Document:

Exhibit
10.11

AMENDED
AND RESTATED

CERTIFICATE OF DESIGNATION

OF

SERIES A PREFERRED STOCK

OF

FUND AMERICAN COMPANIES, INC.

 

 

Pursuant
to Section 151 of the General

Corporation
Law of the State of Delaware

 

 

FUND AMERICAN COMPANIES,
INC., a Delaware corporation (the "Corporation”), certifies that pursuant
to the authority contained in its Certificate of Incorporation, as amended, and
in accordance with the provisions of Section 151 of the General Corporation Law
of the State of Delaware, its Board of Directors (the “Board of Directors”) has
adopted the following resolution creating a series of its preferred stock, par
value $1.00 per share, designated as Series A Preferred Stock:

 

RESOLVED, that a series of
the class of authorized preferred stock, par value $1.00 per share, of the
Corporation be hereby created, and that the designation and amount thereof and
the voting powers, preferences and relative, participating, optional and other
special rights of the shares of such series, and the qualifications, limitations
or restrictions thereof are as follows:

 

Section 1.  Designation and Amount.  The shares of such series shall be designated
as the “Series A Preferred Stock” (the “Series A Preferred Stock”) and the
number of shares constituting such series shall be 300,000.

 

Section 2.  Dividends and Distribution.  (a) 
The holders of shares of Series A Preferred Stock, in preference to the
holders of shares of the common stock, par value $1.00 per share (the “Common
Stock”), of the Corporation and of any other shares of any other class or
series of capital stock of the Corporation (such Common Stock and other capital
stock to be referred to collectively as “Junior Stock”), shall be entitled to
receive, when, as and if declared by the Board of Directors out of net profits
or net assets of the Corporation legally available for the payment of
dividends, cumulative dividends payable in cash at the quarterly rate of
$23.5475 per share, and no more, in equal quarterly payments on March 31, June
30, September 30 and December 31 (or if any of such days is not a Business Day,
the Business Day next preceding such day) in each year (each such date being
referred to herein as a “Quarterly Dividend Payment Date” and any dividend not
paid on such date being referred to herein as “past due”), commencing on the
first Quarterly Dividend Payment Date, which is expected to be March 31,
2001.  The Board of Directors may fix a
record date for the determination of holders of shares of Series A Preferred
Stock entitled to receive payment of a dividend declared thereon,

 

 

 

 

 

which record date shall be no
more than 60 days nor less than 10 days prior to the date fixed for the payment
thereof.

 

(b)  Dividends payable pursuant to paragraph (a)
of this Section 2 shall begin to accrue and be cumulative from the date of
original issue of the Series A Preferred Stock. 
The amount of dividends so payable shall be determined on the basis of a
91.25 day quarter.  On the first Quarterly
Dividend Payment Date, the holders of shares of Series A Preferred Stock shall
be entitled pursuant to this paragraph (b) to receive, when, as and if declared
by the Board of Directors out of the net profits or net assets of the
Corporation legally available for the payment of dividends, a cumulative cash
dividend per share in the amount of (i) $23.5475 multiplied by (ii) a fraction
equal to the number of days from (but not including) such date of original
issue to (and including) the first Quarterly Dividend Payment Date divided by
91.25, and no more.

 

(c)  If any applicable dividend payment or
redemption payment is not made on a Quarterly Dividend Payment Date or the date
set for such redemption, respectively, thereafter all such dividend payments
and redemption payments that are past due and unpaid shall accrue and accumulate
additional dividend amounts at a quarterly rate of 2.35475% compounded each
quarter with respect to any amounts past due, with the amount of such
additional dividend amounts added to such amounts past due until all such
amounts past due shall have been paid in full (or declared and funds sufficient
therefor Set Apart for Payment).

 

(d)  If any dividend or redemption payment on the
Series A Preferred Stock is not paid when due, the Corporation shall be
prohibited from declaring, paying or setting apart for payment any dividends or
making any other distributions on any Junior Stock, and from redeeming,
purchasing or otherwise acquiring (or making any payment to or available for a
sinking fund for the redemption, purchase or other acquisition of any shares of
such stock) (either directly or through any Subsidiary) any shares of Junior
Stock, until all (i) Accrued Dividends and (ii) redemption payments that are
past due are paid in full.  Dividends
paid on the shares of Series A Preferred Stock in an amount less than the total
amount of such Accrued Dividends payable and due on such shares shall be
allocated pro rata on a share-by-share basis among all such shares at the time
outstanding.

 

(e)  The holders of shares of Series A Preferred
Stock shall not be entitled to receive any dividends or other distributions
except as provided in this Certificate of Designation.

 

Section 3.  Voting Rights.  The holders of shares of Series A Preferred
Stock shall have no voting rights, and their consent shall not be required for
the taking of any corporate action, except:

 

(a)  for any voting rights provided in the
Corporation’s Certificate of Incorporation, as it may be amended or restricted
from time to time (the “Certificate of Incorporation”);

 

 

2

 

(b)  for any voting rights required by the General
Corporation Law of the State of Delaware; and

 

(c)  for so long as any shares of Series A
Preferred Stock shall be outstanding, the Corporation shall not amend, alter or
repeal the Certificate of Incorporation or this Certificate of Designation or
otherwise alter or change the preferences, rights or powers of the Series A
Preferred Stock, in each case in a manner that adversely affects the
preferences, rights or powers of the Series A Preferred Stock or increases the
authorized number of shares of Series A Preferred Stock, without first
obtaining the consent or approval of the holders of at least two-thirds of the
number of then-outstanding shares of Series A Preferred Stock, voting as a
single class, given in person or by proxy at a meeting at which the holders of
such shares shall be entitled to vote separately as a class, or by written
consent.

 

Section 4.  Certain Restrictions.  So long as any shares of Series A Preferred
Stock are outstanding, the Corporation and its Subsidiaries shall not declare
or pay any dividend or distribution on Junior Stock or repurchase any shares of
Junior Stock or make any loan to, or guarantee any indebtedness of, White
Mountains Insurance Group, Ltd. (“WTM”) or any Subsidiary of WTM (other than
the Corporation or any of its Subsidiaries), without the written consent of the
holders of a majority of the number of outstanding shares of Series A Preferred
Stock, unless the amount of such dividend, distribution, repurchase, loan or
guarantee by the Corporation or a Subsidiary of the Corporation is less than,
without duplication, (a) the sum of (i) the Corporation’s aggregate
consolidated net income (determined in accordance with United States generally
accepted accounting principles) since January 1, 2001, and (ii) the aggregate
fair market value of any contributions made by WTM or any Subsidiary of WTM
(other than the Corporation or any of its Subsidiaries) since November 30, 2004
to the Corporation or any of its Subsidiaries as either a purchase of Junior
Stock or a capital contribution in respect of existing Junior Stock, which
contributions were not required to be made by WTM or any such Subsidiary of WTM
by any contract or agreement between WTM and the Corporation in existence on
November 30, 2004 minus (b) the sum of (x) the aggregate dividends and
distributions previously paid by the Corporation since January 1, 2001
(provided that, for this purpose, the distribution to Fund American Enterprises
Holdings, Inc., a Delaware corporation, of (A) all of the outstanding shares of
White Mountains Re Holdings, Inc., a Delaware corporation (“WTM Re Holdings”),
(B) all of the outstanding shares of Esurance, Inc., a Delaware corporation
(“Esurance”), owned by the Corporation, (C) the $42,600,000 promissory note
(plus accrued interest and related charges thereon), issued by Esurance, dated
as of March 8, 2001, (D) the 3-year, $150,000,000 note (plus accrued interest
and related charges thereon) issued by White Mountains Re Group, Ltd., a
company existing under the laws of Bermuda, dated as of December 10, 2003, (E)
the 7-year, $150,000,000 senior debenture (plus accrued interest and related
charges thereon) issued by WTM Re Holdings, dated as of November 30, 2004, (F)
the 10-year, $150,000,000 senior debenture (plus accrued interest and related
charges thereon) issued by WTM Re Holdings, dated as of November 30, 2004 and
(G) the 30-year, $200,000,000 junior subordinated debenture

 

 

3

 

 

(plus accrued interest and
related charges thereon) issued by WTM Re Holdings, dated as of November 30,
2004, shall be deemed to be a distribution of $200.0 million), (y) any Accrued
Dividends that are past due and any past due dividends then due to be paid on
equity securities of the Corporation other than the Common Stock (except to the
extent that any such Accrued Dividends or past due dividends otherwise reduce
the Corporation’s aggregate consolidated net income) and (z) the aggregate principal
amount of any other then outstanding indebtedness (plus accrued interest and
other related charges thereon) of WTM or any Subsidiary of WTM (other than the
Corporation or any of its Subsidiaries) guaranteed by or payable to the
Corporation or any of its Subsidiaries (other than guarantees or indebtedness
permitted by the proviso hereto); provided, however, that notwithstanding this
restriction and in addition to what is permitted pursuant thereto, unless
prohibited by Section 2(d) hereof, (1) aggregate dividends not in excess of
$20.0 million (in addition to any dividends paid on the Series A Preferred
Stock) may be paid by the Corporation in each of calendar years 2001, 2002 and
2003 and (2) the Corporation or any of its Subsidiaries may make loans to WTM
or any Subsidiary of WTM (other than the Corporation or any of its
Subsidiaries) and unconditionally guarantee payment of indebtedness (plus
accrued interest and other related charges thereon) of WTM or any such
Subsidiary of WTM (provided any demand for payment in connection with amounts
guaranteed must first be made on WTM or the applicable Subsidiary of WTM,
unless WTM or the applicable Subsidiary of WTM is the subject of a voluntary or
involuntary proceeding under Federal or state bankruptcy, insolvency or similar
law) of up to $150.0 million principal amount in such loans and guaranteed
indebtedness.  For the avoidance of
doubt, this Section 4 shall not prohibit any transactions between the
Subsidiaries of the Corporation or between the Corporation and any of its
Subsidiaries.

 

Section 5.  Redemption.  (a)  On
May 31, 2008 (the “Redemption Date”), if any shares of Series A Preferred Stock
remain outstanding, the Corporation shall (i) redeem all outstanding shares of
Series A Preferred Stock by paying therefor in cash $1,000 per share and (ii)
cause the declaration, as payable, of all Accrued Dividends on the outstanding
shares of Series A Preferred Stock to the Redemption Date and shall pay all
such declared Accrued Dividends.  The
amount payable in connection with the redemption of all of the outstanding
shares of Series A Preferred Stock pursuant to this Section 5 shall be referred
to as the “Redemption Price”.  For the
period beginning on the first day after the immediately preceding Quarterly Dividend
Payment Date and ending on the Redemption Date, the holders of shares of Series
A Preferred Stock shall be entitled to receive a cash dividend per share in the
amount of (i) $23.5475 multiplied by (ii) a fraction equal to the number of
days in such period divided by 91.25. 
Except as provided in this Section 5(a), the Corporation shall not have
any right or obligation to redeem any share of Series A Preferred Stock.

 

(b)  Notice of the redemption of shares of Series
A Preferred Stock pursuant to Section 5(a) shall be mailed no more than 60 days
nor less than 30 days prior to the Redemption Date to each holder of shares of
Series A Preferred Stock to be redeemed, at such holder’s address as it appears
on the transfer books of the Corporation.

 

 

4

 

 

In order to facilitate the
redemption of shares of Series A Preferred Stock, the Board of Directors may
fix a record date for the determination of shares of Series A Preferred Stock
to be redeemed no more than 60 days nor less than 30 days prior to the
Redemption Date.

 

(c)  On or prior to the Redemption Date, the
Corporation shall Set Apart for Payment the Redemption Price and thereafter the
shares of Series A Preferred Stock shall be deemed to have been redeemed on the
Redemption Date, whether or not the certificate(s) for such shares of Series A
Preferred Stock shall be surrendered for redemption and cancelled.  Upon surrender to the Corporation by the
holders of such certificate(s) for shares of Series A Preferred Stock, the
Corporation shall cause the Redemption Price to be paid to such holders.

 

Section 6.  Reacquired Shares.  Any shares of Series A Preferred Stock
redeemed, purchased or otherwise acquired by the Corporation in any manner
whatsoever shall be retired and cancelled promptly after the acquisition
thereof, and, if necessary to provide for the lawful redemption or purchase of
such shares, the capital represented by such shares shall be reduced in
accordance with the General Corporation Law of the State of Delaware.  All such shares shall upon their cancellation
become authorized but unissued shares of preferred stock, par value $1.00 per
share, of the Corporation and may be reissued as part of another series of
preferred stock, par value $1.00 per share, of the Corporation.

 

Section 7.  Liquidation, Dissolution or Winding Up.  (a)  If
the Corporation shall adopt a plan of liquidation or of dissolution, or
commence a voluntary case under the Federal bankruptcy laws or any other
applicable state or Federal bankruptcy, insolvency or similar law, or consent
to the entry of an order for relief in any involuntary case under any such law
or to the appointment of a receiver, liquidator, assignee, custodian, trustee
or sequestrator (or similar official) of the Corporation or of any substantial
part of its property, or make an assignment for the benefit of its creditors,
or admit in writing its inability to pay its debts generally as they become due
and on account of such event the Corporation shall liquidate, dissolve or wind
up, or upon any other liquidation, dissolution or winding up of the
Corporation, no distribution shall be made to the holders of shares of Junior
Stock, unless, prior thereto, the holders of shares of Series A Preferred Stock
shall have received $1,000 per share plus all Accrued Dividends thereon to the
date of such payment.

 

(b)  Neither the consolidation, merger or other
business combination of the Corporation with or into any other Person or
Persons nor the sale, lease, exchange or conveyance of all or any part of the
property, assets or business of the Corporation to a Person or Persons shall be
deemed to be a liquidation, dissolution or winding up of the Corporation for
purposes of this Section 7.

 

Section 8.  Rank. 
The Series A Preferred Stock shall rank, with respect to preferences and
relative, participating, optional and other special rights of the shares of
such series and the qualifications, limitations and restrictions thereof,
including, without

 

 

5

 

 

limitation, with respect to
the payment of dividends and redemption payments and the distribution of
assets, whether upon liquidation or otherwise, prior to all shares of Junior
Stock of the Corporation.

 

Section 9.  Definitions.  For the purposes of this Certificate of
Designation:

 

“Accrued Dividends”, with
respect to a particular date (the “Applicable Date”), means all unpaid
dividends payable pursuant to Section 2 and/or Section 5, whether or not
declared, accrued to the Applicable Date, including any additional dividend
amounts accrued on past due dividend or redemption payments pursuant to Section
2(c).

 

“Business Day” means any day
other than a Saturday, Sunday, or a day on which banking institutions in the
State of New York are authorized or obligated by law or executive order to
close.

 

“Person” shall mean any
person or entity of any nature whatsoever, specifically including an
individual, a firm, a company, a corporation, a partnership, a trust or other
entity.

 

“Set Apart for Payment” shall
mean the Corporation shall have deposited with a bank or trust company doing
business in the Borough of Manhattan, the City of New York, and having a
capital and surplus of at least $50,000,000, in trust for the exclusive benefit
of the holders of shares of Series A Preferred Stock, funds sufficient to
satisfy the Corporation’s payment obligation.

 

“Subsidiary” of any Person
means any corporation or other entity of which a majority of the voting power
of the voting equity securities or equity interest is owned, directly or
indirectly, by such Person.

 

 

6

 

 

[This
page intentionally left blank.]

 

 

7

 

IN WITNESS WHEREOF, the
Corporation has caused this Amended and Restated Certificate of Designation to
be duly executed by its [                     
] and attested to by its Secretary and has caused its corporate seal to
be affixed hereto, this          day
of                , 2004.

 

 

 

                                                                                                                FUND
AMERICAN COMPANIES,

                                                                                                                INC.

 

 

 

                                                                                                                By

 

 

 

ATTEST:

 

 

 

 

 

Secretary

 

 

8Exhibit 10.1

 

SUPPLY AGREEMENT

 

THIS AGREEMENT (the “Agreement”), entered into as of this
24th day of January 2006 (the “Effective Date”), by and among Cambrex Charles
City, Inc. (“CCC”), a corporation organized under the laws of Iowa with a place
of business at 1205 11th Street, Charles City, Iowa 50616-3466,
Genzyme Corporation, a Massachusetts corporation with a place of business at 500 Kendall Street, Cambridge,
Massachusetts 02142 (“Genzyme” or “Purchaser”).

 

W
I T N E S S E T H:

 

WHEREAS, on November 9, 1999, Salsbury Chemicals, Inc.
(nka Cambrex Charles City, Inc.) and GelTex Pharmaceuticals, Inc. entered into
a Supply Agreement governing the supply of Polyallylamine Hydrochloride (PAA)
to GelTex by CCC (the “1999 Agreement”).

 

WHEREAS, Genzyme is the successor in interest to
GelTex Pharmaceuticals, Inc. under the 1999 Agreement.

 

WHEREAS, Genzyme sublicensed certain patent rights
(the “Patent Rights”) obtained from Nitto Boseki Co. Ltd. (“Nittobo”) to CCC
pursuant to the terms of a sublicense agreement dated July 10, 1997 (the “Sublicense
Agreement”) and CCC has experience in the production of PAA, as further
described in Exhibit A hereto (the “Product”);

 

WHEREAS, Cambrex Karlskoga, a corporation
organized under the laws of Sweden with a place of business at SE-691 85
Karlskoga, Sweden (“Karlskoga”) and Genzyme assigned the Patent Rights to
Karlskoga pursuant to the terms of the Sublicense Agreement;

 

WHEREAS, for purposes of this Agreement,
the term “Affiliate” shall mean any corporation or other entity that controls,
is controlled by, or is under common control with a party. A corporation or
other entity shall be regarded as in control of another corporation or entity
if it owns or directly or indirectly controls more than fifty percent (50%) of
the voting stock or other ownership interest of the other corporation or
entity, or if it possesses directly or indirectly, the power to direct or cause
the direction of the management and policies of the corporation or other entity
or the power to elect or appoint more than fifty percent (50%) of the members
of the governing body of the corporation or other entity;

 

WHEREAS, Genzyme requires the Product for the
production of certain non-absorbed phosphate binders (including Renagel® and
any other nonabsorbed phosphate binder produced by Genzyme) and a non-absorbed
cholesterol reducer (Cholestagel®) (hereinafter be referred to collectively as “End
Products”);

 

WHEREAS, the primary raw material for the manufacture
of Product is monoallylamine (“MAA”);

 

WHEREAS, the End Products may be manufactured by
certain third party manufacturers identified in writing to CCC (the “Contract
Manufacturers”) and will be marketed and sold by certain third party
collaborators identified in writing to CCC (the “Collaborators”);

 

WHEREAS, CCC is willing to sell to Genzyme and
Genzyme, either directly or through its Contract Manufacturers, is willing to
purchase from CCC, Product manufactured by CCC in accordance with the price and
other terms set forth herein;

 

 

 

WHEREAS, Genzyme and CCC desire to extend its supply
relationship and replace the 1999 Agreement with this Agreement, effective on
the Effective Date hereof.

 

NOW,
THEREFORE, the parties hereto agree as follows:

 

ARTICLE
I

MANUFACTURE
AND SALE

 

1.01                        Supply.       During the term of this Agreement
and subject to the terms and conditions set forth herein, CCC shall manufacture
and supply to Genzyme and Genzyme shall purchase [                              ]*
of its annual requirements of the Product from CCC. For purposes hereof, Genzyme’s
annual requirements shall include the annual requirements of the Collaborators
and Contract Manufacturers having an obligation to obtain Product through
Genzyme. Genzyme’s Maximum Purchase Volume (MPV) in any one calendar year shall
be [                              ]*.
Should Genzyme's MPV exceed such amount, the parties shall work in good faith
to increase the capacity.

 

1.02                        Safety Stock.  During the Term of this
Agreement, CCC shall maintain a [                              ]*
of Product as safety stock; provided that Genzyme’s total annual purchase
volume exceeds [                        ]*.
Such amount shall be determined based on monthly average of the annual forecast
for Product to be delivered to Haverhill, U.K.

 

1.03                        Quality of Product.  CCC
agrees to manufacture the Product to meet the specifications set forth in
Exhibit A hereto (the “Specifications”), and in accordance with all applicable
regulatory requirements relating to the manufacture of the Product and the
terms and conditions of the Technical Agreement, which is attached hereto as
Exhibit B (the “Technical Agreement”), and shall not deviate in any way
whatsoever therefrom without the written permission of a duly authorized
representative of the Purchasers.

 

1.04                        Secondary Source of Supply.  Genzyme has qualified
Product produced at Karlskoga for use at Genzyme in Haverhill UK, and may
qualify other CCC Affiliates, as a secondary supplier of Product. CCC may only
use such secondary suppliers of Product qualified by Genzyme to manufacture
such portion [                              ]*
as CCC shall determine. In [                     ]*,
Genzyme will use commercially reasonable efforts to arrange for Product
manufactured at [                              ]*.
Notwithstanding its use of a secondary source of supply, CCC shall remain
obligated to supply Genzyme with the quantities of Product described in Section
1.01, and CCC shall be solely responsible for ensuring that all Product
manufactured for Genzyme, whether by CCC or another Affiliate of CCC, satisfies
the quality requirements and meets the warranties sets forth in this Agreement.
If requested by Genzyme, CCC shall use commercially reasonable efforts to cause
the secondary source to enter into a Technical Agreement with Genzyme in a timely
manner.

 

ARTICLE
II

TERM

 

2.01                        Term.                The term of this Agreement shall
commence on the Effective Date and shall terminate [                              ]*
(the “Initial Term”), and is not subject to earlier cancellation by either
party except as otherwise specifically provided herein.

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

 

2.02                        Renewal Term.              The Agreement shall automatically
renew after the Initial Term and continue in effect for [            ]*
periods (each such period being a “Renewal Term”).

 

2.03                        Cancellation.                        Should either party desire to cancel
the Agreement at the end of the Initial Term or at the end of any Renewal Term,
then such party must provide written notice of cancellation to the other party [                              ]*
prior to the termination date of the Initial Term or the relevant Renewal Term,
as the case may be.

 

2.04                        Extension.                                       CCC or Genzyme has the option to
open negotiations on the extension of this Agreement [              ]*
prior to its expiration.

 

ARTICLE
III

PRICE,
ORDERS AND TERMS OF PAYMENT

 

3.01                        Price.                   The Price for the Product is as set
forth in Schedule 3.01 hereof. The Price for Product purchased from [                              ]*
through [                              ]*
shall be adjusted as set forth in Schedules 3.01 and 3.01a, hereof. The Price
for Product purchased from [                              ]*
through [                              ]*
shall be adjusted as set forth in Section 3.02 and Schedule 3.01.

 

3.02                        Price Revision January 1, 2007 -
December 31, 2013 Purchases.   The Price, excluding the
contribution of [              ]*
(the “Base Price”) will be subject to an annual [                              ]*
over the actual price determined for the prior year commencing on January 1,
2007, considering [                              ]*
as set forth in Schedule 3.01. Further, the portion of the Price [                              ]*,
will also be adjusted based upon the [                              ]*
for the upcoming year and [                              ]*.
At the end of each contract year, the [                              ]*
will be determined and any difference in projected price will be invoiced to
Genzyme or credit made to its account. The contribution for [                              ]*
is forecast to be [                    ]*
for each kilogram of Product produced, based upon a price of [            ]*
(plus freight, insurance and applicable duty) 
per kilogram of [               ]*.
Genzyme has the option to independently negotiate the price and supply of [                                       ]*.
The parties also agree to negotiate in good faith [                              ]*
in the event of [                              ]*.

 

3.03                        Rebate.      If this Agreement is executed by the
parties by [                              ]*
(unless a later date is mutually agreed to by the parties) and if Genzyme
orders and takes title to at least [                   ]* of Product between [                              ]* and [                              ]* then CCC shall provide Genzyme a rebate of [                  ]*,
paid through a credit to the Genzyme account for Product.

 

3.04                        Projections.                                 Genzyme or its Contract
Manufacturers shall issue at quarterly intervals a twelve (12) month non
binding forecast estimating its total requirements of Product from CCC
(Forecast). CCC will use these forecasts for planning purposes only, unless and
until such time as Genzyme issues a firm purchase order for delivery of
Product. If during any quarter, the quantity set forth in firm purchase orders
requested by Genzyme exceeds the most recent forecast provided for such quarter
by more than [                              ]*,
CCC shall use its best efforts to accommodate any increases in the quantity of
Product which Genzyme shall request under new purchase orders.

 

3.05                        Purchase Orders.      Quarterly, Genzyme or its Contract
Manufacturers shall submit purchase orders for firm orders of Product with each
rolling forecast issued pursuant to Section 3.04, above. Such purchase orders
shall be firm orders covering the first three months of the

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

 

Forecast and set forth the
quantities of Product to be purchased, the delivery dates and shipping
instructions and place of delivery, and shall allow at least [                         ]*
days for delivery. Each purchase order issued hereunder shall be governed by
the terms of this Agreement, and none of the terms or conditions of Genzyme’s
or CCC’s forms shall be applicable, except for those specifying quantity
ordered, delivery dates, special supply and packing instructions, and invoice
instructions.

 

3.06                        Payment Terms.       Payment for the Product shall be due
to CCC not later than [                          ]*
days from the date of invoice of Product by CCC. All payments and
communications regarding the Product shall be delivered to CCC at the address
designated in Section 9.06 hereof.

 

ARTICLE
IV

DELIVERY
AND TITLE

 

4.01                        Terms of Delivery.    [                              ]*

 

4.02                        Manufacture of Product.

 

A.                                    All Product delivered under this
Agreement shall be manufactured in compliance with the terms and conditions of
the Sublicense Agreement.

 

B.                                    The Product shall be manufactured in
accordance with all applicable regulatory standards and the Technical Agreement.
CCC shall be responsible for maintaining or causing to be maintained, on behalf
of Genzyme, the retention samples of the Product required by applicable
regulatory standards.

 

C.                                    CCC shall provide the current
Material Safety Data Sheet (MSDS) to Genzyme for all Product delivered
hereunder.

 

D.                                    CCC will maintain, and will cause
any Affiliate to maintain, complete and accurate records relating to the
Product and the manufacture, packaging and testing thereof for the period
required by applicable regulatory standards. Without limiting the generality of
the foregoing, CCC shall or shall cause any Affiliate to:

 

1)                                     perform quality assurance and
control tests on each lot of Product manufactured before delivery and shall
prepare and deliver to Genzyme a written report of the results of such tests,
with each report setting forth for each lot delivered the items tested, specifications
and results in a Certificate

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

 

of Analysis containing the types
of information required by applicable regulatory standards, and

 

2)                                     prepare and maintain for a period of
not less than [                              ]*
and for so long as required under applicable regulatory standards for each lot
of Product manufactured a certificate of manufacturing compliance containing
the types of information required by applicable regulatory standards, which
will certify that the lot of Product was manufactured in accordance with
Specifications and cGMPs.

 

E.                                     Each party shall promptly advise the
other of any safety or toxicity problem of which either party becomes aware
regarding the Product or intermediates used in the manufacture of the Product.

 

F.                                      The parties shall make their best
efforts to facilitate the incorporation of process improvements approved by
Genzyme into the Product manufacturing scheme.

 

4.03                        Inspection.    Within a
reasonable time of arrival of the Product at Genzyme’s facility or the facility
of a Contract Manufacturer, as the case may be, the recipient of the Product
shall inspect and test the Product at its cost. If the party testing the Product
finds that the Product does not conform to the Specifications, Genzyme shall
within [                              ]*
after the date of such arrival, give CCC written notice of any claim setting
forth the details of such non-conformity and any payment for such
non-conforming Product shall be delayed until conforming Product has been
accepted. CCC shall replace, at its expense, any non-conforming Product within [                              ]*
after CCC receives the above mentioned written notice. This procedure shall
continue until such time as the recipient of the Product shall determine that
the Product conforms to the Specifications. Disputes between the parties as to
whether all or any part of a shipment rejected conforms to the Product
Specifications shall be resolved by a mutually acceptable third-party testing
laboratory.

 

4.04                        Plant Visits.    CCC shall,
and shall cause any Affiliate to permit representatives of Genzyme and / or its
Collaborators, to visit the facilities where the Product is manufactured for
the purpose of reviewing the manufacture and testing of the Product and related
batch records and of conducting compliance audits associated with cGMPs and
other regulatory requirements. Genzyme agrees to give CCC and any Affiliate, as
the case may be reasonable notice of any proposed visit to a Product facility
by a Genzyme representative or a Collaborator representative. Any such visits
shall be during normal business hours on work days and be subject to a standard
confidentiality agreement. In addition, CCC shall, and shall cause any
Affiliate to, permit governmental inspectors acting pursuant to statutory
authority to inspect the facilities where the Product is being manufactured,
and to review required documentation. CCC shall notify Genzyme in advance of
any planned visit by a governmental inspector and shall promptly notify Genzyme
following an unscheduled visit by a governmental inspector; provided such
visits are related to the manufacture of Product.

 

4.05                        Audit Rights.    CCC agrees
to provide Genzyme with such financial information as Genzyme may reasonably
request in order that Genzyme may verify that any revisions to the Base Price
permitted under Section 3.02 and Schedule 3.01 hereof have been accurately
calculated.

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

 

ARTICLE
V

WARRANTIES,
INDEMNITIES AND INSURANCE

 

5.01                        Warranties.

 

A.                                    CCC warrants that

 

1)                                     Product delivered pursuant to this
Agreement (whether manufactured by CCC or another CCC Affiliate) shall (i)
conform with the Specifications, (ii) be manufactured in accordance with
applicable regulatory standards, (iii) be conveyed with good title, free from
any lawful security interests, lien or encumbrance, and (iv) if applicable
shall not be adulterated or misbranded within the meaning of the Federal Food,
Drug and Cosmetic Act for manufacturers of active pharmaceuticals ingredients;
provided, however, that CCC shall not be liable for misbranding or adulteration
which is due to any labelling, instructions or packaging provided to CCC by
Genzyme; and,

 

2)                                     the facility used to manufacture the
Product is in substantial compliance with all applicable regulatory
requirements and there are no pending or uncorrected citations or adverse
conditions affecting the manufacture of Product noted in any inspection of the
facility.

 

CCC MAKES NO OTHER WARRANTIES,
EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCT. ALL OTHER WARRANTIES, EXPRESS
OR IMPLIED, INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY DISCLAIMED BY
CCC.

 

B.                                    Genzyme warrants that it is
authorized to license the Patent Rights to CCC and Karlskoga and other CCC
Affiliates and that the Contract Manufacturers identified to CCC are authorized
and accepted by Nittobo.

 

C.                                    It is understood and agreed that CCC
has no control over the ultimate use of the Product or use of products that
include or were manufactured with the Product, and CCC shall have no liability
in connection with any such use except as may be set forth below.

 

5.02                        Specifications.                 Genzyme shall deliver to CCC written
notice of any required changes to the Specifications, and CCC will use its best
efforts to accommodate such Specification changes. If any specification change
requested affects CCC’s costs of producing the Product, the parties will
negotiate, in good faith, any increases to the pricing set forth in Sections
3.01 and 3.02 hereof.

 

5.03                        [                              ]*

 

A.                                    Genzyme.   [                              ]*

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

 

B.                                    CCC.                  [                              ]*

 

5.04                        [                              ]*

 

5.05                        Patent.            [                              ]*

 

5.06                        [                              ]*
Procedures.   [                              ]*

 

5.07.                     Minimum Insurance Coverage Limits:                                 Without limiting the scope of its
aforementioned defense, hold harmless and indemnity duties, each party shall maintain at
its sole cost and expense the following insurance; provided that the parties
may self insure all or any

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

 

portion of such insurance. The insurance required
hereunder should include at least the following terms and conditions:

 

A.                                    Policies and Limits.

[                              ]*

 

B.                                    CGL Features:  Said commercial general
liability insurance shall provide primary level coverage for bodily injury, personal
injury, advertising injury, death or property damage (or loss of use thereof)
occurring on, in or about any of the parties’ premises and/or arising out of
the parties’ “work,” which insurance shall be a primary policy. Coverage shall
be afforded with endorsements where necessary to cover risks for
premises-operations, completed operations-products, independent contractors,
and any other activity contemplated by the work.

 

C.                                    Additional Insured Requirements:  Except
for any portion of the insurance that is self-insured, each party will cause
the other to be named as an additional insured on each of the aforementioned
policies by specific endorsement (except Workers Compensation) unless the
insurer so designates the other party in writing under a “blanket” coverage
provision. A party’s additional insured status shall be applicable as to any
occurrence, accident or condition allegedly arising from the work of the other
party (including any of its employees, agents or contractors).

 

D.                                    Certificates of Insurance:  Before
commencing the “work,” each party shall furnish the other a true copy of a
certificate of coverage issued by the responsible insurance carrier or the
party referencing this Agreement, designating the other party as an “additional
insured.”

 

E.                                     Cancellation of Insurance: 
Before cancelling or replacing any insurance required under this
Agreement, each party shall give the other at least thirty (30) days written

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

 

notice, but only if such
replacement coverage diminishes the scope of the existing coverage. If a party
receives actual or constructive notice that insurance required under this
Agreement is to be terminated by an insurer, than that party shall give the
other party notice of such termination as soon as is commercially reasonable
after such party receives such notice, but in no case, more than two (2)
business days after receiving such notice.

 

F.                                      Occurrence v. Claims-Made. Provided such coverage is
reasonably commercially available, all
coverages required under this Agreement will be provided upon an occurrence
basis. When only claims-made coverage is available, each party will use
commerically reasonable efforts to either renew and maintain such coverages or
provide an extended reporting endorsement (tail coverage), provided such
coverage is reasonably commercially available.

 

G.                                    Carrier Rating. Except in the case of self-insurance, all
insurance required under this Agreement shall be placed with an insurer that
has an A.M. Best rating of A-(X) or better.

 

ARTICLE
VI

CONFIDENTIALITY

 

6.01                        Confidential Information.   Each Party shall maintain as confidential and
shall not disclose to a third party, copy, nor use for purposes other than the
performance of this Agreement, any information which relates to another Party’s
or its Affiliates’ business affairs, financial data, pricing, customer lists,
projects, economic information, systems, plans, procedures, operations,
techniques, technology, patent applications, trade secrets, know-how,
inventions, technical data or specifications, testing methods, research and
development activities, clinical studies (including, without limitation,
information related to the participants of such studies), marketing strategies,
the terms of this Agreement or other confidential or proprietary information
(hereinafter “Confidential Information”), and each agrees to protect that
Confidential Information with the same degree of care it exercises to protect
its own Confidential Information (but in no event less than a reasonable
standard of care) and to prevent the unauthorized, negligent, or inadvertent
use, disclosure, or publication thereof. The Parties agree that all
Confidential Information relating to Genzyme rights or property described in
Section 7.01 below shall be Genzyme Confidential Information. Each Party may
disclose Confidential Information of another Party only to its own employees,
consultants or advisors having a need to know for the purposes of this Agreement
(which may include, without limitation, temporary and contract employees,
attorneys, technical experts and accountants), provided always that such
employees, consultants and advisors have signed a non-disclosure agreement with
similar and sufficient clauses protecting the disclosure of confidential
information as contained herein or are otherwise bound by such a duty of
confidentiality.

 

6.02                        Exceptions. The obligations set forth in
Section 6.01 hereof shall not apply to any Confidential Information which the
receiving Party (in each instance a “Receiving Party”) can demonstrate: (i) is
or becomes a matter of public knowledge through no fault of the Receiving
Party; (ii) was rightfully in the Receiving Party’s possession in a complete
and tangible form before it was received from the disclosing Party (in each
instance, a “Disclosing Party”), (iii) is furnished to the Receiving Party on a
non-confidential basis from a third party, provided that such third party is
not bound by an obligation of confidentiality to the Disclosing Party with
respect to such Confidential Information; (iv) is independently developed by
the Receiving Party prior to receipt of

 

 

the Confidential Information; or (v) is
required to be disclosed to comply with applicable laws or regulations, or with
a valid order of a court or other governmental body of the United States or any
political subdivisions thereof, but only to the extent and for the purposes of
such required disclosure and provided that (a) the Disclosing Party is promptly
notified by the Receiving Party in order to provide the Disclosing Party an
opportunity to seek a protective order, and (b) the Receiving Party takes all
reasonable actions to obtain confidential treatment for such information and,
if possible, to minimize the extent of such disclosure.

 

6.03                        Publicity.                                              Except as may be required by
applicable laws and regulations or a court of competent jurisdiction, as
required to meet credit or other financing arrangements, or as required or
appropriate in the reasonable judgment of either party to satisfy the
disclosure requirements of any applicable securities law or regulation, neither
party shall make any public release or other disclosure with respect to this
Agreement or the terms hereof without the prior consent of the other party.

 

ARTICLE
VII

RIGHTS
TO PRODUCT

 

7.01                        Ownership.                                    Any and all improvements,
discoveries and/or inventions, whether or not patentable, which may be made or
conceived by CCC or any of the other CCC Affiliates manufacturing Product
during the Initial Term or any Renewal Term of this Agreement and which is
based on the Patent Rights, the Product or products using the Product, shall be
the sole and exclusive property of Genzyme. CCC shall provide and shall cause
any such CCC Affiliate to provide, full disclosure to Genzyme of all such
improvements, discoveries, and/or inventions described above, and shall execute
or cause to be executed any and all applications, assignments, or other
instruments which Genzyme shall deem necessary or useful in order to apply for
and obtain Letters Patent of the United States and all foreign countries for
discoveries and improvements believed to be inventions, and shall assign and
conveyor caused to be assigned and conveyed to Genzyme sole and exclusive
right, title, and interest in and to the discoveries and improvements and to
all patent applications and patents thereon. Genzyme will bear the cost of
preparation of all such patent applications. Notwithstanding the above, Genzyme
grants CCC a limited, perpetual, royalty-free, world-wide license for any
improvements, inventions or discoveries (whether or not patentable) conceived
by CCC during the Initial Term or any Renewal Term related to, or useful in
connection with the Product manufacturing process (i) for CCC’s use in the
manufacture of the Product and (ii) for CCC’s use in connection with the
manufacture of another product that is not a polyallylamine-based
pharmaceutical product and does not compete with the End Products.

 

ARTICLE
VIII

TERMINATION
FOR CAUSE

 

8.01 Early Termination.               This Agreement may be terminated by
either party as follows:

 

A.                                    By a party immediately upon written
notice by another party that it has filed or has had filed against it a
petition under the Bankruptcy Act, makes an assignment for the benefits of
creditors, has a receiver appointed for it or any of its assets.

 

B.                                    By a party if another party fails to
perform or otherwise breaches any of its material obligations hereunder, by
giving notice of its intent to terminate and stating the grounds therefore. The
party receiving such notice shall have ninety (90) days from receipt thereof if
such breach or failure involves a non-monetary obligation and

 

 

fifteen (15) days if the breach
or failure is regarding a monetary obligation, to cure the failure or breach,
at which time this Agreement shall terminate if such failure or breach has not
been cured. In no event, however, shall such notice of termination be deemed to
waive any rights to damages or any other remedy which the party giving notice
of breach may have as a consequence of such failure or breach.

 

8.02                        Effect of Termination.                      Termination of this Agreement, for
whatever reason, shall not affect the obligations of specified in Section 8.02
or Articles V, VI, VII and IX hereunder.

 

ARTICLE IX

GENERAL PROVISIONS

 

9.01                        Force Majeure.              Any delay in the performance of any of the
duties or obligations of either party hereto (except the payment of money)
caused by an event outside the affected party’s reasonable control shall not be
considered a breach of this Agreement and the time required for performance
shall be extended for a period equal to the period of such delay. Such events
shall include without limitation any delay of FDA approval for products
incorporating Product; government action or regulation, acts of God; acts of a
public enemy; insurrections; riots; injunctions; embargoes; fires; explosions;
floods; or other unforeseeable causes beyond the reasonable control and without
the fault or negligence of the party so affected. The party so affected shall
give prompt notice to the other party of such cause, and shall take whatever
reasonable steps are appropriate in that party’s discretion to relieve the
effect of such cause as rapidly as possible. Notwithstanding the foregoing or
anything else in this Agreement to the contrary, should the force majeure event
result in inability of a party to fully perform hereunder for a period of more
than nine (9) months, the other party shall have the right to immediately
terminate this Agreement.

 

9.02                        Assignment.                              No party shall assign this Agreement
or any part thereof without the prior written consent of the other parties;
provided however, a party, without such consent, may assign or sell the same in
connection with the transfer, license or sale of all or substantially all its
entire business to which this Agreement pertains, in the event of its merger or
consolidation with another company or in the event of the transfer or sale to a
wholly-owned subsidiary.

 

9.03                        Successors In Interest.                        This Agreement shall be binding upon
and inure to the benefit of the parties hereto, their subsidiaries, affiliates,
successors and permitted assigns. Assignment to an Affiliate or subsidiary
shall not release the party making such assignment from responsibility for its
obligations under this Agreement.

 

9.04                        Entire Agreement.                                               This Agreement and schedules and
exhibits thereto and the Technical Agreement, together shall constitute the
entire agreement between the parties hereto and shall supersede any other
agreements, whether oral or written, express or implied, as they pertain to the
Product. This Agreement may not be changed or modified except by written
instrument signed by both parties.

 

9.05                        Relationship.                         The relationship created by this
Agreement shall be strictly that of the buyer and seller. No party is hereby
constituted an employee, an agent or legal representative of the other party
for any purpose whatsoever, and is granted no right or authority hereunder to
assume or create any obligation, express or implied, or to make any
representation, warranties or guarantees, except as are expressly granted or
made in this Agreement.

 

 

9.06                        Notice.          Any notice required hereunder may be served by
either party on the other by personal delivery, or by sending same, post-prepaid,
by registered or by certified mail, or sent by facsimile to the respective
party’s address set forth below:

 

	
  CCC:

  	
  Cambrex Charles City, Inc.

  
	
   

  	
  1205 11th Street

  
	
   

  	
  Charles City, Iowa 50616-3466

  
	
   

  	
  Attention: Site Director

  
	
   

  	
  (fax 641-228-4152)

  
	
   

  	
   

  
	
  with a copy to:

  	
  Cambrex Corporation

  
	
   

  	
  One Meadowlands Plaza

  
	
   

  	
  East Rutherford, NJ 07073

  
	
   

  	
  Attention: General Counsel

  
	
   

  	
  (fax 201-804-9852)

  
	
   

  	
   

  
	
  Genzyme:

  	
  Genzyme Corporation

  
	
   

  	
  500 Kendall Street

  
	
   

  	
  Cambridge, Massachusetts 02142

  
	
   

  	
  Attention: Jim Shuman

  
	
   

  	
  (fax                               )

  
	
   

  	
   

  
	
  with a copy to:

  	
  Legal department

  
	
   

  	
  Metro West Place

  
	
   

  	
  15 Pleasant Street Connector

  
	
   

  	
  Framingham, MA 01701

  

 

or to such other address as one
party may notify the other as provided herein.

 

9.07                        Waiver.      A waiver by
any party for a breach of any of the terms of this Agreement by any other party
shall not be deemed a waiver of any subsequent breach of the terms of this
Agreement.

 

9.08                        Governing Law.      This
Agreement is to be governed by and construed in accordance with the laws of the
State of New York without reference to Choice of Law rules.

 

9.09                        Severability.                             If any provision of this Agreement
or the application of any of such provision to any person or circumstance shall
be held invalid, illegal or unenforceable in any respect by a court of
competent jurisdiction, such invalidity, illegality or unenforceability shall
not affect any other provisions thereof.

 

9.10                        Dispute Resolution.                                       Any controversy or claim arising out
of or relating to this Agreement, or the breach thereof shall be settled by
arbitration in accordance with the Rules of the American Arbitration
Association and judgment upon award rendered by the Arbitrator(s) may be
entered in

 

 

any court having jurisdiction
thereof. Written notice of demand for arbitration shall be filed with the other
party to the Agreement and with the American Arbitration Association within a
reasonable time after the dispute has arisen. Any such arbitration shall be
held in Charles City, Iowa if the arbitration is demanded by Genzyme and in
Boston, Massachusetts if CCC demands the arbitration.

 

9.11                        Counterparts.                      This Agreement may be executed in
any number of counterparts, each of which once executed and delivered, shall be
deemed an original, but all of which constitute but one and the same Agreement.
All headings, captions, exhibits, schedules and tables are inserted by
convenience of reference only and shall not affect the meaning or
interpretation of any provision hereof.

 

IN
WITNESS WHEREOF, the parties by there authorized representatives have executed this
Agreement as of the date first above written.

 

Cambrex Charles City, Inc.

 

	
  /s/ James A. Mack

  	
   

  
	
  By: James A. Mack

  
	
   

  
	
  Title: President, CEO,
  Chairman

  
	
   

  
	
  Date: 2-28-06

  
	
   

  
	
  Genzyme Corporation

  
	
   

  
	
  /s/ Michael S. Wyzga

  	
   

  
	
  By: Michael S. Wyzga

  
	
   

  
	
  Title: CFO

  
	
   

  
	
  Date: 2-4-06

  

 

 

Schedule 3.01

 

Price

 

[                              ]*

 

 

 

 

 

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

 

Schedule 3.01a

 

[                              ]*

 

 

 

 

 

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

 

Exhibit A

Specifications

 

[                              ]*

 

 

 

 

 

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

 

 

EXHIBIT B

 

TECHNICAL AGREEMENT

 

[                              ]*

 

 

 

 

 

*Confidential information omitted and filed
separately with the Securities and Exchange Commission.

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00112-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00112-of-00352.parquet"}]]