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EXHIBIT 10.9
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AGREEMENT OF LICENSE TERMINATION,
STOCK REPURCHASE AND MUTUAL GENERAL RELEASE
This Agreement is made as of the 29th day of August, 1997, by and between,
on the one hand, Biopure Corporation ("Biopure"), a Delaware corporation, and
Biopure Europe Ltd. ("Licensor"), a Delaware corporation (collectively called
the "Biopure Parties" herein), and, on the other hand, X. Xxxxx Melsungen AG, a
German corporation ("Xxxxx").
RECITALS
A. Reference is made to the following agreements: the License Agreement
dated January 29, 1990 between Licensor and Xxxxx, as amended (the "License
Agreement"), the Investment Agreement dated January 29, 1990 between Biopure,
Xxxxx and other parties thereto, as amended (the "Investment Agreement"), the
Technical Assistance and Supply Agreement dated January 29, 1990 between Biopure
and Xxxxx, as amended (the "Technical Assistance Agreement") and the Amendment
and Rights Agreement dated May 26, 1988 between Biopure, Xxxxx and other parties
thereto (the "Rights Agreement"). All such agreements are herein referred to as
the "B&B Agreements".
B. Pursuant to the License Agreement, Xxxxx obtained an exclusive license
to make, sell and use "Royalty Products" (as defined in the License Agreement)
in the "Territory" (as defined in the License Agreement). Pursuant to the
Investment Agreement and its predecessor agreement dated August 7, 1987 and
other miscellaneous transactions, Xxxxx acquired 3,020,934 shares of Biopure
Class A Common Stock, par value $.01 per share (the "Shares").
C. Since 1987, Xx. Xxxxxxx Xxxxxxx has served on the Board of Directors of
Biopure as a nominee of Xxxxx.
D. Except as expressly provided herein, the parties hereto have agreed to
terminate, as between Xxxxx and the Biopure Parties, their respective rights,
duties and obligations under the B&B Agreements.
E. The parties hereto wish by the execution, delivery and performance of
this Agreement to compromise and settle all differences between and among them.
TERMS AND CONDITIONS
Now therefore, on the terms and subject to the conditions hereinafter set
forth, the Biopure Parties and Xxxxx hereby agree as follows:
1. Termination of License & Technical Assistance Agreement.
Effective upon the execution and delivery of this Agreement, Xxxxx and the
Biopure Parties hereby terminate the License Agreement and the Technical
Assistance Agreement and the same shall thereafter have no further force and
effect except with respect to Section 9 of the License Agreement and Section 4
of the Technical Assistance Agreement (collectively, the "Confidentiality
Requirements"), both of which sections shall remain in full force and effect.
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2. Return/Destruction of Information. Within thirty (30) days
following the execution and delivery of this Agreement:
(a) Xxxxx shall provide to Biopure the information listed in
Attachment 1;
(b) to the extent that any such information described in Attachment
I consists of copies delivered to Xxxxx by Biopure or if Xxxxx has other
confidential or proprietary information related to Biopure or its products,
Xxxxx shall either return or destroy such copies or information and certify
their destruction to Biopure; and
(c) in the event that after the execution and delivery of this
Agreement Xxxxx discovers in its possession additional materials described in
Subparagraphs 2(a) or 2(b) herein, Xxxxx will promptly deliver to Biopure, or
destroy, as applicable, such additional materials.
Notwithstanding the foregoing, Xxxxx may retain such originals or copies of the
foregoing as may be necessary or appropriate but all such information shall be
maintained by Xxxxx as confidential information pursuant to the Confidentiality
Requirements.
3. Termination of Rights and Duties Under Other Agreements. Xxxxx
hereby relinquishes all rights under the Investment Agreement and the Rights
Agreement and Xxxxx and Biopure hereby release each other from each of their
respective duties and obligations owed to such other party pursuant to the
Investment Agreement and Rights Agreement effective upon the execution and
delivery of this Agreement. However so long as Xxxxx is a shareholder of
Biopure, Biopure shall provide to Xxxxx monthly, quarterly and annual financial
statements (in the form provided to Biopure's directors) at the same time it
provides such information to its directors.
4. Royalties.
(a) For purposes of this Agreement, the following definitions
shall apply:
i) European Royalty. The term "European Royalty" shall
mean an amount equal to two percent (2%) of Net Sales and, without
duplication, two percent (2%) of all license or other fees received by
Biopure or any of its affiliates for any license to make, use or sell the
Royalty Products or Oxypure.
ii) Hemopure. The term "Hemopure" shall have the same
meaning as contained in the License Agreement and is known, in its current
form, as HBOC-201.
iii) Net Sales. The term "Net Sales" shall mean, without
duplication, the gross sales price of the Royalty Products or Oxypure sold
for use in the Territory, as invoiced by Biopure or any of its affiliates
or licensees (except for Royalty Products sold by Biopure for resale to
such licensees), less all cash or trade discounts, allowances, credits for
returns of defective merchandise or otherwise, any tax or other
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charge imposed directly on sales (including without limitation value added
taxes), and all charges which are customarily separately stated for
packing and transportation, insurance premiums, customs duties and all
other charges which are customarily separately stated. In the event of
sales by either Biopure or a licensee to an affiliate of such seller, the
term Net Sales shall be deemed to be the price at which Biopure or a
licensee is then selling to an unaffiliated person.
iv) Oxypure. The term "Oxypure" shall have the same
meaning as contained in the License Agreement.
v) Royalty Products. The term "Royalty Products" shall
have the same meaning as contained in the License Agreement.
vi) Stock Royalty. The term "Stock Royalty" shall mean
an amount equal to five percent (5%) of Net Sales and, without
duplication, five percent (5%) of all license or other fees not comprising
a royalty or other payment, however denominated, calculated on the basis
of actual sales, received by Biopure or any of its affiliates for any
license to make, use or sell the Royalty Products or Oxypure.
vii) Territory. The term "Territory" shall mean have the
same meaning as contained in the License Agreement; i.e., the following
countries: Andorra, Austria, Belgium, Denmark, Finland, France, Germany,
Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, Netherlands,
Norway, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, and the
United Kingdom.
(b) The European Royalty shall be paid to Xxxxx until aggregate
European Royalties paid equal $7,500,000 and shall be paid quarterly in arrears
in U.S. dollars within forty-five (45) days following the end of each calendar
quarter.
(c) The Stock Royalty payment shall be deposited into the Escrow
Account and held subject to the terms of the Escrow Agreement and this
Agreement, and the European Royalty shall be paid by check mailed, or by wire
transfer, to Xxxxx, at Xxxxx'x election.
(d) Within thirty (30) days following the end of each calendar
quarter, Biopure shall provide to Xxxxx a royalty statement, certified as true
and correct by an officer of Biopure, setting forth, with respect to the
preceding calendar quarter, the amount of Net Sales, identified by each seller
of the Royalty Products and Oxypure, and all license and other fees received by
Biopure or its Affiliates upon which the Stock Royalty or the European Royalty
is calculated.
(e) Biopure shall permit a reputable international firm of public
accountants selected by Xxxxx to inspect, examine and audit its books and
accounts at such times as Xxxxx may reasonably request (but not more frequently
than once each calendar year) for the purpose of verifying Net Sales, the
royalty statements and determining the correctness of royalty payments
hereunder. The cost of all inspections, examinations and audits shall be borne
by Xxxxx, except that the cost of any audit will be borne by Biopure if the
audit reveals an
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underpayment of royalty payments for any period in question of more than five
percent (5%) and any additional royalty payments shall be paid with five (5)
days of their determination plus interest at ten percent (10%) per annum.
5. Escrow Agreement. Simultaneously with the execution and delivery
of this Agreement, an "Escrow" shall be established by both Biopure and Xxxxx by
executing and delivering to the escrow agent (the "Escrow Agent") the escrow
agreement in the form of Exhibit A (the "Escrow Agreement").
(a) Concurrently therewith,
i) Xxxxx shall deliver to Escrow the certificates
representing the Shares together with signed, undated stock powers for
each certificate representing the Shares; and
ii) Biopure shall deliver to Escrow a cashier's check
for One Million Dollars ($1,000,000) and the Escrow Agent shall maintain
such funds, in trust for the benefit of Xxxxx, in an interest bearing
account (the "Escrow Account").
(b) Effective with each delivery by Biopure of funds to the
Escrow Agent for deposit into the Escrow Account, Biopure grants Xxxxx a
security interest in such funds and in the Escrow Account to secure Biopure's
purchase obligations pursuant to this Agreement. Biopure shall execute any
further documents necessary or appropriate to perfect Xxxxx'x security interest
in such funds.
(c) Xxxxx shall be entitled to vote, and shall receive all
dividends related to, those Shares being held by the Escrow Agent until their
delivery to Biopure.
6. Sale and Purchase of the Shares. Biopure agrees to purchase the
Shares pursuant to this Agreement and in compliance with the procedures set
forth in the Escrow Agreement and to pay to Xxxxx the sum of six million three
hundred thousand dollars ($6,300,000) payable as hereinafter set forth (the
"Stock Price"). In addition, Xxxxx shall be entitled to all earnings which are
earned with respect to the funds deposited into the Escrow (the "Earnings").
(a) Biopure shall deliver to the Escrow Agent for deposit into
the Escrow Account not less than one million dollars ($1,000,000) upon each
anniversary of the date of this Agreement, and, within forty-five (45) days
following each calendar quarter, an amount equal to the Stock Royalty until the
aggregate of such amounts deposited into the escrow, exclusive of all Earnings,
equal the Stock Price. In any event, the total amount of the Stock Price shall
be delivered by Biopure to the Escrow Agent for deposit into the Escrow Account
not later than the fifth anniversary of the date of this Agreement. Biopure
shall have the right at any time to make additional payments to the Escrow and
to accelerate the purchase of the Shares upon the deposit with the Escrow of the
entire unpaid Stock Price.
(b) Xxxxx shall have the right, at any time and from time to
time, to complete the sale of a portion of the Shares in Escrow at a price per
share equal to $2.0854 in
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accordance with Section 3(b) of the Escrow Agreement.
(c) When the amount on deposit in the Escrow Account equals
$6,300,000 (or $6,3000,000 less $2.0854 times each Share previously delivered
to, and paid for by, Biopure) exclusive of any Earnings, the sale of the all of
the Shares (or the balance of the Shares if any have been previously delivered
to Biopure) shall be deemed to have been consummated.
(d) When the sale of any of the Shares is consummated
hereunder, the certificates for such Shares and the related stock powers shall
be delivered by the Escrow Agent to Biopure, and all right, title and interest
in and to the Shares shall thereafter vest in Biopure and the purchase price and
all Earnings shall be paid by the Escrow Agent to Xxxxx.
7. Taxation Indemnity.
(a) If Xxxxx provides Biopure and the escrow agent with an
executed ownership certificate (U.S. Internal Revenue Service Form 1001), then
(i) neither Biopure nor the escrow agent shall withhold any tax pursuant to
Section 1441 of the Internal Revenue Code (the "Code") from any payment to be
made to Xxxxx pursuant to Section 6 herein and the Escrow Agreement; and (ii)
Biopure shall indemnify and hold harmless Xxxxx from and against any liability
or claim for income tax that may be asserted by the Internal Revenue Service
against Xxxxx by reason of said payments whether such claim is based upon
Sections 881 (with respect to interest income only), 483, 1273 or 1274, as the
same now exists or may hereinafter be amended, or any corresponding or successor
provision.
(b) This covenant shall terminate if Xxxxx: (i) assigns its
beneficial ownership interest in the Purchase Agreement or (ii) fails to qualify
for a withholding exemption under the U.S.-German tax treaty or (iii) fails to
renew the ownership certificate upon its expiration.
8. Representations and Warranties. The parties represent and
covenant as follows:
(a) Xxxxx represents and acknowledges that it has been a
shareholder of Biopure since 1987, that in such capacity and through
representation on the Biopure Board of Directors it has been furnished with the
information made available by Biopure to its shareholders and directors and that
it has had the opportunity to obtain from Biopure or from other sources
sufficient information to enable it to evaluate the terms of this Agreement.
Xxxxx further acknowledges the non-public character of certain of the foregoing
information and shall maintain the confidentiality of any such information
except to the extent it is made publicly available.
(b) Xxxxx hereby represents that the Shares constitute all of
the shares of stock of Biopure held or beneficially owned by Xxxxx.
(c) Xxxxx hereby represents and warrants that the signatory of
this Agreement on behalf of Xxxxx is duly authorized to execute and deliver this
Agreement on
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behalf of Xxxxx and that the execution, delivery and performance by Xxxxx of
this Agreement have been duly authorized by all necessary corporate action on
the part of Xxxxx. The Biopure Parties hereby represent and warrant that the
signatory of this Agreement on their behalf is duly authorized to execute and
deliver this Agreement on behalf of Biopure and the Licensor and that the
execution, delivery and performance by Biopure and the Licensor of this
Agreement have been duly authorized by all necessary corporate action on the
part of Biopure and the Licensor.
(d) Upon the date of each delivery of funds to the Escrow
Agent for deposit into the Escrow Account, the Biopure Parties, and each of them
jointly and severally, represent and warrant that:
i) Biopure is duly organized, validly existing and in
good standing under the laws of the jurisdiction of its incorporation and
is solvent, able to meet its debts as they mature and is able under law to
redeem the Shares hereunder; and
ii) This Agreement and the Escrow Agreement have been
duly authorized and validly executed and delivered and the consummation of
the transactions contemplated hereunder and under the Escrow Agreement do
not violate either Biopure Party's charter, or any agreement to which
either is a party or constitute a violation of any law, regulation or
directive to which they are subject.
9. Opinion of Counsel. Biopure shall cause counsel, reasonably
acceptable to Xxxxx, to provide its opinion to Xxxxx that Biopure has duly
authorized, executed and delivered this Agreement, that the execution and
delivery of this Agreement and the consummation of the transactions contemplated
hereby will not violate or conflict with any law, statute, regulation or order.
10. Mutual Release. The Biopure Parties, on their own respective
behalf and on behalf of their respective executors, administrators, legal or
personal representatives, affiliates, successors or assigns, on the one hand,
and Xxxxx, on its own behalf, and on behalf of its affiliates, successors and
assigns, on the other hand, do hereby mutually and reciprocally remise, release
and forever discharge each other and the respective administrators, executors,
legal or personal representatives, successors and assigns of each other, of and
from all, and all manner of, actions, causes of action, suits, debts, dues, sums
of money, accounts, reckonings, covenants, contracts, controversies, agreements,
promises, commissions, damages, judgments, executions, claims, third-party
claims and demands whatsoever in law or in equity that they or either of them
ever had, now has, or that they or their administrators, executors, legal or
personal representatives, successors and assigns hereafter can or may have, by
reason of any act, omission, matter, cause or thing whatsoever occurring at any
time prior to the execution of these presents, whether known or unknown,
suspected or unsuspected, foreseen or unforeseen, liquidated or unliquidated,
matured or unmatured. This release does not affect any rights or relationships
between the Biopure Parties inter se. Notwithstanding anything in this Agreement
to the contrary, the provisions of this Section shall not apply to the rights
and duties of the parties hereto which are contained in this Agreement or the
Escrow Agreement or limit the respective rights of the parties hereto to enforce
the terms of this
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Agreement or the Escrow Agreement.
11. No Third Party Beneficiaries. Except as provided in Section 9,
no person other than the parties signatory to this Agreement shall be deemed a
beneficiary of this Agreement.
12. Governing Law. This Agreement shall be construed in accordance
with the laws of the Commonwealth of Massachusetts applicable to agreements made
in and wholly to be performed within the Commonwealth of Massachusetts.
13. Entire Agreement. This Agreement together with Exhibit A hereto
and the Escrow Agreement represent the entire agreement of the parties with
regard to the subject matter hereof and thereof, and may not be altered or
amended except by a writing signed by the parties hereto or their duly
authorized representatives. There are no representations, promises,
understandings or agreements made by or to any of the parties regarding the
subject matter of this Agreement and the Escrow Agreement which are not
expressly set forth herein or therein. Each party has sought and obtained the
advice of its respective counsel and is not relying upon any promises,
representations or advice of the opposing party or their counsel in entering
into this Agreement.
14. Subject Headings. The subject headings of the paragraphs of this
Agreement are included solely for purposes of convenience and reference only,
and shall not be deemed to explain, modify, limit, amplify or aid in the
meaning, construction or interpretation of any of the provisions of this
Agreement.
15. Notices. All written notices or other written communications
required under this Agreement shall be deemed properly given when provided to
the parties entitled thereto by personal delivery (including delivery by
services such as messengers and airfreight forwarders), by electronic means
(such as by electronic mail, telex or facsimile transmission) or by mail sent
registered or certified mail, postage prepaid at the following addresses (or to
such other address of a party designated in writing by such party to the
others):
Any Biopure Party:
c/o Xxxx X. Xxxxxx
Biopure Corporation
00 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx 00000
Telefax No. (000) 000-0000
Xxxxx:
X. Xxxxx Xxxxxxxxx XX
Xxxx-Xxxxx-XxxxXx 0
X-00000 Xxxxxxxxx, Xxxxxxx
Attn: Hr. Xxxxx Xxxxx,
General Counsel
Telefax No. 011-49-5661-71-1551
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All notices given by electronic means shall be confirmed by delivering to the
party entitled thereto a copy of said notice by certified or registered mail,
postage prepaid, return receipt requested. All written notices shall be deemed
delivered and properly received five (5) days after mailing the notice, in the
case of written notice given by mail, or upon the earlier of two (2) days after
the mailing of the confirmation notice or upon actual receipt of the notice
provided by personal delivery or electronic means
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
duly executed and delivered by persons authorized as of the date first set forth
above.,
X. XXXXX MELSUNGEN AG
/s/ Xxxxxx X. Xxxxxxxx /s/ Xxxxxxx Xxxxxxx
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by Xxxxxx X. Xxxxxxxx, by Xxxxxxx Xxxxxxx,
Member of the Board Member of the Board
BIOPURE CORPORATION BIOPURE EUROPE LTD.
/s/ Xxxx X. Xxxxxx /s/ Xxxx X. Xxxxxx
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by Xxxx X. Xxxxxx, President by Xxxx X. Xxxxxx, President
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Attachment I
X. XXXXX DOCUMENTATION
The information required from X. Xxxxx falls into two categories: (1) existing
documentation which based upon review of our files, must be transferred to
Biopure to complete the dossiers on all three German trials (i.e.,
XX-0000-XXX-XX-X-0000/Xxxx/Xxxxxxx, -0000/Xxxxxxx/Xxxxxxx am Xxxx, and
-0153/Jena/Xxxxxxxx); and (2) machine-readable data sets, analyses, and/or
reports, which may be in various stages of completion.
Existing Documentation.
1. Original Case Report Forms ("CRFs") from the high-dose Koln group
(1.2g/kg), expected numbers 1301-1312.
2. Original versions or copies of all existing site correspondence (all
trials).
3. Original versions or copies of all existing Ethics Committee
correspondence (trial-0153 only).
4. Original version or copies of all monitoring reports (all trials).
5. Drug accountability records (all trials).
6. If available, clinical laboratory validation documentation (all trials).
NOTE: With the exception of the CRFs, these documents are almost certainly
written in German. Although it would be nice to have, there is no reason
to demand translation prior to transfer.
Analyses and Reports. To the extent they exist, we need all these items for all
trial; if not all are available for a given trial, we need all that are complete
at present:
1. SAS-readable data sets, along with annotated CRFs, database structure,
dictionaries, audit trail, and other details of quality assurance level.
2. Individual patient listings and PROC UNIVARIATE distributions.
3. Summary data tables, plus English version of the statistical analysis
plan.
4. Graphical displays.
5. Draft Final Study Report, in English.
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The following information should be provided by or returned by X. Xxxxx or
documented that copies provided to them have been confidentially destroyed:
1. All copies of U.S. IND submissions/presentations/communications
(BB-IND-2935) provided.
2. All copies, documentation, CRFs, data tables and reports for clinical
studies using HBOC-201 in Europe under X. Xxxxx'x direction.
3. All correspondence and/or submissions regarding HBOC-201 with any
regulatory authority, agency or government.
4. All correspondence and/or submissions to any institutional review board
(or equivalent) regarding HBOC-201.
5. All documents, data, or reports regarding any preclinical study conducted
by or under the direction of X. Xxxxx including studies done by
independent investigators.
6. All publications or pending publications regarding the product resulting
from work sponsored by or known to X. Xxxxx.
7. All reports or documentation regarding manufacturing, importation, or use
of the product in Germany, including reports/documentation/communications
regarding use of Cambridge manufactured product.
8. Information regarding the manufacturing and testing or product provided to
X. Xxxxx by Biopure
Xxxxxxxxx - X. Xxxxx Requested Documents
1. BSE- Notification of the "BfArM" dated 28.03.96: Hemopure (HBOC-201)
Classification of the Risk Relevant Characteristics"
2. Other communications with the BfArM concerning viral or prior safety
issues.
3. Letter and attached data concerning Oxyglobin stability, addressed from
Xxxxxx Xxxxxxxxx to Johannes Bottrich, dated July 22, 1996.
4. Procedure for bovine IgG ELISA assay, sent form Xxxxxx Xxxxxxxxx to
Johannes Bottrich, dated September 25, 1991.
5. Research and Development report #RDR-005, "Get Permeation Chromatography
of Hemopure coupled with Laser Light Scattering or intrinsic Viscosity
Detection for Determination of Protein Molecular Weight," sent from
Xxxxxxxxx Xxxxxx to Xxxxxxxx Bottrich, dated July 11, 1991.
Biopure Reports:
1. "Validation of Clearance of Scrapie Agent in HBOC Production Process,"
Xxxxxxx Xxxxx, Xxxxxx X Xxxxxxxxx, W. Xxxxxxx Xxxxx, RDR-0113, 1-22
(1996).
2. "Determination of Viral Clearance of Polymerized Bovine Hemoglobin
Production Process," Xxxxxxx Xxxxx, Xxxxxx X. Xxxxxxxxx, W. Xxxxxxx Xxxxx,
RDR-087, 1-60 (1996).
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