about Product
safety, contraindications, treatment programs in the indications specified by the approved
Product insert, stability, storage and shipping, pharmacology, and other information that
either Party believes in its reasonable judgment is relevant to safe and effective Product use.
The Party giving notice shall provide reasonable follow-up information and prompt written
replies to verbal or written questions from the other Party pertinent to medical information
services about the Product. On a periodic basis as agreed by both Parties, but no less than
annually, each Party shall provide the other Party a written summary of information about the
Product, which in the reasonable judgment of the Party providing the information, is material
for the medical services information of the other Party.”

	 	12.	 	The penultimate sentence of Section 4 (t) is amended to read as follows:

 

 

“If the Product defect causing the corrective action shall be found to result solely from one
of the Party’s , its Affiliates’ or sublicensees’ marketing, use or sale of the Product, then
the costs and expenses of such corrective action shall be paid by such Party.”

	 	13.	 	A new sentence is added following the end of the Section 4 (t) to read as follows:

“The Licensor shall be responsible for the costs of any corrective action (i) outside of the
Territory and (b) within the Territory, if found to result solely from the manufacture and
supply of the Product hereunder.”

	 	14.	 	The first paragraph of Section 5 (a) is amended to read as follows:

“The Purchase Price to be paid by the Licensee for the Product in Finished Packaged Form shall
be the Base Price of thirty percent (30%) of Net Sales, whichever is greater, unless otherwise
agreed as contemplated in paragraph 4 (q).”

	 	15.	 	The second paragraph of Section 5 (a) (which, for the avoidance of doubt, begins with
“Whether the Net Sales were made..” and ends with “..from the reference of the dispute or
difference.”) is deleted in its entirety and not replaced.
	 
	 	16.	 	Section 5 (f) is deleted and not replaced.
	 
	 	17.	 	The last sentence of Section 13 is amended to read as follows:

“In the event that the Licensee shall continue to market the Product under the terms of this
Agreement for twenty-five (25) years from the Effective Date in the European Union and Canada,
Licensee shall thereafter own the Trademarks and related goodwill in the Territory.”

	 	18.	 	The address of Ares Trading S.A. referred to in Section 17 is Ares Trading SA, c/o
Zone Industrielle de l’Ouriettaz, 1267 Coinsins, Switzerland. A copy of each notice to
Licensee shall be sent to General Counsel, Serono International SA, 9 chemin des Mines,
1202 Geneva, Switzerland. The address of Columbia Laboratories (Bermuda) Ltd., referred to
in Section 17 is Canon’s Court, 22 Victoria Street, PO Box HM 1179, Hamilton HM 12,
Bermuda. A copy of each notice to Licensor shall be sent to General Counsel, Columbia
Laboratories, Inc., 354 Eisenhower Parkway, Livingston, New Jersey 07039, USA.
	 
	 	19.	 	Effectiveness. This Amendment shall enter into effect as of the Closing Date (as such
term is defined in the U.S. Agreement).
	 
	 	20.	 	Counterparts; Fax; Signatures. This Amendment may be executed in any two (2)
counterparts, including by facsimile, each of which, when executed, shall be deemed to be
an original and both of which together shall constitute the one and same document.
	 
	 	21.	 	Full Force and Effect. Except as set forth in this Amendment and in the U.S.
Agreement, the License and Supply Agreement shall remain in full force and effect.

 

 

IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed and delivered by their
respective duly authorized officers.

ARES TRADING S.A.

	 	 	 	 	 
	By:

	 	/S/ Francois Naef
 

	 	 
	 

	 	Name: Francois Naef	 	 
	 

	 	Title: Senior Executive Vice President	 	 
	 
	 	 	 	 
	By:

	 	/S/ Franck Latrille	 	 
	 

	 	 	 	 
	 

	 	Name: Franck Latrille	 	 
	 

	 	Title: Senior Executive Vice President	 	 

COLUMBIA LABORATORIES (Bermuda), Ltd.

	 	 	 	 	 
	By:

	 	/S/ Robert S Mills
 

	 	 
	Name:

	 	Robert S Mills	 	 
	Title:

	 	President	 	 

SIGNATURE PAGE TO AMENDMENT NO. 1

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