Exhibit 10.17(b)
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INTELLECTUAL PROPERTY
AND OTHER ASSETS PURCHASE AGREEMENT
Between
SANOFI-SYNTHELABO
And
ANESTA GmbH
Dated December 13, 2001
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**Certain portions of this document have been omitted based upon a
request for confidential treatment that has been filed with the Commission.
The omitted portions have been filed separately with the Commission.
TABLE OF CONTENTS
(Not part of this Agreement)
Page
Article 1: DEFINITIONS AND TERMS.............................................................................2
1.1 Specific Definitions..............................................................................2
1.2 Other Definitional Provisions.....................................................................5
Article 2: TRANSFER OF INTELLECTUAL PROPERTY AND ASSETS AND LIABILITIES......................................5
2.1 Purchase and Sale of Transferred Assets...........................................................5
2.2 Obligations Undertaken............................................................................5
Article 3: PURCHASE PRICE - PAYMENT OF PURCHASE PRICE - Advance Payment Indemnity............................7
Article 4: CLOSING/COMPLETION................................................................................8
4.1 Closing ....................................................................................8
4.2 Deliveries by Seller..............................................................................8
4.3 Deliveries by Purchaser...........................................................................9
4.4 Completion Date...................................................................................9
4.5 Local Transfers...................................................................................9
Article 5: REPRESENTATIONS AND WARRANTIES OF SELLER.........................................................10
5.1 Corporate Organization...........................................................................10
5.2 Corporate Authorization..........................................................................10
5.3 No Violations - Consents and Approvals...........................................................11
5.4 Transferred Contracts............................................................................11
5.5 Compliance With Specifications...................................................................11
5.6 Product Registrations............................................................................11
5.7 Litigation ...................................................................................12
5.8 Title and Ownership..............................................................................12
5.9 Encumbrances.....................................................................................12
5.10 Sales and Profits Prior to Closing...............................................................12
5.11 Absence of Lease.................................................................................13
5.12 No Breach of Novo Nordisk A/S Representations and Warranties.....................................13
5.13 Brokers and Finders..............................................................................13
Article 6: REPRESENTATIONS AND WARRANTIES OF PURCHASER......................................................13
6.1 Corporate Organization...........................................................................13
6.2 Corporate Authorization..........................................................................13
6.3 No Violations - Consents and Approvals...........................................................14
6.4 Brokers and Finders..............................................................................14
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Article 7: COVENANTS OF THE PARTIES.........................................................................14
7.1 Operation of the Transferred Assets Pending the Completion Date..................................14
7.2 Reasonable Efforts...............................................................................15
7.3 Execution of Agreements..........................................................................15
7.4 Transfer of the Product Registrations, Related Applications and Dossiers.........................15
7.5 Transfer of the Transferred Contracts............................................................18
7.6 Transfer of Books and Records and Promotional Material...........................................19
7.7 Transfer of Ongoing Clinical Studies and Adverse Event Reporting Responsibilities................19
7.8 Confidentiality..................................................................................20
7.9 Non-Competition..................................................................................21
7.10 Further Actions..................................................................................21
Article 8: CONDITIONS PRECEDENT TO CLOSING..................................................................21
8.1 General Conditions...............................................................................21
8.2 Conditions to Obligations of Purchaser...........................................................21
8.3 Conditions to Obligations of Seller..............................................................22
Article 9: TERMINATION......................................................................................22
Article 10: INDEMNIFICATION FOR BREACH OF REPRESENTATIONS AND WARRANTIES...................................22
10.1 Indemnification:.................................................................................22
10.2 Indemnification for Direct Claims................................................................23
10.3 Third Party Claims:..............................................................................23
10.4 Limitation on Indemnity Payments.................................................................24
10.5 Survival of Representations and Warranties.......................................................25
Article 11: GENERAL PROVISIONS..............................................................................25
11.1 Expenses and Taxes...............................................................................25
11.2 Amendments ......................................................................................26
11.3 Entire Agreement.................................................................................26
11.4 Public Announcements.............................................................................26
11.5 Governing Law - Arbitration......................................................................26
11.6 Counterparts ................................................................................... 27
11.7 Headings ........................................................................................27
11.8 Notices ........................................................................................27
11.9 Severability ................................................................................... 28
11.10 Binding Effect - No Assignment - Substitution....................................................28
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LIST OF SCHEDULES
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Schedule I.1 List of Categories A Countries..............................................................1
Schedule I.2 List of Categories B Countries..............................................................2
Schedule I.3 List of Categories C Countries..............................................................3
Schedule I.5 List of the Product Registrations and of Pending Applications...............................4
Schedule I.6 List of Required Consents...................................................................5
Schedule I.8 Transferred Contracts.......................................................................6
Schedule 5 Disclosure Schedule.........................................................................7
Schedule 5.10 Sales of the Licensed Product and corresponding profits/losses..............................8
Schedule 7.4(a)(i) Identity of Purchaser's Designee.....................................................9
Schedule 7.4(b)(i) List of the Countries in which Seller has not submitted an Application
for a Product Registration to the competent Governmental Body.......................10
Schedule 7.4(b)(ii) List of the Countries in which Seller has
submitted an Application for a Product Registration to
the competent Governmental Body but where the Product
Registration is not already granted ................................................11
Schedule 7.4(b)(iii) List of the Countries in which Seller has
submitted an Application for a Product Registration to
the competent Governmental Body but where the Licensed
Product is not already marketed ....................................................12
Schedule 7.7.1 Ongoing Clinical Studies............................................................13
iii
This Intellectual Property and Other Assets Purchase Agreement (the
"Agreement") is made on December 13, 2001, by and between Sanofi-Synthelabo, a
French corporation with its principal place of business located at 000, xxxxxx
xx Xxxxxx, 00000 Xxxxx, Xxxxxx ("Sanofi-Synthelabo" or the "Seller") and Anesta
GmBH, a Swiss corporation with its principal place of business at Xxxxxxxxxxxxxx
0, 0000 Xxxx, Xxxxxxxxxxx (the "Purchaser").
Sanofi-Synthelabo and Purchaser are individually referred to as a
"Party" and collectively as the "Parties".
Unless otherwise indicated, capitalized terms used herein shall have
the meaning set forth in Article I hereof.
WITNESSETH:
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Whereas, Sanofi-Synthelabo is licensed by Novo Nordisk A/S for the use
of industrial property rights related to pharmaceutical drugs containing
tiagabine as its active ingredient, Novo Nordisk A/S having retained full
ownership of the trademark Gabitril(R) (and in South Africa
Gebitril(R));Affiliates
WHEREAS, Anesta GmbH intends to purchase and acquire certain
intellectual property and other assets and rights (including the right to the
hereinabove referred license agreement between Sanofi-Synthelabo and Novo
Nordisk A/S with respect to the Territory) related to such pharmaceutical
product, and Sanofi-Synthelabo intends to sell such intellectual property and
other assets and rights;
NOW, THEREFORE, in consideration of the premises and the mutual
representations, warranties, covenants and agreements contained herein, the
Parties hereto agree as follows:
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ARTICLE 1: DEFINITIONS AND TERMS
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1.1 Specific Definitions
--------------------
As used in this Agreement, the following terms shall have the meanings
set forth or as referenced below:
"Affiliate" shall mean, as to any Person, any other Person that,
directly or indirectly, controls, is controlled by, or is under common control
with, such Person. For the purpose of this definition, "control" means the
possession of the power to direct or cause the direction of management and
policies of such Person, whether through ownership of voting securities or
otherwise.
"Agreement" shall mean this Agreement, as the same may be amended or
supplemented from time to time in accordance with the terms hereof, including
the Annexes and Schedules hereto.
"Ancillary Agreements" shall mean collectively, the Gabitril License
Amendment, the Gabitril Consent to Assignment, the Transitory Distribution
Agreement, the Long Term Distribution Agreement and the Toll Manufacturing
Agreement.
"Business Days" shall mean any day other than a Saturday, a Sunday or a
day on which banks in Paris (France) are obligated by law or executive order to
close.
"Category A Countries" shall mean all the countries listed on Schedule
I.1 where the Licensed Product is currently marketed on the basis of an existing
Product Registration and where Purchaser intends, either directly or through a
Purchaser's Designee, to take over the distribution and sale of such Licensed
Product as soon as the corresponding Product Registration shall have been
transferred to it.
"Category B Countries" shall mean all the countries listed on Schedule
I.2 where the Licensed Product is currently marketed on the basis of an existing
Product Registration and where Purchaser intends, either directly or through a
Purchaser's Designee, to take over the distribution and sale of such Licensed
Product at the expiration, on a country by country basis, of the Transitory
Distribution Agreement.
"Category C Countries" shall mean all the countries listed on Schedule
I.3 where the Licensed Product is currently marketed on the basis of an existing
Product Registration and where Purchaser intends, either directly or through a
Purchaser's Designee, to take over the distribution and sale of such Licensed
Product at the expiration on a country by country basis, of the Long Term
Distribution Agreement.
"Category D Countries" shall mean all the countries of the Territory
which are not Category A Countries, Category B Countries and Category C
Countries, and where the Licensed Product, whether registered or not registered,
is not currently marketed at the date of execution of this Agreement.
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"Closing" shall mean the closing of the transactions contemplated in
this Agreement.
"Closing Date" shall have the meaning specified in Section 4.1 (a).
"Disclosure Schedule" shall have the meaning specified in Article 5.
"Dossiers" shall mean any and all product registration applications,
their respective pricing and reimbursement approval applications (if
applicable), including all supporting files, writings, data, studies and
reports, compiled in final form and submitted to the competent local
Governmental Body for granting of a Product Registration and of the relevant
pricing and reimbursement approval (if applicable);
"Completion Date" shall have the meaning specified in Section 4.4.
"Gabitril License Agreement" shall mean the License Agreement dated as
of December 2, 1997 between Sanofi, a French corporation the legal successor of
which is Sanofi-Synthelabo, and Novo Nordisk A/S.
"Gabitril License Amendment" shall mean the Amendment to the Gabitril
License Agreement to be entered into prior to the Closing between Novo Nordirsk
A/S and Sanofi-Synthelabo.
"Gabitril Consent to Assignment" shall mean the agreement to be entered
into, on, or prior to, the Closing, between Novo Nordisk A/S, Purchaser and
Sanofi-Synthelabo whereby Novo Nordisk A/S consents to the assignment by Seller
to Purchaser of its rights and obligations under the Gabitril License Agreement
with respect to the Territory.
"Governmental Body" shall mean any government or governmental or
regulatory body thereof, or political subdivision thereof, whether national,
federal, state, local or foreign, or any other agency or instrumentality
thereof.
"Licensed Product" shall have the meaning specified in Section 1.6 of
the Gabitril License Agreement.
"Long Term Distribution Agreement" shall mean the distribution
agreement to be entered into, on the Closing, between Sanofi Winthrop Industrie
and Purchaser, according to which Sanofi Winthrop Industrie and/or certain
Affiliates will continue after the Completion Date to distribute the Licensed
Products for a long term period after the Completion Date in the Category C
Countries.
"Net Sales" shall mean Seller and/or Seller's Affiliates gross receipt
from sales of Licensed Product when invoiced to a third party, less the
following deductions actually allowed and taken by such third party: (i) trade,
cash and/or quantity discounts allowed, if any (ii) refund, credit, return,
rebate or allowances effectively reducing the selling price, (iii) value added
taxes and sales taxes, (iv) duties, (v) freight, insurance and other
transportation charges to the extent added to the sales price and set forth
separately as such on the total amount invoiced.
"Obligations Undertaken" shall have the meaning specified in Section
2.2 (a).
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"Person" shall mean any individual, corporation, partnership,
association, trust or other legal entity or organization, having legal
personality, or the right to xxx in its own name.
"Product Registration" shall mean, to the extent transferable, any
approvals issued by the relevant Governmental Bodies of any country in the
Territory to import, distribute and/or sell the Licensed Product in such
country. To the extent transferable, the Product Registration shall include the
pricing and reimbursement approval (if applicable). Schedule I.5 sets forth the
list of (i) all Product Registrations issued to the Seller and/or to its
Affiliates relating to the importation, distribution and sale of the Licensed
Product, and (ii) of all applications for a Product Registration currently
pending.
"Purchaser's Designee" shall have the meaning specified in Section
14.10.
"Required Consents" shall mean the consents, approvals and waivers
referred to on Schedule I.6.
"Specifications" shall mean the specifications of the Licensed Product
and raw materials as defined in the Product Registrations.
"Territory" shall mean the territory licensed to Seller under the
Gabitril License Agreement, as such territory is specified in Section 1.16 of
such Gabitril License Agreement, with the exception of France.
"Toll Manufacturing Agreement" shall mean the toll manufacturing
agreement to be entered into on the Closing between Sanofi-Synthelabo Ltd, an
Affiliate of Seller, and Purchaser, pursuant to which Sanofi-Synthelabo Ltd will
toll manufacture the Licensed Products after the Completion Date in its
manufacturing plant located at Fawdon (UK) for a certain period of time after
the Completion Date.
"Transferred Assets" shall have the meaning specified in Section 2.1
(a).
"Transferred Books and Records" shall mean all books and records
relating exclusively to the Licensed Product, including without limitation
accounting books and records and the results of tests and studies made by
Sanofi-Synthelabo or its Affiliates in connection with the Licensed Product,
with the exception of such books and records which relate exclusively to France,
and excluding customer lists if any.
"Transferred Contracts" shall mean the contracts listed on Schedule I.8
and Unsatisfied Orders.
"Transitory Distribution Agreements" shall mean the distribution
agreements to be entered into between Sanofi-Synthelabo, acting on behalf of
certain of its Affiliates (or directly by such Affiliates), and Purchaser,
pursuant to which such Sanofi-Synthelabo Affiliates will continue after the
Completion Date to distribute the Licensed Products for a short term period
after the Completion Date in the Category A and B Countries.
"Unsatisfied Order" shall have the meaning specified in Section 2.1(a).
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[**]
1.2 Other Definitional Provisions
-----------------------------
(a) The words "hereof", "herein", "hereinafter", "hereinabove" and
words of similar import, when used in this Agreement, shall refer to this
Agreement as a whole and not any particular provision of this Agreement. A
reference to an Article, Section, Schedule or Annex is, except as otherwise
expressly stated, a reference to an Article or Section of, or a Schedule or
Annex to, this Agreement.
(b) Terms defined in the singular shall have a comparable meaning when
used in the plural, and vice versa.
(c) The words "include", "includes" and "including" are not limiting.
ARTICLE 2: TRANSFER OF INTELLECTUAL PROPERTY AND ASSETS AND LIABILITIES
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2.1 Purchase and Sale of Transferred Assets
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(a) Upon the terms and subject to the conditions of this Agreement,
subject to the conditions precedent set forth in Article 8, on the Completion
Date, Seller shall, and/or shall cause its Affiliates to, sell, transfer, and
assign to Purchaser, and Purchaser shall purchase, acquire and assume from
Seller and/or its Affiliates, all right, title, and interest of the Seller
and/or such Affiliates under the Gabitril License Agreement, to which
Sanofi-Synthelabo is entitled as of the date hereof, including the product
development rights (as provided for in the Gabitril License Agreement), all the
rights inuring to Sanofi-Synthelabo under the license of trademarks and patents
granted thereunder, and all related goodwill (including without limitation
Unsatisfied Orders of Licensed Products received from third parties (other than
Affiliates of Seller) within the Territory prior to the Completion Date), but in
each case only with respect to the Territory. "Unsatisfied Orders" shall mean
for the purposes of this Agreement, any order of Licensed Products which is not
shipped by Seller or its Affiliates on the Completion Date.
(b) The Transferred Assets shall exclude any asset or right not
specifically listed in Section 2.1(a). In particular, shall not be included in
the Transferred Assets, any and all rights to the accounts receivable related to
the sales of the Licensed Product prior to the Completion Date (other than with
respect to any Unsatisfied Orders of Licensed Products), such rights remaining
vested in Seller and/or its Affiliates.
2.2 Obligations Undertaken
----------------------
(a) Upon the terms and subject to the conditions of this Agreement,
subject to the conditions precedent set forth in Article 8, on the Completion
Date, Purchaser shall undertake to fulfill and be liable for the following
obligations, liabilities, commitments and/or
5
indebtedness of the Seller and/or its Affiliates (the "Obligations Undertaken")
in each case only with respect to the Territory:
(i) any obligation, liability, commitment and/or indebtedness
incurred after the Completion Date in respect of any of the Transferred Assets,
including, but not limited to, any obligation arising under the Gabitril License
Agreement, including any liabilities of the Seller related to Seller's
representations and warranties in the Gabitril License Agreement;
(ii) any obligation, liability, commitment and/or indebtedness
incurred after the Completion Date with respect to the manufacture, marketing,
distribution and/or sale of the Licensed Product; and
(iii) any obligation, liability, commitment and/or indebtedness
specifically undertaken by Purchaser under this Agreement.
(b) The Parties agree that Purchaser shall not hereunder assume or
become liable for any obligation, commitment and or indebtedness other than the
Assumed Liabilities. In particular, the following shall not be included in the
Assumed Liabilities (i) any and all obligations related to accounts payable with
respect to goods purchased or services rendered prior to the Completion Date,
Seller and/or its Affiliates remaining liable for the payment of such accounts
payable, and (ii) any and all obligations, liabilities, commitments and/or
indebtedness relating to the employment contract of Seller's and Seller's
Affiliates' employees dedicated to the operation of the Transferred Assets and
of the related business, Seller and Seller's Affiliates remaining fully liable
for any such obligations, liabilities, commitments and/or indebtedness.
(c) For the avoidance of doubt, prior to the Completion Date,
Sanofi-Synthelabo shall terminate, and shall cause each of its Affiliates to
terminate, at its own cost and expenses, to the extent they relate to the
Licensed Product and the Territory (i) the sub-license agreement between
Sanofi-Synthelabo and Sanofi-Winthrop Industrie according to which
Sanofi-Synthelabo has granted to Sanofi-Winthrop Industrie a sub-license of the
industrial property rights related to the Licensed Product, and (ii) any and all
the existing distribution agreements between Sanofi-Winthrop Industrie and
Seller's Affiliates pertaining to the distribution of Licensed Products in the
Territory, as such agreements are referred to in the Recitals to this Agreement.
Seller shall indemnify and hold harmless Purchaser from and against any claim of
any of such Seller's Affiliates in connection with the termination of the here
above referred agreements and/or the collection of the Purchase Price.
For the further avoidance of doubt, it is expressly understood and
agreed that none of the employees of Seller or its Affiliates is employed in
whole, or for more than one half of his working hours in connection with the
distribution or sale of Licensed Product and therefore Purchaser shall not be or
be deemed liable for any transfer or deemed transfer of employees, in
consequence of which Seller shall indemnify Purchaser if its becomes obliged to
bear any liability related to Seller's employees of Seller or its Affiliates.
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ARTICLE 3: PURCHASE PRICE - PAYMENT OF PURCHASE PRICE -
---------- --------------------------------------------
ADVANCE PAYMENT INDEMNITY
-------------------------
(a)Upon the terms and subject to the conditions of this Agreement,
Purchaser shall deliver or cause to be delivered to Seller at the Closing, in
full payment of the aforesaid sale, transfer and assignment of the Transferred
Assets, immediately available funds in the total amount of Euros [**]. Payment
of the purchase price shall be made by a bank check ("cheque de banque") drawn
on Credit Suisse, or another bank of first rank international reputation, to be
delivered to Seller on the Closing. The Purchase Price shall not be subject to
any adjustment or revision and represents the entire purchase price of the
Transferred Assets.
(b)In consideration for the fact that the Purchaser shall pay the
Purchase Price on the Closing Date but that the transfer of the Transferred
Assets shall only occur on the Completion Date, Seller shall pay to Purchaser,
as an advance payment indemnity, an amount equal to the net margin of Seller 's
Affiliates or any order of Licensed Product shipped to third party customers in
the Territory (other than Affiliates of Seller) from, and including, the Closing
Date to the Completion Date (the "Net Margin"). For the purpose of this clause,
Net Margin shall be equal to the following:
[**]
Net Sales shall have the same meaning as in the Transitory Distribution
Agreement(s). Net Sales from the Closing Date to December 31 shall be deemed to
be equal to 18/31st of the Net Sales during the entire month of December.
Seller shall notify Purchaser of the amounts of Net Margin, together with the
amount and localization of the Net Sales on which such Net Margin was made,
within 20 Business Days from the Completion Date. Purchaser (or a designated
representative of Purchaser) shall have the right to review all work papers and
procedures used to calculate the Net Sales and shall have the right to perform
any other reasonable procedures necessary to verify the accuracy thereof.
Unless, within fifteen (15) Business Days after notification to Purchaser of the
amount of the Net Margin, Purchaser notifies Seller in writing that it objects
to the calculation of the Net Margin and specifies the basis for such objection,
such calculation of Net Margin shall become final and binding upon the Parties
for the purpose of this Article 3. If Purchaser objects and if Purchaser and
Seller are unable to resolve all of Purchaser's objections within fifteen (15)
Business Days after such notification has been given, all remaining matters in
dispute shall be submitted to the office of KPMG-Peat Marwick located in the
Paris Region, or if such office of KPMG-Peat Marwick is not available or refuses
to act, another accounting firm to be chosen among the offices of
internationally reputed accounting firms ("big five") in the Paris Region other
than the auditors of Seller or Purchaser (KPMG - Peat Marwick or such other
firm, as the case may be, are referred to herein as the "Accounting Firm"). In
the event Seller and Purchaser are unable to agree upon the selection of the
Accounting Firm within five (5) Business Days after expiration of the herein
above referred fifteen (15) Business Day period, the Accounting Firm shall be
appointed by the International Center for Expertise of the International Chamber
of Commerce, Paris, France at the request of the most diligent party. The
International Center for Expertise shall not, however, administer the dispute
resolution procedure. The request to the International Center
7
for Expertise shall include a copy of the present clause and shall stipulate
that the Accounting Firm shall be a French firm affiliated to one of the "big
five" networks and based in the Paris Region. The Accounting Firm shall, acting
as experts and not as arbitrators, make a final determination as to all
remaining matters in dispute with respect to Net Margin which determination
shall be conclusive and binding on Purchaser and Seller. Purchaser and Seller
agree to cooperate with each other in order to resolve any and all matters in
dispute as soon as possible. Purchaser shall provide Seller and Seller's
accountants full access to the Transferred Books and Records, to any other
information, and to its employees, and shall cooperate with Seller, to the
extent necessary for Seller to calculate the Net Margin.
Within thirty (30) Business Days after the Net Margin has been finally
determined in accordance with the procedure set forth above, Seller shall pay
the Net Margin to Purchaser. Such payment shall be made by wire transfer to the
account specified by Purchaser to this effect.
ARTICLE 4: CLOSING/COMPLETION
---------- ------------------
4.1 Closing
-------
(a) Unless otherwise mutually agreed between the Parties, the Closing
will take place at 10:00 a.m. at the Geneva offices of Sanofi S.A./AG on
December 13, 2001 (the "Closing Date") provided that all the conditions
precedent set forth in Article 8 have been satisfied, or such later date as the
Parties hereto may agree.
(b) Notwithstanding anything to the contrary contained in this
Agreement, to the extent that the sale, transfer and assignment of any
Transferred Asset requires any Required Consent and such Required Consent shall
not have been obtained at or prior to the Closing Date, this Agreement shall not
constitute a sale, transfer and/or assignment, or any attempted sale, transfer
and/or assignment with respect to such Transferred Asset, until such Required
Consent is obtained.
4.2 Deliveries by Seller
--------------------
At the Closing, Seller shall deliver or cause to be delivered to
Purchaser the following:
(a) The Gabitril License Amendment, duly executed by Novo-Nordisk A/S
and Sanofi-Synthelabo;
(b) The Gabitril Consent to Assignment, duly executed by Novo-Nordisk
A/S and Sanofi-Synthelabo;
(c) The Toll Manufacturing Agreement duly executed by Sanofi-Synthelabo
Ltd, and
(d) The Transitory Distribution Agreements and the Long Term
Distribution Agreement duly executed by Seller, and
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(e) All such other deeds, endorsements, assignments and other
instruments as, in the reasonable opinion of Purchaser, shall be necessary to
vest in Purchaser title to the Transferred Assets.
(f) The Inventory Purchase Agreement duly executed by Sanofi-Winthrop
Industrie.
4.3 Deliveries by Purchaser
-----------------------
At the Closing, Purchaser shall deliver or cause to be delivered to
Seller the following:
(a) The payment of the Purchase Price as set forth in Section 3.1;
(b) Subject to delivery under Section 4.2 (b), the Gabitril Consent to
Assignment, duly executed by Novo-Nordisk A/S, Sanofi-Synthelabo and Purchaser;
(c) Toll Manufacturing Agreement duly executed by Purchaser, and
(d) The Transitory Distribution Agreements and the Long Term
Distribution Agreement duly executed by Purchaser, and
(e) All such other instrument of assignment as, in the reasonable
opinion of Seller, shall be necessary to vest in Purchaser the Obligations
Undertaken as of the Completion Date.
(f) The payment of the Initial Purchase Price as specified in the
Inventory Purchase Agreement.
4.4 Completion Date
---------------
Notwithstanding any other provision of this Agreement, the Parties
agree that the transfer of the Transferred Assets and the Undertaking to fulfill
the Obligations Undertaken, as provided in Article 2 hereof shall be effective
on January 31st, 2002 (the "Completion Date"), in order to enable the parties to
take all measures each of them deems appropriate in order to implement the
transaction contemplated hereby without description.
4.5 Local Transfers
---------------
If required by local laws or regulations, including but not limited to
tax laws or regulations, or necessary for tax purposes, and as evidenced by
appropriate legal opinions of Purchaser's counsels and/or Seller's counsel,
local closings in each such country shall take place on Completion or as
promptly as practicable after the Completion (the "Local Transfers") and Seller
and Purchaser shall, or shall cause their respective Affiliates, to execute and
deliver such instruments and take such actions, consistent with the terms and
conditions of this Agreement, as in the reasonable opinion of Purchaser's
counsels and/or Seller's counsels, as the case may be, may be required to
complete such Local Transfers. Any portion of the Purchase Price that would be
payable for such Local Transfers by Purchaser or by any Purchaser's Designee
will be determined by mutual agreement of the Parties, provided
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that if the Parties do not reach an agreement on this issue within thirty days,
such price shall be equal to a portion of the Purchase Price determined pro-rata
to net sales of Licensed Product over the twelve month period from December 1,
2000 to November 30, 2001, and shall be deemed (i) to be included in the
Purchase Price, and (ii) to have been paid to Seller, or the concerned Seller's
Affiliate, as anticipated payment, with the Purchase Price. Accordingly, to the
extent any amount needs to be paid by Purchaser or Purchaser's Designee to
Seller in connection with any such Local Transfer, Seller shall, within three
(3) Business Days after the date of each Local Transfer, reimburse Purchaser for
the full amount of the payment made in respect of the Transferred Assets
transferred at such Local Transfer. Such Local Transfers shall be subject to the
provisions of Section 11.1. In no case shall the transactions contemplated under
this Agreement be deemed to be conditioned upon, or subject to, the execution of
the here above referred instruments.
ARTICLE 5: REPRESENTATIONS AND WARRANTIES OF SELLER
---------- ----------------------------------------
Seller hereby represents and warrants to Purchaser that, except as
disclosed in Schedule 5 attached hereto (the "Disclosure Schedule"):
5.1 Corporate Organization
----------------------
Each of Seller and of its Affiliates in the Territory is a corporation
duly organized, validly existing and in good standing under the laws of the
jurisdiction of such incorporation and Seller and such Affiliates of Seller have
all requisite corporate power and authority to own and operate their properties
and to carry on their businesses as now conducted.
5.2 Corporate Authorization
-----------------------
Each of Seller and of its Affiliates in the Territory has full
corporate power and authority to execute and deliver this Agreement and each
other agreement, document, instrument or certificate contemplated by this
Agreement to be executed by Seller or such Affiliates of Seller in connection
with the consummation of the transactions contemplated hereby and thereby and to
perform fully its obligations hereunder and thereunder. The execution, delivery
and performance by Seller of this Agreement and the execution, delivery and
performance by Seller and/or such Affiliates of Seller of any of the Ancillary
Agreements has been duly authorized or, as far as the Ancillary Agreements are
concerned, shall have been duly authorized at the Closing Date, by all necessary
corporate action on the part of Seller and/or such Affiliates of Seller. This
Agreement constitutes, and each of the Ancillary Agreements when so executed and
delivered will constitute, legal, valid and binding obligations of Seller and/or
such Affiliates of Seller enforceable against each of them in accordance with
their respective terms.
5.3 No Violations - Consents and Approvals
--------------------------------------
Subject to receipt of the Required Consents, if any, the execution,
delivery and performance of this Agreement and of the Ancillary Agreements and
the consummation of
10
the transactions contemplated hereby and thereby, do not and will not (i)
conflict with, violate, result in the breach of, or constitute a default under
any law or regulation applicable to Seller and/or any of the Affiliates of
Seller (ii) conflict with, violate, result in the breach of, or constitute a
default under, any provision of the certificate of incorporation or by-laws or
similar documents of Seller or of any of the Affiliates of Seller, (iii)
conflict with, violate, result in the breach of, constitute a default under, or
result in the termination, cancellation, acceleration of any right or obligation
of Seller or such Affiliates of Seller under the Gabitril License Agreement
and/or the Transferred Contracts, or more generally otherwise modify the terms
or conditions of such Gabitril License Agreement and/or Transferred Contracts,
except as provided under the Gabitril License Amendment. Except for the Required
Consents, no consents, approvals or waivers are required on the part of Seller
or such Affiliates of Seller in connection with the execution delivery and
performance of this Agreement or of any of the Ancillary Agreements, or the
consummation of the transactions contemplated hereby and thereby.
5.4 Transferred Contracts
---------------------
Seller and/or its Affiliates have performed all of the obligations
required to be performed under the Transferred Contracts, and none of them is in
material default thereunder. To Seller's knowledge, no party to any of the
Transferred Contracts is in material default thereunder. Neither Seller nor any
of its Affiliates has received from any party to any of the Transferred
Contracts (i) any notice that any such party intends to terminate any such
Transferred Contract, or (ii) any claim of material breach from any such party
with respect to the performance of obligations pursuant to any such Transferred
Contract. Each such Transferred Contract constitutes the legal, valid and
binding obligations of Seller or its Affiliates, and such Transferred Contract
is enforceable in accordance with its terms. Except for Required Consents,
Purchaser will succeed to all rights, title and interests of Seller and/or its
Affiliates under each Transferred Contract without necessity to obtain the
consent by the other party or parties to the assignment of such Transferred
Contract.
5.5 Compliance With Specifications
------------------------------
All the Licensed Product under its finished form sold or to be sold
prior to the Completion Date was in compliance with the Specifications.
5.6 Product Registrations
---------------------
(a) To Seller's knowledge, each Product Registration listed on Schedule
I.5 has been validly issued by the appropriate Governmental Body.
(b) Seller and/or its Affiliates are in material compliance with all
regulatory, agency and other requirements of all competent Governmental Bodies
relating to the Product Registrations listed on Schedule I.5, and (ii) neither
Seller nor any of its Affiliates has received any notice or charge, which has
not been complied with or withdrawn, by such Governmental Bodies asserting any
material violation of any such regulatory, agency or other requirement.
11
5.7 Litigation
----------
There are no Legal Proceedings pending against Seller or any of its
Affiliates, or to Seller's knowledge currently threatened, that relate (i) to
the manufacture, distribution and/or sale of the Product, or (ii) to any of the
Transferred Assets. [**].
5.8 Title and Ownership
-------------------
Seller and/or its relevant Affiliate has good and marketable title to,
and ownership of, the Transferred Assets and related business which have been
created and/or developed by them on the basis of the rights granted by
Novo-Nordisk A/S under the Gabitril License Agreement. Except as otherwise
expressly set forth herein, Seller does not make any express or implied warranty
regarding the condition of any of the Transferred Assets or of it related
business.
5.9 Encumbrances
------------
The Transferred Assets are free and clear of all pledges, liens or
other encumbrances.
5.10 Sales and Profits Prior to Closing
----------------------------------
Schedule 5.10 attached to this Agreement contain the information
relating to the sales of the Licensed Product, as realized by Seller and/or its
Affiliates with non-related customers, during the three (3) year period
preceding the Closing and the corresponding net profits or losses during the
same period. Considering the specificity of the Transferred Assets, Purchaser
acknowledges and agrees that such profit and loss figures, which have been
determined according to Sanofi-Synthelabo group's accounting rules and extracted
from Sanofi-Synthelabo group's analytical accounting system, are only estimates
prepared in good faith on the basis of the books and records of Seller and of
the structure of operations in place within the Sanofi-Synthelabo group, and
that, as such, they are not relevant to assess the expected profitability in the
future of the business related to the Transferred Assets as such business may be
operated in a group other than the Sanofi-Synthelabo group. Purchaser
acknowledges and agrees that through the Due Diligence Process referred to in
Section 10.3 (a) of this Agreement it has had access, prior to the date hereof,
to all information necessary for Purchaser to assess the expected profitability
of the business related to the Transferred Assets, following the Closing Date.
12
5.11 Absence of Lease
----------------
No right to occupancy of any real estate to the benefit of Purchaser
shall result from, or arise out of, the sale, transfer and assignment of the
Transferred Assets under this Agreement.
5.12 No Breach of Novo Nordisk A/S Representations and Warranties
------------------------------------------------------------
There is no specific fact, event or circumstance which it considers
likely to constitute a breach by Novo Nordisk A/S of Novo Nordisk's
representations and warranties under Section 18 of the Gabitril License
Agreement.
5.13 Brokers and Finders
-------------------
There is no investment banker, broker, finder or other intermediary
which has been retained by or is authorized to act on behalf of Seller or any
Affiliate of Seller who might be entitled to any fee or commission from
Purchaser or any Affiliate of Purchaser in connection with the transactions
contemplated by this Agreement or any of the Ancillary Agreements.
ARTICLE 6: REPRESENTATIONS AND WARRANTIES OF PURCHASER
---------- -------------------------------------------
Purchaser hereby represents and warrants to Seller as follows:
6.1 Corporate Organization
----------------------
Purchaser is a corporation duly organized, validly existing and in good
standing under the laws of the jurisdiction of its incorporation and Purchaser
has all requisite corporate power and authority to own and operate its
properties and to carry on its business as now conducted.
6.2 Corporate Authorization
-----------------------
Purchaser has full corporate power and authority to execute and deliver
this Agreement and each other agreement, document, instrument or certificate
contemplated by this Agreement to be executed by Purchaser in connection with
the consummation of the transactions contemplated hereby and thereby and to
perform fully its obligations hereunder and thereunder. The execution, delivery
and performance by Purchaser of this Agreement and of any of the Ancillary
Agreements has been duly authorized by all necessary corporate action on the
part of Purchaser. This Agreement constitutes, and each of the Ancillary
Agreements when so executed and delivered on or prior to the Closing Date will
constitute, legal, valid and binding obligations of Purchaser enforceable
against it in accordance with their respective terms.
13
6.3 No Violations - Consents and Approvals
--------------------------------------
The execution, delivery and performance by Purchaser of this Agreement
or of any of the Ancillary Agreements and the consummation of the transactions
contemplated hereby and thereby, do not, and will not, (i) conflict with,
violate, result in the breach of, or constitute a default under any law or
regulation applicable to Purchaser, (ii) conflict with, violate, result in the
breach of, or constitute a default under, any provision of the certificate of
incorporation or by-laws of Purchaser, (iii) conflict with, violate, result in
the breach of, constitute a default under, or result in the termination,
cancellation, acceleration of any right or obligation of Purchaser or under any
contract by which Purchaser is bound. No consents, approvals or waivers are
required on the part of Purchaser in connection with the execution and delivery
of this Agreement or of any of the Ancillary Agreements, or the consummation of
the transactions contemplated hereby and thereby.
6.4 Brokers and Finders
-------------------
There is no investment banker, broker, finder or other intermediary
which has been retained by or is authorized to act on behalf of Purchaser or any
of its Affiliates who might be entitled to any fee or commission from Seller or
any Affiliate of Seller in connection with the transactions contemplated by this
Agreement or any of the Ancillary Agreements.
ARTICLE 7: COVENANTS OF THE PARTIES
---------- ------------------------
7.1 Operation of the Transferred Assets Pending the Completion Date
---------------------------------------------------------------
Until the Completion Date, Seller shall, and shall cause its Affiliates
to, (unless prior written consent of Purchaser or except as otherwise
contemplated by this Agreement):
(a) Continue to deal with the Transferred Assets consistent with past
practices; in particular and without limitation to the generality of the
foregoing, Seller shall and shall cause its Affiliates to deal with any
Unsatisfied Orders of Licensed Products in the ordinary course of business
consistent with past practice and taking into according specific requirement of
third party customers.
(b) In the event that Seller or any of its Affiliates receives written
notice by a competent Governmental Body of a material violation of any
regulatory, agency or other requirement relating to the Product Registrations,
undertake all such actions as may be necessary to cure such material violation;
(c) Not amend or terminate the Gabitril License Agreement.
Notwithstanding the foregoing, nothing in this Agreement shall be
interpreted or construed to create, for Seller or for any of its Affiliates, an
obligation to launch during this period, or after the Completion Date, the
Licensed Product in any country of the Territory where, at the date hereof,
there is a Product Registration but the Licensed Product is not already
marketed.
14
7.2 Reasonable Efforts
------------------
Upon the terms and subject to the conditions hereof, each of the
Parties shall use its commercially reasonable efforts to fulfill the conditions
precedent set forth in Article 8 hereof to the extent if is within its power to
fulfill such conditions. Each Party shall use all its commercially reasonable
efforts to cooperate with the other Party for such purpose.
7.3 Execution of Agreements
-----------------------
On the Closing Date, Seller and Purchaser shall execute the Gabitril
Consent to Assignment and shall execute, or shall cause their respective
Affiliates to execute, the Ancillary Agreements.
7.4 Transfer of the Product Registrations, Related Applications
and Dossiers
----------------------------------------------------------------
The Product Registrations and related applications shall be transferred
to Purchaser, or the Purchaser's Designee in accordance with the following
provisions:
(a) In all countries of the Territory with the exception of the
Category D Countries, the following provisions shall apply (on a country by
country basis):
(i) In Category A Countries, Seller and/or the relevant Affiliates
of Seller shall use all commercially reasonable efforts to complete the transfer
of the corresponding Product Registrations as promptly as practicable after the
Completion Date to the benefit of the Purchaser's Designee, the identity of
which is specified in Schedule 7.4 (a) (i).
Purchaser shall cause each of the Purchaser's Designee to
accept the transfer of the corresponding Product Registrations and, for such
purpose, shall formalize with Seller and/or Seller's Affiliates, as promptly as
practicable, all necessary documents. More generally, Purchaser shall use all
commercially reasonable efforts, and shall cause the hereinabove referred
Purchaser's Designees to use all commercially reasonable efforts to assist
Seller and/or Seller's Affiliates for the transfer of such Product
Registrations.
If the transfer is not possible within the hereafter referred
time limits, and/or permitted under applicable laws and regulations in any
country in the Territory, Seller and/or the relevant Affiliates of Seller shall
have the right in such country (i) to discontinue the promotion of the Licensed
Product at the expiration of a period of [**] after the Completion Date, and
(ii) to discontinue the sale of the Licensed Product at the expiration of a
period of [**] after the Completion Date, it being understood that, in such
case, Seller and/or the relevant Affiliates of Seller shall use all commercially
reasonable efforts to maintain the corresponding Product Registration in full
force and not to withdraw it until the expiration of a period of [**] after the
Completion Date, unless said date is extended by mutual written agreement of the
Parties. At the expiration of such [**] period, Seller and/or the relevant
Affiliates of Seller shall have the right to withdraw such Product Registration.
(ii) In Category B Countries, Seller shall cause its corresponding
Affiliates to continue to distribute and sell the Licensed Product after the
Completion Date under the terms and conditions of the Transitory Distribution
Agreements.
15
According to such Transitory Distribution Agreements:
(x) the corresponding Seller's Affiliate shall continue to
sell the Licensed Product in its country, consistent with past practice, in its
name but as Purchaser's distributor under conditions identical to the conditions
described in paragraph (i) hereinabove.
(y) Not later than [**] after the Completion Date, Purchaser
shall notify to Seller the name of the Purchaser's Designee for each Category B
Country, and Seller and/or the relevant Seller's Affiliate shall use all
commercially reasonable efforts to complete the transfer of the corresponding
Product Registrations as promptly as practicable after the expiration of this
[**] period, to the benefit of such Purchaser's Designee.
Purchaser shall cause each of the Purchaser's Designee to accept the
transfer of the corresponding Product Registration and, for such purpose, to
formalize with Seller and/or the relevant Seller's Affiliates, as soon as
possible, all necessary documents. More generally, Purchaser shall use all
commercially reasonable efforts, and shall cause the hereinabove referred
Purchaser's Designee to use all commercially reasonable efforts, to assist
Seller for the transfer of such Product Registration.
Should Purchaser not have communicated to Seller, at the expiration of
the hereinabove referred [**] period, the name of Purchaser's Designee for any
specific country, then the corresponding Product Registration shall be
transferred by Seller, and/or by the relevant Seller's Affiliates, to Purchaser,
every time that such transfer is possible and permitted by applicable laws and
regulations.
If the transfer is not possible within the hereafter referred time
limits, and/or not permitted under applicable laws and regulations, the
corresponding Seller's Affiliate shall have the right (i) to discontinue the
promotion of the Licensed Product at the expiration of a period of [**] from the
date of expiration of the hereabove referred [**] period, and (ii) to
discontinue the sale of the Licensed Product at the expiration of a period of
[**] from the date of expiration of such [**] period, it being understood that,
in such case, Seller shall cause its corresponding Affiliates to use all
commercially reasonable efforts to maintain the corresponding Products
Registration in full force and not to withdraw it until the expiration of a
period of [**] from the date of expiration of such [**] period, unless said date
is extended by mutual written agreement of the Parties. At the expiration of
such [**] period, Seller and/or the corresponding Seller's Affiliates shall have
the right to withdraw such Product Registration.
Accordingly, the Transitory Distribution Agreements shall terminate, on
a country by country basis, either (i) on the date at which the corresponding
Product Registration shall have been transferred to Purchaser or to Purchaser's
Designee in accordance with the hereinabove provisions, or (ii) should the
transfer not be possible within the hereabove referred time limits and/or not
permitted under applicable laws and regulations, on the date at which Seller
and/or the relevant Seller's Affiliates shall have decided to discontinue the
sale of the Licensed Product in accordance with the hereinabove provisions.
16
(iii) In Category C Countries, Seller shall cause its Affiliates
to continue, to distribute and sell the Licensed Product after the Completion
Date under the terms and conditions of the Long Term Distribution Agreement. The
corresponding Product Registrations shall be transferred to Purchaser, or
Purchaser's Designee at the expiration of the Long Term Distribution Agreement
under the conditions defined in such agreement.
(b) In category D Countries, the following provisions shall apply (on a
country by country basis):
(i) In countries in which, at the date hereof, Seller, and/or the
relevant Seller's Affiliates, has not submitted an application for a Product
Registration to the competent Governmental Body, a list of which is attached
hereto as Schedule 7.4 (b) (i), on or as soon as practicable after the
Completion Date, Seller, or the relevant Seller's Affiliates, shall hand over
the corresponding Dossiers to Purchaser, to the extent such Dossiers exist at
the date hereof and regardless of the status of the preparation of such Dossiers
at such date. For the avoidance of doubt, nothing in this Agreement shall
interpreted or construed to create for Seller, or for any of its Affiliates, an
obligation to complete, after Closing, the preparation of any Dossier with
respect to any country of the Licensed Territory.
(ii) In countries of the Licensed Territory in which, at the date
hereof, Seller, and/or the relevant Seller's Affiliates, has submitted an
application for a Product Registration to the competent Governmental Body but
such Product Registration is not already granted at the Completion Date, a list
of which, at the date hereof, is attached hereto as Schedule 7.4 (b) (ii), on or
as soon as practicable after the Completion Date, Seller, or the relevant
Seller's Affiliates, shall transfer the benefit of said Product Registration
application and shall hand over the related Dossier to Purchaser, or to
Purchaser's Designee, every time said transfer is possible and permitted under
applicable laws and regulations.
Purchaser shall use all commercially reasonable efforts, and
shall cause the hereinabove referred Purchaser's Designee, to assist Seller,
and/or the relevant Seller's Affiliates, for the transfer of such Product
Registration application.
If the transfer is not possible and/or permitted under
applicable laws and regulations, Seller shall not proceed with and/or shall
withdraw such Product Registration application, at Seller's discretion (but
after consultation with Purchaser) and Purchaser shall, if it so decides, submit
a new application. For such purpose, Seller shall hand over to Purchaser a clean
copy of the Dossier submitted for such application along with the corresponding
registration history.
(iii) In countries of the Territory in which, at the date hereof,
Seller and/or the relevant Seller's Affiliates has obtained a Product
Registration from the competent Governmental Body but where the Licensed Product
is not already marketed, a list of which is attached hereto as Schedule 7.4 (b)
(iii), on or as soon as practicable after the Completion Date, Seller or the
relevant Seller's Affiliates, shall transfer said Product Registration and shall
hand over the related Dossier to Purchaser, or to Purchaser's Designee, every
time said transfer is possible and permitted under applicable law and
regulations.
17
Purchaser shall use its commercially reasonable efforts, and
shall cause the hereinabove referred Purchaser's Designee, to assist Seller,
and/or the relevant Seller's Affiliates, for the transfer of such Product
Registration
If the transfer is not possible and/or permitted under
applicable laws and regulations, Seller, and/or the relevant Seller's
Affiliates, shall have the right, at Seller's discretion (but after consultation
with Purchaser), to withdraw such Product Registration and Purchaser shall, if
it so decides, submit a new application. For such purpose, Seller, or the
relevant Seller's Affiliates, shall hand over to Purchaser a clean copy of the
related Dossier along with the corresponding registration history.
(c) Each of the Parties shall bear all its internal costs resulting
from the implementation of the provisions this Section 7.4. Purchaser, or
Purchaser's Designee, shall bear all external costs resulting from the
implementation of the provisions of this Section 7.4. Purchaser shall therefore,
upon presentation of the appropriate documentation evidencing such costs,
reimburse to Seller or its Affiliates, as appropriate all the external costs
incurred by Seller and such Affiliates, for the implementation of the provisions
of this Section 7.4. Such reimbursement shall be made on a quarterly basis and
at cost.
(d) During the period from the Completion Date to the date at which the
transfer of each Product Registration shall have been completed for a specific
country, Seller and/or the relevant Affiliates and/or Distributors of Seller
shall continue to sell, provide, market and distribute the Licensed Product in
such country, or shall cause its Affiliates to continue to do so, consistent
with past practice, in its name but as Purchaser's distributor, according to the
conditions, and for the duration of the relevant Transitory Distribution
Agreement.
7.5 Transfer of the Transferred Contracts
-------------------------------------
(a) On the Completion Date, and subject to the Required Consents,
Seller shall transfer, or shall cause its Affiliates to transfer, to Purchaser
the Transferred Contracts, including any and all Unsatisfied Orders for Licensed
Products received from customers in the Territory prior to such Completion Date.
Seller shall use, and shall cause each of its Affiliates to use, all its
commercially reasonable efforts to obtain the Required Consents as promptly as
practicable after the Completion Date (to the extent relating to Transferred
Contracts it entered into).
(b) In each instance in which a Required Consent cannot be obtained, or
if an attempted transfer or assignment would be ineffective or would adversely
affect the ability of Seller and/or the relevant Affiliates of Seller to convey
the interest in question to Purchaser, Seller and/or such relevant Affiliates
shall use all its commercially reasonable efforts to enter into any such
alternative arrangement and agreement with Purchaser as may be appropriate in
order to allow Purchaser to realize, receive and enjoy substantially similar and
equivalent rights and benefits. For the avoidance of doubt, nothing in this
Agreement shall be interpreted or construed (i) as an attempt to transfer or
assign any Transferred Contract that is by its terms non-transferable or
assignable without the consent of the other party or parties thereto, and (ii)
as far as any such Required Consent is concerned, as a condition precedent to
Purchaser's obligations under this Agreement.
18
7.6 Transfer of Books and Records and Promotional Material
------------------------------------------------------
As promptly as reasonably possible after the Completion Date, Seller
shall transmit, and/or shall cause its Affiliates to transmit, to Purchaser all
Transferred Books and Records, Dossiers and promotional material relating to the
Licensed Product, with the exception of the Transferred Books and Records and
the promotional material the possession of which will be necessary or useful to
Seller and/or such Affiliates for the implementation of its/their obligations
under this Agreement or under any of the Ancillary Agreements, such Transferred
Books and Records being, in such case, transmitted to Purchaser following full
completion of such obligations by Seller and/or its Affiliates.
Seller and/or its Affiliates shall have the right to retain the
Transferred Books and Records for legal, regulatory, tax or accounting purposes,
so long as Seller or its Affiliates provide at least one copy of such Books and
Records to Purchaser.
Seller shall give, and shall cause its Affiliates to give, access to
its and/or their books and records that relate only partially to the Licensed
Product subject to the following conditions: (i) the information relating to the
Licensed Product will be necessary to Purchaser for the manufacture and/or sale
of the Licensed Product or to satisfy Purchaser's tax or financial reporting
requirements, (ii) such books and records do not contain information relating to
the activities of Seller, any of its Affiliates, and/or any third party the
nature and/or content of which would be confidential for Seller, its Affiliates,
or to any third party, (iii) the access will be given in Seller's offices at
normal business hours, and (iv) all information included in such books and
records that do not relate to the Licensed Product shall be subject to the
signature by Purchaser, prior to disclosure, of a confidentiality and restricted
use agreement containing provisions at least as strict as the provisions defined
in Section 20.2 of the Gabitril License Agreement. If the information relating
to the Licensed Product can be physically extracted from the corresponding books
and records, Purchaser shall have the right to require Seller to extract such
information. All internal and external costs incurred by Seller as consequence
of such extraction shall be borne by Purchaser.
7.7 Transfer of Ongoing Clinical Studies and Adverse Event
Reporting Responsibilities
--------------------------------------------------------------
7.7.1 (a) As of the Completion Date, Purchaser shall assume all
responsibilities and costs, and obtain all rights, including ownership of the
corresponding results with respect to ongoing clinical studies the list of which
is attached hereto as Schedule 7.7.1. (the "Ongoing Clinical Trials").
(b) In the event that a transfer of responsibilities from Seller or any
of its Affiliates under the hereabove provision can be proven to cause a
detrimental effect on any of such Ongoing Clinical Trials, the Parties agree
that, upon Purchaser's reasonable request, Seller or its relevant Affiliates,
shall continue its activities on Purchaser's behalf provided that (i) Purchaser
shall reimburse Seller or its relevant Affiliates for its direct internal and
external costs associated with such activities, and (ii) Purchaser shall use its
best efforts to be or become able to carry out such activities by itself, and
(iii) Seller shall in no event be obliged, to continue such activities, except,
as otherwise agreed, beyond March 31st, 2002.
19
(c) Not later than thirty (30) days after the date hereof, the Parties
shall define in good faith the detailed conditions of implementation of the
hereabove provisions.
7.7.2. (i) In countries of the Territory in which Seller and/or
relevant Affiliates of Seller shall continue to sell the Licensed Product
according to the Transitory Distribution Agreements and to the Long Term
Distribution Agreement, Seller and/or the relevant Affiliates of Seller shall
comply with the Adverse Event Reporting provisions contained in such
distribution agreements for the duration hereof.
(ii) In countries of the Territory in which, at the Completion Date,
Seller and/or the relevant Seller's Affiliates has obtained a Product
Registration from the competent Governmental Body but where the Licensed Product
is not marketed, Seller shall, on a country by country basis, ensure that, it
and each of the relevant Seller's Affiliates shall (i) record, investigate,
summarize and review all adverse events and serious adverse events and (ii)
adhere to all requirements of local law which relate to the reporting and
investigation of adverse events and serious adverse events, until the date of
transfer of the Product Registration to Purchaser's Designee.
In addition, until the date of transfer of the Product Registration to
Purchaser's Designee, on a country per country basis, each Party shall report to
the other (with respect to Purchaser, via its Affiliate Cephalon Inc.) all
safety information relating to the Licensed Product in accordance with the
"agreement concerning the exchange of information on Adverse Drug Reactions /
Adverse Events (Adverse Experiences) and Quality Deficiencies (Potentially
resulting in Medical Risks) with regard to Pharmaceutical Products" entered by
and between Cephalon Inc., the parent company of Purchaser, and the Seller on
April 24, 2001.
Promptly following the Completion Date, the Purchaser agrees to enter
with Cephalon Inc., in an agreement with respect to the reporting of adverse
events and serious adverse events, which terms shall be consistent with the
above mentioned adverse event reporting agreement.
7.8 Confidentiality
---------------
The terms and conditions of this Agreement shall be maintained in
confidence by each of the Parties from and after the date hereof with the same
degree of care as it maintains its own confidential and proprietary information
and shall not be - without the prior written consent of the other Party not to
be unreasonably withheld - published, disseminated or disclosed to any third
party nor used by such Party for any purpose except to the extent necessary for
the performance of this Agreement.
7.9 Non-Competition
---------------
During a period of three (3) years after the Completion Date, Seller
shall not, directly or through any of its Affiliates, except in accordance with
the terms and conditions of any agreement (including the Ancillary Agreements)
between Seller and/or its Affiliates, on the one hand, Purchaser and/or its
Affiliates, on the other hand, manufacture, distribute and/or
20
sell any pharmaceutical product containing Tiagabine (as such term is defined in
Section 1.17 of the Gabitril License Agreement) as active ingredient, in the
Territory.
7.10 Further Actions
---------------
Each of the Parties shall, and shall cause its Affiliates, to execute
and deliver such instruments and take such other actions as, in the reasonable
opinion of the other Party, may be required to carry out the intent of this
Agreement, and consummate the transactions contemplated hereby. In particular
and without limitation to the foregoing, Seller shall cause its Affiliates to
cooperate with Purchaser and its Affiliates in order to ensure a smooth and
orderly transfer of the manufacturing and distribution of the Licensed Products
upon termination or expiration of the Transitory Distribution Agreements and of
the Toll Manufacturing Agreement, as provided pursuant to the provisions of such
agreements.
ARTICLE 8: CONDITIONS PRECEDENT TO CLOSING
---------- -------------------------------
8.1 General Conditions
------------------
The obligations of each Party hereto to consummate the transactions
contemplated by this Agreement shall be subject to the satisfaction at or prior
to the Closing of the following conditions:
(a) No order, statute, rule, regulation, executive order, injunction,
stay, decree or restraining order shall have been enacted, entered, promulgated
or enforced by any court of competent jurisdiction or Governmental Body that
prohibits the consummation of the transactions contemplated hereby, and no
Proceeding by any third party, including, but not limited to, any Governmental
Body shall be pending which seeks to prohibit or declare illegal or invalid or
which seeks to enjoin or obtain monetary damages in respect of, the transactions
contemplated hereby;
(b) Novo Nordisk A/S shall have executed the Gabitril License
Amendment; and
(c) Novo Nordisk A/S shall have executed the Gabitril Consent to
Assignment.
8.2 Conditions to Obligations of Purchaser
--------------------------------------
The obligations of Purchaser to consummate the transactions
contemplated by this Agreement shall be subject to the satisfaction, or waiver
by Purchaser, at or prior to the Closing, of the following conditions: (i)
Seller shall have performed in all material respects its obligations required
under this Agreement to be performed by it at or prior to the Closing
(including, but not limited to deliveries according to Section 4.2), and (ii)
the representations and warranties made by Seller according to the provisions of
this Agreement shall be true and correct in all material respects at and as of
the date hereof and at and as of the Closing Date as though restated on and as
of such date (except in the case of any representation or warranty that by its
terms is made as of a date specified therein, in which case such representation
or warranty shall be true and correct in all material respect as of such date).
21
8.3 Conditions to Obligations of Seller
-----------------------------------
The obligations of Seller to consummate the transactions contemplated
by this Agreement shall be subject to the satisfaction, or waiver by Seller, at
or prior to the Closing, of the following conditions: (i) Purchaser shall have
performed in all material respects its obligations required under this Agreement
to be performed by it at or prior to the Closing (including, but not limited to,
deliveries according to Section 4.3) and (ii) the representations and warranties
made by Purchaser according to the provisions of this Agreement shall be true
and correct in all material respects at and as of the date hereof and at and as
of the Closing Date as though restated on and as of such date (except in the
case of any representation or warranty that by its terms is made as of a date
specified therein, in which case such representation or warranty shall be true
and correct in all material respect as of such date).
ARTICLE 9: TERMINATION
---------- -----------
This Agreement may be terminated and the transactions contemplated
hereby may be abandoned at any time prior to the Closing:
(a) by the written agreement of each of Purchaser and Seller; or
(b) by either Purchaser or Seller, by giving written notice of such
termination to the other Party, if the Closing shall have not occurred on, or
before the expiration of a period of three (3) months after the date of
execution of this Agreement.
ARTICLE 10: INDEMNIFICATION
----------- ---------------
FOR BREACH OF REPRESENTATIONS AND WARRANTIES
--------------------------------------------
10.1 Indemnification:
----------------
(a) Indemnification by Seller: From, and after, the Closing, and
subject to the provisions of this Article 10, Seller hereby agrees to indemnify
and hold harmless Purchaser and/or its Affiliates from and against any and all
claims, liabilities, obligations, judgments, penalties, losses, costs and
expenses (including, without limitation, the reasonable fees and expenses of
counsel (collectively referred to as the "Damages") incurred by Purchaser and/or
its Affiliates in connection with (i) any material inaccuracy or breach of any
representation or warranty on the part of Seller contained herein, and (ii) any
obligation, liability, commitment and/or indebtedness incurred in connection
with the operation of the Transferred Assets and of the related business prior
to the Closing.
(b) Indemnification by Purchaser: From, and after, the Closing, and
subject to the provisions of this Article 10, Purchaser hereby agrees to
indemnify and hold harmless Seller and/or its Affiliates from and against any
and all Damages incurred by Seller or Seller's Affiliates in connection with (i)
any material inaccuracy or breach of any representation or warranty on the part
of Purchaser contained herein, and (ii) any of the Obligations Undertaken.
22
(c) All claims made by any Party (the "Indemnifiable Party") against
the other Party (the "Indemnifying Party") under this Article 10 shall be
asserted as contemplated by Section 10.2 below.
10.2 Indemnification for Direct Claims
---------------------------------
In the event of a claim (other than a Third Party Claim as defined in
Section 10.3) made by one party and/or its Affiliates under Section 10.1 (a) or
(b) as the case may be (a "Direct Claim"), the Indemnifiable Party shall notify
such Direct Claim in writing to the Indemnifying Party with reasonable
promptness, specifying the nature of such Direct Claim and the amount or
estimated amount thereof (which estimate shall not be conclusive of the final
amount of such Direct Claim).
10.3 Third Party Claims:
-------------------
(a) In the event that (i) any claim, demand or action, suit or legal,
administrative, arbitration or other alternative dispute resolution proceeding
or investigation (each, a "Proceeding" and collectively, "Proceedings") is
asserted or instituted by any party other than the Parties and their Affiliates
which could give rise to Damages for which an Indemnifying Party would be liable
to an Indemnifiable Party hereunder (such Proceeding being hereinafter referred
to as a "Third Party Claim"), the Indemnifiable Party shall with reasonable
promptness send to the Indemnifying Party a written notice specifying the nature
of such claim or demand and the amount or estimated amount (which estimate shall
not be conclusive of the final amount of such claim and demand) (a "Third Party
Claim Notice").
(b) In the event of a Third Party Claim, the Indemnifying Party may
retain counsel of its choice, reasonably acceptable to the Indemnifiable Party,
to represent the Indemnifiable Party and any others the Indemnifying Party may
reasonably designate in connection with such claim or demand and shall pay the
fees and disbursements of such counsel with regard thereto. If requested by the
Indemnifying Party, the Indemnifiable Party agrees to cooperate with the
Indemnifying Party and its counsel in contesting any claim or demand which the
Indemnifying Party defends, or, if appropriate and related to the claim in
question, in making any counterclaim against the person asserting the Third
Party Claim or demand, or any cross-complaint against any person. No claim or
demand may be settled without the consent of the Indemnifying Party, which
consent shall not be unreasonably withheld or delayed.
(c) From and after the delivery of a Third Party Claim Notice
hereunder, at the reasonable request of the Indemnifying Party, the
Indemnifiable Party shall grant the Indemnifying Party and its representatives
all reasonable access to the books, records and properties of the Indemnifiable
Party to the extent reasonably related to the matters to which the Third Party
Claim Notice relates. The Indemnifying Party will not, and shall require that
its representatives do not, use (except in connection with such Third Party
Claim Notice) or disclose to any third Person other than the Indemnifying
Party's representatives (except as may be required by applicable Laws) any
information obtained pursuant to this Section which is designated confidential
by the Indemnifiable Party. All such access shall be granted during normal
business hours and shall be granted under conditions which will not interfere
with the business and operations of the Indemnifiable Party.
23
10.4 Limitation on Indemnity Payments.
--------------------------------
(a) General Limitations:
-------------------
(i) Subject to the provisions of Section 10.4 (b) (i), if an
Indemnifying Party pays to an Indemnifiable Party an amount in respect of a
Claim, and the Indemnifiable Party subsequently recovers or is entitled to
recover part or all of such amount from a third party (including tax
authorities) in relation to the same Claim, the Indemnifiable Party shall take
all reasonable steps to obtain such payment and, immediately thereupon, shall
pay to the Indemnifying Party the amount thereby recovered from such third
party; provided, however, that the cumulated sums paid to the Indemnifying Party
shall not exceed the amount paid by the Indemnifying Party and shall also not
exceed the amount paid by such third party less any costs, fees and expenses,
duly evidenced, incurred by the Indemnifiable Party in connection with the
recovery of such amount from such third party.
(ii) No Party hereto shall be entitled, under Section 10.1, to
claim any indemnification (x) on the basis of any and all facts, events or
circumstances which are explicitly disclosed in this Agreement or in any
Schedule hereto or (y) in respect of any breach of a representation or warranty
to the extent it was aware of such breach at the date hereof.
In particular, Purchaser acknowledges that it has been given
access by Seller to the documents listed in the Data Room Index communicated
today by Seller to Purchaser during a due diligence process (the "Due Diligence
Process"), and that, without limiting in any way the generality of the
foregoing, Purchaser shall not be entitled to claim any indemnification under
this Agreement on the basis of any and all facts or matters which have been
explicitly disclosed to Purchaser during such Due Diligence Process.
(iii) No Indemnifiable Party may seek or obtain indemnification
more than one (1) time from the same Indemnifying Party for any claim in which
the facts and circumstances are identical in all material respects to the facts
and circumstances with respect to which there was a final determination or
settlement under this Article 10 of a claim brought by such Indemnifiable Party
against such Indemnifying Party. If any claim for indemnification is based upon
a liability which is contingent only, the Indemnifiable Party shall not be
liable to make any indemnification payment unless and until such contingent
liability becomes due and payable; provided however that any claim for
indemnification that is made with respect to a contingent liability prior to the
termination of the survival period defined in Section 10.4 shall not be denied,
and no Indemnifying Party's liability hereunder shall be extinguished because
such liability remains contingent at the end of such survival period.
(iv) The Indemnifiable Party shall take all reasonable steps to
avoid or mitigate any Damages in respect of which it might be entitled to
indemnification pursuant to this Article 10.
(b) Limitation on Indemnity Payments by Seller
------------------------------------------
(i) No claim for indemnification under Article 10 may be made by
Purchaser or aggregated for the purposes of paragraph (ii) below, and no payment
in respect
24
thereof shall be required from Seller or any of its Affiliates with respect to
any Damage for which Purchaser shall be entitled to a claim towards Novo Nordisk
A/S according to the provisions of Section 19 of the Gabitril License Agreement.
(ii) No claim for indemnification under this Article 10 may be
made by Purchaser and no payment in respect of any material inaccuracy or breach
of any representation or warranty on the part of Seller contained herein shall
be required from Seller or any of its Affiliates unless (x) the amount of each
individual claim for which indemnification is sought exceeds Euros [**], and (y)
the aggregate amount of Damages resulting from such individual claims exceeds
Euros [**] (and then only for the amount of such excess).
10.5 Survival of Representations and Warranties
------------------------------------------
(a) The Parties hereby agree that, except as set forth in Section 10.4
(b), the representations and warranties contained in this Agreement shall
survive the execution and delivery of this Agreement and the Closing hereunder
for a period of three (3) years after the Closing and any claim for
indemnification arising out, or resulting from, an alleged inaccuracy or breach
of any such representations and warranties must be made prior to the termination
of such period.
(b) Each representation and warranty contained in Sections 5.1, 5.2,
5.3, 6.1, 6.2 and 6.3 shall survive the execution and delivery of this Agreement
and the Closing hereunder until the applicable statute of limitations governing
claims with respect to such representations and warranties has expired.
ARTICLE 11: GENERAL PROVISIONS
----------- ------------------
11.1 Expenses and Taxes
------------------
Each Party shall pay all fees and expenses incurred by it in connection
with this Agreement and the transactions contemplated hereby, except that the
Parties agree that all applicable excise, sales, use, registration and/or value
added transfer, stamp, documenting, filing, recordation, and other similar taxes
(excluding, for the avoidance of doubt, income taxes), levies, fees and charges,
if any, that may be imposed upon, or payable or collectible or incurred in
connection with this Agreement and the transactions contemplated hereby shall be
borne by Purchaser, regardless of the Party on which such taxes, levies, fees or
charges are imposed.
11.2 Amendments
----------
This Agreement may be amended, supplemented or modified and any
provision hereof may be waived, only pursuant to a written instrument making
specific reference to this Agreement and executed by duly authorized
representatives of the Parties.
25
11.3 Entire Agreement
----------------
This Agreement constitutes the entire agreement among the Parties with
respect to the matters herein and supersedes any previous agreements and
understandings between the Parties with respect to those matters.
11.4 Public Announcements
--------------------
Purchaser and Seller will consult with each other before issuing any press
release or otherwise making any public statements with respect to this
Agreement, the other Party's name or the transactions contemplated hereby and
neither Anesta nor Sanofi-Synthelabo shall issue any such press release or make
any such public statement without having first submitted a draft thereof to the
other Party. The issuance thereof shall not be made without the prior written
approval of the other Party (such approval not to be unreasonably withheld).
However, such approval shall be unnecessary if the disclosing Party is subject
to a legal requirement to disclose the existence and terms of this Agreement. In
such event, the disclosing Party shall notify without delay the other Party and
provide the other Party with a copy of the contemplated disclosure prior to
submission or release as the case may be, unless notifying is impossible due to
circumstances beyond the Party's control. The other Party may provide comments
to the submission or release and the disclosing Party shall in such case take
into consideration all such reasonable comments. Unless otherwise agreed with
the other Party the disclosing Party shall only disclose such information that
is needed to comply with the applicable law.
11.5 Governing Law - Arbitration
---------------------------
(a) This Agreement shall be governed in all respects by the laws of
France, including validity, interpretation and effect, without regards to the
principle of conflicts of laws that might otherwise be applicable.
(b) All disputes arising in connection herewith shall be finally
settled under the Rules of Conciliation and Arbitration of the International
Chamber of Commerce ("ICC") as in effect as of the date of commencement of the
arbitration proceedings, by three (3) arbitrators. The arbitration proceeding
shall take place in Paris (France) and shall be conducted in the English
language. The arbitration decision shall be binding upon the Parties and
judgment upon any award rendered may be entered in any court having
jurisdiction.
11.6 Counterparts
------------
This Agreement may be executed in any number of counterparts, each of
which shall be deemed an original, but all of which together shall constitute a
single instrument.
11.7 Headings
--------
The descriptive headings of the several Articles and Sections of this
Agreement are inserted for convenience only and do not constitute a part of this
Agreement.
26
11.8 Notices
-------
All notices and other communications under this Agreement shall be in
writing and in English language and shall be deemed to have been duly given when
delivered in person or upon confirmation of receipt when transmitted by
facsimile transmission or on receipt after dispatch by registered or certified
mail, postage prepaid, addressed as follows (or at such other address as the
Party to whom notice is to be given has furnished in writing to the other
Party):
If to Seller:
Sanofi-Synthelabo
000, Xxxxxx xx Xxxxxx
00000 Xxxxx (Xxxxxx)
Attention: General Counsel
Telephone: x00(0) 0 00 00 00 30
Facsimile: x00(0) 0 00 00 00 85
With a copy to:
Xxxxx, Day, Xxxxxx & Xxxxx
000, xxx xx Xxxxxxxx Xxxxx-Xxxxxx
00000 Xxxxx (Xxxxxx)
Attention: Gael Saint Olive
Telephone: x00(0) 0 00 00 00 39
Facsimile: +33(0) 1 56 59 39 38
If to Purchaser:
Xxxxxx XxxX
Xxxxxxxxxxxxxx 0
0000 Xxxx, Xxxxxxxxxxx
Attention: General Manager
Telephone: + 00 00 000 0000
Facsimile: + 41 41 342 1870
With a copy to:
Cephalon, Inc.
000 Xxxxxxxxxx Xxxxxxx,
Xxxx Xxxxxxx
Xxxxxxxxxxxx 00000-0000 (U.S.A.)
Attention: General Counsel & Secretary
Telephone: + 0 000 000 0000
Facsimile: + 1 610 738 6590
27
With a copy to:
Dechert
00, xxxxxx Xxxxxx
00000 Xxxxx (Xxxxxx)
Attention: Xxxxxx Xxxxxxxxxxx
Telephone: x00(0) 0 00 00 00 00
Facsimile: x00(0) 0 00 00 00 05
11.9 Severability
------------
The invalidity or unenforceability of any provision of this Agreement
shall not affect the validity or unenforceability of any other provision of this
Agreement, each of which shall remain in full force and effect. However the
Parties agree to substitute any invalid or unenforceable provision by a valid
and enforceable provision which maintains, to the greatest extent possible, the
respective interests of the Parties as established by the present terms and
conditions of the Agreement.
11.10 Binding Effect - No Assignment - Substitution
---------------------------------------------
This Agreement shall be binding upon and inure to the benefit of the
Parties and their respective successors and permitted assigns. Nothing in this
Agreement shall create or be deemed to create any third party beneficiary rights
in any Person not party to this Agreement. No assignment of this Agreement or of
any rights or obligations hereunder may be made by any Party without the prior
written consent of the other Party and any attempted assignment without such
required consent shall be null and void.
Notwithstanding the foregoing, Seller acknowledges and agrees that
Purchaser may designate any Affiliate or any third party to which it decides to
grant the right to distribute and sell the Licensed Product (the "Purchaser's
Designee) to substitute Purchaser as transferee of the Product Registrations in
accordance with the provisions of Section 7.4, provided however that no such
substitution shall relieve Purchaser of, and shall not modify in any way, any of
Purchaser's obligations, liabilities, and/or commitments hereunder.
28
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the
date first above written in ................. originals, in Geneva - Switzerland
Seller:
SANOFI-SYNTHELABO
/s/ Xxxx Xxxxx
.....................
By: Xxxx Xxxxx
Title: Director, Legal Operations
Purchaser:
ANESTA GmbH
/s/ Xxxxx Xxxxxx
.....................
By: Xxxxx Xxxxxx
Title: Attorney in Fact
SCHEDULE I.1
LIST OF CATEGORIES A COUNTRIES
[**]
SCHEDULE I.2
LIST OF CATEGORIES B COUNTRIES
[**]
SCHEDULE I.3
LIST OF CATEGORIES C COUNTRIES
[**]
SCHEDULE I.5
LIST OF THE PRODUCT REGISTRATIONS AND OF PENDING APPLICATIONS
[**]
SCHEDULE I.6
LIST OF REQUIRED CONSENTS
[**]
SCHEDULE I.8
TRANSFERRED CONTRACTS
[**]
SCHEDULE 5
DISCLOSURE SCHEDULE
[**]
SCHEDULE 5.10
SALES OF THE LICENSED PRODUCT AND CORRESPONDING PROFITS/LOSSES
[**]
SCHEDULE 7.4(A)(I)
IDENTITY OF PURCHASER'S DESIGNEE
[**]
SCHEDULE 7.4(B)(I)
LIST OF THE COUNTRIES IN WHICH SELLER HAS NOT SUBMITTED AN APPLICATION FOR A
PRODUCT REGISTRATION TO THE COMPETENT GOVERNMENTAL BODY
[**]
SCHEDULE 7.4(B)(II)
LIST OF THE COUNTRIES IN WHICH SELLER HAS SUBMITTED AN APPLICATION FOR A PRODUCT
REGISTRATION TO THE COMPETENT GOVERNMENTAL BODY BUT WHERE THE PRODUCT
REGISTRATION IS NOT ALREADY GRANTED
[**]
SCHEDULE 7.4(B)(III)
LIST OF THE COUNTRIES IN WHICH SELLER HAS SUBMITTED AN APPLICATION FOR A PRODUCT
REGISTRATION TO THE COMPETENT GOVERNMENTAL BODY BUT WHERE THE LICENSED PRODUCT
IS NOT ALREADY MARKETED
[**]
SCHEDULE 7.7.1
ONGOING CLINICAL STUDIES
[**]
