Exhibit 10.31
PORTIONS OF THIS AGREEMENT HAVE BEEN OMITTED FROM THIS AGREEMENT AND FILED
SEPARATELY WITH THE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
TERMINATION AGREEMENT
This Termination Agreement, dated March 20, 1998 (the "Effective
Date"), is entered into among NaPro BioTherapeutics, Inc., a Delaware
corporation ("NaPro"), IVAX Corporation, a Florida corporation ("IVAX"), Xxxxx
Xxxxxx Pharmaceuticals, Inc., a Florida corporation ("BNP"), and D&N Holding
Company, a Delaware corporation ("D&N"). NaPro shall be referred to herein as a
"party" to this Agreement and IVAX, BNP and D&N shall collectively be referred
to herein as a "party" to this Agreement.
RECITALS
IVAX is the parent company of BNP and D&N. NaPro and BNP are parties to
an agreement, dated June 7, 1993, as amended April 12, 1994 and January 25,
1996, relating to the manufacture, marketing and distribution of paclitaxel (the
"Prior Agreement"), and NaPro and D&N are parties to a Subscription Agreement
dated as of June 7, 1993, a Stockholders Agreement dated as of June 7, 1993, a
Registration Agreement dated as of June 7, 1993, a Subscription Agreement dated
as of April 12, 1994, and a Registration Rights Agreement dated as of April 12,
1994 (collectively, the "Related Agreements"). NaPro and BNP desire to terminate
the Prior Agreement and their respective rights and obligations under such
agreement on the terms and conditions of this Agreement, and NaPro and D&N
desire to terminate the Related Agreements and their respective rights and
obligations under such agreements on the terms and conditions of this Agreement
so that this Agreement comprises the entire agreement between the parties.
AGREEMENT
In consideration of the Recitals and the mutual promises set forth in
this Agreement, NaPro, IVAX, BNP and D&N agree as set forth below.
1. DEFINITIONS. In this Agreement, the following terms when used with
initial capital letters shall have the meanings set forth below:
(a) "Affiliate" shall mean with respect to a Person, any other
Person controlling controlled by or under common control with such Person. For
the purposes of this definition, "control" (including, with the correlative
meanings, "controlling", "controlled by" and "under common control with"), with
respect to any Person means the direct or indirect ownership of more than fifty
percent (50%) of the outstanding voting or equity interest in such Person.
(b) "BNP Formulation" shall mean the formulation of paclitaxel
injection presently described in *[TEXT REDACTED]
(c) "BNP Territory" shall mean the United States, Canada,
Europe (including the European Union, Eastern Europe and CIS), Argentina, Chile,
Uruguay, Brazil, China and Taiwan.
(d) "CIS" shall mean the Commonwealth of Independent States,
or any successor state or states.
(e) "Confidential Information" shall have the meaning set
forth in Section 7(a) of this Agreement.
(f) "Dollars or $" shall mean U.S. Dollars.
(g) "Exclusive Faulding Territory" shall mean Australia, New
Zealand, Singapore, Malaysia, Thailand, the Philippines, Indonesia, India, Hong
Kong and South Korea.
(h) "Ex works" shall mean such delivery term as defined in the
current edition of the International Chamber of Commerce publication
"Incoterms".
(i) "Faulding" shall mean X.X. Xxxxxxxx & Co., Limited.
(j) "FDA" shall mean the United States Food and Drug
Administration or any successor body.
(k) "GMP" shall mean good manufacturing practice as required
by FDA regulations.
(l) "IND" shall mean the application with the regulatory
authority required in a particular country in relation to a product in order
that such product may be used for investigational clinical use with human
subjects notwithstanding that the local name for such an application may be
different.
(m) "Loss" shall mean all loss, damage, cost and expense,
including reasonable attorneys' fees, but shall exclude claims for lost profits
and other consequential losses.
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* The portion of this agreement marked "*[TEXT REDACTED]" indicates that such
portion has been omitted from this agreement and filed separately with the
Commission pursuant to a Confidential Treatment Request.
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(n) "NaPro Patent" shall mean NaPro's U.S. patent application
entitled *[TEXT REDACTED] and any and all divisional applications or
continuations of such patent application and any patents issued thereupon and
the equivalent thereof in all countries of the BNP Territory.
(o) "Paclitaxel" shall mean the chemical entity of the formula
set forth in Exhibit G attached hereto.
(p) "Person" shall mean any company, corporation, partnership,
trust, or any other legal entity.
(q) "Product" shall mean Paclitaxel which meets the
Specification.
(r) "Registration" shall mean the registration with the
regulatory authority required in a particular country in relation to a product
in order that such product can be marketed for human use to the general public
in that country.
(s) "Reserved Patents" shall mean all of the patents and
patent applications which NaPro owns or controls as of the Effective Date (other
than the NaPro Patent) relating to the manufacture, finishing or pharmaceutical
uses of Paclitaxel, and any substitute, continuation, continuation-in-part,
division, reissue, renewal, extension or addition thereof, and any foreign
applications corresponding to any of such patents and patent applications and
any patents which issue in any country based on any of said patent applications.
(t) "Specification" shall mean the specification for the
Product set forth on Exhibit F.
(u) "Third Party" shall mean a Person other than BNP, NaPro,
or any Affiliate of BNP or NaPro.
2. TERMINATION OF PRIOR AGREEMENT AND RELATED AGREEMENTS. As of the
Effective Date, the Prior Agreement and the Related Agreements are terminated in
all respects and of no further force or effect and, notwithstanding anything in
the Prior Agreement or the Related Agreements to the contrary (including but not
limited to Section 6.3 of the Prior Agreement), no party shall have any further
rights or obligations under such agreements.
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The portion of this agreement marked "*[TEXT REDACTED]" indicates that
such portion has been omitted from this agreement and filed separately with the
Commission pursuant to a Confidential Treatment Request.
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3. RELEASE. On the Effective Date, NaPro agrees to execute and deliver
to IVAX, BNP and D&N the form of release attached hereto as Exhibit A-1 and
IVAX, BNP and D&N each agree to execute and deliver to NaPro the form of release
attached hereto as Exhibit A-2.
4. PATENT LICENSE.
(a) GRANT OF LICENSE. Subject to Sections 4(b), 4(c) and
11(i), NaPro hereby grants to BNP a non-exclusive, royalty-free license under
the NaPro Patent to manufacture, use, sell, offer for sale and import paclitaxel
injection in the BNP Territory, until the expiration of the NaPro Patent in each
country of the BNP Territory (the "License").
(b) CONSIDERATION FOR LICENSE. In consideration of the License
and the other rights granted to BNP pursuant to the terms of this Agreement:
(i) Within two (2) business days after the Effective
Date, BNP shall make a payment to NaPro equal to six million seventy thousand
dollars ($6,070,000) by wire transfer of immediately available funds to an
account designated by NaPro; provided, however, that two million dollars
($2,000,000) of such amount shall be placed in escrow (the "Escrow Payment") and
transferred to NaPro in accordance with the provisions of Section 6(b)(iv)
hereof;
(ii) Within five (5) business days after NaPro files
its 1997 annual report on Form 10-K and delivers a copy of such report to BNP,
BNP shall transfer to NaPro one million one hundred twenty six thousand three
hundred ninety eight (1,126,398) shares of NaPro common stock ("Common
Stock"),which transfer shall be effected by the delivery to NaPro of the stock
certificate or certificates representing such shares together with appropriately
executed stock powers;
(iii) Subject to clause (v) below, within two (2)
business days after NaPro notifies BNP of the issuance of the NaPro Patent in
the United States, which notice shall include proof of issuance, BNP shall make
a payment to NaPro equal to three million seven hundred fifty thousand dollars
($3,750,000) by wire transfer of immediately available funds to an account
designated by NaPro; and
(iv) Subject to clause (v) below, within two (2)
business days after NaPro notifies BNP of the grant of the NaPro Patent in the
European Patent Office, which notice shall include proof of grant, BNP shall
make a payment to NaPro equal to two million six hundred ten thousand dollars
($2,610,000) by wire transfer of immediately available funds to an account
designated by NaPro.
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(v) BNP's obligation to make the payments set forth
in 4(b)(iii) and 4(b)(iv) shall be subject to the following conditions: (1) the
License is then in full force and effect and (2) the BNP Formulation would
infringe the claims of the issued patent, provided, however, that if BNP
believes that the BNP Formulation does not infringe upon the claims of the
issued patent and elects not to pay the fee as set forth in (iii) or (iv) above,
then the License shall no longer include such patent.
(c) NO ASSIGNMENT OR TRANSFER. The License is personal to BNP
and may not be assigned or transferred or sublicensed in any manner, other than
to an Affiliate of BNP that has agreed in writing to be bound by the terms and
conditions of this Agreement, without the prior written consent of NaPro;
provided that this clause shall in no way restrict the ability of BNP to (1)
appoint marketing partners or distributors for paclitaxel injection or (2)
subcontract with Third Parties to manufacture paclitaxel injection for BNP or
BNP's marketing partners and distributors. Notwithstanding the foregoing, in the
event that (i) BNP or any Affiliate of BNP shall appoint any of the companies
listed on Exhibit E attached hereto as a marketing partner or distributor of
paclitaxel injection, or (ii) BNP shall become an Affiliate of any of the
companies listed on Exhibit E attached hereto, then NaPro shall have the right
to terminate the License upon written notice to BNP, and upon such termination
by NaPro the License shall be of no further force or effect; provided that BNP
may enter into any other type of arrangement with such companies, including
without limitation, arrangements for the supply of Paclitaxel or arrangements
for the contract manufacture of paclitaxel injection.
(d) PROSECUTION OF NAPRO PATENT. NaPro shall, through counsel
of its own choosing and at its own expense, take all reasonable steps to file,
prosecute and maintain the NaPro Patent in all countries within the BNP
Territory where such patent is pending, whether by means of patent cooperation
treaties or otherwise. NaPro agrees to promptly provide BNP's patent counsel, in
such period of time as shall accord BNP and its patent counsel a reasonable
period of time for review and comment to the extent possible, given filing
deadlines, with a copy of all filings related to the NaPro Patent in such
countries prior to the time any such filings are made. To the extent possible
given filing deadlines, BNP and its patent counsel shall be provided with an
opportunity to comment on all such filings and NaPro shall consider all
reasonable comments made by BNP and its patent counsel received in time for such
comments to be incorporated into such filings. In addition to the foregoing,
NaPro agrees to promptly provide BNP's patent counsel with copies of all papers,
specifications, amendments, replies, official actions and other documents and
correspondence with the patent offices of such countries relating to the filing,
prosecution and maintenance of the NaPro Patent, including, without limitation,
copies of each patent application filed in the patent offices of such countries
and each patent that issues thereon with respect to the NaPro Patent. Neither
BNP nor any of its Affiliates shall have the right to enforce the NaPro Patent.
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(e) RESERVED PATENTS. Other than the NaPro Patent, BNP
acknowledges and agrees that nothing in this Agreement grants BNP or any of its
Affiliates any rights under or any patents or patent applications owned now or
in the future by NaPro or any of its Affiliates, including without limitation
the Reserved Patents.
5. OUTSTANDING RECEIVABLE. BNP shall make a payment to NaPro equal to
one million dollars ($1,000,000) in full satisfaction of all amounts due to
NaPro under the Prior Agreement, including all outstanding unpaid invoices for
Product. Such payment shall be made within two (2) business days after the
Effective Date by wire transfer of immediately available funds to an account
designated by NaPro.
6. SUPPLY OF PRODUCT.
(a) CANCELLATION OF PURCHASE ORDERS AND FORECASTS. All
outstanding purchase orders for Product and forecasts under the Prior Agreement
are canceled in all respects as of the Effective Date.
(b) SUPPLY OF PRODUCT.
(i) DELIVERY OF PRODUCT. NaPro shall deliver a total
of *[TEXT REDACTED] of Product to BNP in accordance with the delivery schedule
attached hereto as Exhibit B. NaPro acknowledges that (i) BNP has paid for and
is the owner of *[TEXT REDACTED] of such Product, (ii) that the remaining *[TEXT
REDACTED] of such Product has been processed to a semi-finished state
exclusively for BNP, (iii) that BNP has already paid to NaPro *[TEXT REDACTED]
for *[TEXT REDACTED] of such semi-finished Product and that BNP is the owner of
such semi-finished Product; and (iv) that BNP has already paid to NaPro *[TEXT
REDACTED] for *[TEXT REDACTED] of such semi-finished Product, which price
includes the price for converting such semi-finished Product to finished
Product, and that BNP is the owner of such Product. Pending delivery of such
Product to BNP, NaPro agrees to maintain such Product segregated from its other
inventory and to identify such Product as owned by BNP, in a manner reasonably
acceptable to BNP. Upon reasonable notice to NaPro, BNP shall have the right to
inspect such Product during normal business hours to ensure NaPro's compliance
with this paragraph. For purposes of notifying NaPro's creditors of BNP's
ownership of such Product, on the Effective Date NaPro will execute and deliver
to BNP a UCC-1 financing statement in a form reasonably acceptable to BNP. NaPro
shall also take such further actions and execute such further documents as BNP
may reasonably request to secure BNP's interest in such Product.
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The portion of this agreement marked "*[TEXT REDACTED]" indicates that
such portion has been omitted from this agreement and filed separately with the
Commission pursuant to a Confidential Treatment Request
6
(ii) FORCE MAJEURE. NaPro shall not be liable to BNP
in the event that performance of its supply obligations hereunder shall be
prevented by events of force majeure, including without limitation acts of God,
acts of government, accident, fire, delay or destruction of means of transport
or other disaster, but NaPro shall use reasonable efforts to avoid or remove the
cause of such nonperformance and shall continue performance hereunder with the
utmost dispatch whenever such cause is removed.
(iii) PAYMENT FOR PRODUCT. The first *[TEXT REDACTED]
of Product delivered by NaPro pursuant to Section 6(b)(i) shall require no
additional payment by BNP. For the remaining *[TEXT REDACTED] of Product to be
delivered to BNP pursuant to Section 6(b)(i), the ex works price to convert such
Product from semi-finished to finished state shall be *[TEXT REDACTED]. NaPro
shall invoice such Product upon delivery ex works Boulder (or other NaPro
Facility) and payment for the Product shall be due thirty (30) days net.
Payments shall be made by wire transfer to the account specified by NaPro from
time to time.
(iv) RELEASE FROM ESCROW. In addition to the payments
for Product to be made by BNP pursuant to Section 6(b)(iii), upon delivery of
Product to BNP in the quantities set forth on Exhibit B, BNP shall release from
escrow the amount of money set forth on such Exhibit B corresponding to such
Product quantity. In the event that NaPro fails to supply Product according to
such delivery schedule, then BNP may issue NaPro a notice of default of this
supply obligation. If (a) ninety (90) days following such notice, NaPro remains
in default, or (b) NaPro is unable to supply Product due to a force majeure
event that lasts for a period of six (6) months, BNP may cancel the remainder of
scheduled deliveries. BNP shall be entitled to immediately recover the remaining
escrow amount, and NaPro shall, within two business days after cancellation of
the remaining delivery schedule, pay to BNP any Loss not covered by the
remaining escrow amount. The maximum Loss which NaPro shall be responsible for
in connection with failure to supply Product as set forth in Exhibit B shall be
*[TEXT REDACTED] not delivered.
(v) MANUFACTURE OF PRODUCT. NaPro shall manufacture
or have Manufactured Product according to the Specification and in accordance
with all applicable United States laws and regulations, including GMP
regulations as applicable. NaPro warrants and guarantees that the Product shall
meet the Specification. With each lot of Product supplied by NaPro to BNP,
whether manufactured by NaPro or otherwise, NaPro shall submit to BNP an
appropriate certificate of analysis confirming compliance with the
Specification.
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The portion of this agreement marked "*[TEXT REDACTED]" indicates that
such portion has been omitted from this agreement and filed separately with the
Commission pursuant to a Confidential Treatment Request
7
(vi) INSPECTIONS. NaPro shall, upon reasonable notice
and at reasonable times, but not more often than once a year (except if a
deficiency or defect or other similar problem is detected, in which event
reinspections may be conducted as often as reasonably necessary to ascertain
that such deficiency or defect or other such problem has been cured), afford
BNP's Quality Assurance and Quality Compliance representatives (which are not
manufacturing or production personnel) (hereinafter referred to "Q&A
Representatives") access to NaPro's premises where the Product manufactured for
BNP is being tested and manufactured and make available books, records and
documents as reasonably required to ascertain that the Product is being
manufactured in accordance with the Specification and all applicable United
States laws and regulations, including without limitation, GMP regulations.
During such inspections, NaPro shall permit BNP's Q&A Representatives to contact
and question the quality assurance and quality compliance personnel of NaPro for
the sole purpose set forth in the preceding sentence. NaPro shall promptly
notify BNP of any inspections by any health regulatory authorities of the
premises where the Product is being manufactured and shall promptly provide BNP
with copies of all correspondence, reports, notices, findings and other material
pertinent to such inspections or otherwise relating to the production of
Paclitaxel, as they are received or produced by or on behalf of NaPro from or to
the FDA or any other federal, state or foreign governmental or regulatory
authority. Without limiting the generality of the foregoing, NaPro shall
promptly provide BNP with copies of all regulatory letters, warning letters, and
letters of adverse findings received by NaPro or any of its agents relating to
the production, use or sale of Paclitaxel supplied to BNP, including without
limitation FDA Form 483. For all materials provided to BNP pursuant to this
Section 6(b)(vi), those portions of materials that contain information that
discloses NaPro intellectual property or trade secrets (including, without
limitation, information relating to the production and manufacture of
Paclitaxel) shall be redacted and not provided to BNP; provided, however, that
complete full copies of such materials without such redaction shall be made
available for review (but not copying) by BNP's Q&A Representatives at NaPro's
offices.
(vii) SHIPPING. NaPro shall deliver the Product Ex
works NaPro's manufacturing facility. NaPro shall cooperate with BNP to ship the
Product to BNP or the finisher designated by BNP or to such other location as
BNP's purchase order shall specify, at BNP's expense. Risk of loss to the
Product shall pass upon delivery to BNP's common carrier. BNP shall be
responsible for obtaining any necessary import or export licenses to ship the
Product. Following delivery of the Product to BNP, BNP shall forthwith check a
representative sample of the Product for conformity to the Specification and
inform NaPro by written notice of any damaged or otherwise defective Product
supplied by NaPro hereunder and shall, upon the request of NaPro, return the
damaged or defective Product to NaPro and the reasonable cost of return shall be
borne by NaPro and NaPro shall as soon as practicable replace the damaged or
defective Product free
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of any additional charges, provided that such damage or defect shall not have
been caused by BNP or the shipper to BNP.
(viii) ADDITIONAL PRODUCT. At the request of BNP,
NaPro shall manufacture and sell to BNP up to *[TEXT REDACTED] of Product
containing *[TEXT REDACTED] to be mutually agreed upon by NaPro and BNP at a
price to be mutually agreed upon between the parties.
(ix) *[TEXT REDACTED]. NaPro shall continue its
ongoing *[TEXT REDACTED] for Product and provide BNP with the results of such
study, and BNP shall maintain the results of such study in confidence pursuant
to the provisions of Section 7 hereof.
(c) RESTRICTION ON SALE OF PRODUCT. Without the prior written
consent of NaPro: (i) BNP shall not sell any product containing Paclitaxel
supplied by NaPro within the Exclusive Faulding Territory, and (ii) during the
time in which NaPro is a supplier of Product to BNP pursuant to this Agreement
or the License is in full force and effect, BNP shall not sell paclitaxel
injection in the Exclusive Faulding Territory.
(d) RIGHT OF REFERENCE. BNP and, to the extent necessary, its
marketing partners and distributors, shall have the right to reference NaPro's
Drug Master File in connection with the sale of paclitaxel injection containing
Product supplied by NaPro under the Prior Agreement or this Agreement. This
right shall terminate upon the completion of BNP's sale of paclitaxel injection
containing Product supplied by NaPro. In the United States, Canada, and the
European Union, BNP and its Affiliates shall endeavor to sell paclitaxel
injection containing NaPro Paclitaxel prior to selling Paclitaxel supplied by
other sources. While this right is in effect, NaPro shall maintain its Drug
Master File in the United States, Canada and the European Union. NaPro will
consult with and assist BNP as reasonably requested in interactions with
regulatory authorities within the United States, Canada, and the European Union
in connection with NaPro's Drug Master File and BNP's pending applications for
Registration in such countries. NaPro shall further provide such letters and
documents to such regulatory authorities as are required to respond to the
questions and comments of such regulatory authorities regarding NaPro's Drug
Master File and BNP's pending applications for Registration in such countries as
will enable BNP to make reference to NaPro's Drug Master File in support of
BNP's submissions or filings with said authorities and as will enable BNP to
respond to questions and comments of such regulatory authorities regarding the
portions of such applications which contain information provided by NaPro, to
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The portion of this agreement marked "*[TEXT REDACTED]" indicates that
such portion has been omitted from this agreement and filed separately with the
Commission pursuant to a Confidential Treatment Request
9
the extent such documents or information are in the possession of NaPro. BNP
shall pay NaPro's out-of-pocket costs for such assistance. NaPro shall not make
any amendments to its Drug Master File which would require an amendment to any
of BNP's regulatory applications or otherwise require BNP to make any filing
with any regulatory authority until after such amendment has been approved or
such filing made. BNP shall use its reasonable best efforts to obtain such
approvals or make such filings in a timely manner.
7. CONFIDENTIAL INFORMATION.
(a) CONFIDENTIAL INFORMATION. NaPro and BNP have disclosed
information to each other pursuant to the Prior Agreement and NaPro may disclose
information to BNP pursuant to this Agreement which the disclosing party
considers to be confidential ("Confidential Information"). Such Confidential
Information shall expressly include *[TEXT REDACTED] and any information
provided by any party to the other pursuant to filing an IND or Registration,
including, without limitation, clinical and pre-clinical data, including
information received from Faulding. Confidential Information shall not include
any information which:
(i) Is now, or hereafter becomes, through no act or
failure to act on the part of the receiving party, generally known or available
to the public;
(ii) Is known to the receiving party at the original
time of disclosure as evidenced by written documents in the possession of the
receiving party;
(iii) Is hereafter furnished to the receiving party
by a Third Party, as a matter of right and without restriction on disclosure;
(iv) Is disclosed by the receiving party with the
written approval of the disclosing party; or
(v) Is independently developed by a party without use
of the other party's Confidential Information, as evidenced by the developing
party's writte records.
(b) RESTRICTION ON DISCLOSURE AND USE. As of the Effective
Date, except as provided below, neither party shall disclose any Confidential
Information received from the other party to any Third Party or use any
Confidential Information received from the other party for any purpose.
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The portion of this agreement marked "*[TEXT REDACTED]" indicates that
such portion has been omitted from this agreement and filed separately with the
Commission pursuant to a Confidential Treatment Request
10
(c) RETURN OF CONFIDENTIAL INFORMATION. Within forty-five (45)
days after the Effective Date, NaPro shall (1) deliver to BNP all Confidential
Information received from BNP that is in tangible form, (2) destroy all such
Confidential Information that is in electronic form, and (3) destroy all
documents created by NaPro or its agents which contain or such Confidential
Information. Within forty-five (45) days after the Effective Date, BNP shall (A)
deliver to NaPro all Confidential Information received from NaPro that is in
tangible form, (B) destroy all such Confidential Information that is in
electronic form, and (C) destroy all documents created by BNP or its agents
which contain or incorporate such Confidential Information, except for the
Confidential Information specified on Exhibit C-1 ("BNP Retained Information").
Notwithstanding the foregoing, outside counsel for each of NaPro and BNP may
retain one copy of Confidential Information received from the other party solely
for purposes of maintaining a record of the actual Confidential Information
returned pursuant to this Agreement and each party's compliance with the
provisions of this Agreement. Within five (5) business days after a party is
required to return Confidential Information to the other pursuant to this
Agreement, such party shall deliver to the other a certificate of compliance
with its obligations under this Section 7 in the form attached hereto as Exhibit
C-2 in the case of NaPro, and Exhibit C-3 in the case of BNP, and signed by the
persons listed on Exhibits C-2 in the case of NaPro and Exhibit C-3 in the case
of BNP.
(d) RIGHT TO USE AND RETAIN CERTAIN INFORMATION.
(i) NaPro shall have no right to retain or use
Confidential Information of BNP.
(ii) BNP shall have the right to use BNP Retained
Information, but only for purposes of formulation, obtaining Registrations
within the BNP Territory, and manufacturing finished paclitaxel injection (but
not bulk Paclitaxel). BNP shall under no circumstances use any Confidential
Information, including any Retained Information, for the purposes of
manufacturing or having manufactured bulk Paclitaxel. BNP shall have the right
to use Confidential Information of Faulding provided to it pursuant to the Prior
Agreement solely within the BNP Territory and solely for the purposes of
obtaining Registrations within the BNP Territory.
(iii) Faulding shall have the right to use
Confidential Information of BNP consisting solely of pre-clinical and clinical
data relating to Paclitaxel, the Product and the BNP Formulation developed under
applications for Registrations or INDs which was provided to Faulding in
accordance with the Prior Agreement prior to the Effective Date, if any, solely
within
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the Exclusive Faulding Territory and solely for the purposes of obtaining
Registrations within the Exclusive Faulding Territory. Faulding shall not be
permitted to disclose any such information to NaPro or any Third Party except to
(i) governmental regulatory authorities in connection with any applications for
an IND or Registration for paclitaxel injection and any applications for import
or export license with respect to the Product or paclitaxel injection in the
Exclusive Faulding Territory and (ii) clinicians or others in connection with
the filing of such applications. Faulding shall take precautions consistent with
those described in Section 7(f) of this Agreement with respect to such
information. NaPro shall use commercially reasonable efforts to cause Faulding
to comply with this Section 7(d)(iii).
(e) RESTRICTED DISCLOSURE. BNP will restrict dissemination of
BNP Retained Information to only those employees of BNP with a need to know such
information for the purposes of fulfilling BNP's obligations or exercising its
rights pursuant to this Agreement. No BNP Retained Information shall be
disclosed in any manner to any Third Party, including prospective suppliers,
distributors, marketers or other Persons, except that such information may be
provided to (i) governmental regulatory authorities in connection with any
applications for an IND or Registration for paclitaxel injection and any
applications for import or export license with respect to the Product or
paclitaxel injection in the BNP Territory; (ii) clinicians or others in
connection with the filing of such applications; (iii) a Third Party finisher of
Product as may be necessary for such Third Party to finish the Product; (iv)
pharmaceutical companies with which BNP has entered into an arrangement to
assist in the marketing and selling or distribution of paclitaxel injection; or
(v) Third Parties if required pursuant to any proceeding before a court of
governmental authority, provided that BNP gives NaPro notice of such required
disclosure so that NaPro may seek a protective order or other appropriate
remedy. BNP shall under no circumstances disclose any BNP Retained Information
identified in Section A of Exhibit C-1 to any Third Party which, itself or
through an Affiliate, manufactures bulk Paclitaxel.
(f) PRECAUTIONS. BNP shall maintain the BNP Retained
Information as confidential, and protect the same from misuse, espionage, loss
or theft and shall not disclose the BNP Retained Information to others except as
provided in this Section 7 and shall cause any Person (other than any
governmental agency or authority) receiving BNP Retained Information to sign a
confidentiality agreement with obligations at least as strict as those contained
in this Section 7 and with respect to any governmental agency or authority,
shall use reasonable efforts to have such agency or authority maintain the
confidential nature of such BNP Retained Information.
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(g) EQUITABLE REMEDIES. In the event of a breach or threatened
breach by a party of the provisions of this Section 7, the non-breaching party
shall be entitled to an injunction restraining the breaching party from
disclosing, in whole or in part, such Confidential Information. Nothing herein
shall be construed as prohibiting the non-breaching party from pursuing any
other remedies available to it for such breach or threatened breach, including
the recovery of damages from the breaching party.
8. CERTAIN REPRESENTATIONS AND WARRANTIES.
(a) BY BNP. BNP represents and warrants to NaPro as of the
date of this Agreement that (1) BNP has not disclosed any Confidential
Information received from NaPro except as permitted by the Prior Agreement, (2)
BNP has not assigned or licensed any of NaPro's intellectual property to any
Third Party, (3) BNP has not authorized any Third Party to market and sell any
Paclitaxel product other than Xxxxx X.X., which company was granted the right to
distribute BNP's paclitaxel injection in Germany, (4) other than such agreement
with Xxxxx X.X. or agreements with Affiliates of BNP, BNP has not entered into
any marketing or distribution contract or relationship relating to Paclitaxel,
(5) BNP has disclosed to NaPro all of BNP's material activities and material
regulatory interactions regarding development of paclitaxel injection products,
and (6) other than in connection with the agreement with Xxxxx X.X., BNP has not
received any cash consideration from any Third Party in return for the grant of
rights or formation of a contract or other relationship relating to Paclitaxel.
(b) BY IVAX, BNP AND D&N. Each of IVAX, BNP and D&N represent
and warrant to NaPro as of the date of this Agreement that (1) the execution,
delivery and performance of this Agreement by it has been duly authorized by all
requisite corporate action, (2) this Agreement has been duly executed and
delivered by it, and constitutes its legal, valid and binding obligation,
enforceable in accordance with its terms, (3) the execution, delivery and
performance of this Agreement by it do not and will not violate or conflict with
any provision of law or regulation, or any order, judgment or decree of any
court or governmental or regulatory authority, or any provision of its charter
or bylaws, or any agreement to which it is a party, (4) no consent, approval or
authorization of, or registration, qualification or filing with any governmental
or regulatory authority is required to be made by it in connection with the
execution, delivery or performance by it of this Agreement, (5) it has read and
understands this Agreement, it had the assistance of counsel in connection with
the negotiation, execution and delivery of this Agreement, and it voluntarily
entered into this Agreement and (6) with respect to D&N only, D&N has read and
is familiar with NaPro's periodic filings as filed with the United States
Securities and Exchange Commission.
(c) BY NAPRO. NaPro represents and warrants to BNP as of the
date of this Agreement that (1) NaPro has not disclosed any Confidential
13
Information received from BNP except as permitted by the Prior Agreement, (2)
Exhibit D is a complete list of all Reserved Patents, (3) except for *[TEXT
REDACTED], its foreign equivalents and any continuations, continuations-in-part,
divisions, reissues, renewals, extensions or additions thereof, none of the
Reserved Patents (assuming the issuance of all patent applications)*[TEXT
REDACTED], (4) assuming a noninfringing bulk drug supply, none of the Reserved
Patents would be infringed by BNP's making, using, importing, selling or
offering for sale the BNP Formulation in the BNP Territory, (5) Exhibit H
comprises a list of all countries (both within and outside the BNP Territory)
where the NaPro Patent is currently pending or issued, (6) NaPro believes that
the NaPro Patent will issue in the United States, and, to NaPro's knowledge
after due inquiry, the NaPro Patent, if and when issued, will be valid and
enforceable; however, NaPro makes no other representations or warranties,
whether express or implied, with respect to the NaPro Patent, (7) other than the
Prior Agreement and its agreement with Faulding dated January 19, 1994, NaPro
has not entered into any marketing or distribution contract or relationship
relating to Paclitaxel, (8) the execution, delivery and performance of this
Agreement by NaPro has been duly authorized by all requisite corporate action,
(9) this Agreement has been duly executed and delivered by NaPro, and
constitutes the legal, valid and binding obligation of NaPro, enforceable in
accordance with its terms, (10) the execution, delivery and performance of this
Agreement by NaPro do not and will not violate or conflict with any provision of
law or regulation, or any order, judgment or decree of any court or governmental
or regulatory authority, or any provision of NaPro's charter or bylaws, or any
agreement to which NaPro is a party, (11) no consent, approval or authorization
of, or registration, qualification or filing with any governmental or regulatory
authority is required to be made by NaPro in connection with the execution,
delivery or performance by NaPro of this Agreement, and (12) NaPro has read and
understands this Agreement, NaPro had the assistance of counsel in connection
with the negotiation, execution and delivery of this Agreement, and NaPro
voluntarily entered into this Agreement.
9. STANDSTILL AGREEMENT. IVAX agrees that for a period of ten (10)
years from the Effective Date, neither it nor any of its Affiliates will, unless
specifically invited in writing by NaPro: (a) acquire, offer or propose to
acquire, solicit an offer to sell or agree to acquire, directly or indirectly,
alone or in concert with others, by purchase or otherwise, any direct or
indirect beneficial interest in any NaPro voting securities of any type,
including debt or equity securities, or direct or indirect rights, warrants or
options to acquire, or securities convertible into or exchangeable for, any
--------
The portion of this agreement marked "*[TEXT REDACTED]" indicates that
such portion has been omitted from this agreement and filed separately with the
Commission pursuant to a Confidential Treatment Request
14
NaPro voting securities; (b) make, or in any way participate in, directly or
indirectly, alone or in concert with others, any "solicitation" of "proxies" to
vote (as such terms are used in the proxy rules of the Securities and Exchange
Commission promulgated pursuant to Section 14 of the Exchange Act) or seek to
advise or influence in any manner whatsoever any person or entity with respect
to the voting of any NaPro voting securities; (c) form, join or in any way
participate in a "group" (within the meaning of Section 13(d)(3) of the Exchange
Act) with respect to any NaPro voting securities; (d) acquire, offer to acquire
or agree to acquire, directly or indirectly, alone or in concert with others, by
purchase, exchange or otherwise, (i) any of NaPro's assets, tangible and
intangible, or (ii) direct or indirect rights, warrants or options to acquire
any such assets, except for such assets as are then being offered for sale by
NaPro; (e) arrange, or in any way participate, directly or indirectly, in any
financing for the purchase of any NaPro voting securities or securities
convertible or exchangeable into or exercisable for any NaPro voting securities
or NaPro assets, except for such assets as are then being offered for sale by
NaPro; (f) otherwise act, alone or in concert with others, to seek or propose to
NaPro or any of its shareholders any business combination, restructuring,
recapitalization or similar transaction to or with NaPro or otherwise seek,
alone or in concert with others, to control, change or influence NaPro's
management, board of directors or policies or nominate any person as a director
of NaPro or propose any manner to be voted upon by NaPro's shareholders; or (g)
announce an intention to do, or enter into any agreement or understanding with
others to do, any of the actions restricted or prohibited under clauses (a)
through (f) of this Section.
10. INDEMNITY.
(a) NAPRO INDEMNITY. Subject to the provisions of Section
10(c) below, NaPro shall protect, indemnify and hold harmless BNP and its
Affiliates from and against all Loss incurred by BNP, its Affiliates or its
distributors or marketing partners by reason of:
(i) DEFECT. Any failure of the Product supplied to
BNP pursuant to this Agreement or the Prior Agreement to meet the Specification;
(ii) BREACH. The breach by NaPro of any of the
obligations, representations, warranties and covenants contained herein; and
(iii) INFRINGEMENT. Any claim of patent or trade
secret infringement against such Person under the laws or regulations of the
United States, Canada or any country in the European Union relating to the
manufacture, composition or sale of the Product supplied by NaPro to BNP
pursuant to this Agreement or the Prior Agreement.
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(b) BNP INDEMNITY. Subject to the provisions of Section 10(c)
below, BNP shall protect, indemnify and hold harmless NaPro and its Affiliates
from and against all Loss incurred by NaPro by reason of:
(i) DEFECT. The manufacture by BNP of any product
containing the Product (whether supplied pursuant to this Agreement or the Prior
Agreement) to the extent of a defect caused by BNP;
(ii) BNP ACTIVITIES. The formulation, storage,
handling, promotion, distribution, Registration or sale of any product
containing the Product or the storage or handling of the Product by BNP, its
Affiliates or its distributors (whether supplied pursuant to this Agreement or
the Prior Agreement); provided, however, that such indemnification obligation
shall not apply to legal fees and expenses incurred by NaPro in connection with
*[TEXT REDACTED] and
(iii) BREACH. The breach by BNP of any of the
obligations, representations, warranties and covenants contained herein.
(c) ACTION BY PARTIES. Neither party shall be obligated to
indemnify and hold harmless the other from or against any Loss due to the other
party's negligence or other wrongdoing or to the extent that any such Loss is a
result of the action or inaction of the other party for which such other party
would be obligated to indemnify such party.
11. MISCELLANEOUS PROVISIONS.
(a) NO NAPRO INVOLVEMENT WITH CLINICAL DEVELOPMENT OR
MARKETING. The parties acknowledge and agree that NaPro has no obligation or
right, and shall not assist or counsel BNP regarding BNP's clinical development,
administration, marketing or distribution of any product including but not
limited to the BNP Formulation.
(b) ENTIRE AGREEMENT. This Agreement constitutes the entire
agreement between the parties with respect to the subject matter hereof, and
cancels and supersedes all prior negotiations, understandings and agreements
(including but not limited to the Prior Agreement and the Related Agreements)
between the parties concerning the subject matter hereof.
--------
The portion of this agreement marked "*[TEXT REDACTED]" indicates that
such portion has been omitted from this agreement and filed separately with the
Commission pursuant to a Confidential Treatment Request
16
(c) WAIVER AND AMENDMENT. This Agreement may not be amended
except pursuant to a written instrument signed by the parties. No right of a
party, and no breach of any term of this Agreement, can be waived and no
election under this Agreement can be made unless such waiver or election is in
writing signed by the party to be charged with such waiver or election.
(d) GOVERNING LAW. This Agreement shall be governed by the
laws of the State of New York, without regard to the choice of law principles
thereof.
(e) CONSTRUCTION. This Agreement (including its Exhibits) were
and shall be deemed to have been drafted by the parties; accordingly, any rule
pertaining to the construction of contracts to the effect that ambiguities are
to be resolved against the drafting party shall not apply to the interpretation
of this Agreement.
(f) SEVERABILITY. The provisions of this Agreement shall be
severable, and if any of them are held invalid or unenforceable, for any reason,
such provision shall be replaced with a provision which accomplishes, to the
extent possible, the original business purpose of such provision in a valid and
enforceable manner. The invalidity or unenforceability of one provision shall
not affect any other provision of this Agreement
(g) NOTICES. Any notice required or permitted to be given
under this Agreement shall be made in writing by registered mail, return receipt
requested, or by overnight courier, and shall be deemed given on the date
received. Notices to IVAX, BNP and D&N shall be sent to the appropriate company
at 0000 Xxxxxxxx Xxxxxxxxx, Xxxxx, Xxxxxxx 00000, Attention: General Counsel,
and notices to NaPro shall be sent to NaPro BioTherapeutics, Inc., 0000 Xxxxx
Xxxx, Xxxx X, Xxxxxxx, Xxxxxxxx 00000, Attention: Chief Executive Officer.
(h) BANKRUPTCY OR INSOLVENCY. For purposes of Section 365(n)
of the United States Bankruptcy Code, all rights and licenses granted under this
Agreement are, and shall be deemed to be, licenses of rights to "Intellectual
Property" as defined under Section 101(56) of such code. The parties agree that
BNP, as a licensee of such rights under this Agreement, shall retain and may
fully exercise all of its rights and elections under the United States
Bankruptcy Code, including but not limited to the right to continue to exercise
the rights licensed under this Agreement following the bankruptcy of NaPro.
(i) TERMINATION OF LICENSE. In the event: (i) BNP fails to make
the payments or fails to remit the NaPro securities to NaPro as required
pursuant to Section 4(b) or Section 5 of this Agreement, (ii) BNP discloses to a
Third Party the Confidential Information of NaPro identified on Exhibit I
attached hereto in violation of Section 7, or (iii) Section 8(a)(1) of this
Agreement is not true in all material respects, then NaPro shall have the right
to terminate the License, provided that BNP shall first be given a sixty (60)
17
day period in which to cure any such breach of clauses (ii) or (iii). BNP shall
have the right to terminate the License at any time upon written notice to
NaPro. In the event of any termination pursuant to this Section 11(i), BNP shall
have no obligation to make any payments to NaPro under Section 4(b) which would
be due after the date of termination.
(j) PUBLICITY. Each of NaPro and IVAX shall issue a press
release in the form attached hereto as Exhibits J-1 and J-2, respectively, at a
mutually agreed time (the "Initial Release"). Thereafter, the parties will
consult with each other before issuing any press release or otherwise making any
public statements with respect to this Agreement, the Prior Agreement or the
relationship between the parties and shall not issue any such press release or
make any such public statements without the prior written approval of the other
party, except (1) either party may make public statements (other than in the
form of a press release) to the extent such statements are consistent with the
Initial Release and do not disclose any information which was not disclosed in
the Initial Release or is not publicly available as a result of a disclosure
made pursuant to clause (2) of this paragraph; and (2) to the extent required by
applicable law or the rules of any applicable stock exchange, in which case the
issuing party shall use its best efforts to consult with the other party before
issuing any such release or making any such public statement
(k) EXECUTION. This Agreement may be executed by facsimile and
in any number of counterparts, each of which when so executed shall be deemed to
be an original and all of which when taken together shall constitute this
Agreement
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
Effective Date.
NaPro BioTherapeutics, Inc. IVAX Corporation
By: /s/ Xxxxxxx X. Xxxxxxx By: /s/ Xxxxx X. Xxxxxxx
------------------------------ -------------------------------
Xxxxxxx X. Xxxxxxx Xxxxx X. Xxxxxxx
Chairman of the Board President and Chief
Operating Officer
Xxxxx Xxxxxx Pharmaceuticals, Inc. D&N Holding Company
By: /s/ Xxxxx X. Xxxxxxx By: /s/ Xxxxxxx X. Xxxxxxxxxx
----------------------------- -------------------------------
Xxxxx X. Xxxxxxx Xxxxxxx X. Xxxxxxxxxx
President Secretary
18
