EXHIBIT 4.6
THE CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL
TREATMENT REQUEST IN ACCORDANCE WITH RULE 24B-2 OF THE SECURITIES AND
EXCHANGE ACT OF 1934, AS AMENDED. REDACTED PORTIONS OF THIS EXHIBIT
ARE MARKED BY AN ***.
ASSET PURCHASE AND ASSIGNMENT AGREEMENT
This Asset Purchase and Assignment Agreement (this "Agreement") is
entered into as of November 3, 2005, (the "Effective Date") by and among
Mylan Pharmaceuticals Inc., a West Virginia corporation ("Xxxxx Xxxxxx"),
and Mylan Bertek Pharmaceuticals Inc., a Texas corporation ("Bertek")
(Xxxxx Xxxxxx and Bertek, referred to herein individually and collectively
as "Seller"), and Vernalis (R&D) Limited, a United Kingdom company
("Buyer"). Buyer and Seller are each sometimes referred to herein as a
"Party" and collectively as the "Parties."
WHEREAS, Buyer desires to acquire the Acquired Assets (as defined
herein) and assume the Assumed Liabilities (as defined herein) from Seller;
and
WHEREAS, Seller desires to sell to Buyer such Acquired Assets and
assign to Buyer such Assumed Liabilities, all as more particularly set
forth in this Agreement.
NOW, THEREFORE, for good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties, intending to be
legally bound, hereby agree as follows:
ARTICLE 1
DEFINITIONS; INTERPRETATION
1.1 Definitions. Capitalized terms used in this Agreement, unless
otherwise defined, shall have the meanings set forth below:
"Acquired Assets" shall mean all of the following: (i) the Acquired
Intellectual Property, (ii) Seller's rights under the Assigned Contracts,
(iii) without prejudice to the Retained Japanese Rights, the Permits, (iv)
the Books and Records, (v) the items described in Part 1 of Schedule
2.4(b); and (vi) any other assets (if any) Controlled by Seller which
relate solely to the Product. Notwithstanding any of the foregoing, the
Acquired Assets shall not include the Excluded Assets or any other assets
of the Seller. For the sake of clarity, Seller owns no equipment which is
solely related to the Product.
"Acquired Intellectual Property" shall mean (a) the Intellectual
Property Rights set forth in Exhibit A; and (b) all Intellectual Property
Rights owned or Controlled by Seller used solely for or in connection with
the Product.
"Affiliate" shall mean, with respect to any Person, any other Person
who directly or indirectly, through one or more intermediaries, controls,
is controlled by, or is under common control with, such Person. For
purposes of this definition only, the term "control" shall mean the
possession, directly or indirectly, of the power to direct or cause the
direction of the management and policies of a Person, whether through the
ownership of voting securities, by contract or otherwise, and the terms
"controlled" and "controlling" have meanings correlative thereto.
"Assigned Contracts" shall mean the Contracts set forth on Exhibit B
hereto.
"Assumed Liabilities" shall mean, subject to the terms and conditions
of this Agreement, the following liabilities and obligations of Seller to
the extent related to the period on and following Closing: (i) all
liabilities, obligations, responsibilities and commitments of Seller under
the Assigned Contracts, except those liabilities related to the Cost of
Goods as described n Section 2.2 of the Transition Period Services
Agreement which liability for Cost of Goods will be assumed by Buyer
following the transition of the supply chain activity Services to Buyer as
described in Section 1.5 of the Transition Period Services Agreement and
(ii) all regulatory liabilities, obligations, responsibilities and
commitments of Seller pursuant to or arising from the Permits including,
without limitation, the Post-Marketing Commitments.
"Books and Records" shall mean the books, records, documentation,
data, databases (excluding Third Party software), and other information
described in Exhibit F hereto.
"Business Day" shall mean any day on which banking institutions are
not required or authorized to close in New York, New York.
"Buyer's Knowledge" means Buyer's and its Affiliates' knowledge having
made reasonable investigation with respect to any such facts and
information.
"Contract" shall mean any contract, agreement, indenture, note, bond,
loan, instrument, lease, conditional sale contract, mortgage, license,
franchise, insurance policy, commitment or other arrangement or agreement,
whether written or oral.
"Control" shall mean possession of the right, whether directly or
indirectly, and whether by ownership, license or otherwise (without the
need to obtain consent), to assign, or grant a license, sublicense or other
right as provided for herein without violating the terms of any agreement
or other arrangement with any Third Party.
"Encumbrances" shall mean any claim, lien, pledge, option, charge,
deed of trust, security interest, mortgage, encumbrance, restriction on
transfer (such as a right of first refusal or other similar rights, but not
including any restrictions on transfer arising under federal or state
securities laws), defect of title or other similar right of any Third Party
whether voluntarily incurred or arising by operation of law, and includes
any agreement to give any of the foregoing in the future, and any
contingent sale or other title retention agreement or lease in the nature
thereof.
"Excluded Assets" shall mean the
(a) Retained Japanese Rights;
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(b) all Contracts other than the Assigned Contracts provided that upon
assignment of the Xxxxxx Agreement to the Buyer, the Xxxxxx Agreement shall
be an Assigned Contract; and
(c) all inventory of Product other than that listed in Part 1 of
Schedule 2.4(b)
"Excluded Liabilities" shall mean all debts, obligations, taxes,
duties and liabilities of Seller and its Affiliates (all of which are
expressly excluded from the purchase and sale contemplated hereby), other
than the Assumed Liabilities. For the sake of clarity, Excluded Liabilities
shall include (i) any liability or obligation of Seller under this
Agreement and the other Transaction Documents, (ii) any payment or credit
obligation under an Assigned Contract which arises after Closing but which
relates to sales occurring, or services or activities conducted prior to,
Closing, and (iii) all other liabilities of Seller other than as expressly
contemplated by the definition of "Assumed Liabilities."
"FDA" shall mean the U.S. Food and Drug Administration, or any
successor entity thereto.
"FDCA" shall mean the Federal Food, Drug and Cosmetic Act of 1938, as
amended.
"Governmental Entity" shall mean any federal, state, local or foreign
governmental, regulatory or administrative body, agency, department, board,
commission or governmental entity or unit, any court or judicial
governmental entity, any public, private or industry regulatory
governmental entity, whether federal, state, local, foreign or otherwise,
or any Person lawfully empowered by any of the foregoing to enforce or seek
compliance with any Law.
"IND" shall mean the Investigational New Drug Application 52,844.
"Intellectual Property Rights" means the rights associated with or
arising out of any of the following: (a) trade secret rights and
corresponding rights in confidential information and other non-public
information (whether or not patented or patentable), including ideas,
formulas, compositions, inventor's notes, discoveries and improvements,
know-how, manufacturing and production processes and techniques, testing
information, research and development information, inventions, invention
disclosures, unpatented blueprints, drawings, specifications, designs,
plans, proposals and technical data, business and marketing plans, market
surveys, market know-how and customer lists and information; (b) all
trademarks, service marks, logos, domain names, copyrights, database
rights, design rights, trade dress and trade names, and other indicia of
commercial source or origin (whether registered, common law, statutory or
otherwise), all registrations and applications to register the foregoing
anywhere in the world and all goodwill associated therewith; and (c) any
similar, corresponding or equivalent rights to any of the foregoing
anywhere in the world.
"Interim Agreement" shall mean the agreement set out in Exhibit G.
"Law" or "Laws" shall mean any applicable federal, state, local or
foreign law, statute, constitution, ordinance, decree, requirement, code,
order, judgment, injunction, restriction, rule or regulation in effect of
any Governmental Entity.
"Loss" or "Losses" shall mean any and all losses, liabilities, costs,
deficiencies, fines, damages, penalties and expenses, and any legal or
other reasonable expenses incurred in
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connection with investigating or defending any claim, whether or not
resulting in damages; provided, however, that indirect, incidental,
consequential and punitive damages shall not be included in any calculation
of "Losses" except to the extent awarded in a Third Party claim.
"NDA" shall mean the New Drug Application 21-264.
"North America" shall mean the United States of America, its
territories and possessions (including the freely-associated Commonwealth
of Puerto Rico), Canada and Mexico.
"Open Final Study Reports" shall have the meaning given to it in the
Transition Period Services Agreement.
"Orphan Drug Designation" shall mean the FDA's act of granting a
request for designation of the Product as intended for a rare disease or
condition pursuant to the Orphan Drug Xxx 0000 Section 526 or 21 CFR
316.24.
"Permits" shall mean the NDA, IND, and the Orphan Drug Designation.
"Person" shall mean an individual, partnership, corporation, limited
liability company, joint stock company, unincorporated organization or
association, trust, joint venture, association or other organization,
whether or not a legal entity, or any Governmental Entity.
"Post-Marketing Commitments" shall mean any and all obligations,
responsibilities and commitments required by the FDA and/or other
Governmental Entity with respect to the Product and/or the Permits, whether
outstanding as of Closing or arising thereafter, except the Open Final
Study Reports which Seller shall be responsible for completing to the
extent and only to the extent set forth in the Transition Period Services
Agreement. Buyer acknowledges that attached hereto as Exhibit E is the
status of the outstanding Post-Marketing Commitments as of the Effective
Date.
"Product" shall mean the pharmaceutical product APOKYN(TM)
(apomorphine hydrochloride subcutaneous injection), as described on Exhibit
C hereto.
"Registered IP" means any Acquired Intellectual Property that is the
subject of an application, certificate, filing, registration or other
document issued, filed with, or recorded by any Governmental Entity,
including any trademark registrations and applications.
"Retained Japanese Rights" means the retained rights of Seller (a) to
possess a copy of the NDA but excluding the right to use or exploit the
same save as provided in (b) and (b) to convey to Britannia
Pharmaceuticals, Limited or its nominee the transferable and sublicensable
right to possess a copy of the NDA and to use the information and
Intellectual Property Rights therein solely in Japan and solely for the
purposes related to or relevant to the importation, use, development,
manufacture, marketing and sale of apomorphine products (regardless of form
or formulation) in Japan.
"Seller's Knowledge" means Seller's and its Affiliates' knowledge
having made reasonable investigation with respect to any such facts and
information.
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"Taxes" shall mean all taxes, charges, fees, duties, levies, or other
assessments of any kind whatsoever, including (without limitation) income,
gross receipts, net proceeds, ad valorem, turnover, real and personal
property (tangible and intangible), sales, use, franchise, excise, value
added, stamp, user, transfer, fuel, excess profits, occupational, interest
equalization, windfall profits, and employees' income withholding,
unemployment and Social Security taxes, which are imposed by the United
States, or any state, local or foreign government or subdivision or agency
thereof, including any interest, penalties or additions to tax related
thereto.
"Tax Return" shall mean any return, declaration, report, claim for
refund or information return or statement relating to Taxes, including any
schedule or attachment thereto and including any amendment thereof.
"Third Party" shall mean any Person other than Buyer, Seller and their
respective Affiliates.
"Transaction Documents" shall mean this Agreement, the Transition
Period Services Agreement, the Xxxx of Sale, the IP Assignments, and the
other documents, instruments, exhibits, annexes, schedules, or certificates
contemplated hereby and thereby.
"Transition Period Services Agreement" shall mean that agreement
between the Parties pertaining to the delivery of specified support
services by Seller to Buyer for a limited period following Closing in the
form specified in Exhibit D.
"Xxxxxx Agreement" shall mean the Supply Agreement by and between
Mylan Pharmaceuticals Inc. and Xxxxxx Pharma-Fertigung GmbH & Co. KG
("Xxxxxx") dated as of April 1, 2004, as well as the corresponding Quality
Agreement.
1.2 Other Defined Terms. The following terms are defined in the
sections indicated.
Xxxx of Sale........................ Section 3.2(c)
Closing............................. Section 3.1
Confidentiality Agreement........... Section 6.4
Costs............................... Section 3.5
Disputes............................ Section 4.8(c)
Indemnified Party................... Section 7.4(a)
IP Assignments...................... Section 3.3(c)
Purchase Price...................... Section 2.4
Required Consents................... Section 3.3(f)
Services............................ Transition Period
Services Agreement
Transfer Taxes...................... Section 6.5
Transition Team..................... Transition Period
Services Agreement
1.3 Business Days. Whenever the last day for the exercise of any
privilege or the discharge of any duty hereunder shall fall upon any day
which is not a Business Day, the party having such
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privilege or duty may exercise such privilege or discharge such duty on the
next succeeding Business Day.
1.4 Terminology. Unless otherwise indicated to the contrary herein by
the context or use thereof: (i) the words, "herein," "hereto," "hereof" and
words of similar import refer to this Agreement as a whole and not to any
particular Section or paragraph hereof; (ii) the word "including" shall
mean "including, but not limited to"; (iii) masculine gender shall also
include the feminine and neutral genders, and vice versa; (iv) words
importing the singular shall also include the plural, and vice versa; and
(v) references to statutes shall include all regulations promulgated
thereunder and references to statutes or regulations shall be construed as
including any and all further statutory and regulatory provisions
consolidating, amending, expanding, implementing, or replacing the statute
or regulation.
ARTICLE 2
PURCHASE AND SALE OF ASSETS;
ASSIGNMENT AND ASSUMPTION
2.1 Purchase and Sale of Assets. On and subject to the terms and
conditions of this Agreement, Buyer agrees to purchase from Seller at
Closing, and Seller agrees to sell, transfer, convey, assign and deliver to
Buyer at Closing, all of the Acquired Assets at Closing for the
consideration specified below in Section 2.4.
2.2 Assignment of Contracts and Permits.
(a) Subject to the terms and conditions of this Agreement, Seller will
assign and transfer to Buyer, and Buyer will accept and assume from Seller,
effective as of Closing, Seller's right, title and interest in and to, the
Assigned Contracts and all of the Permits save for the Retained Japanese Rights.
Anything in this Agreement to the contrary notwithstanding, this
Agreement shall not constitute an agreement to assign or transfer any
Contract or Permit or any claim or right or any benefit or obligation
thereunder or resulting therefrom if an assignment or transfer thereof,
without the consent of a Third Party thereto, would constitute a breach or
violation thereof or is otherwise prohibited. If such consent is required
or if an attempted assignment is ineffective, Seller shall use its
commercially reasonable efforts to secure such consent as soon as possible
after Closing and, pending receipt of such consent shall cooperate with
Buyer to provide for Buyer the benefits under any such Assigned Contract or
Permit.
(b) In relation to those Contracts (other than the Assigned Contracts and
the Xxxxxx Agreement) copies of which are received by Buyer from Seller prior to
Closing, Seller is free to terminate any such Contract. In Seller's sole
discretion, Seller may, within sixty (60) days after Closing, present to Buyer
any Contract regarding the Product or Acquired Assets for Buyer's consideration
to assume. If Buyer provides written notice to Seller within ten (10) Business
Days of such presentation by Seller that Buyer desires to assume said Contract,
Seller will cooperate to effect such assignment of the Contract to Buyer. Any
Contract so assumed shall be deemed to be an Assigned Contract as of Closing for
the purposes of this Agreement and Exhibit B shall be deemed to be amended
accordingly.
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2.3 Assumption of Liabilities. On and subject to the terms and
conditions of this Agreement, Buyer agrees to assume and become responsible
for all of the Assumed Liabilities from and after Closing. Buyer will not
assume or have any responsibility, however, with respect to any Excluded
Liabilities.
2.4 Purchase Price. In consideration for the sale of the Acquired
Assets by Seller to Buyer, Buyer shall pay to Seller
(a) an amount of Twenty-Three Million US Dollars (US $23,000,000.00)
at Closing (the "Purchase Price"); and
(b) an amount equal to a dollar-for-dollar true-up for the sum of (a)
those items listed in Part 1of Schedule 2.4(b); and (b) any additional
inventory of Product ordered by Seller on Buyer's instructions after the
Closing and paid for by Seller pursuant to Section 2.2. of the Transition
Period Services Agreement, less the amounts paid by Buyer for any such
items and inventory pursuant to Section 2.2 of the Transition Period
Services Agreement. Such amount shall be calculated and paid within thirty
(30) days of expiry of receipt of the other items listed in Schedule 2.4(b)
and of the inventory of Product remaining following expiry of the Service
Period of the Supply Chain Activity Services as provided in Section 1.5(b)
of the Transition Period Services Agreement.
2.5 Payment of Purchase Price. Payment by Buyer of the Purchase Price
shall be made by the transfer of immediately available funds to an account
in the US designated by Seller.
ARTICLE 3
CLOSING; DELIVERIES
3.1 The Closing. The closing of the sale and purchase of the Acquired
Assets (the "Closing") shall take place at the offices of the Seller at 000
Xxxxxxxx Xxxxx Xxxx, Xxxxxxxxxx, Xxxx Xxxxxxxx, at 10:00 a.m., local time,
on the Effective Date. At the Closing, the Parties will exchange funds,
certificates and other documents as specified in this Agreement.
3.2 Deliveries by Buyer. At the Closing, Buyer shall deliver to Seller
the following:
(a) cash in the non-refundable amount of Twenty Three Million Dollars
($23,000,000.00). For clarity the amounts to be computed pursuant to Section
2.4(b) shall be paid in accordance with Section 3.5;
(b) a counterpart to the Transition Period Services Agreement in the form
of Exhibit D hereto and a counterpart to the Interim Agreement in the form of
Exhibit G hereto, each duly executed on behalf of Buyer;
(c) a counterpart to a Xxxx of Sale and Assignment and Assumption Agreement
in substance consistent with this Agreement and in customary form (the "Xxxx of
Sale"), duly executed on behalf of Buyer;
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(d) a certified copy of a resolution of Buyer's Board of Directors
approving the transactions contemplated by this Agreement; and
(e) the letters set out in Schedule 3.2(e) duly executed on behalf of
Buyer.
(f) a copy of a search against the Buyer conducted at Companies House dated
a recent date prior to the Closing.
3.3 Deliveries by Seller. At the Closing, Seller shall deliver to
Buyer the following:
(a) a counterpart to the Transition Period Services Agreement, and a
counterpart to the Interim Agreement in the form of Exhibit G hereto, each duly
executed on behalf of Seller;
(b) a counterpart to the Xxxx of Sale, duly executed on behalf of Seller;
(c) assignments (the "IP Assignments") of the Acquired Intellectual
Property identified in Part 1 of Exhibit A, in customary form;
(d) a certificate from the Secretaries of State of West Virginia and of
Texas, dated a recent date prior to the Closing, certifying as to Seller's good
standing;
(e) a certificate from the Secretary of Seller, certifying as to Seller's
certificate of incorporation and by-laws, and actions taken by the Board of
Directors of Seller approving the transactions contemplated by this Agreement;
(f) the consents ("Required Consents") set forth on Schedule 3.3(f); and
(g) the letters set out in Schedule 3.3(g) duly executed on behalf of
Seller.
3.4 Post Closing Accounts Arrangements. For all credits price
concessions, rebates, administrative fees, reimbursements, chargebacks,
rejections, returns (including the cost of destroying any return) and
similar ("Costs") (as referred to in the Transition Period Services
Agreement, Section 2.2) paid or issued subsequent to Closing that pertain:
(a) to the sale of Product prior to Closing, Seller shall be
responsible for those Costs; and
(b) to the sale of the Product subsequent to Closing, Buyer shall be
responsible for those Costs.
Buyer shall reimburse the Seller, and Seller shall reimburse Buyer,
for any payments made by it for which the other is responsible
pursuant to this Section, in each case against invoice. Determination
of liability for any particular Cost shall be made using the
methodology that most accurately and reasonably allocates Costs as
outlined above, such as lot number of the Product sold, or where it is
not possible to determine the lot number of Product sold, by the
timing between incurring the Cost and the time of actual payment (such
time lag to be reasonable to both Parties) or such other method as the
Parties may agree. If the Parties cannot agree on allocation of any
Cost, the calculation will be submitted for determination
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to an international, independent public accounting firm mutually
selected by the Parties, and such determination will be binding on the
Parties. For ease of administration, the Parties agree to accept the
following assumptions:
(i) for Medicaid rebates, rebates that are claimed within 180 days of
Closing will be deemed to pertain to Seller's sales and rebates
claimed thereafter (or any with Buyer's label) will be deemed to
pertain to Buyer's sales;
(ii) with respect to returns, each Party is responsible for all
returns relating to entire lots of Product sold by it. Where each
Party has sold part of a lot of Product, unless otherwise agreed,
returns will be destroyed and the responsibility for the Costs of
such returns will be allocated between Buyer and Seller in
proportion to volume of sales of Product made by it from that
lot. The Parties believe the above calculation would be the most
reasonable basis for allocating returns, however, if after
reviewing the actual return activity, a Party believes an
alternate basis is more accurate it may propose such alternate
basis. If the Parties cannot agree on the suggested alternate
allocation of returns, the calculation will be submitted for
determination to an international, independent public accounting
firm mutually selected by the Parties, and such determination
will be binding on the Parties.
3.5. Transfer / Delivery of Acquired Assets. The Parties agree that
the transfer/delivery off the Acquired Assets from Seller to Buyer shall be
done in accordance with the terms set forth in the Transition Period
Services Agreement. The Parties acknowledge that Seller may retain a copy
of all Books and Records for regulatory, liability or archival purposes as
set out in the Transition Period Services Agreement.
ARTICLE 4
REPRESENTATIONS AND WARRANTIES OF SELLER
Seller represents and warrants to Buyer as of the Effective Date:
4.1 Corporate Organization; Authority. Xxxxx Xxxxxx is a corporation
duly organized, validly existing and in good standing under the laws of the
State of Xxxx Xxxxxxx, and has all requisite corporate power and authority
to conduct its business as it is now being conducted and to own, lease and
operate its properties and assets. Bertek is a corporation duly organized,
validly existing and in good standing under the laws of the State of Texas,
and has all requisite corporate power and authority to conduct its business
as it is now being conducted and to own, lease and operate its properties
and assets.
4.2 Authority Relative to this Agreement. Seller has all requisite
power and authority (including corporate power or authority) to execute and
deliver this Agreement and the other Transaction Documents to which it is a
party and to consummate the transactions provided for herein and therein.
The execution and delivery by Seller of this Agreement and the other
Transaction Documents to which it is a party and the consummation of the
transactions contemplated hereby and thereby have been duly and validly
authorized by the Board of Directors, and no other corporate proceedings on
the part of Seller are necessary to authorize this Agreement
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or the other Transaction Documents to which it is a party or to consummate
the transactions contemplated hereby or thereby. This Agreement has been
duly and validly executed and delivered by Seller, and, assuming this
Agreement has been duly authorized, executed and delivered by Buyer, this
Agreement constitutes a valid and binding agreement of Seller, enforceable
against Seller in accordance with its terms, except that such enforcement
may be subject to bankruptcy, insolvency, reorganization, moratorium
(whether general or specific) or other similar Laws now or hereafter in
effect relating to creditors' rights generally.
4.3 No Violations; Consents and Approvals. Except as set forth in
Schedule 4.3, neither the execution and delivery by Seller of this
Agreement or the other Transaction Documents to which it is a party, nor
the consummation of the transactions contemplated hereby or thereby, will
(a) violate any Law, ruling or other restriction of any Governmental Entity
to which Seller is subject, (b) breach or violate any provision of the
Certificate of Incorporation or By-laws of Seller, (c) conflict with,
result in a material breach of, result in the acceleration of, result in a
notice obligation under, create in any party a right to accelerate,
terminate or modify or cancel, any Contract to which Seller is a party or
by which Seller is bound, (d) result in the creation of any Encumbrance
upon the Acquired Assets, or (e) except as otherwise expressly contemplated
by this Agreement, require any consent, waiver, approval, authorization of,
permit from, filing with, or notification to any Governmental Entity or any
other Person in connection with the execution, delivery and performance of
this Agreement and the other Transaction Documents and the consummation of
the transactions contemplated hereby and thereby; provided, however, that
this Section 4.3 shall not extend to any consent, waiver, approval,
authorization, Permit, filing or notification that may be required due to
Buyer's status as a foreign entity. This Section does not affect Section
2.2(b).
4.4 Compliance with Law. Seller has complied in all material respects
with all Laws applicable to the Product, the Acquired Assets and the
Assumed Liabilities (and any of them) and Seller's operations in connection
therewith and no action, suit, proceeding, hearing, investigation, charge,
complaint, claim, demand or notice has been filed or commenced against
Seller alleging any failure to so comply.
4.5 Assigned Contracts. With respect to each Assigned Contract and the
Xxxxxx Agreement, except as set forth in Schedule 4.5(a): (i) such Assigned
Contract and the Xxxxxx Agreement is in full force and effect; (ii) Seller
is not in material breach or default thereunder, and, to Seller's
Knowledge, no event has occurred which with notice or lapse of time would
reasonably be expected to constitute a material breach or default, or
permit termination, modification, or acceleration, under such Assigned
Contract or the Xxxxxx Agreement; (iii) neither Seller nor, to Seller's
Knowledge, any other party to such Assigned Contract or the Xxxxxx
Agreement has repudiated any material provision thereof; and (iv) Seller
has not received any notice that it has violated, defaulted under or
breached such Assigned Contract or the Xxxxxx Agreement. Other than the
Assigned Contracts and the Contracts copies of which were received by Buyer
from Seller prior to the Effective Date (including the Xxxxxx Agreement),
Seller has not entered into any Contract which is at the Effective Date
material to the Product.
4.6 Litigation. Except as set forth on Schedule 4.6, there is not
currently and has not been previously any action, suit or proceeding
pending, decided or settled or, to Seller's Knowledge, threatened, against
Seller, relating in any way to the Product, the Acquired Assets or the
Assumed
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Liabilities (or any of them) or to Seller's operations in connection
therewith, before any court or Governmental Entity or arbitral body or
other dispute resolution body. There is no investigation or inquiry being
conducted or, to Seller's Knowledge, threatened, by any Governmental Entity
involving Seller, or relating to Seller's use, development,
commercialization or manufacture of the Product. Except as set forth in
Schedule 4.6, Seller has not received notice that it is subject to any
outstanding judgment, order, injunction, default notice or decree of any
Governmental Entity.
4.7 Rights in Acquired Assets. Save for those Acquired Assets
identified in Schedule A as being licensed to Seller, Seller has good title
to all of the Acquired Assets, free and clear of all Encumbrances. With
respect to those Acquired Assets identified in Schedule A as being licensed
to Seller, Seller's license interest is valid and subsisting and free of
all Encumbrances. Following consummation of the transactions contemplated
by this Agreement, Buyer will have the same rights, titles, and interests
in and to the Product and the Acquired Assets from and after Closing as
Seller has on the date immediately prior to the Effective Date. The
Acquired Assets, together with the (a) the Contracts copies of which were
received by Buyer from Seller prior to the Effective Date; and (b) the
inventory listed in Part 2 of Schedule 2.4(b); constitute all assets and
rights owned or Controlled by Seller and any of its Affiliates which are
material to the Product.
4.8 Intellectual Property.
(a) Except as expressly stated in Schedule 4.8, all of the Acquired
Intellectual Property is either (i) wholly and exclusively owned by Seller free
and clear of all options, rights, licenses, restrictions, interests of any kind,
and Encumbrances or (ii) duly, validly, wholly, and exclusively licensed to
Seller in North America and Seller's license interest is valid and subsisting
and free of all Encumbrances. Schedule A accurately identifies which Acquired
Intellectual Property is owned by Seller and which is licensed to Seller.
(b) There are no claims pending or, to Seller's Knowledge, threatened, with
regard to the use, ownership or licensing to or by Seller of any of the Acquired
Intellectual Property. As of the Effective Date, Seller has and as of Closing
Seller will have the legal power to convey to Buyer all of its ownership and
license interests in the Acquired Intellectual Property.
(c) There is not currently and there has not been previously, any pending,
decided or settled injunction, claim, lawsuit, proceeding, hearing,
investigation, complaint, arbitration, mediation, demand, ITC investigation,
decree, or any other dispute, disagreement, or claim related to the Acquired
Intellectual Property (collectively referred to hereinafter as "Disputes"), nor,
to Seller's Knowledge, has any such Dispute been threatened, challenging the
legality, validity, enforceability or ownership of or Seller's rights to any
Acquired Intellectual Property.
(d) To Seller's Knowledge, none of the Acquired Intellectual Property has
been infringed, is being infringed, has been misappropriated, or has been the
subject of any unauthorized use or disclosure. The Seller does not and its
Affiliates do not own or Control any patent or patent application relating to
the Product.
(e) There is not currently and there has not been previously any pending,
decided or settled or, to Seller's Knowledge, threatened, claim that the use,
development, commercialization or manufacture of the Product, or the use or
exploitation of the Acquired Intellectual Property or Seller, by virtue of its
11
practice thereof, has infringed, is infringing, or will infringe any
Intellectual Property Rights of any Third Party. Neither Seller nor any of its
Affiliates have granted or created any contractual, legal, or other restriction
on the use of any of the Acquired Intellectual Property other than as set forth
in any document establishing Seller's right to such Acquired Intellectual
Property or in Schedule 4.8 and to Seller's Knowledge, no such restriction
exists. Notwithstanding the foregoing or anything to the contrary herein, Buyer
acknowledges that Seller has not sought or procured a "freedom to operate"
opinion from patent counsel with respect to the development, manufacture,
importation, sale marketing, distribution or other use the Product, and no duty
on the part of Seller to seek or procure such an opinion shall be implied from
this Section 4.8(e) or any other provision hereof.
(f) All Registered IP included among the Acquired Intellectual Property and
all registered trademarks and service marks, and applications for registration
of trademarks and service marks owned (in whole or in part) by Seller have been
(and all of the foregoing that are licensed to Seller have been, to Seller's
Knowledge) duly registered and/or filed with or issued by each appropriate
Governmental Entity and all necessary maintenance fees have been (or, with
respect to licensed rights have been, to Seller's Knowledge) timely paid to
continue all such rights in effect and such rights have not lapsed or been
cancelled.
(g) Seller has taken commercially reasonable measures and precautions to
safeguard and maintain the confidentiality of all Acquired Intellectual Property
(except such Acquired Intellectual Property whose value would be unimpaired by
public disclosure). Seller has and enforces a policy requiring each employee and
consultant to execute proprietary information, confidentiality and assignment
agreements substantially in Seller's standard form.
(h) All fees, annuities, royalties, honoraria and other payments that are
or were due from Seller on or before the Effective Date for any of the Acquired
Intellectual Property or the Assigned Contracts related thereto have been paid.
4.9 Permits. No violations are or have been recorded in respect of any
Permit by the entity that issued the Permit, and no proceeding is pending
or, to Seller's Knowledge, threatened, to suspend, revoke, limit or modify
either Permit. Exhibit E sets out the status of all outstanding
Post-Marketing Commitments as of the Effective Date.
4.10 Regulatory Compliance. Seller has not used in any capacity the
services of any person debarred under section 306 of the FDCA in connection
with any work performed on the Product.
4.11 Stock. All raw materials, finished goods and inventory of Product
comprising Acquired Assets are saleable and usable for the purpose for
which it is intended.
4.12 Product Registration Files. The NDA and IND have been maintained
in accordance with all Laws and guidance documents in all material
respects.
4.13 Information. Seller has made available to Buyer all information
in its or its Affiliates possession or Control which it reasonably believes
to be material to the Product, the Acquired Assets and the Assumed
Liabilities.
12
4.14 Affiliates. No Affiliate of Seller owns or controls any assets or
rights which are material to the Product, and no Affiliate of Seller has
ever tested, developed, marketed or sold the Product.
4.15 Ordinary Course. Over the past three (3) months before the
Effective Date, Seller has not offered any special promotions regarding the
Product that are substantially different from Seller's past practice
regarding the Product. Aggregate sales of Product by Seller since October
1, 2005 have not exceeded US$***.
ARTICLE 5
REPRESENTATIONS AND WARRANTIES OF BUYER
Buyer represents and warrants to Seller as of the Effective Date:
5.1 Corporate Organization; Authority. Buyer is a corporation, duly
organized, validly existing and in good standing under the laws of England
and has all requisite corporate power and authority to conduct its business
as it is now being conducted and to own, lease and operate its properties
and assets. Buyer is qualified to do business as a foreign corporation in
each jurisdiction where the failure to be so qualified would have a
material and adverse effect on Buyer. Buyer has appointed Xx. Xxxxx
Xxxxxxxxx of CanReg Inc as its agent in the US for regulatory purposes.
5.2 Authority Relative to this Agreement. Buyer has full corporate
power and authority to execute and deliver this Agreement and the other
Transaction Documents to which it is a party and to consummate the
transactions contemplated hereby and thereby. The execution and delivery by
Buyer of this Agreement and the other Transaction Documents to which it is
a party and the consummation of the transactions contemplated hereby and
thereby have been duly and validly authorized by its Board of Directors,
and no other corporate proceedings on the part of Buyer are necessary to
authorize the execution and delivery of this Agreement and the other
Transaction Documents to which it is a party or to consummate the
transactions contemplated hereby. This Agreement has been duly and validly
executed and delivered by Buyer and, assuming this Agreement has been duly
authorized, executed and delivered by Seller, constitutes the valid and
binding agreement of Buyer, enforceable against Buyer in accordance with
its terms, except that such enforcement may be subject to bankruptcy,
insolvency, reorganization, moratorium (whether general or specific) or
other similar laws now or hereafter in effect relating to creditors' rights
generally.
5.3 No Violations; Consents and Approvals. Neither the execution and
delivery by Buyer of this Agreement or the other Transaction Documents to
which it is a party, nor the consummation of the transactions contemplated
hereby or thereby, will (a) violate any Law, ruling or other restriction of
any Governmental Entity to which it is subject, (b) breach or violate any
provision of its constitutional documents, (c) conflict with, result in a
material breach of, result in the acceleration of, create in any party a
right to accelerate, terminate or modify or cancel, any Contract to which
it is a party or by which it is bound, (d) result in the creation of any
Encumbrance upon any of its assets, or (e) require any material consent,
waiver, approval, authorization of, permit from, filing with, or
notification to any Governmental Entity or any other Person in connection
with its execution delivery and performance of this Agreement and or the
other Transaction Documents and
13
the consummation of the transactions contemplated hereby and thereby,
except as otherwise expressly contemplated by this Agreement.
5.4 Litigation. There is not currently and has not previously been any
action, suit or proceeding pending, decided or settled or, to Buyer's
Knowledge, action, suit or proceeding threatened, against Buyer before any
Governmental Entity or arbitral body which will impair or delay Buyer's
ability to consummate the transactions contemplated by this Agreement, and
to Buyer's Knowledge, there are no circumstances existing which are likely
to give rise to any such action, suit or proceeding. Buyer has not received
notice that it is subject to any outstanding judgment, order, injunction,
default notice or decree of any Governmental Entity or arbitral body which
is reasonably likely to materially impair or delay Buyer's ability to
consummate the transactions contemplated by this Agreement.
5.5 Brokers and Finders. Neither Buyer nor any of its officers,
directors or employees has employed any investment banker, broker or finder
that would impose any liability on Seller for any investment banking fees,
brokerage fees, commissions or finders' fees in connection with the
transactions contemplated by this Agreement.
5.6 Sufficient Funds. Buyer has sufficient financial wherewithal to:
(a) perform all of its obligations pursuant to this Agreement, including
payment for the Purchase Price; (b) meet the Post-Marketing Commitments
outstanding as of the Effective Date as set out in Exhibit E and, to
Buyer's Knowledge, all other Post-Marketing Commitments; and (c) meet all
of Buyer's obligations that come due in the ordinary course of business.
5.7 Post-Marketing Commitments. Buyer acknowledges that from and after
Closing, Buyer shall be, and hereby is, responsible to the FDA and any or
all other applicable Governmental Entities for full performance of all the
Post-Marketing Commitments. Buyer has the necessary expertise to properly
perform all of the Post-Marketing Commitments. Buyer acknowledges, and the
Parties agree, that, from and after Closing, Seller will have no further
obligations whatsoever for, or in connection with, the Post-Marketing
Commitments.
5.8 Due Diligence. Buyer has conducted a comprehensive review and
analysis of all information made available by Seller to Buyer and
acknowledges that Buyer has been provided adequate access to the personnel,
properties, premises and records of Seller for such review and analysis.
EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES CONTAINED IN THIS AGREEMENT,
BUYER ACKNOWLEDGES THAT NEITHER SELLER NOR ANY OF ITS AFFILIATES MAKES ANY
OTHER EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY IN CONNECTION WITH THE
TRANSACTION CONTEMPLATED BY THIS AGREEMENT.
5.9 Notice of NDA Updates. Buyer hereby agrees that it will in
response to written requests received from time to time from Britannia
Pharmaceuticals, Limited or its nominee inform such Person whether or not
Buyer has filed an update to the NDA with the FDA since the previous
request (or in respect of the first such request, since the Closing)
provided that Buyer's sole liability in respect of a breach of this
obligation will be to provide the response pursuit to a repeated request.
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ARTICLE 6
FURTHER ASSURANCES
6.1 Efforts; Further Assurances. Subject to the terms and conditions
herein provided, (i) each of Seller and Buyer shall use its respective
commercially reasonable efforts to obtain all consents, approvals and
authorizations that are required to be obtained under any Law, and (ii)
each of Seller and Buyer shall use its respective commercially reasonable
efforts to effect all necessary registrations and filings and submissions
of information requested or required by Governmental Entities; in each
case, as may be required to give full effect to the transactions
contemplated by this Agreement and the Transaction Documents. Each of
Seller and Buyer further covenants and agrees, with respect to a threatened
or pending preliminary or permanent injunction or other order, decree or
ruling or statute, rule, regulation or executive order that would adversely
affect the ability of the Parties to consummate the transactions
contemplated hereby, to use their respective commercially reasonable
efforts to prevent the entry, enactment or promulgation thereof, as the
case may be. Each party, shall at the request of the other party, execute
such documents and do such other acts and things as may be reasonably
required to vest in Buyer the Acquired Assets and the Assumed Liabilities.
6.2 Public Announcements. Each Party shall give the other an
opportunity for prior review and comment on its proposed press release, and
shall not issue its press release until it has been approved by both Buyer
and Seller (approval not to be unreasonably withheld or delayed). Neither
Party shall, and they shall ensure that their respective Affiliates do not,
otherwise make any public statements with respect to this Agreement and the
transactions contemplated hereby or issue any press release or make any
such public statement without the consent of the other Party, except that
such approval shall not be required for a public statement to the extent
either Party is advised by its legal counsel that such disclosure is
required by Law or the rules of a stock exchange to which a Party is
subject.
6.3 Fees and Expenses. Except as expressly contemplated hereby, each
Party agrees to bear its own expenses in connection with the transactions
contemplated hereby, including fees and expenses of accountants, attorneys,
investment advisors, and other professionals.
6.4 Confidentiality. Any confidential information disclosed by one
Party and/or its Affiliates to the other Party and/or its Affiliates shall
be subject to the terms of that certain confidentiality agreement by and
between Mylan Laboratories Inc. and Vernalis (R&D) Ltd dated August 30,
2005 ("Confidentiality Agreement"), which is incorporated herein by
reference in its entirety.
6.5 Transfer Taxes. All sales, use and transfer taxes, including but
not limited to any value added, stock transfer, stamp duty and real,
personal, or intangible property transfer taxes, in each case chargeable to
the Buyer by reason of its acquisition of the Acquired Assets, including
any interest or penalties in respect thereof (the "Transfer Taxes") shall
be paid by Buyer. Seller and Buyer shall cooperate with each other and use
their commercially reasonable efforts to minimize the Transfer Taxes
attributable to the transfer of the Acquired Assets.
6.6 Cooperation on Tax Matters.
15
(a) Each of Buyer and Seller agree to furnish or cause to be furnished
to the other, upon request, as promptly as practicable, such information
(including access to books and records) and assistance relating to the
Product and any Acquired Assets as is reasonably necessary for the filing
of any Tax Return, the preparation for, or conduct of, any tax audit, or
the prosecution or defense of any claim, suit or proceeding relating to any
proposed tax adjustment relating to the Acquired Assets. Buyer and Seller
shall keep all such information and documents received by them confidential
unless otherwise required by Law or the rules of any stock exchange and
other documents related to taxes as are reasonably necessary to carry out
the intent of this Agreement.
(b) Buyer and Seller agree to retain or cause to be retained all books
and records pertinent to the Acquired Assets until the applicable period
for assessment of Taxes under Laws applicable to it (giving effect to any
and all extensions or waivers) has expired, and such additional period as
necessary for any administrative or judicial proceedings to which it is
subject to relating to any proposed assessment, and to abide by all record
retention agreements entered into by it with any taxing authority.
ARTICLE 7 INDEMNIFICATION
7.1 Indemnification Obligation of Seller.
(a) Seller shall indemnify Buyer, its Affiliates and their respective
stockholders, officers, directors, employees, agents, representatives and
successors and assigns (each a "Buyer Indemnitee" and, collectively the "Buyer
Indemnitees") in respect of, and save and hold each Buyer Indemnitee harmless
against any Losses which such Buyer Indemnitee suffers, sustains or becomes
subject to as a result of or by virtue of, without duplication:
(i) any facts or circumstances which constitute a
misrepresentation or breach of any representation or warranty made by
Seller set forth in this Agreement or any Transaction Document, or in
any certificate, document or instrument to be delivered by Seller
pursuant to this Agreement;
(ii) any non-fulfillment or breach of any covenant of Seller set
forth in this Agreement;
(iii) any Excluded Liabilities;
(iv) any claim by a Third Party for (a) infringement of Third
Party Intellectual Property Rights; (b) personal injury, death,
damage to property or other damage, which in each case either (i)
arises before Closing and relates to activities conducted in relation
to the Product, the Acquired Assets, or the use, marketing,
manufacturing or sale of the Product; or (ii) arises on and/or after
Closing but relates to activities conducted in relation to the
Product, or the use, marketing, manufacturing or sale of the Product,
prior to Closing; or
(v) Seller's negligence or willful misconduct.
16
7.2 Indemnification Obligation of Buyer.
(a) Buyer will indemnify Seller, its Affiliates and their respective
stockholders, officers, directors, employees, agents, representatives and
successors and assigns (each a "Seller Indemnitee" and, collectively the "Seller
Indemnitees") in respect of, and save and hold each Seller Indemnitee harmless
against any Losses which such Seller Indemnitee suffers, sustains or becomes
subject to as a result of or by virtue of, without duplication:
(i) any facts or circumstances which constitute a
misrepresentation or breach of any representation or warranty made by
Buyer set forth in this Agreement or in any Transaction Document, or
in any certificate, document, or instrument to be delivered by Buyer
pursuant to this Agreement;
(ii) any non-fulfillment or breach of any covenant of Buyer set
forth in this Agreement;
(iii) any of the Assumed Liabilities;
(iv) any claim by a Third Party for (a) infringement of Third
Party Intellectual Property Rights; (b) personal injury, death, damage
to property or other damage, which in each case arises after Closing
and relates to activities conducted in relation to the Product, the
Acquired Assets, or the use, marketing, manufacturing or sale of the
Product, after Closing; and
(v) Buyer's negligence or willful misconduct.
7.3 Indemnification Procedures.
(a) Any Person making a claim for indemnification pursuant to Section 7.2
or 7.3 above (each, an "Indemnified Party") must give the Party from whom
indemnification is sought (an "Indemnifying Party") written notice of such claim
promptly after the Indemnified Party receives any written notice of any action,
lawsuit, proceeding, investigation or other claim (a "Proceeding") against or
involving the Indemnified Party by any Person or otherwise discovers the
liability, obligation or facts giving rise to such claim for indemnification;
provided, that the failure to notify or delay in notifying an Indemnifying Party
will not relieve the Indemnifying Party of its obligations pursuant to Section
7.2 or 7.3 above, as applicable, except to the extent that such failure or delay
actually xxxxx the Indemnifying Party.
(b) With respect to the defense of any Proceeding in respect of which an
Indemnified Party would seek indemnification from the Indemnifying Party
pursuant to Section 7.1 or 7.2 above, at its option, an Indemnifying Party may
appoint as lead counsel of such defense any legal counsel approved by the
Indemnified Party, such approval not to be unreasonably withheld or delayed.
(c) Notwithstanding Section 7.3(b) above: (i) the Indemnified Party will be
entitled to participate in the defense of such claim and to employ counsel of
its choice for such purpose at its own expense, the Indemnifying Party will not
be entitled to assume control of the defense of such claim (and the Indemnified
Party will have the right to control such defense), and the Indemnifying Party
will pay the reasonable fees and expenses of legal counsel retained by the
Indemnified Party, if:
17
(i) the Indemnified Party reasonably believes an adverse
determination of such Proceeding would be reasonably likely to have a
material and adverse effect upon the Indemnified Party's business;
(ii) the Indemnified Party reasonably believes that there exists
a conflict of interest which, under applicable principles of legal
ethics, could prohibit a single legal counsel from representing both
the Indemnified Party and the Indemnifying Party in such Proceeding;
or
(iii) the Indemnified Party reasonably believes that the
Indemnifying Party has failed or is failing to prosecute or defend
vigorously such claim following written notice and a thirty (30) day
opportunity to cure.
(d) the Party controlling the claim or proceeding must obtain the prior
written consent of the other Party (which will not be unreasonably withheld,
delayed or conditioned) prior to entering into any settlement of such claim or
Proceeding or ceasing to defend such claim or Proceeding; provided that any such
settlement shall provide for the full release of all claims against the party
whose consent is required.
7.4 Payment. Upon the determination of the liability under this
Article 7 or otherwise between the parties or by judicial proceeding, the
appropriate party shall pay to the other, as the case may be, within twenty
(20) Business Days after such determination, the amount of any claim for
indemnification made hereunder. All amounts not paid when due under this
Article 7 will accrue interest, payable on demand, at a rate equal to the
lesser of (i) two (2) percent above the prime rate of Citibank per annum
and (ii) the maximum rate allowable under Law, from the date due until paid
in full and each paying party will pay the other party's reasonable and
documented out-of-pocket costs and expenses (including, without limitation,
reasonable attorneys' fees and expenses) incurred in attempting to collect
any such amounts.
7.5 Adjustment for Insurance. The amount of indemnity payable under
Section 7.2 or Section 7.3 shall be calculated after giving effect to any
proceeds actually received from insurance policies covering the Loss that
is the subject of the claim for indemnity, net of any increase in premium
as a result of such claim.
ARTICLE 8
GENERAL PROVISIONS
8.1 Amendment and Modification. This Agreement may be amended,
modified or supplemented only by prior written agreement
signed by the Parties.
8.2 Waiver of Compliance; Consents. Any failure of any of the Parties
to comply with any obligation, covenant, agreement or condition contained
herein may be waived by the Party entitled to the benefits thereof only by
waiver in writing, but such waiver or failure to insist upon strict
compliance with such obligation, covenant, agreement or condition shall not
operate as a waiver of, or estoppel with respect to, any subsequent or
other failure.
8.3 Notices. All notices, requests, claims, demands and other
communications hereunder shall be in writing and shall be deemed to have
been duly given when delivered in person, by
18
confirmed facsimile transmission, confirmed courier service, or by
registered or certified mail (airmail postage prepaid, return receipt
requested) to the respective Parties as follows:
If to Buyer:
Vernalis (R&D) Limited
Xxxxxxx Xxxxx, Xxxxxxxx
Xxxxxxxxx, XX00 0XX
Xxxxxx Xxxxxxx
Facsimile No.: x00 (0) 000 000 0000
Attention: Company Secretary
and
If to Seller:
Mylan Pharmaceuticals Inc.
000 Xxxxxxxx Xxxxx Xxxx
Xxxxxxxxxx, XX 00000
Facsimile No.: 000-000-0000
Attn: Vice President Business Development and Strategic Marketing
marked to be copied to:
Chief Legal Officer
Mylan Pharmaceuticals Inc.
0000 Xxxxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxxxx, XX 00000
Facsimile No.: 000-000-0000
or to such other address as the person to whom notice is given may have
previously furnished to the others in writing in the manner set forth above
(provided that notice of any change of address shall be effective only upon
receipt thereof).
8.4 Assignment. This Agreement and all of the provisions hereof shall
be binding upon and inure to the benefit of the Parties hereto and their
respective successors and permitted assigns, but neither this Agreement nor
any of the rights, interests or obligations hereunder shall be assigned by
any Party hereto without the prior written consent of the other Party, nor
is this Agreement intended to confer upon any other person except the
Parties hereto any rights or remedies hereunder; provided, however, that
(a) Buyer may assign any or all of its rights, interests and obligations
hereunder to any Affiliate of Buyer; and provided further, that Buyer may
assign its rights and delegate its obligations hereunder to (i) any Person
in connection with a sale of all or substantially all of the Acquired
Assets, (ii) any Person who acquires all of the capital stock of Buyer, or
(iii) any Person providing financing to Buyer or its Affiliates; and (b)
Seller may (i) assign or delegate any or all of its rights interests and
obligations hereunder to any of its Affiliates or to a successor by way of
19
a sale of all or substantially all of the assets of Seller, or a merger or
similar transaction and (ii) assign any of its rights to payment hereunder
to any Third Party. This Agreement shall inure to the benefit of, and be
binding upon, the Parties hereto and their successors and permitted
assigns.
8.5 Dispute Resolution. In the event of any claim arising out of or
relating to any provision of this Agreement, failing resolution of the
controversy or claim, the matter shall be referred to the Chief Executive
Officer of Buyer and the President of Xxxxx Xxxxxx on behalf of Seller who
shall, as soon as practicable, attempt in good faith to resolve the
controversy or claim. If such controversy or claim is not resolved within
fifteen (15) Business Days of the date of initial referral by any Party of
the matter to the chief executive officers, either Party shall be free to
initiate legal proceedings in accordance with Section 8.8.
8.6 Specific Performance. Each of the Parties acknowledge and agree
that the other Party would be damaged irreparably and could not be made
whole by monetary damages in the event any of the provisions of this
Agreement are not performed in accordance with their specific terms or
otherwise are breached. Therefore, each Party agrees to the granting of
specific performance of this Agreement and injunctive or other equitable
relief in favor of the other Party as a remedy for any such breach, in
addition to any other remedy to which it may be entitled, at law or in
equity.
8.7 Disclaimer of Warranties. EXCEPT TO THE EXTENT OTHERWISE EXPRESSLY
STATED IN THIS AGREEMENT, (a) SELLER HEREBY EXPRESSLY DISCLAIMS ANY
WARRANTY REGARDING THE VALIDITY OF THE ACQUIRED ASSETS AND MAKES NO
REPRESENTATION WHATSOEVER WITH REGARD TO THE SCOPE OF THE ACQUIRED ASSETS
OR THAT THE ACQUIRED ASSETS MAY BE EXPLOITED BY BUYER, ITS AFFILIATES AND
LICENSEES WITHOUT INFRINGING THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS;
AND (b) SELLER HEREBY EXPRESSLY DISCLAIMS ANY AND ALL IMPLIED AND EXPRESS
WARRANTIES INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR
FITNESS FOR ANY PARTICULAR PURPOSE OF THE ACQUIRED ASSETS OR ANY OTHER
SUBJECT MATTER OF THIS AGREEMENT.
8.8 Governing Law and Jurisdiction.
(a) This Agreement and any claims or disputes arising out of or related to
this Agreement or to the transactions contemplated hereby or to the inducement
of any Party to enter herein (whether for breach of contract, tortious conduct
or otherwise and whether predicated on common law, statute or otherwise) shall
be governed by and construed in accordance with the laws of the State of New
York (regardless of the laws that might otherwise govern under principles of
conflicts of law) as to all matters, including but not limited to matters of
validity, construction, effect, performance and remedies.
(b) Each Party irrevocably agrees that any legal action, suit or
proceedings against it arising out of or in connection with this Agreement or in
the transactions contemplated hereby or thereby or to the inducement of any
party to enter herein or therein (whether for breach of contract, tortious
conduct or otherwise and whether predicated on common law, statute or otherwise)
shall be brought exclusively in the United States District Court for the
Southern District of New York, or, if such court does not have subject matter
jurisdiction, the state courts of New York located in New York County and hereby
20
irrevocably accepts and submits to the exclusive jurisdiction and venue of the
aforesaid courts in personam, with respect to any such action or proceeding.
(c) The New York courts are the most appropriate and convenient courts to
settle any such dispute and each party waives objection to the New York courts
on grounds of inconvenient forum or otherwise as regards proceedings out of or
in connection with this Agreement.
(d) Each of the Parties agrees that service of any process, summons or
document to such party's respective addresses set forth in Article 8.3 shall be
effective service of process for any action, suit or proceeding in New York with
respect to any matter for which it has submitted to jurisdiction pursuant to
Section 8.8(a). This Section does not affect any other method of service allowed
by law.
(e) EACH PARTY HEREBY WAIVES TO THE FULLEST EXTENT PERMITTED BY LAW ANY
RIGHT IT MAY HAVE TO A JURY TRAIL OF ANY LITIGATION, CLAIM OR CAUSE OF ACTION
DIRECTLY OR INDIRECTLY BASED ON OR ARISING OUT OF, UNDER OR IN CONNECTION WITH
THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY IT. EACH PARTY (A) CERTIFIES
THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF THE OTHER PARTY HAS REPRESENTED,
EXPRESSLY OR OTHERWISE THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF
LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT
AND THE OTHER PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY,
AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 8.8 IN
THE EVENT OF LITIGATION, THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A
TRIAL BY THE COURT.
8.9 Counterparts. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. Facsimile signatures
will be binding on the Parties and Guarantor.
8.10 Severability. Any term or provision of this Agreement that is
invalid or unenforceable in any situation in any jurisdiction shall not
affect the validity of enforceability of the remaining terms and provisions
hereof or the validity or enforceability of the offending term or provision
in any other situation or in any other situation or in any other
jurisdiction. If the final judgment of a court of competent jurisdiction
declares that any term or provision hereof is invalid or unenforceable, the
Parties agree that the court making the determination of invalidity or
unenforceability shall have the power to reduce the scope, duration, or
area of the term or provision, to delete specific words or phrases, or to
replace any invalid or unenforceable term or provision with a term or
provision that is valid and enforceable and that comes closest to
expressing the intention of the invalid or unenforceable term or provision,
and this Agreement shall be enforceable as so modified after the expiration
of the time within which the judgment may be appealed.
8.11 Captions. The article and section headings contained in this
Agreement are solely for the purpose of reference, are not part of the
agreement of the parties and shall not in any way affect the meaning or
interpretation of this Agreement.
8.12 Construction. The language used in this Agreement will be deemed
to be the language chosen by the Parties to express their mutual intent,
and no rule of strict construction shall be
21
applied against any Party. Any reference to any federal, state, local, or
foreign statute or law shall be deemed also to refer to all rules and
regulations promulgated thereunder, unless the context requires otherwise.
8.13 Entire Agreement. This Agreement, including the documents,
schedules, certificates and instruments referred to herein, the Transaction
Documents and the Confidentiality Agreement embody the entire agreement and
understanding of the Parties hereto in respect of the transactions
contemplated by this Agreement. There are no restrictions, promises,
representations, warranties, covenants or undertakings, other than those
expressly set forth or referred to herein or therein. This Agreement
supersedes all prior agreements and understandings between the Parties with
respect to such transactions.
8.14 Independent Contractors. It is understood and agreed that the
Parties are independent contractors and nothing contained in this Agreement
is intended to make either Party a general or special agent, legal
representative, joint venturer, partner or employee of the other or
otherwise as participants in a joint or common undertaking for any purpose.
Personnel supplied by a Party shall work for that Party and shall not, for
any purpose, be considered as partners, joint venturers, employees or
agents of the other Party. Each Party assumes full responsibility for the
acts of its personnel while performing services hereunder and shall be
responsible solely for their supervision, direction and control,
compensation, benefits and taxes. Neither party has, expressly or by
implication, or may represent itself as having, directly or indirectly, any
authority to act for or on behalf of the other Party or to make contracts
or enter into any agreements in the name of the other party, or to obligate
or bind the other party in any manner whatsoever.
8.15 Interpretation. The parties acknowledge that this Agreement is a
product of negotiations and that no inference should be drawn regarding the
drafting or preparation of this Agreement.
8.16 Guaranty. Subject to (i) the obligation of Seller to provide
Buyer with any notice required by this Agreement, (ii) the application of
any applicable cure period set forth in this Agreement; and (iii) the
non-payment by the Buyer of any amount as and when due under this
Agreement, Vernalis plc ("Guarantor") hereby guarantees, in favor of
Seller, (a) the prompt and full performance of the payment obligations of
Buyer under this Agreement as due on demand of Seller; and (b) the prompt
and full payment of any amounts owed by Buyer to Seller as due on demand of
Seller, under this Agreement (the "Guaranty"). Guarantor waives presentment
notice, dishonor and notice of dishonor and any other defenses (but not
defenses that Buyer would be entitled to raise against Seller). This
Guaranty is an absolute, unconditional and irrevocable continuing guaranty
of the performance of Buyer's obligations and payment under this Agreement.
22
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed as of the date first written above.
MYLAN PHARMACEUTICALS INC.
By:
------------------------------------
Print Name:
----------------------------
Title:
---------------------------------
MYLAN BERTEK PHARMACEUTICALS INC.
By:
------------------------------------
Print Name:
----------------------------
Title:
---------------------------------
VERNALIS (R&D) LIMITED.
By:
------------------------------------
Print Name:
----------------------------
Title:
---------------------------------
For purposes of Section 8.16:
VERNALIS PLC
By:
------------------------------------
Print Name:
----------------------------
Title:
---------------------------------
23
EXHIBIT G
Interim Agreement
(see attached)
30
INTERIM AGREEMENT
This Interim Agreement (this "Agreement") is entered into as of November 3,
2005, (the "Effective Date") by and among Mylan Pharmaceuticals Inc., a West
Virginia corporation ("Xxxxx Xxxxxx"), and Mylan Bertek Pharmaceuticals Inc., a
Texas corporation ("Bertek") (Xxxxx Xxxxxx and Bertek, individually and
collectively "Seller") and Vernalis (R&D) Limited, an English company ("Buyer").
Buyer and Seller are each sometimes referred to herein as a "Party" and
collectively as the "Parties."
1. Xxxxx Xxxxxx is a party to a certain Supply Agreement and associated
Quality Agreement with Xxxxxx Pharma-Fertigung GmbH & Co. KG (the "Xxxxxx
Agreement" and "Xxxxxx") dated as of April 1, 2004, pertaining to the
manufacture of APOKYN(R) (apomorphine hydrocloride for subcutaneous injection)
(the "Product"). The Parties intending to effect an assignment of the Xxxxxx
Agreement from Xxxxx Xxxxxx to Buyer, have contacted Xxxxxx for the purpose of
facilitating such assignment. Based upon such contact, the Parties believe that
Xxxxxx'x consent to such assignment is imminent. The Parties have entered into
this Agreement in order to provide for Buyer the benefits under the Xxxxxx
Agreement.
2. Xxxxx Xxxxxx hereby agrees that it will comply with its obligations
under, will not create an encumbrance on, and will not amend or terminate, the
Xxxxxx Agreement until the earliest to occur of (i) Xxxxxx delivers its written
consent to the assignment of the Xxxxxx Agreement to Buyer and assigns the
Xxxxxx Agreement to Buyer in which case Xxxxx Xxxxxx will not adversely affect
the Xxxxxx Agreement, (ii) Buyer (or an affiliate) and Xxxxxx enter into an
agreement in substitution for the Xxxxxx Agreement and Xxxxxx delivers to Seller
a written release from the Xxxxxx Agreement in form and substance reasonably
acceptable to Seller, and (iii) the second anniversary of the Effective Date. In
no event will this Agreement terminate later than the second anniversary of the
Effective Date. Nevertheless, the Parties recognize that Seller does not
guaranty Xxxxxx will supply Product and that Xxxxxx retains the right to
terminate the Xxxxxx Agreement under circumstances described therein. Seller,
prior to the first to occur of the events described in clauses (i), (ii), or
(iii) above will receive orders for Product from Buyer, place such orders with
Xxxxxx, and otherwise operate to provide to Buyer the benefits of the Xxxxxx
Agreement. Seller shall supply Product to Buyer, such supply to be at the prices
and on exactly the same terms as the Xxxxxx Agreement (with Seller being
substituted for Xxxxxx and Buyer being substituted for Xxxxx Xxxxxx). Seller
shall also promptly notify Buyer of any notice received under or pursuant to the
Xxxxxx Agreement and consult with Buyer with respect to the response to any such
notice, and if the notice is notice of breach, take all steps required by Buyer
to remedy such breach and avoid termination of the Xxxxxx Agreement
3. Seller shall promptly notify Buyer of any breach of the Xxxxxx Agreement
by Xxxxxx. To the extent a breach of this Agreement by Seller is caused by a
breach of the Xxxxxx Agreement by Xxxxxx, Seller shall, at Buyer's request and
expense do and take all such actions as Buyer may reasonably request to enforce
the terms of the Xxxxxx Agreement, (including without limitation pursuing any
legal or other action and/or settling any such action, all as directed by
Buyer), and Seller shall not make admissions which might prejudice any such
action. Seller shall also deliver to Buyer all damages and costs recovered
pursuant to, and the benefit of any other remedy and/or
31
settlement resulting from, any action taken by Seller pursuant to
Buyer's request. The remedy set out in this Section 3 shall be Buyer's sole
remedy for any breach of this Agreement to the extent such breach is caused by a
breach of the Xxxxxx Agreement by Xxxxxx.
4. Buyer hereby agrees to pay Seller for Product at the time and to the
extent that quantities of Product forecasted by Buyer for purchase for each
month become a firm purchase commitment. Buyer will submit orders to Xxxxx
Xxxxxx for presentation to Xxxxxx. The price to Buyer for Product shall be that
charged by Xxxxxx to Seller. In the event that Buyer requests Seller to continue
to provide supply chain activity services, analytical testing and quality
services, or other services in connection with making the benefits of the Xxxxxx
Agreement available to Buyer beyond the time required by the Transition Period
Services Agreement due to the continuing existence of this Agreement, Buyer
shall pay thereafter to Seller (i) $*** per month for supply chain activity
services and other services, and (ii) for analytical testing services: $*** per
lot of active pharmaceutical ingredient; $*** per lot of inactive ingredient;
$*** per lot of final product; and $*** per stability test interval. On the
first anniversary of the Effective Date, such charges shall be adjusted to
reflect any increase in the cost of living during the prior 12 months.
Expiration of this Agreement shall be coincidental with the first to occur of
the events set forth in clauses (i), (ii) and (iii) of Section 2 above.
5. Buyer hereby acknowledges that in order for Xxxxx Xxxxxx to procure
Product it will be necessary for Buyer to respond promptly to inquiries of Xxxxx
Xxxxxx from time to time about a variety of matters including, but not limited
to, those having regulatory implications. Buyer agrees to promptly respond as
soon a reasonably practicable to enable Seller to respond to Xxxxxx as required
under the Xxxxxx Agreement to any and all inquiries made by Xxxxx Xxxxxx for
purposes of acting under the Xxxxxx Agreement. Buyer and Seller hereby agree to
reasonably cooperate to fulfill the intended objectives of this Agreement.
Further, the Parties shall endeavor to establish plans and procedures to
implement operation of this Agreement.
6. Buyer agrees to indemnify, hold harmless, and defend Seller against any
third party claim made against Seller and all losses, damages, claims, costs,
and expenses, interest, awards, judgments, and penalties awarded against Seller
pursuant to such third party claim, and reasonable attorneys' fees and other
reasonable out-of-pocket costs incurred defending such third party claim
("Damages") to the extent such Damages result from the supply of Product or
performance of services under this Agreement other than those Damages arising
from the default, negligence or willful misconduct of Seller. Seller agrees to
indemnify, hold harmless, and defend Buyer against any and all Losses (as
defined in the Asset Purchase Agreement) arising out of any third party claim
incurred by Buyer or Buyer's Affiliates as a result of the default, negligence
or willful misconduct of Seller under this Agreement other than those Losses (as
defined in the Asset Purchase and Assignment Agreement of even date herewith and
entered into by the Parties) arising from the default, negligence or willful
misconduct of Buyer. The procedures by which a claim for indemnification shall
be brought forward and the payment of any amount due as a result shall be as set
forth in Sections 7.3 and 7.4 of the Asset Purchase and Assignment Agreement of
even date herewith and entered into by the Parties.
7. Buyer and Seller will use commercially reasonable efforts to obtain from
Xxxxxx consent to an assignment of the Xxxxxx Agreement from Xxxxx Xxxxxx to
Buyer as soon as possible,
32
whereupon Xxxxx Xxxxxx will assign the Xxxxxx Agreement to Buyer. Upon such
assignment, the Xxxxxx Agreement shall become an Assigned Contract for the
purposes of the Asset Purchase and Assignment Agreement made between the Parties
of even date. Buyer will use commercially reasonable efforts to obtain from
Xxxxxx a substitute agreement for the supply of Product as soon as practicable,
if requested by Xxxxxx. Seller will not obstruct Buyer in securing either an
assignment or a separate agreement with Xxxxxx.
8. . IN NO EVENT SHALL SELLER BE LIABLE TO BUYER FOR INDIRECT, PUNITIVE,
SPECIAL, CONSEQUENTIAL OR EXEMPLARY DAMAGES OF ANY KIND, INCLUDING LOSS OF
PROFITS, AND LOSS OR INTERRUPTION OF BUSINESS. DURING THE FIRST NINETY (90) DAYS
FOLLOWING EFFECTIVE DATE SELLER'S AGGREGATE LIABILITY ARISING FROM OR RELATING
TO ANY BREACH OF THIS AGREEMENT SHALL BE LIMITED TO CORRECTION OR RE-PERFORMANCE
OF THE SERVICES BY SELLER AT SELLER'S EXPENSE. THEREAFTER, THE SELLER'S
AGRREGATE LIABILITY, EXCEPT FOR GROSS NEGLIGENCE OR WILFULL MISCONDUCT, ARISING
FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT SHALL BE LIMITED TO CORRECTION
OR RE-PERFORMANCE OF THE SERVICES BY SELLER AT SELLER'S EXPENSE. This Section 8
shall not be construed to limit a Party's obligations under Section 6.
9. Seller shall be entitled to terminate this Agreement in the event of a
material breach by Buyer thirty (30) days after receipt by Buyer of written
notice of such breach if such failure is not cured within such thirty (30) day
period. The benefits of this Agreement are personal to Buyer and are not for the
benefit of any successor or assign of Buyer or any other third party. Sections 5
and 7 shall survive the expiration or early termination of this Agreement.
10. Amendment and Modification. This Agreement may be amended, modified or
supplemented only by prior written agreement signed by the Parties.
11. Waiver of Compliance; Consents. Any failure of any of the Parties to
comply with any obligation, covenant, agreement or condition contained herein
may be waived by the Party entitled to the benefits thereof only by waiver in
writing, but such waiver or failure to insist upon strict compliance with such
obligation, covenant, agreement or condition shall not operate as a waiver of,
or estoppel with respect to, any subsequent or other failure.
12. Notices. All notices, requests, claims, demands and other
communications hereunder shall be in writing and shall be deemed to have been
duly given when delivered in person, by confirmed facsimile transmission,
confirmed courier service, or by registered or certified mail (airmail postage
prepaid, return receipt requested) to the respective Parties as follows:
If to Buyer:
Vernalis (R&D) Limited
Xxxxxxx Xxxxx, Xxxxxxxx
XXXXXXXXX, XX00 0XX
XXXXXX XXXXXXX
Facsimile No.: x00 (0) 000 000 0000
Attention: Company Secretary
33
and
If to Seller:
Mylan Pharmaceuticals Inc
000 Xxxxxxxx Xxxxx Xxxx
Xxxxxxxxxx, XX 00000.
Facsimile No. 000 000 0000
Attn: Vice President Business Development and Strategic Marketing
marked to be copied to:
Chief Legal Officer
Mylan Pharmaceuticals Inc.
0000 Xxxxxxxxx Xxxxx, Xxxxx 000
Xxxxxxxxxxx, XX 00000
Facsimile No.: 000-000-0000
13. Dispute Resolution. In the event of any claim arising out of or
relating to any provision of this Agreement, failing resolution of the
controversy or claim, the matter shall be referred to the Chief Executive
Officer of Buyer and the President of Xxxxx Xxxxxx on behalf of Seller who
shall, as soon as practicable, attempt in good faith to resolve the controversy
or claim. If such controversy or claim is not resolved within fifteen (15)
business days of the date of initial referral by any Party of the matter to the
chief executive officers, either Party shall be free to initiate legal
proceedings in accordance with Section 14.
14. Governing Law and Jurisdiction.
(a) This Agreement and any claims or disputes arising out of or related to
this Agreement or to the transactions contemplated hereby or to the inducement
of any Party to enter herein (whether for breach of contract, tortious conduct
or otherwise and whether predicated on common law, statute or otherwise) shall
be governed by and construed in accordance with the laws of the State of New
York (regardless of the laws that might otherwise govern under principles of
conflicts of law) as to all matters, including but not limited to matters of
validity, construction, effect, performance and remedies.
(b) Each Party irrevocably agrees that any legal action, suit or
proceedings against it arising out of or in connection with this Agreement or in
the transactions contemplated hereby or thereby or to the inducement of any
party to enter herein or therein (whether for breach of contract, tortious
conduct or otherwise and whether predicated on common law, statute or otherwise)
shall be brought exclusively in the United States District Court for the
Southern District of New York, or, if such court does not have subject matter
jurisdiction, the state courts of New York located in New York County and hereby
irrevocably accepts and submits to the exclusive jurisdiction and venue of the
aforesaid courts in personam, with respect to any such action or proceeding.
34
(c) The New York courts are the most appropriate and convenient courts to
settle any such dispute and each party waives objection to the New York courts
on grounds of inconvenient forum or otherwise as regards proceedings out of or
in connection with this Agreement.
(d) Each of the Parties agrees that service of any process, summons or
document to such party's respective addresses set forth in Section 12 shall be
effective service of process for any action, suit or proceeding in New York with
respect to any matter for which it has submitted to jurisdiction pursuant to
Section 14(a). This Section does not affect any other method of service allowed
by law.
(e) EACH PARTY HEREBY WAIVES TO THE FULLEST EXTENT PERMITTED BY LAW ANY
RIGHT IT MAY HAVE TO A JURY TRAIL OF ANY LITIGATION, CLAIM OR CAUSE OF ACTION
DIRECTLY OR INDIRECTLY BASED ON OR ARISING OUT OF, UNDER OR IN CONNECTION WITH
THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED BY IT. EACH PARTY (A) CERTIFIES
THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF THE OTHER PARTY HAS REPRESENTED,
EXPRESSLY OR OTHERWISE THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF
LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT
AND THE OTHER PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY,
AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 14 IN
THE EVENT OF LITIGATION, THIS AGREEMENT MAY BE FILED AS A WRITTEN CONSENT TO A
TRIAL BY THE COURT.
15. Counterparts. This Agreement may be executed in two (2) or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. Facsimile signatures will
be binding on the Parties and Guarantor.
16. Severability. Any term or provision of this Agreement that is invalid
or unenforceable in any situation in any jurisdiction shall not affect the
validity of enforceability of the remaining terms and provisions hereof or the
validity or enforceability of the offending term or provision in any other
situation or in any other situation or in any other jurisdiction. If the final
judgment of a court of competent jurisdiction declares that any term or
provision hereof is invalid or unenforceable, the Parties agree that the court
making the determination of invalidity or unenforceability shall have the power
to reduce the scope, duration, or area of the term or provision, to delete
specific words or phrases, or to replace any invalid or unenforceable term or
provision with a term or provision that is valid and enforceable and that comes
closest to expressing the intention of the invalid or unenforceable term or
provision, and this Agreement shall be enforceable as so modified after the
expiration of the time within which the judgment may be appealed.
17. Interpretation. The parties acknowledge that this Agreement is a
product of negotiations and that no inference should be drawn regarding the
drafting or preparation of this Agreement.
18. Guaranty. Subject to (i) the obligation of Seller to provide Buyer with
any notice required by this Agreement, (ii) the application of any applicable
cure period set forth in this
35
Agreement; and (iii) the non-payment by the Buyer of any amount as and when due
under this Agreement, Vernalis plc ("Guarantor") hereby guarantees, in favor of
Seller, (a) the prompt and full performance of the payment obligations of Buyer
under this Agreement as due on demand of Seller; and (b) the prompt and full
payment of any amounts owed by Buyer to Seller as due on demand of Seller, under
this Agreement (the "Guaranty"). Guarantor waives presentment notice, dishonor
and notice of dishonor and any other defenses (but not defenses that Buyer would
be entitled to raise against Seller). This Guaranty is an absolute,
unconditional and irrevocable continuing guaranty of the performance of Buyer's
obligations and payment under this Agreement.
36
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be
executed as of the date first written above.
MYLAN PHARMACEUTICALS INC.
By:
------------------------------------
Print Name:
----------------------------
Title:
---------------------------------
MYLAN BERTEK PHARMACEUTICALS INC.
By:
------------------------------------
Print Name:
----------------------------
Title:
---------------------------------
37
VERNALIS (R&D) LIMITED
By:
------------------------------------
Print Name:
----------------------------
Title:
---------------------------------
For purposes of Section 18 only:
VERNALIS PLC
By:
------------------------------------
Print Name:
----------------------------
Title:
---------------------------------
38
