EXHIBIT 1
EXCHANGE AGREEMENT
THIS EXCHANGE AGREEMENT (this "Agreement") is entered into as of
July 16, 2004, by and among NOVAVAX, INC., a Delaware corporation (the
"Company"), KING PHARMACEUTICALS, INC., a Tennessee corporation ("King"), and
PARKEDALE PHARMACEUTICALS, INC., a Michigan corporation ("Parkedale").
WHEREAS, pursuant to that certain December 2000 Note Purchase
Agreement dated as of December 19, 2000 (the "December 2000 Note Purchase
Agreement"), between the Company and King, King made loans to the Company in the
aggregate principal amount of $25,000,000, and the Company issued to King (a) a
4% Convertible Senior Note of the Company dated December 19, 2000, in the
aggregate principal amount of $20,000,000 (together with the allonge dated
September 7, 2001, the "First December 2000 Note") and (b) a 4% Convertible
Senior Note of the Company dated September 7, 2001, in the aggregate principal
amount of $5,000,000 (the "Second December 2000 Note");
WHEREAS, pursuant to that certain September 2001 Note Purchase
Agreement dated as of September 7, 2001 (the "September 2001 Note Purchase
Agreement"), between the Company and King, King made a loan to the Company in
the aggregate principal amount of $5,000,000, and the Company issued to King a
4% Convertible Senior Note of the Company dated September 7, 2001, in the
aggregate principal amount of $5,000,000 (the "September 2001 Note");
WHEREAS, pursuant to that certain June 2002 Note Purchase Agreement
dated as of June 26, 2002 (the "June 2002 Note Purchase Agreement"), between the
Company and King, King made a loan to the Company in the aggregate principal
amount of $10,000,000, and the Company issued to King a 4% Convertible Senior
Note of the Company dated June 26, 2002, in the aggregate principal amount of
$10,000,000 (the "June 2002 Note"; together with the First December 2000 Note,
the Second December 2000 Note and the September 2001 Note, the "Notes");
WHEREAS, in connection with the December 2000 Note Purchase
Agreement, the Company and King entered into that certain Investor Rights
Agreement dated as of December 19, 2000 (as amended by the First Amendment to
Investor Rights Agreement dated as of September 7, 2001, the "Original Investor
Rights Agreement");
WHEREAS, in connection with the June 2002 Note Purchase Agreement,
the Company and King entered into that certain Amended and Restated Investor
Rights Agreement dated as of June 26, 2002 (the "Amended and Restated Investor
Rights Agreement"), which amended and restated the Original Investor Rights
Agreement;
WHEREAS, in connection with the December 2000 Note Purchase
Agreement, the Company and King entered into that certain Registration Rights
Agreement dated as of December 19, 2000 (as amended and restated on September 7,
2001, the "Original Registration Rights Agreement");
WHEREAS, in connection with the June 2002 Note Purchase Agreement,
the Company and King entered into that certain Second Amended and Restated
Registration Rights Agreement dated as of June 26, 2002 (the "Second Amended and
Restated Registration Rights Agreement"), which amended and restated the
Original Registration Rights Agreement;
WHEREAS, King and the Company are parties to that certain License
Agreement dated as of December 19, 2000 (the "HPV License Agreement);
WHEREAS, the Company and Parkedale are parties to that certain
Pharmaceutical Quality Agreement dated June 1, 2001 (the "Pharmaceutical Quality
Agreement") regarding, among other things, manufacturing and quality control
matters under the HPV License Agreement;
WHEREAS, Parkedale and the Company are parties to that certain
Supply Agreement dated as of October 21, 1999 (the "Supply Agreement") and that
certain License and Supply Agreement dated as of October 21, 1999 (the "License
and Supply Agreement"; together with the Supply Agreement, the "Adjuvant License
and Supply Agreements") regarding the licensing and supply of proprietary
adjuvants, including a Novasome(R) delivery system;
WHEREAS, King and the Company are parties to that certain
Copromotion Agreement dated as of January 8, 2001 (the "Original Copromotion
Agreement"), as amended by that certain First Amendment to the Copromotion
Agreement dated as of June 29, 2001, as further amended by that certain Second
Amendment to the Copromotion Agreement dated as of June 29, 2001, as further
amended by that certain Third Amendment to the Copromotion Agreement dated as of
June 26, 2002 (the Original Copromotion Agreement, as amended, the "Copromotion
Agreement");
WHEREAS, King and the Company are parties to that certain Agreement
for Purchase and Sale of Assets Relating to AVC(TM) Products dated as of January
8, 2001 (the "Original AVC Purchase Agreement"), as amended by that certain
First Amendment to AVC Purchase Agreement dated as of June 26, 2002 (the
Original AVC Purchase Agreement, as amended, the "AVC Purchase Agreement");
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WHEREAS, King and the Company are parties to that certain Supply
Agreement dated as of January 8, 2001 (the "Original AVC Supply Agreement"), as
amended by that certain First Addendum to the AVC(TM) Cream Supply Agreement
dated as of February 25, 2003 (the Original AVC Supply Agreement, as amended,
the "AVC Supply Agreement": together with the AVC Purchase Agreement, the "AVC
Agreements");
WHEREAS, king and the Company are parties to that certain Exclusive
License and Distribution Agreement dated as of January 8, 2001 (the "Original
Exclusive License and Distribution Agreement"), as amended by that certain First
Amendment to the Exclusive License and Distribution Agreement dated as of June
29, 2001, as further amended by that certain Second Amendment to the Exclusive
License and Distribution Agreement dated as of June 29, 2001 (the Original
Exclusive License and Distribution Agreement, as amended, the "Exclusive License
and Distribution Agreement": together with the December 2000 Note Purchase
Agreement, the September 2001 Note Purchase Agreement, the June 2002 Note
Purchase Agreement, the Original Investor Rights Agreement, the Amended and
Restated Investor Rights Agreement, the Original Registration Rights Agreement,
the Second Amended and Restated Registration Rights Agreement, the HPV License
Agreement, the Pharmaceutical Quality Agreement, the Adjuvant License and Supply
Agreements, the Copromotion Agreement, and all other contracts and agreements
(oral or written) to which King or any of its subsidiaries, on the one hand, and
the Company or any of its subsidiaries, on the other hand, are parties prior to
the date hereof (other than the AVC Agreements), the "Collaboration
Agreements");
WHEREAS, the parties desire that the Company redeem the Notes from
King for the consideration and upon the terms and conditions set forth in this
Agreement;
WHEREAS, the Company desires to terminate the Collaboration
Agreements, and King is willing to agree to terminate, or cause to be
terminated, the Collaboration Agreements in consideration for the Company's
issuance to King of shares of Common Stock of the Company, all subject to and in
accordance with the terms and conditions set forth in this Agreement;
WHEREAS, the Company desires to make offers of employment to certain
employees of King, and King is willing to permit the Company to make such
offers, all subject to and in accordance with the terms and conditions set forth
in this Agreement; and
WHEREAS, capitalized terms used but not defined herein shall have
the respective meanings ascribed to such terms in Annex I attached hereto.
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NOW THEREFORE, in consideration of the foregoing premises and the
representations, warranties, covenants and agreements herein contained, the
parties hereto, intending to be legally bound, agree as follows:
SECTION 1. EXCHANGE TRANSACTIONS; CLOSING
1.1 REDEMPTION OF NOTES.
At the Closing (as defined below), (a) King shall deliver the
original Notes to the Company, free and clear of all liens, claims and
encumbrances, and (b) in consideration for all right, title and interest in the
Notes, the Company shall pay to King the sum of Twenty-Two Million Dollars
($22,000,000) in cash by wire transfer of immediately available funds to an
account or accounts specified by King in writing (the "Redemption Payment"). For
the avoidance of doubt, the parties agree and acknowledge that the Redemption
Payment constitutes payment in full of all of the Company's obligations under
the Notes, including interest that was otherwise due and payable under the Notes
on June 30, 2004.
1.2 ISSUANCE OF SHARES; TERMINATION OF AGREEMENTS.
At the Closing, (a) the Company shall issue and deliver to King
three million two hundred fifty-two thousand thirty-three (3,252,033) shares of
Common Stock (as defined below) of the Company (the "Exchange Shares"), free and
clear of all liens, claims and encumbrances, and (b) in consideration for the
Exchange Shares, King, Parkedale and the Company shall execute and deliver the
Termination Agreement in the form attached as Exhibit A hereto (the "Termination
Agreement") providing for, among other things, the release by the Company, King
and Parkedale of all of their rights under the Collaboration Agreements, all as
more specifically set forth therein.
1.3 TRANSFER OF EMPLOYEES.
(a) Schedule 1.3 attached hereto sets forth a list of sales
representatives employed as of the date hereof by King or any affiliate of King
in the women's health division of King or such affiliates (collectively, the
"Subject Employees"), including the annual salary or wage rate (as applicable)
of each such Subject Employee. For a period of seven (7) business days after the
Closing Date, the Company shall have the right to make offers of employment to
some or all of the Subject Employees at their then-current salary or wage rate
(as applicable). Any Subject Employee who accepts employment with the Company
will, as of the date of hire, be included in the Company's employee benefit
plans and bonus programs, subject to the terms of such plans and programs, and
will be subject to the Company's employment policies, all as generally
applicable to the Company's employees who are similarly situated. For the
avoidance of doubt, the employment
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of any Subject Employee by the Company shall be contingent upon the consummation
of the Closing hereunder. The Company agrees that all such Subject Employees who
are employed by the Company shall be credited under the Company's current 401(k)
plan with their service with King and its subsidiaries for purposes of
determining any period of eligibility to participate or to vest in the benefits
thereunder (and for no other plan or purpose, including Company equity and bonus
plans, vacation, sick leave or otherwise).
(b) On the seventh (7th) business day after the Closing Date, the
Company shall deliver to King a certificate (the "Transferred Employee
Certificate") duly executed by an executive officer of the Company, certifying
to a list of the names of the Subject Employees who have accepted employment
with, and who have been hired by, the Company (such Subject Employees, the
"Transferred Employees"). Notwithstanding anything to the contrary set forth in
this Agreement, the Company shall not assume or otherwise be responsible for any
obligations and liabilities of King or any of King's subsidiaries to any
Transferred Employee (or otherwise relating to the employment or termination of
the employment of any Transferred Employee by or with King or any of King's
subsidiaries).
(c) At the Closing, in consideration for the covenants and
agreements of the Company set forth in this Section 1.3, King shall pay to the
Company the sum of Three Million Two Hundred Twenty Thousand Dollars
($3,220,000) (the "Employee Payment") by wire transfer of immediately available
funds to an account specified in writing by the Company.
(d) At the Closing, in consideration for King allowing the Company
to make offers of employment to the Subject Employees, the Company shall issue
and deliver to King five hundred twenty-three thousand five hundred
seventy-seven (523,577) shares of Common Stock of the Company (the "Sales Force
Shares"), free and clear of all liens, claims and encumbrances.
1.4 PAYMENT OF MARKETING EXPENSES.
At the Closing, King shall pay to the Company, in cash by wire
transfer of immediately available funds to an account specified by the Company
in writing, the sum of Four Million Seven Hundred Eighty-One Thousand Sixty-Four
Dollars ($4,781,064) (the "Marketing Expense Payment"), representing King's
share of budgeted marketing expenses under the Copromotion Agreement and the
Exclusive License and Distribution Agreement for the 2004 calendar year.
1.5 CERTAIN ADJUSTMENTS.
If between the date of this Agreement and the date that all of the
Exchange Shares and the Sales Force Shares have been duly and validly issued to
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King pursuant to this Section 1, the outstanding shares of Common Stock shall be
changed into a different number of shares by reason of any reclassification,
recapitalization, split-up, combination or exchange of shares, or any dividend
payable in stock or other securities or other property shall be declared thereon
with a record date within such period, then the number of the Exchange Shares
and the Sales Force Shares issuable to King pursuant to this Section 1 shall be
adjusted accordingly to provide the same economic effect as contemplated by this
Agreement prior to such reclassification, recapitalization, split-up,
combination, exchange or dividend.
1.6 RETURN OF PROPERTY.
At the Closing or, to the extent impracticable to effect at the
Closing, within thirty (30) days after the Closing, (a) the Company shall return
to King and, if necessary, reassign to King pursuant to a ▇▇▇▇ of sale or other
assignment instrument reasonably acceptable to King, all property and
proprietary rights of King currently held by the Company, including the King HPV
Confidential Information; and (b) King and Parkedale shall, and shall cause
their affiliates to, return to the Company and, if necessary, reassign to the
Company pursuant to a ▇▇▇▇ of sale or other assignment instrument reasonably
acceptable to the Company, all property and proprietary rights of the Company
currently held by King, Parkedale or any of their respective affiliates,
including the Novavax HPV Confidential Information.
1.7 CLOSING; ORDER OF CLOSING.
(a) Subject to the satisfaction or waiver of the conditions set
forth in Section 5 hereof (other than those conditions that by their nature are
to be satisfied at the Closing, but subject to the satisfaction or waiver of
such conditions), the closing of the transactions contemplated in this Agreement
(the "Closing") shall take place at the offices of Ropes & ▇▇▇▇ LLP, ▇▇
▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇, on July 19, 2004, or on such other
date, and at such other place, as the parties mutually agree in writing. The
date on which the Closing shall occur shall be referred to as the "Closing
Date".
(b) At the Closing, the consummation of the transactions
contemplated by this Agreement shall occur in the following order:
(i) first, King shall relinquish King's rights set forth in
Section 7 of the Amended and Restated Investor Rights Agreement; and
(ii) second, the consummation of the transactions
contemplated by Section 1.1 and all other transactions contemplated to occur at
the
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Closing pursuant to this Agreement (collectively, the "Transactions") shall take
place.
1.8 CLOSING DELIVERIES.
(a) By King and Parkedale. At the Closing, King and Parkedale, as
applicable, shall deliver to the Company the following:
(i) the original Notes;
(ii) the Termination Agreement duly executed by King and
Parkedale;
(iii) the Anaconda Release described in Section 4.2(c) duly
executed by King and Parkedale;
(iv) the Registration Rights Agreement in the form attached
as Exhibit B hereto (the "Registration Rights Agreement"; together with the
Termination Agreement, the "Related Agreements"), duly executed by King;
(v) the assignment instruments, if any, contemplated by
Section 1.6(b) duly executed by King and Parkedale;
(vi) the Employee Payment;
(vii) the Marketing Expense Payment; and
(viii) the certificate described in Section 5.2(c).
(b) By the Company. At the Closing, the Company shall deliver to
King the following:
(i) the Redemption Payment;
(ii) the Termination Agreement duly executed by the Company;
(iii) the Anaconda Release described in Section 4.2(c) duly
executed by Anaconda Opportunity Fund, L.P. ("Anaconda");
(iv) stock certificate(s) representing the Exchange Shares
duly endorsed by the Company;
(v) stock certificate (s) representing the Sales Force
Shares duly endorsed by the Company;
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(vi) the Registration Rights Agreement duly executed by the
Company;
(vii) the assignment instruments, if any, contemplated by
Section 1.6(a) duly executed by the Company; and
(viii) the certificates and other deliveries described in
Section 5.1(c).
SECTION 2. REPRESENTATIONS AND WARRANTIES OF THE COMPANY
Except for the matters disclosed in the Company's Disclosure Letter
attached hereto, the Company hereby represents and warrants to King as of the
date hereof and as of the Closing Date as follows:
2.1 ORGANIZATION, GOOD STANDING AND QUALIFICATION.
The Company is a corporation duly organized, validly existing and in
good standing under the laws of the State of Delaware and has all requisite
corporate power and authority to carry on its business as now conducted and as
proposed to be conducted. The Company is duly qualified to transact business and
is in good standing in each jurisdiction in which the failure so to qualify
would have a material adverse effect on the business, operations, properties,
assets or condition (financial or otherwise) of the Company and its subsidiaries
taken as a whole (a "Material Adverse Effect").
2.2 AUTHORIZATION.
The Company has all requisite corporate power and authority (a) to
execute, deliver and perform the Company's obligations under this Agreement and
the Related Agreements, (b) to issue the Exchange Shares and the Sales Force
Shares to King, and (c) to execute, deliver and perform the Company's
obligations under all other agreements, instruments and certificates to be
executed and delivered by the Company pursuant to or in connection with this
Agreement and the Related Agreements. All corporate action on the part of the
Company, its officers, directors and stockholders for the authorization,
execution and delivery of this Agreement and the Related Agreements, and the
performance of all obligations of the Company hereunder and the authorization,
issuance and delivery of the Exchange Shares and the Sales Force Shares has been
taken.
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2.3 ENFORCEABILITY.
This Agreement constitutes, and the Related Agreements when executed
by the Company will constitute, valid and legally binding obligations of the
Company, enforceable in accordance with their terms, except (a) as limited by
applicable bankruptcy, insolvency, reorganization, moratorium, and other laws of
general application affecting enforcement of creditors' rights generally and (b)
as limited by laws relating to the availability of specific performance,
injunctive relief, or other equitable remedies.
2.4 VALID ISSUANCE OF EXCHANGE SHARES AND SALES FORCE SHARES.
The Exchange Shares and the Sales Force Shares will be duly and
validly issued, fully paid and nonassessable and not subject to preemptive or
similar rights, and the Exchange Shares and the Sales Force Shares will be
issued in compliance with all applicable federal and state securities laws, when
issued and delivered in accordance with the terms of this Agreement, for the
consideration expressed herein. No approval of the stockholders of the Company
is required to issue the Exchange Shares or the Sales Force Shares.
2.5 CAPITALIZATION; INDEBTEDNESS.
(a) The authorized capital stock of the Company consists of one
hundred million (100,000,000) shares of common stock, $0.01 par value per share
(the "Common Stock") and two million (2,000,000) shares of preferred stock, $.01
par value per share (the "Preferred Stock"). As of June 30, 2004: (i)
thirty-four million eight hundred twenty-five thousand eight hundred eighty-five
(34,825,885) shares of Common Stock were issued and outstanding; (ii) four
million nine hundred nine thousand six hundred eighteen (4,909,618) shares of
Common Stock were reserved for issuance upon the exercise of outstanding stock
options or other rights to purchase or receive the Common Stock granted under
the Company's 1995 Stock Option Plan; (iii) two hundred seventy thousand
(270,000) shares of Common Stock were reserved for issuance upon the exercise of
outstanding stock options or other rights to receive the Common Stock granted
under the Company's Director Stock Option Plan; (iv) five million one hundred
eighty-eight thousand one hundred forty-seven (5,188,147) shares of Common
Stock were reserved for issuance upon the conversion of the Notes; (v) two
hundred fifty-three thousand eight hundred forty-eight (253,848) shares of
Common Stock were held by the Company in the Company's treasury; (vi) no shares
of Preferred Stock were issued or outstanding; and (vii) warrants to purchase
seventy thousand (70,000) shares of Common Stock were issued and outstanding.
(b) All outstanding shares of capital stock of the Company are
duly authorized, validly issued, fully paid and nonassessable and not subject to
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preemptive or similar rights. Except as set forth in this Section 2.5, except as
provided in the Collaboration Agreements (including the Notes) and except for
changes resulting from the issuance of shares of Common Stock pursuant to the
Company stock option plans and warrants, or as expressly permitted by this
Agreement, (i) there are not issued, reserved for issuance or outstanding (A)
any shares of capital stock or other voting securities of the Company, (B) any
securities of the Company or any Company subsidiary convertible into or
exchangeable or exercisable for shares of capital stock or voting securities of
or ownership interests in the Company or any Company subsidiary, or (C) any
warrants, calls, options or other rights to acquire from the Company or any
Company subsidiary, or any obligation of the Company or any Company subsidiary
to issue, any capital stock, voting securities or other ownership interests in,
or securities convertible into or exchangeable or exercisable for capital stock
or voting securities of or other ownership interests in, the Company or any
Company subsidiary; (ii) there are no outstanding obligations of the Company or
any Company subsidiary to repurchase, redeem or otherwise acquire any such
securities or to issue, deliver or sell, or cause to be issued, delivered or
sold, any such securities; and (iii) except as described in this Agreement or
the Related Agreements, the Company is not presently under any obligation, has
not agreed or committed, and has not granted rights, to register under the
Securities Act of 1933, as amended (the "Securities Act"), or the Securities
Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise file any
registration statement under the Securities Act or the Exchange Act covering,
any of its currently outstanding capital stock or other securities or any of its
capital stock or other securities that may be subsequently issued.
(c) Except as provided in the Collaboration Agreements (including
the Notes), neither the Company nor any Company subsidiary is a party to any
agreement granting any preemptive or antidilutive rights with respect to any
securities of the Company or any Company subsidiary that are outstanding as of
the date hereof, or with respect to any securities of the Company or any Company
subsidiary that may be subsequently issued upon the conversion or exercise of
any instrument outstanding as of the date hereof. The execution, delivery and
performance of this Agreement and the Related Agreements and the issuance of the
Exchange Shares and the Sales Force Shares will not trigger any preemptive,
antidilutive or similar rights under any agreement to which the Company or any
Company subsidiary is a party, except as provided in the Collaboration
Agreements (including the Notes). Other than Fielding Pharmaceutical Company, a
Delaware corporation ("Fielding"), the Company does not directly or indirectly
beneficially own any securities or other beneficial ownership interests in any
other person.
2.6 SEC REPORTS AND ABSENCE OF CHANGES.
(a) The Company has heretofore filed with the United States
Securities and Exchange Commission (the "SEC") all forms, statements, reports
and
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documents (together with all exhibits, amendments and supplements thereto, the
"SEC Filings") required to be filed by the Company under each of the Securities
Act and the Exchange Act and the SEC rules and regulations thereunder, including
an Annual Report on Form 10-K for the year ended December 31, 2003 (the "2003
10-K"). As of their respective filing dates, none of the SEC Filings, at the
time they were filed, contained any untrue statement of a material fact or
omitted to state a material fact required to be stated therein or necessary in
order to make the statements made, in the light of the circumstances under which
they were made, not misleading.
(b) Except as disclosed in the SEC Filings, since December 31, 2003, the
Company has conducted its businesses only in the ordinary course of business
consistent with past practice, and there has not been (i) any Material Adverse
Effect on the Company, (ii) any declaration, setting aside or payment of any
dividend or other distribution (whether in cash, stock or property) with respect
to any of the Company's capital stock, (iii) any split, combination or
reclassification of any of the Company's capital stock or any issuance or the
authorization of any issuance of any other securities in respect of, in lieu of
or in substitution for shares of its capital stock, (iv) (A) any granting by the
Company or Fielding to any current or former director, officer or employee of
the Company or Fielding of any increase in compensation, bonus or other
benefits, except for normal increases in compensation, bonuses or other benefits
in the ordinary course of business consistent with past practice, (B) any
granting by the Company or Fielding to any such current or former director,
officer or employee of any increase in severance or termination pay, except for
the granting of any increase in severance or termination pay to employees in the
ordinary course of business consistent with past practice, (C) any entry by the
Company or Fielding into, or any material amendment of, any material employment,
deferred compensation, consulting, severance, termination or indemnification
agreement with any such current or former director, officer or employee or (D)
any material amendment to, or material modification of, any option outstanding
under the Company stock option plans, (v) any damage, destruction or loss,
whether or not covered by insurance, that would be reasonably likely to have a
Material Adverse Effect, or (vi) any change in accounting methods, principles or
practices by the Company materially affecting its assets, liabilities or
businesses, except insofar as may have been required by a change in generally
accepted accounting principles.
2.7 FINANCIAL STATEMENTS.
The audited consolidated financial statements of the Company
included or incorporated by reference in the 2003 10-K have been prepared in
accordance with the published rules and regulations of the SEC and with U.S.
generally accepted accounting principles applied on a consistent basis
throughout the periods indicated therein and with each other, except as may be
indicated therein or in the notes thereto, and fairly present in all material
respects the
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financial condition of the Company and its subsidiaries as of the respective
dates thereof and the results of their operations and statements of cash flows
for the respective periods then ended. Except as reflected in such financial
statements, the Company and its subsidiaries have no material liabilities,
absolute or contingent, other than ordinary course liabilities incurred since
the date of the last such financial statements in connection with the conduct of
the business of the Company and its subsidiaries.
2.8 GOVERNMENTAL CONSENTS.
Except for (a) any notification, if any, required to be filed or
supplied pursuant to the ▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Antitrust Improvements Act of 1976,
as amended, and the rules and regulations thereunder (the "HSR Act"), in
connection with the transactions contemplated by this Agreement, (b)
registration of the Exchange Shares and the Sales Force Shares under the
Securities Act pursuant to the Registration Rights Agreement, (c) listing of the
Exchange Shares and the Sales Force Shares on the Exchange, and (d) any filings
required under federal and state securities laws in connection with the issuance
of the Exchange Shares or the Sales Force Shares, no consent, approval, order or
authorization of, or registration, qualification, designation, declaration or
filing with, any federal, state or local governmental authority is required on
the part of the Company in connection with the Company's valid execution,
delivery and performance of this Agreement or any of the Related Agreements. The
filings under federal and state securities laws, if any, will be effected by the
Company at its cost within the applicable stipulated statutory period.
2.9 LITIGATION.
There is no action, suit, proceeding or investigation pending or, to
the knowledge of the Company, currently threatened against the Company or any of
its subsidiaries which questions the validity of this Agreement or the Related
Agreements, or the right of the Company to enter into such agreements and
instruments or to consummate the transactions contemplated hereby or thereby.
Except as disclosed in SEC Filings, there is no action, suit, proceeding or
investigation pending or, to the knowledge of the Company, currently threatened
against the Company, which singly or in the aggregate, if the subject of an
unfavorable decision, ruling or finding, would have or would reasonably be
expected to have a Material Adverse Effect.
2.10 NO BROKERS.
There are no claims, agreements, or commitments for brokerage
commissions or finder's fees or similar compensation in connection with the
transactions contemplated by this Agreement or otherwise, based on any
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arrangement made by or on behalf of the Company or any of its subsidiaries, and
the Company agrees to indemnify and hold King harmless against any damages
incurred as a result of any such claim, agreement, or commitment.
2.11 NO CONFLICTS.
The execution and delivery of this Agreement and the Related
Agreements by the Company do not, and the performance by the Company of its
obligations under this Agreement and the Related Agreements will not, (i)
conflict with or violate the certificate or articles of incorporation or bylaws
of the Company or any of its subsidiaries, or conflict with or violate any law,
statute, ordinance, rule, regulation, order, judgment or decree applicable to
the Company or any of its subsidiaries or by which any of their respective
properties or assets is bound or affected, or (ii) result in any breach of or
constitute a default (or an event which with or without notice or lapse of time
or both would become a default) under, or give to others any rights of
termination, amendment, acceleration or cancellation of, or result in the
creation of any lien, claim or encumbrance on any of the properties or assets of
the Company or any of its subsidiaries pursuant to, any note, bond, mortgage,
indenture, contract, agreement, lease, license, permit, franchise or other
instrument or obligation to which the Company or any of its subsidiaries is a
party or by which the Company, any of its subsidiaries or any of their
respective properties or assets is bound or affected, except, in the case of
clause (ii) above, for any such breaches, defaults or other alterations or
occurrences that (A) would not prevent or delay consummation of the transactions
contemplated in this Agreement and the Related Agreements in any material
respect or otherwise prevent the Company from performing its obligations under
this Agreement and the Related Agreements in any material respect, and (B) have
not had and would not be reasonably likely to have a Material Adverse Effect.
2.12 FDA MATTERS.
As to each product subject to the jurisdiction of the U.S. Food and
Drug Administration ("FDA") under the Federal Food, Drug and Cosmetic Act, as
amended, and the regulations thereunder ("FDCA") that is manufactured, packaged,
labeled, tested, distributed, sold, and/or marketed by the Company or any of its
subsidiaries (each such product, a "Pharmaceutical Product"), to the knowledge
of the Company, such Pharmaceutical Product is being manufactured, packaged,
labeled, tested, distributed, sold and/or marketed by the Company in compliance
with all applicable requirements under FDCA and similar laws, rules and
regulations relating to registration, investigational use, premarket clearance,
licensure, or application approval, good manufacturing practices, good
laboratory practices, good clinical practices, product listing, quotas,
labeling, advertising, record keeping and filing of reports except where the
failure to be in compliance would not have a Material Adverse Effect. There is
no pending, completed or, to the
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Company's knowledge, threatened action (including any lawsuit, arbitration, or
legal or administrative or regulatory proceeding, charge, complaint, or
investigation) against the Company or any of its subsidiaries, and none of the
Company or any of its subsidiaries has received any notice, warning letter or
other communication from the FDA or any other governmental entity, which (i)
contests the premarket clearance, licensure, registration, or approval of, the
uses of, the distribution of, the manufacturing or packaging of, the testing of,
the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii)
withdraws its approval of, requests the recall, suspension, or seizure of, or
withdraws or orders the withdrawal of advertising or sales promotional materials
relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any
clinical investigation by the Company or any of its subsidiaries, (iv) enjoins
production at any facility of the Company or any of its subsidiaries, (v) enters
or proposes to enter into a consent decree of permanent injunction with the
Company or any of its subsidiaries, or (vi) otherwise alleges any violation of
any laws, rules or regulations by the Company or any of its subsidiaries, and
which, either individually or in the aggregate, would have a Material Adverse
Effect.
2.13 ABSENCE OF CLAIMS.
The Company has no knowledge of any claims against King or any of
its affiliates with respect to any of the AVC Agreements.
2.14 SOLVENCY.
The Company is not now and has not ever been subject to any
voluntary or involuntary petition in bankruptcy or any voluntary or involuntary
proceeding relating to insolvency, receivership, liquidation, composition or
assignment for the benefit of creditors and, to the Company's knowledge, no
involuntary proceeding or petition is or has been threatened against the
Company. The Company is solvent and will be solvent at the Closing, and the
Transactions will not render the Company insolvent. The Company owns property
whose fair saleable value is greater than the amount required to pay all of its
debts (including contingent debts). The Company is able to pay and, to the
Company's knowledge, will be able to pay for the first twelve (12) months after
Closing, the Company's debts as they mature.
2.15 FAIR CONSIDERATION.
The Transactions are for fair consideration and are the product of
arm's length negotiations. The Company is receiving reasonably equivalent value
in exchange for the consideration being provided to King in connection with the
Transactions, including the Redemption Payment, the Exchange Shares and the
Sales Force Shares.
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2.16 GOOD FAITH.
The Company has entered into the Transactions in good faith and
without the intent to hinder, delay or defraud any creditor.
2.17 ADEQUATE CAPITAL.
Immediately upon the consummation of the Transactions, the Company
shall have adequate capital in light of the Company's currently intended
business operations to meet the Company's obligations.
SECTION 3. REPRESENTATIONS AND WARRANTIES OF KING
King and Parkedale hereby, jointly and severally, represent and
warrant to the Company on the date hereof and as of the Closing Date as follows:
3.1 ORGANIZATION, GOOD STANDING AND QUALIFICATION.
Each of King and Parkedale is a corporation duly organized, validly
existing and in good standing under the laws of the State of Tennessee and State
of Michigan, respectively, and has all requisite corporate power and authority
to carry on its respective business as now conducted and as proposed to be
conducted.
3.2 AUTHORIZATION.
Each of King and Parkedale has all requisite corporate power and
authority to execute, deliver and perform its respective obligations under this
Agreement, the Related Agreements and all other agreements, instruments and
certificates to be executed and delivered by King or Parkedale pursuant to or in
connection with this Agreement and the Related Agreements. All corporate action
on the part of King and Parkedale, their respective officers, directors and
stockholders for the authorization, execution and delivery of this Agreement and
the Related Agreements and the performance of all obligations of King and
Parkedale hereunder has been taken.
3.3 ENFORCEABILITY.
This Agreement constitutes, and the Related Agreements when executed
by King and Parkedale will constitute, valid and legally binding obligations of
King and Parkedale, enforceable in accordance with their terms, except (a) as
limited by applicable bankruptcy, insolvency, reorganization, moratorium and
other laws of general application affecting enforcement of creditors'
-15-
rights generally and (b) as limited by laws relating to the availability of
specific performance, injunctive relief or other equitable remedies.
3.4 GOVERNMENTAL CONSENTS.
Except for (a) any notification, if any, required to be filed or
supplied pursuant to the HSR Act in connection with the transactions
contemplated by this Agreement, and (b) any filings required to be made or
supplied pursuant to Section 13 or 16 of the Exchange Act, no consent, approval,
order or authorization of, or registration, qualification, designation,
declaration or filing with, any federal, state or local governmental authority
is required on the part of King or Parkedale in connection with King's and
Parkedale's valid execution, delivery and performance of this Agreement or any
of the Related Agreements.
3.5 LITIGATION.
There is no action, suit, proceeding or investigation pending or, to
the knowledge of King or Parkedale, currently threatened against King or any of
its subsidiaries which questions the validity of this Agreement or any of the
Related Agreements, or the right of King or Parkedale to enter into such
agreements and instruments or to consummate the transactions contemplated hereby
or thereby.
3.6 NO CONFLICTS.
Except as set forth on Schedule 3.6, the execution and delivery of
this Agreement and the Related Agreements by King and Parkedale do not, and the
performance by King and Parkedale of their respective obligations under this
Agreement and the Related Agreements will not, (i) conflict with or violate the
certificate or articles of incorporation or bylaws of King or any of its
subsidiaries, or conflict with or violate any law, statute, ordinance, rule,
regulation, order, judgment or decree applicable to King or any of its
subsidiaries or by which any of their respective properties or assets is bound
or affected, or (ii) result in any breach of or constitute a default (or an
event which with or without notice or lapse of time or both would become a
default) under any note, bond, mortgage, indenture, contract, agreement, lease,
license, permit, franchise or other instrument or obligation to which King or
any of its subsidiaries is a party or by which King, any of its subsidiaries or
any of their respective properties or assets is bound or affected, except, in
the case of clause (ii) above, for any such breaches, defaults or other
occurrences that would not prevent or delay consummation of any of the
transactions contemplated in this Agreement and the Related Agreements in any
material respect or otherwise prevent King or Parkedale from performing its
obligations under this Agreement or any of the Related Agreements in any
material respect.
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3.7 ABSENCE OF CLAIMS.
Neither King nor Parkedale has any knowledge of any claims against
the Company or any of its subsidiaries with respect to any of the AVC
Agreements.
3.8 ACCREDITED INVESTOR.
King is an "accredited investor" as such term is defined in Rule
501(a) of the Securities Act and is receiving the Exchange Shares and the Sales
Force Shares for its own account for investment purposes and not with a view to,
or for sale in connection with, any distribution thereof in violation of the
Securities Act or any applicable state securities law, nor with any present
intention of distributing or selling the same in violation of the Securities Act
or any applicable state securities law. King has sufficient knowledge and
experience in financial and business matters so as to be capable of evaluating
the merits and risks of its investment in the Exchange Shares and the Sales
Force Shares and is capable of bearing the economic risks of such investment.
3.9 NO BROKERS.
Except with respect to amounts payable to UBS Securities LLC, there
are no claims, agreements, or commitments for brokerage commissions or finder's
fees or similar compensation in connection with the transactions contemplated by
this Agreement or otherwise based on any arrangement made by or on behalf of
King or any of its subsidiaries or affiliates, and King agrees to indemnify and
hold the Company harmless against any damages incurred as a result of any such
claim, agreement, or commitment.
SECTION 4. COVENANTS OF THE PARTIES; HPV MATTERS
4.1 MUTUAL COVENANTS.
(a) The Company and King shall promptly complete any filing that
may be required pursuant to the HSR Act (each an "HSR Filing"), or shall
mutually agree that no such filing is required. If any HSR Filing shall be
required in connection with the transactions contemplated by this Agreement,
then the Company and King shall diligently take, or fully cooperate in the
taking of, all necessary and proper steps, and provide any additional
information reasonably requested in order to comply with, the requirements of
the HSR Act. Each party shall pay its own expenses in connection with the HSR
Filings and the Company shall pay any filing fees associated with the HSR
Filings.
(b) The Company, King and Parkedale, as promptly as practicable,
(i) will make, or cause to be made, all such filings and submissions under laws,
-17-
rules and regulations applicable to them as may be required for them to
consummate the transactions contemplated hereby in accordance with the terms of
this Agreement and the Related Agreements, and (ii) will use commercially
reasonable efforts to obtain, or cause to be obtained, all authorizations,
approvals, consents and waivers from all governmental authorities necessary to
be obtained by them in order for them to consummate such transactions.
(c) Except as otherwise required by law (including their
respective filing and disclosure obligations under the Securities Act, the
Exchange Act and the rules and regulations promulgated thereunder), Nasdaq
National Market ("Nasdaq") and applicable stock exchange requirements, from the
date of this Agreement until thirty (30) days after the Closing Date, neither
the Company, King nor any of King's subsidiaries shall, and each of them shall
cause their respective affiliates, officers, directors, representatives and
agents not to, issue or cause the publication of any press release or public
announcement with respect to the transactions contemplated by this Agreement,
except for the issuance of the press release attached hereto at Exhibit C or as
otherwise mutually agreed by the parties in writing.
(d) The Company, King and each of their respective subsidiaries
shall, from the date of this Agreement and at all times thereafter, maintain
strict confidentiality with respect to all confidential or proprietary documents
and information furnished to such party by or on behalf of the other party.
Nothing shall be deemed to be confidential information that (it being understood
that the receiving party shall bear the burden of proof with respect to the
following): (i) was known to the receiving party at the time of its disclosure
by or on behalf of the disclosing party; (ii) becomes publicly known or
available other than through disclosure by the receiving party; (iii) is
received by the receiving party from a third party not actually known by the
receiving party (after due inquiry) to be bound by a confidentiality agreement
with or obligation to the other party; or (iv) is independently developed by the
receiving party without reference to or use of such confidential information.
Notwithstanding the foregoing provisions of this Section 4.1(d), each of the
Company, King and King's subsidiaries may disclose such confidential information
(A) to the extent required or deemed advisable on the advice of counsel to
comply with applicable laws (including the Securities Act, the Exchange Act, and
the rules and regulations under the Securities Act or the Exchange Act), and
applicable Nasdaq and stock exchange requirements, (B) to its officers,
directors, employees, representatives, financial advisors, attorneys,
accountants, agents, underwriters, lenders, investors and any other potential
sources of financing (provided that each of the Company, King and their
respective subsidiaries shall be responsible for any violation of the
restrictions hereunder by its respective representatives), (C) to any
governmental authority in connection with, and to the extent required to effect,
the Transactions, and (D) in the event it is required in response to a valid
order by a governmental, quasi-governmental, judicial or quasi-judicial entity
to disclose any such confidential information.
-18-
Notwithstanding anything to the contrary contained herein, the terms and
conditions of this Section 4.1(d) shall not apply to King HPV Confidential
Information or Novavax HPV Confidential Information.
(e) Neither party shall make, and each party shall ensure that
none of such party's directors or officers shall disparage the other party or
any of the other party's officers, directors, employees, stockholders or
affiliates, or the pharmaceutical products to which any of the Collaboration
Agreements relate, including the pharmaceutical product marketed under the name
ESTRASORB ("Estrasorb" and, together with such other pharmaceutical products,
the "Collaborative Pharmaceutical Products").
(f) Each party shall cooperate with the other party, and exchange
such information as is reasonably requested by the other party, and otherwise
facilitate an orderly transition, and effect the transfer of all Collaborative
Pharmaceutical Products (other than the pharmaceutical product marketed under
the name NORDETTE) and related assets from King and its subsidiaries to the
Company as contemplated by Section 1.6(b).
4.2 ADDITIONAL COVENANTS OF THE COMPANY.
(a) For a period of sixty (60) days after the Closing Date, the
Company shall not enter into any agreement with any other party, including
Organon International, Inc. ("Organon") or any of its affiliates, pertaining to
the sale, licensing or copromotion of Estrasorb. As used in this Section 4.2(a),
the term "affiliates" means any person or entity controlled by, controlling or
under common control with Organon and the term "control" has the meaning
ascribed to such term in Rule 12b-2 promulgated under the Exchange Act.
(b) The Company shall use reasonable best efforts to cause
Anaconda to execute and deliver to King at Closing the Anaconda Release in the
form attached hereto at Exhibit D.
(c) The Company shall use commercially reasonable efforts to cause
the Exchange Shares and the Sales Force Shares to be approved for listing on the
principal U.S. national securities exchange on which the Common Stock is listed
or, if the Common Stock is listed on Nasdaq, then the Exchange Shares and the
Sales Force Shares will be listed on Nasdaq (such place of listing of the
Exchange Shares and the Sales Force Shares, the "Exchange"), subject only to
official notice of issuance.
(d) From the date hereof until the Closing Date, the Company shall
operate its business in the ordinary course consistent with past practice,
except for such activities specifically contemplated by this Agreement,
including related financing activities.
-19-
4.3 CERTAIN HPV MATTERS.
(a) From and after the Closing Date, the Company shall not, and
shall cause the Novavax Parties not to, use or disclose King HPV Confidential
Information, whether or not embodied in writing or other tangible form, for any
purpose whatsoever without the prior written consent of King, which consent may
be withheld in King's sole and absolute discretion. The Company, on behalf of
itself and each other Novavax Party, further acknowledges that all originals and
copies of any King HPV Confidential Information, however and whenever produced,
are the sole property of King, Parkedale and/or their respective affiliates, as
applicable. From and after the Closing Date, the Company shall, and shall cause
the Novavax Parties to, cease any further disclosure of King HPV Confidential
Information to or by any other Novavax Party, and further agrees to require any
other Novavax Party who has access to any King HPV Confidential Information to
comply with the obligations hereunder, and shall exercise reasonable diligence
to obtain their compliance with such obligations. From and after the Closing
Date, each Novavax Party shall promptly surrender to King, Parkedale and/or
their respective affiliates all King HPV Confidential Information that is in
tangible form, including King HPV Confidential Information that has been reduced
to or placed on one or more writings, drawings, schematics, tapes, disks, or
other forms of documentation, together with any materials, things, prototypes,
samples and equipment belonging to any King Party, and the Company shall not,
and shall cause the Novavax Parties not to, thereafter retain or deliver to any
other person, third party or entity any of the foregoing or any summary thereof.
The Company hereby agrees that it shall be responsible for the obligations of
the other Novavax Parties hereunder and executes this Agreement on behalf of
itself and the other Novavax Parties. From and after the Closing Date, the
Company shall, and shall cause the Novavax Parties to, use at least the same
degree of care (which at a minimum shall be reasonable) to avoid unauthorized
dissemination of King HPV Confidential Information as the Company employs for
its own information of a similar nature that the Company does not want to have
disseminated. In the event any Novavax Party is required in response to a valid
order by a governmental, quasi-governmental, judicial or quasi-judicial entity
to disclose King HPV Confidential Information, it shall not be a violation of
this Agreement to comply; provided, however, that in the event the Company
receives such an order from or after the Closing Date, the Company shall notify
King and Parkedale of such request or requirement, promptly upon receipt of the
same and give King or Parkedale a reasonable opportunity to quash such order and
to obtain a protective order requiring that such King HPV Confidential
Information and documents that are the subject of such order be held in
confidence by such governmental, quasi-governmental, judicial or quasi-judicial
entity or, if disclosed, be used only for purposes for which the order was
issued; and provided, further, that if a disclosure order is not quashed or a
protective order is not obtained, the King HPV Confidential Information
disclosed in response to such order will be
-20-
limited to that information which is legally required to be in the response to
such disclosure order.
(b) From and after the Closing Date, King and Parkedale shall not,
and shall cause the King Parties not to, use or disclose Novavax HPV
Confidential Information, whether or not embodied in writing or other tangible
form for any purpose whatsoever without the prior written consent of the
Company, which consent may be withheld in the Company's sole and absolute
discretion. Each of King and Parkedale, on behalf of itself and each other King
Party, acknowledges that all originals and copies of any Novavax HPV
Confidential Information, however and whenever produced, are the sole property
of the Company and/or its affiliates, as applicable. From and after the Closing
Date, King and Parkedale shall, and shall cause the King Parties to, cease any
further disclosure of Novavax HPV Confidential Information to or by any other
King Party, and further agree to require any other King Party who has access to
any Novavax HPV Confidential Information to comply with the obligations
hereunder, and shall exercise reasonable diligence to obtain their compliance
with such obligations. From and after the Closing Date, each King Party shall
promptly surrender to the Company all Novavax HPV Confidential Information that
is in tangible form, including Novavax HPV Confidential Information that has
been reduced to or placed on one or more writings, drawings, schematics, tapes,
disks, or other forms of documentation, together with any materials, things,
prototypes, samples and equipment belonging to any Novavax Party, and King and
Parkedale shall not, and shall cause the King Parties not to, thereafter retain
or deliver to any other person, third party or entity any of the foregoing or
any summary thereof. Each of King and Parkedale hereby agrees that it shall be
responsible for the obligations of the other King Parties hereunder and executes
this Agreement on behalf of itself and the other King Parties. From and after
the Closing Date, each of King and Parkedale shall, and shall cause the King
Parties to, use at least the same degree of care (which at a minimum shall be
reasonable) to avoid unauthorized dissemination of Novavax HPV Confidential
Information as each of King and Parkedale employs for its own information of a
similar nature that King or Parkedale does not want to have disseminated. In the
event any King Party is required in response to a valid order by a governmental,
quasi-governmental, judicial or quasi-judicial entity to disclose Novavax HPV
Confidential Information, it shall not be a violation of this Agreement to
comply; provided, however, that in the event King or Parkedale receives such an
order from or after the Closing Date, King or Parkedale shall notify the Company
of such request or requirement, promptly upon receipt of the same and give the
Company a reasonable opportunity to quash such order and to obtain a protective
order requiring that such Novavax HPV Confidential Information and documents
that are the subject of such order be held in confidence by such governmental,
quasi-governmental, judicial or quasi-judicial entity or, if disclosed, be used
only for purposes for which the order was issued; and provided, further, that if
a disclosure order is not quashed or a protective order is not obtained, the
Novavax HPV
-21-
Confidential Information disclosed in response to such order will be limited to
that information which is legally required to be in the response to such
disclosure order.
(c) Each party will retain ownership of all information, data, HPV
Know-How, inventions, discoveries, programs, copyrights, improvements, devices,
designs, apparatus, patents, patent applications, practices, processes, methods,
products, techniques, trade secrets, ideas, or other intellectual property
relating to the subject matter of the HPV License Agreement which was owned by
it at the commencement of the HPV License Agreement. The parties agree that the
Company will own and/or have sole rights in and to the Novavax HPV Confidential
Information and will have an undivided joint interest in the HPV Joint
Improvements and the HPV Products (with King) and that King will solely own the
King HPV Confidential Information and will have an undivided joint interest in
the HPV Joint Improvements and the HPV Products (with the Company). Nothing in
this Agreement shall (i) grant the Company any rights to the King HPV
Confidential Information or any other technology that King may acquire or
license or (ii) ▇▇▇▇▇ ▇▇▇▇ or Parkedale any rights to the Novavax HPV
Confidential Information or any other technology that the Company may acquire or
license. From and after the Closing Date, each of King, Parkedale, and the
Company shall have the right to use, disclose or commercially exploit any HPV
Joint Improvement or HPV Product without the consent of, and without any
obligation to, any other party hereto. Each party agrees that, from and after
the Closing Date, each Novavax Party shall promptly provide to King and each
King Party shall promptly provide to the Company, a copy of any and all HPV
Joint Improvements or HPV Products in the possession of such party that are in
tangible or other recorded form.
(d) Each party represents, as of the date of this Agreement and as
of the Closing Date, that it has not disclosed any King HPV Confidential
Information or Novavax HPV Confidential Information to any person, third party
or entity, other than the King Parties or the Novavax Parties.
4.4 CERTAIN ADJUVANT MATTERS.
(a) Each party will retain ownership of all information, data,
Adjuvant Know-How, inventions, discoveries, programs, copyrights, improvements,
devices, designs, apparatus, patents, patent applications, practices, processes,
methods, products, techniques, trade secrets, ideas, or other intellectual
property or confidential information owned by it at the commencement of the
License and Supply Agreement. The Company shall solely own the Novavax Adjuvant
IP and shall own an undivided joint interest in the Adjuvant Joint Improvements
(with Parkedale). Parkedale shall solely own the Parkedale Products, the
Influenza Products (to the extent such products do not constitute Novavax
Adjuvant IP) and the Adjuvant Know-How of Parkedale and shall own an undivided
joint interest in the Adjuvant Joint Improvements (with the Company).
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(b) From and after the Closing Date, each of King, Parkedale and
the Company shall have the right to use, disclose or commercially exploit any
Adjuvant Joint Improvement without the consent of, and without any obligation
to, any other party hereto. Each party agrees that, from and after the Closing
Date, (i) each Novavax Party shall promptly provide to Parkedale and each King
Party shall promptly provide to the Company, a copy of any and all Adjuvant
Joint Improvements in the possession of such party that are in tangible or other
recorded form and (ii) the King Parties shall promptly provide to the Company
copies of any and all data in their possession resulting from experiments with
the Novavax Adjuvant IP; provided, however, that such data shall constitute the
confidential information of King and Parkedale under Section 4.1(d); and
provided, further, that the King Parties' provision of such data to the Company
shall not affect such data's status as Adjuvant Know-How of Parkedale.
4.5. ADVERTISING AND PROMOTIONAL MATERIALS.
(a) The parties acknowledge that as of the date of this Agreement,
the Company has in its possession certain advertising and promotional materials
relating exclusively to Estrasorb which bear the names, logos, trademarks or
trade names of King and/or its affiliates (the "Advertising and Promotional
Materials"). The Company may distribute the Advertising and Promotional
Materials in connection with the Company's marketing, promotion and sale of
Estrasorb until the earlier of (i) the date such Advertising and Promotional
Materials have been distributed or (ii) the date that is one hundred eighty
(180) days after the Closing Date; provided, however, that the Company shall use
commercially reasonable efforts to remove, mask or otherwise cover, or cause to
be removed, masked or otherwise covered, the names, logos, trademarks and trade
names of King and/or its affiliates as they appear on such Advertising and
Promotional Materials (other than on the Advertising and Promotional Materials
designed as inserts for newspapers and other periodicals). The Company shall
not, and shall have no right to, use or distribute such Advertising and
Promotional Materials for any other purpose. The Company acquires no right,
title, or interest in or to any of King's and/or its affiliates' names, logos,
trademarks, trade names or other proprietary rights. The Company further agrees
that the Company shall not deface nor alter such Advertising and Promotional
Materials, except to remove, mask or otherwise cover the names, logos,
trademarks and trade names of King and/or its affiliates. Upon King's reasonable
request, the Company shall permit King to inspect the Advertising and
Promotional Materials to ensure that they are, and are being used in, compliance
with this Section 4.5(a).
(b) The Company shall indemnify, defend and hold harmless the King
Parties from and against any and all claims, actions, causes of action,
assessments, judgments, deficiencies, damage, loss, liability, and expense of
any nature whatsoever (including attorneys' fees and expenses) solely arising
out of the use or distribution of the Advertising and Promotional Materials.
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SECTION 5. CONDITIONS PRECEDENT TO CLOSING
5.1 CONDITIONS TO OBLIGATIONS OF KING AND PARKEDALE.
The obligations of King to consummate the Closing under this
Agreement are subject to the fulfillment on or before the Closing Date of the
following conditions, the waiver of which shall not be effective without the
written consent of King thereto:
(a) Representations and Warranties. The representations and
warranties of the Company contained in Section 2 shall be true and correct on
and as of the Closing Date with the same effect as though such representations
and warranties had been made on and as of the Closing Date.
(b) Performance. The Company shall have performed and complied
with all agreements, obligations and conditions contained in this Agreement that
are required to be performed or complied with by the Company on or before the
Closing.
(c) Compliance Certificate. An authorized executive officer of the
Company shall have delivered to King a certificate certifying that the
conditions specified in Section 5.1(a) and Section 5.1(b) have been fulfilled.
(d) No Order. No stop order or other order enjoining the issuance
of the Exchange Shares or the Sales Force Shares at the Closing shall have been
issued, and no proceedings for such purpose shall be pending or threatened by
the SEC or any commissioner of corporations or similar officer of any state
having jurisdiction over the transactions contemplated by this Agreement or any
of the Related Agreements, and no preliminary or permanent injunction or other
order, consent, integrity agreement, decree or ruling issued by a court of
competent jurisdiction or by a governmental, regulatory or administrative agency
or commission nor any statute, rule, regulation or executive order promulgated
or enacted by any governmental authority shall be in effect that would restrain
or otherwise prevent the consummation of any of the transactions contemplated by
this Agreement or any of the Related Agreements.
(e) Certificate. At the Closing, the Company shall have furnished
to King a certificate, signed by an authorized executive officer of the Company,
certifying as to the representations and warranties set forth in Section 2.14,
Section 2.15 and Section 2.17.
(f) Opinion of Counsel. At the Closing, the Company shall have
furnished to King an opinion of Ropes & ▇▇▇▇ LLP in a form reasonably acceptable
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to King, and an opinion of White White & Van Etten LLP in a form reasonably
acceptable to King.
(g) Listing. The Exchange Shares and the Sales Force Shares shall
have been validly approved by the Exchange and any other applicable regulatory
authorities for listing on the Exchange, and no further action shall be required
in connection therewith.
(h) HSR Act. If an HSR Filing is required, then any waiting
periods with any extensions thereof under the HSR Act shall have expired or been
terminated.
(i) Closing Deliveries. The Company shall have delivered or caused
to be delivered to King each of the documents specified in Section 1.8(b).
5.2 CONDITIONS TO OBLIGATIONS OF THE COMPANY.
The obligations of the Company to consummate the Closing under this
Agreement are subject to the fulfillment on or before the Closing of the
following conditions, the waiver of which shall not be effective without the
consent of the Company thereto:
(a) Representations and Warranties. The representations and
warranties of King and Parkedale contained in Section 3 shall be true and
correct on and as of the Closing Date with the same effect as though such
representations and warranties had been made on and as of the Closing Date.
(b) Performance. King and Parkedale shall have performed and
complied with all agreements, obligations and conditions contained in this
Agreement that are required to be performed or complied with by King on or
before the Closing.
(c) Compliance Certificate. An officer of King and Parkedale shall
have delivered to the Company a certificate certifying that the conditions
specified in Section 5.2(a) and Section 5.2(b) have been fulfilled.
(d) No Order. No stop order or other order enjoining the issuance
of the Exchange Shares or the Sales Force Shares at the Closing shall have been
issued, and no proceedings for such purpose shall be pending or threatened by
the SEC or any commissioner of corporations or similar officer of any state
having jurisdiction over the transactions contemplated by this Agreement or any
of the Related Agreements, and no preliminary or permanent injunction or other
order, consent, integrity agreement, decree or ruling issued by a court of
competent jurisdiction or by a governmental, regulatory or administrative agency
or
-25-
commission nor any statute, rule, regulation or executive order promulgated or
enacted by any governmental authority shall be in effect that would restrain or
otherwise prevent the consummation of any of the transactions contemplated by
this Agreement or any of the Related Agreements.
(e) HSR Act. If an HSR Filing is required, then any waiting
periods with any extensions thereof under the HSR Act shall have expired or been
terminated.
(f) Closing Deliveries. King and Parkedale shall have delivered or
caused to be delivered to the Company each of the documents specified in Section
1.8(a).
SECTION 6. TERMINATION.
6.1 TERMINATION.
(a) This Agreement may be terminated at any time prior to the
Closing as follows:
(i) by mutual written consent of King and the Company;
(ii) by King or Parkedale, upon breach of any representation,
warranty, covenant or agreement of the Company set forth in this Agreement, in
any case, such that the conditions set forth in Section 5.1(a) or Section
5.1(b) would not be satisfied as a result of such breach; provided, that such
breach has not been cured by the Company within thirty (30) days after the
Company receives written notice of such breach from King; and
(iii) by the Company, upon a breach of any representation,
warranty, covenant or agreement of King set forth in this Agreement, in any
case, such that the conditions set forth in Section 5.2(a) or Section 5.2(b)
would not be satisfied as a result of such breach; provided, that such breach
has not been cured by King within thirty (30) days after King receives written
notice of such breach from the Company.
(b) Unless otherwise extended pursuant to a written agreement of
the parties, this Agreement shall automatically terminate without further action
if the Closing shall not have occurred prior to 4:00 p.m. eastern standard time
on July 19, 2004.
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6.2 EFFECT OF TERMINATION.
If this Agreement is terminated pursuant to Section 6.1, this
Agreement shall become null and void and of no further force and effect, except
for the provisions of (a) Section 4.1(d) relating to confidential information,
(b) Section 6.1 and this Section 6.2, (c) Section 7.3 relating to governing law
and consent to jurisdiction and (d) Section 7.7 relating to certain expenses.
Nothing in this Section 6.2 shall be deemed to release any party from any
liability for any breach by such party of the terms and provisions of this
Agreement or to impair the right of a party to compel specific performance by
the other parties of its obligations under this Agreement.
6.3 SPECIFIC PERFORMANCE.
The parties acknowledge that the transactions contemplated hereby
are unique and specifically identifiable. Accordingly, the parties further agree
and stipulate that, if the Closing does not occur because of the willful failure
of King or Parkedale, on the one hand, or the Company, on the other hand, to
perform their respective obligations hereunder, then (a) monetary damages and
any other remedy at law shall not be adequate, (b) the non-defaulting party
shall be entitled to specific performance as the remedy for such breach, (c)
each party agrees to waive any objection to the remedy of specific performance,
(d) each party agrees that the granting of specific performance by any court
shall not be deemed, construed or interpreted to be harsh or oppressive to the
party who is ordered specifically to perform its obligations under this
Agreement and (e) in connection with any action for specific performance, the
prevailing party shall be entitled to reasonable attorneys' fees and other costs
of prosecuting or defending such action. The right to seek specific performance
hereunder shall not preclude any party to seek any other remedy at law or in
equity.
SECTION 7. MISCELLANEOUS.
7.1 SURVIVAL.
(a) All representations, warranties and covenants contained herein
or made in writing by or on behalf of the Company in connection herewith shall
survive the execution and delivery of this Agreement and the Closing; provided,
however, that, (i) except for the representations and warranties of the Company
in Sections 2.1, 2.2, 2.3, 2.4 and 2.10, the representations and warranties of
the Company in Section 2 shall survive for a period of twelve (12) months after
the Closing Date, and (ii) the representations and warranties of the Company in
Sections 2.1, 2.2, 2.3, 2.4 and 2.10 shall survive for the duration of the
applicable statute of limitations. All representations, warranties and covenants
contained herein or made in writing by or on behalf of the Company in connection
herewith
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may be relied upon by only King and Parkedale and their successors and permitted
assigns regardless of any investigation made at any time by or on behalf of King
or Parkedale or any such successor or permitted assign.
(b) All representations, warranties and covenants contained herein
or made in writing by or on behalf of King or Parkedale in connection herewith
shall survive the execution and delivery of this Agreement and the Closing;
provided, however, that (i) except for the representations and warranties of
King and Parkedale in Sections 3.1, 3.2, 3.3 and 3.9, the representations and
warranties of King and Parkedale in Section 3 shall survive for a period of
twelve (12) months after the Closing Date, and (ii) the representations and
warranties of the Company in Sections 3.1, 3.2, 3.3 and 3.9 shall survive for
the duration of the applicable statute of limitations. All representations,
warranties and covenants contained herein or made in writing by or on behalf of
King and Parkedale in connection herewith may be relied upon by only the Company
and its successors and permitted assigns regardless of any investigation made at
any time by or on behalf of the Company or any such successor or permitted
assign.
(c) Notwithstanding anything to the contrary in this Agreement,
any representation, warranty or covenant which is the subject of a claim which
is asserted in writing within the survival periods specified in this Section 7.1
shall survive with respect to such claim or dispute until final resolution
thereof.
7.2 ASSIGNMENT; SUCCESSORS AND ASSIGNS.
Neither this Agreement nor any of the rights, interests or
obligations hereunder shall be assigned by the Company without the prior written
consent of King or by King or Parkedale without the prior written consent of the
Company. Except as otherwise provided herein, the terms and conditions of this
Agreement shall inure to the benefit of and be binding upon the respective
successors and permitted assigns of the parties. Nothing in this Agreement,
express or implied, is intended to confer upon any party other than the parties
hereto or their respective successors and assigns any rights, remedies,
obligations, or liabilities under or by reason of this Agreement, except as
expressly provided in this Agreement.
7.3 GOVERNING LAW; CONSENT TO JURISDICTION.
(a) This Agreement, the rights of the parties and all claims,
actions, causes of action or suits, litigation, controversies, investigations,
hearings, charge, complaints, demands, notices or proceedings arising in whole
or in part under or in connection herewith, shall be governed by, and construed
in accordance with, the laws of the State of Delaware, without giving effect to
any choice of law or conflict of law rules or provisions (whether of the State
of Delaware or any other jurisdiction)
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that would cause the application of the laws of any jurisdiction other than the
State of Delaware.
(b) The parties irrevocably submit to the exclusive jurisdiction
of any court located in the City of Wilmington, Delaware or the United States
Federal Court sitting in the District of Delaware over any suit, action or
proceeding arising out of or relating to this Agreement. Each of the parties
consents to process being served in any such suit, action or proceeding by
serving a copy thereof upon the agent for service of process; provided, that to
the extent lawful and possible, written notice of such service will also be
mailed to such party, as the case may be. Each of the parties agrees that such
service will be deemed in every respect effective service of process upon such
party in any such suit, action or proceeding and will be taken and held to be
valid personal service upon such party. Nothing in this subsection will affect
or limit any right to serve process in any manner permitted by law, or to
enforce in any lawful manner a judgment obtained in a court described in this
Section 7.3 in any other jurisdiction. Each of the parties waives any right it
may have to assert the doctrine of forum non conveniens or to object to venue to
the extent any proceeding is brought in a court located in the City of
Wilmington, Delaware or the United States Federal Court sitting in the District
of Delaware.
7.4 COUNTERPARTS.
This Agreement may be executed in two or more counterparts, each of
which shall be deemed an original, but all of which together shall constitute
one and the same instrument.
7.5 TITLES AND SUBTITLES.
The titles and subtitles used in this Agreement are used for
convenience only and are not to be considered in construing or interpreting this
Agreement.
7.6 NOTICES.
All notices, demands or other communications to be given or
delivered under or by reason of the provisions of this Agreement shall be in
writing and shall be deemed to have been given (a) when delivered personally to
the recipient, (b) when telecopied to the recipient (with hard copy sent to the
recipient by reputable overnight courier service (charges prepaid) that same
day) if telecopied before 5:00 p.m. Eastern time on a business day, and
otherwise on the next business day, or (c) one (1) business day after being sent
to the recipient by reputable overnight courier service (charges prepaid). Such
notices, demands and other communications shall be sent to the following persons
at the following addresses:
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To the Company:
Novavax, Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Chief Executive Officer
Telecopy: (▇▇▇) ▇▇▇-▇▇▇▇
With a copy to
Ropes & ▇▇▇▇ LLP
▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
Attention: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, ▇▇. Esq.
Telecopy: (▇▇▇) ▇▇▇-▇▇▇▇
To King:
King Pharmaceuticals, Inc.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Attn: Executive Vice President of Legal Affairs
and General Counsel
Telecopy: (▇▇▇) ▇▇▇-▇▇▇▇
or to such other address or to the attention of such other person as the
recipient party has specified by prior written notice to the sending party.
7.7 EXPENSES.
Irrespective of whether the Closing is effected, each party shall
pay all costs and expenses (including the fees and expenses of its lawyers and
other advisors) that it incurs with respect to the negotiation, execution,
delivery and performance of this Agreement. Notwithstanding the foregoing, the
Company shall pay any and all stamp, transfer and other similar taxes payable or
determined to be payable in connection with the execution and delivery of this
Agreement or any securities issued by the Company hereunder, and shall save and
hold King harmless from and against any and all liabilities with respect to or
resulting from any delay in paying, or omission to pay, such taxes.
7.8 AMENDMENTS AND WAIVERS.
Any term of this Agreement may be amended and the observance of any
term of this Agreement may be waived (either generally or in a particular
instance
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and either retroactively or prospectively), only with the written consent of the
Company, King and Parkedale.
7.9 SEVERABILITY.
If one or more provisions of this Agreement are held to be
unenforceable under applicable law, such provision shall be excluded from this
Agreement and the balance of the Agreement shall be interpreted as if such
provision were so excluded and shall be enforceable in accordance with its
terms.
7.10 ENTIRE AGREEMENT.
This Agreement and the Related Agreements constitute the entire
agreement among the parties with respect to the subject matter hereof and no
party shall be liable or bound to any other party in any manner by any
warranties, representations, or covenants except as specifically set forth
herein or therein with respect to such subject matter.
7.11 CONSTRUCTION.
(a) The parties acknowledge that the parties have reviewed and
revised this Agreement with their respective counsel and that the normal rule of
construction to the effect that any ambiguities are to be resolved against the
drafting party shall not be employed in the interpretation of this Agreement.
(b) Unless the context of this Agreement otherwise requires: (i)
words of any gender include each other gender; (ii) words using the singular or
plural number also include the plural or singular number, respectively; (iii)
the terms "hereof", "herein", "hereby" and derivative or similar words refer to
this entire Agreement; (iv) all references herein to "Articles" or "Sections"
are to Articles or Sections of this Agreement; (v) the term "or" has, except as
otherwise indicated, the inclusive meaning represented by the phrase "and/or";
(vi) the words "include", "includes" and "including" shall be deemed to be
followed by the phrase "without limitation" and "parties" or "Parties" means the
signatories to this Agreement.
(c) The term, "knowledge," when used with respect to any person or
entity, means the actual knowledge after reasonable investigation, of the
current officers, other employees, directors and other representatives of such
person or entity, including the chairman of the board of directors of each such
person or entity, in each case who could reasonably be expected to have
knowledge of the matter in question.
[THE REMAINDER OF THIS PAGE INTENTIONALLY LEFT BLANK.]
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IN WITNESS WHEREOF, the parties have executed this Exchange
Agreement as of the date first above written.
NOVAVAX, INC.
By: /s/ ▇▇▇▇▇▇ ▇▇▇▇
-------------------------
Name: ▇▇▇▇▇▇ ▇▇▇▇
Title: President and
Chief Executive Officer
KING PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
-----------------------------
Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Title: President and Chief Executive Officer
PARKEDALE PHARMACEUTICALS, INC.
By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
-----------------------------
Name: ▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Title: President and Chief Executive Officer
ANNEX I
DEFINITIONS
"Adjuvant(s)" shall mean any and all agents which enhance a product
or method involved in or concerned with the treatment or prevention or infection
of influenza virus, e.g., an immune response of an influenza virus vaccine,
which are owned, controlled, and/or developed by the Company and/or its
affiliates, or which the Company and/or its affiliates has a license or right to
use, such as the Novasome delivery system(s).
"Adjuvant Field" shall mean the use of Novavax Adjuvant IP in any
manner whatsoever to develop, create, invent, manufacture, promote, market,
offer-for-sale, sell, import and/or export an Influenza Product involved in or
concerned with the treatment or prevention of influenza virus or any other
purpose for which an Influenza Product may be indicated.
"Adjuvant Joint Improvement(s)" shall mean any and all ideas,
conceptions, reductions to practice, modifications, changes, alterations,
adaptations, revisions, or improvements relating to and/or derivatives of any
intellectual property or product that accrued or resulted from the joint
activities of the Company and/or its affiliates with Parkedale and/or its
affiliates outside of the Adjuvant Field during the term of the License and
Supply Agreement.
"Adjuvant Know-How" shall mean all tangible and intangible technical
and other information including, but not limited to ideas, conceptions,
reductions-to-practice, discoveries, data, designs, chemical structures,
formulae, materials, intermediates, inventions (whether patentable or not),
methods, models, prototypes, samples, influenza technology, works (whether
copyrightable or not), assays, research plans, procedures, designs, experiments,
tests, results of experimentation and testing (including results of research or
development), processes (including manufacturing processes, uses, specifications
and techniques), laboratory records, note books, chemical, pharmacological,
toxicological, clinical, analytical and quality control data, trial data, case
report forms, data analyses, reports, manufacturing data, summaries and
information contained in submissions to and from ethical committees and
regulatory authorities, which relates to or concerns an Adjuvant, a Parkedale
Product, Adjuvant Patent Rights, a Novasome delivery system, a Novavax Adjuvant
Improvement, a Parkedale Improvement and/or an Influenza Product. Adjuvant
Know-How includes all documents and copies thereof (whether in written,
machine-readable, physical or graphic form) and other things (such as
prototypes, materials, samples, models, etc.) which contain, embody or refer to
the Adjuvant Know-How. Such information, documents or things will not be
excluded from being Adjuvant Know-How hereunder by reason of the fact that they
become available to the public only through a wrongful act or omission to act of
a party hereto or a sublicense or distributor of a party hereto. The fact that
an item is
known to the public shall not be taken to exclude the possibility that a
compilation including the item, and/or a development relating to the item, is
(and remains) not known to the public. Adjuvant Know-How includes, but is not
limited to, any and all rights that protect the Adjuvant Know-How, such as
copyrights/software, rights, trade secret rights, database rights and/or design
rights.
"Adjuvant Patent Right(s)" shall mean: (a) any and all United States
and foreign (i) pending and abandoned patent applications, (ii) patents issuing
from such patent applications, and (iii) issued patents, together with any and
all divisions, reissues, reexaminations, continuations, continuations-in part,
extensions and additions thereof, which describe, relate to and/or claim an
Adjuvant (including, but not limited to, an Adjuvant either alone or in
combination, use of an Adjuvant, and manufacture of an Adjuvant or an
intermediate therefore) as of the date of the License and Supply Agreement; (b)
any and all inventions which describe, relate to or concern a Novavax Adjuvant
Improvement; (c) any and all United States and foreign (i) pending and abandoned
patent applications, and (ii) patents issuing from such patent applications,
together with any and all divisions, reissues, reexaminations, continuations,
continuations-in part, extensions and additions thereof, which describe, relate
to and/or claim a Novavax Adjuvant Improvement, now or in the future; and (d)
any and all other United States and foreign pending and abandoned patent
applications and issued patents necessary or useful in the Adjuvant Field.
"HPV" shall mean human papillomavirus.
"HPV Confidential Information" shall mean and include any and all
confidential and proprietary information and HPV Know-How which is not in the
public domain, whether in oral, written, machine-readable or graphic form, which
is furnished by one party or its affiliate (the "Disclosing Party"), either
directly or indirectly, pursuant to and under the HPV License Agreement or the
Pharmaceutical Quality Agreement, to the other party or its affiliate (the
"Receiving Party"), and which the Receiving Party has a reasonable basis to
believe is confidential to the Disclosing Party or is treated by the Disclosing
Party as confidential, unless such information: (a) was known to the Receiving
Party prior to receipt from the Disclosing Party, as documented in written
records or publications that lawfully are in the possession of the Receiving
Party; (b) was lawfully available to the trade or to the public prior to receipt
from the Disclosing Party; (c) becomes lawfully available to the trade or to the
public after receipt from the Disclosing Party through no act on the part of the
Receiving Party; (d) is in the general public domain other than as a result of a
breach of this confidential relationship; (e) is embodied in an agreement
entered into by the parties hereto in writing which releases such information
from the terms of this confidentiality obligation; (f) at any time is received
in good faith by the Receiving Party from a third party, which information was
lawfully in possession of the third party, and which the third party had the
right to disclose and did not receive from one of the parties to the HPV
License Agreement or the Pharmaceutical Quality Agreement; or (g) is
independently developed by an employee or agent of the Receiving Party without
access to the confidential and proprietary information or HPV Know-How, prior to
receipt of such confidential and proprietary information or HPV Know-How from
the Disclosing Party, as demonstrated by contemporaneous written records.
"HPV Field" shall mean (a) the use of Novavax HPV Trade Secret
Information and Novavax HPV Field Know-How in any manner whatsoever to develop,
create, invent, manufacture, promote, market, offer-for-sale, sell, import
and/or export an HPV Product involved in or concerned with the treatment or
prevention of HPV or any other purpose for which an HPV Product may be
indicated, including the treatment of cervical cancer, and (b) the subsequent
exploitation of an HPV Product.
"HPV Joint Improvement(s)" shall mean the ideas, conceptions,
reductions to practice, modifications, changes, alterations, adaptations,
revisions, or improvements identified on Annex I-A.
"HPV Know-How" shall mean all tangible and intangible technical and
other information including ideas, conceptions, reductions-to-practice,
discoveries, data, designs, chemical structures, formulae, materials,
intermediates, inventions (whether patentable or not), methods, models,
prototypes, samples, HPV technology, works (whether copyrightable or not),
assays, research plans, procedures, designs, experiments, tests, results of
experimentation and testing (including results of research or development),
processes (including manufacturing processes, uses, specifications and
techniques), laboratory records, notebooks, chemical, pharmacological,
toxicological, clinical, analytical and quality control data, trial data, case
report forms, data analyses, reports, manufacturing data, summaries and
information contained in submissions to and from ethical committees and
regulatory authorities, which relates to the HPV Field. HPV Know-How includes
all documents and copies thereof (whether in written, machine-readable, physical
or graphic form) and other things (such as prototypes, materials, samples,
models, etc.) which contain, embody or refer to the HPV Know-How. Such
information, documents or things will not be excluded from being HPV Know-How
hereunder by reason of the fact that they become available to the public only
through a wrongful act or omission to act of a party hereto or a sublicensee or
distributor of a party hereto. The fact that an item is known to the public
shall not be taken to exclude the possibility that a compilation including the
item, and/or a development relating to the item, is (and remains) not known to
the public. HPV Know-How includes any and all rights that protect the HPV
Know-How, such as copyrights, software rights, trade secret rights, database
rights and/or design rights.
"HPV Product(s)" shall mean any pharmaceutical product which is
developed, created, invented or manufactured with at least some portion or
aspect
of the Novavax HPV IP, which is used to treat HPV or cervical cancer, and which
is a product resulting from King's use of Novavax HPV IP, but shall exclude any
improvement by King or the Company based upon an HPV Product.
"Influenza Product(s)" shall mean any Parkedale Product together
with at least some portion or aspect of the Novavax Adjuvant IP, such as an
Adjuvant and especially a Novasome delivery system which is used to treat
influenza.
"King HPV Confidential Information" shall mean any King Improvement,
any King HPV Know-How and all other HPV Confidential Information of any King
Party, including the information identified on Annex I-B.
"King HPV Know-How" shall mean all HPV Know-How that accrues or
results from the activities of King, Parkedale or their respective affiliates or
which is owned by, licensed to or assignable to King, Parkedale or their
respective affiliates, and shall not include any HPV Joint Improvements.
"King Improvement(s)" shall mean any and all ideas, conceptions,
reductions to practice, modifications, changes, alterations, adaptations,
revisions, or improvements relating to and/or derivatives of Novavax HPV IP, an
HPV Product and/or King HPV Know-How, that accrue or result from the activities
of King, Parkedale and/or their respective affiliates or which are assignable to
King, Parkedale and their respective affiliates, but shall not include any HPV
Joint Improvements.
"King Party" shall mean any of King, Parkedale, their respective
affiliates and the respective shareholders, officers, directors, agents,
trustees, beneficiaries, employees, successors and assigns of King, Parkedale
and their respective affiliates.
"Novavax Adjuvant IP" shall mean the Adjuvants, Novasome delivery
system, Adjuvant Patent Rights, Novavax Adjuvant Improvements, and Adjuvant
Know-How of the Company, which is useful in the Adjuvant Field.
"Novavax Adjuvant Improvement(s)" shall mean any and all ideas,
conceptions, reductions to practice, modifications, changes, alterations,
adaptations, revisions, or improvements relating to and/or derivatives of an
Adjuvant, a Novasome delivery system, Adjuvant Patent Rights, and/or Adjuvant
Know-How of the Company that accrue or result from the activities of the Company
and/or the Company's affiliates or which are assignable to the Company and/or
the Company's affiliates.
"Novavax General Know-How" has the meaning set forth in subsection
(e) of the definition of Novavax HPV IP.
"Novavax HPV Confidential Information" shall mean any Novavax HPV
Improvement, any Novavax HPV Know-How, any Novavax HPV Trade Secret Information,
and all other Novavax HPV IP or other HPV Confidential Information of any
Novavax Party, including the information listed on Annex I-C.
"Novavax HPV Field Know-How" has the meaning set forth in subsection
(d) of the definition of Novavax HPV IP.
"Novavax HPV Improvement(s)" shall mean any and all ideas,
conceptions, reductions to practice, modifications, changes, alterations,
adaptations, revisions, or improvements relating to and/or derivatives of
Novavax HPV IP that accrue or result from the activities of the Company and/or
its affiliates or which are assignable to the Company and/or its affiliates, but
shall not include any HPV Joint Improvements.
"Novavax HPV IP" shall mean the following:
(a) Texas A&M University System License: any license between
the Company and the Texas A&M University System related to US ▇▇▇. No. 4,745,051
and No. 4,879,236, as amended or modified.
(b) US Government License: any non-exclusive license to the
Company from the United States of America as represented by the Department of
Health under US ▇▇▇. No. 5,437,951, No. 5,7709,996, No. 5,716,620, No.
5,744,142, No. 5,756,284, No. 5,871,998 and No. 5,985,610, as amended or
modified.
(c) Novavax HPV Trade Secret Information: The Company has
developed improved methods for the purification of recombinant virus-like
particles from baculovirus-infected insect cell including chromatographic steps
to capture and resolve purified intact VLPs that are stable for usage as
vaccines and/or diagnostic reagents. The method has been demonstrated for VLPs
of human papillomavirus (HPV) capsid proteins. For purposes of clarification,
"Novavax HPV Trade Secret Information" shall not include any HPV Joint
Improvements.
(d) Novavax HPV Field Know-How: this includes any and all
trade secret information and technical HPV Know-How owned, licensed or
controlled by the Company relating only to the HPV Field, but shall not include
any HPV Joint Improvements.
(e) Novavax General Know-How: this includes any and all
intellectual property owned or controlled by the Company, not mentioned above,
which is useful in the HPV Field, but shall not include any HPV Joint
Improvements.
(f) Novavax Inventions and Patent Applications: this includes
inventions related to novel insect cell lines capable of expressing secreted
VLPs, HPV L1 VLPs comprised of optimized HPV L1 genes and L1 gene expression,
HPV chimeric VLPs comprised of optimized HPV L1 and L2 fusion genes including
▇▇, ▇▇, and E7 wt and modified genes and L2 fusion gene expression, and HPV VLP
purification as described in USPTO and PCT patent applications, but shall not
include any HPV Joint Improvements.
"Novavax HPV Know-How" shall mean all HPV Know-How that accrues or
results from the activities of the Company or its affiliates or which is owned
by, licensed to or assignable to the Company or its affiliates, including the
Novavax HPV Field Know-How and the Novavax General Know-How, and shall not
include any HPV Joint Improvements.
"Novavax HPV Trade Secret Information" has the meaning set forth in
subsection (c) of the definition of Novavax HPV IP.
"Novavax Party" shall mean any of the Company, its affiliates, and
the respective shareholders, officers, directors, agents, trustees,
beneficiaries, employees, successors and assigns of the Company and its
affiliates.
"Parkedale Improvement(s)"shall mean any and all ideas, conceptions,
reductions to practice, modifications, changes, alterations, adaptations,
revisions, or improvements relating to and/or derivatives of a Parkedale
Product, Adjuvant Know-How of Parkedale, and/or an Influenza Product that accrue
or result from the activities of Parkedale and/or Parkedale's affiliates or
which are assignable to Parkedale and/or Parkedale's affiliates.
"Parkedale Product(s)" shall mean any preparations, product, or
pharmaceutical which is free of Novavax Adjuvant IP involved in or concerned
with the treatment or prevention of an influenza virus, such as Fluogen, or any
other purpose for which a Parkedale Product may be indicated.