EXHIBIT 10.1
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
DEVELOPMENT AND LICENSE AGREEMENT
BETWEEN
NABI BIOPHARMACEUTICALS
AND
PHARMACIA AND UPJOHN COMPANY
DATED AS OF APRIL 3, 2003
DEVELOPMENT AND LICENSE AGREEMENT
THIS DEVELOPMENT AND LICENSE AGREEMENT dated as of April 3, 2003 (the
"Agreement") is made between NABI BIOPHARMACEUTICALS, a Delaware corporation
having its principal place of business at 0000 Xxxx xx Xxxxxxxx Xxxxxxxxx, Xxxx
Xxxxx, XX 00000 ("Nabi"), and PHARMACIA AND UPJOHN COMPANY, acting through its
Animal Health business, a Delaware corporation having its principal place of
business at 0000 Xxxxxxx Xx, Xxxxxxxxx, XX 00000 ("Pharmacia").
RECITALS
1. Nabi is a biopharmaceutical company focused on the development and
commercialization of drugs that prevent and treat infection and autoimmune
diseases.
2. During the course of its work in the area of vaccines, Nabi has
developed certain proprietary technology related to the prevention and control
of S. AUREUS infections.
3. Nabi is interested in licensing this technology for use in the Field
(as hereinafter defined) to a party which can maximize its potential by
obtaining approval from appropriate governmental regulatory authorities of
products embodying such technology, and then selling such products on a
worldwide basis.
4. Pharmacia manufactures and sells animal health pharmaceutical and
biological products on a worldwide basis.
5. Pharmacia is interested in obtaining an exclusive, worldwide license
to Nabi's technology in the Field.
6. Nabi is willing to grant such a license upon the terms and
conditions set forth below.
NOW, THEREFORE, in consideration of the premises and of the covenants
herein contained, the parties hereto mutually agree as follows:
ARTICLE 1. DEFINITIONS
1.1 "AFFILIATE" shall mean any corporation or other entity, which
directly or indirectly controls, is controlled by or is under common control
with a party to this Agreement. A corporation or other entity shall be regarded
as in control of another corporation or entity if it owns or directly or
indirectly controls more than fifty (50%) of the voting stock or other ownership
interest of the other corporation or entity, or if it possesses, directly or
indirectly, the power to direct or cause the direction of the management and
policies of the corporation or other entity or the power to elect or appoint
fifty percent (50%) or more of the members of the governing body of the
corporation or other entity.
1.2 "DEVELOPMENT PHASE" shall mean for each Licensed Product the period
commencing on the Effective Date and continuing for each country or jurisdiction
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until Final Marketing Approval for the Licensed Product has been obtained in
such country or jurisdiction.
1.3 "EFFECTIVE DATE" shall mean the date first written above.
1.4 [***].
1.5 "EXCLUDED TECHNOLOGY" shall mean all patent claims (whether of an
issued patent or pending patent application), inventions (whether or not
patentable), trade secrets, know-how and other intellectual property of any kind
unique to the development and/or manufacture of [***].
1.6 "FIELD" shall mean vaccines for the prevention and treatment of S.
AUREUS infections in cattle using Nabi Technology and Patent Rights.
1.7 "FINAL MARKETING APPROVAL" shall mean final approval of the
governing health authority to market (including pricing approval where needed) a
Licensed Product in a country (at times this may be referred to as registration
or a government license).
1.8 "FIRST COMMERCIAL SALE" shall mean the first sale for use or
consumption by the general public of a Licensed Product.
1.9 "IMPROVEMENTS" shall mean all inventions (whether or not
patentable), information, know-how and data of any kind owned or controlled by,
or licensed (with the right to sublicense) to, Pharmacia during the term of this
Agreement for use in connection with the development, manufacture or use of
Licensed Products but expressly excluding Nabi Technology and Patented Rights.
1.10 "LICENSED PRODUCTS" shall mean any product in the Field (a) which
would be within a Valid Claim of a pending patent application included in the
Patent Rights or which, but for the license granted herein, would infringe a
Valid Claim of an issued patent included in the Patent Rights or (b) any product
in the Field that is not encompassed by 1.10(a) and which utilizes Nabi
Technology.
1.11 "NABI TECHNOLOGY" shall mean all present unpatented or
unpatentable inventions, trade secrets, know-how, data, and other intellectual
property of any kind owned or controlled by, or licensed (with the right to
sublicense) to, Nabi necessary or useful for the manufacture, use or sale of the
Licensed Products, but expressly excluding Excluded Technology and Patent
Rights.
1.12 "NET SALES" shall mean all worldwide sales of the Licensed
Products by Pharmacia, its Affiliates and its and their sublicensees as reported
by the Pharmacia Global Sales Reporting System, or any succeeding comparable
global sales reporting system. Net Sales as reported by the Pharmacia Global
Sales Reporting System is the gross invoiced sales price of a Licensed Product
less: [***]. All translations to U.S. dollars shall be made using the
methodology employed in the Pharmacia Global Sales Reporting System. [***].
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1.13 "PATENT RIGHTS" shall mean the United States and foreign patent
applications an/or issued patents set forth in Exhibit A hereto; any division,
continuation or continuation-in-part of any such applications; any foreign
patent applications corresponding to any such patent applications; and any U.S.
or foreign patents or the equivalent thereof issuing thereon or any reissue or
extension thereof. Patent Rights shall not include Excluded Technology.
1.14 "THIRD PARTY" shall mean any entity other than Nabi or Pharmacia
and their respective Affiliates.
1.15 "VALID CLAIM" shall mean either (a) a claim of an issued and
unexpired patent which has not been held permanently revoked, unenforceable or
invalid by a decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for appeal, and
which has not been admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise or (b) a claim of a pending patent application which
claim was filed in good faith and has not been abandoned or finally disallowed
without the possibility of appeal or re-filing of said application.
ARTICLE 2. LICENSE GRANT
2.1 GRANT OF LICENSE RIGHTS BY NABI TO PHARMACIA. Subject to the
provisions of Section 2.3, Nabi hereby grants to Pharmacia the exclusive
worldwide (subject to the provisions of Section 9.2.4) right and license under
the Patent Rights and Nabi Technology to use, manufacture, have manufactured,
distribute for sale and sell the Licensed Products for use in the Field.
2.2 SUBLICENSES. Pharmacia shall have the right to grant sublicenses
under the Patent Rights and the Nabi Technology to Affiliates of Pharmacia and,
with the prior written consent of Nabi, which shall not be unreasonably
withheld, to Third Parties. A copy of each sublicense granted by Pharmacia under
this Agreement shall be furnished to Nabi promptly after execution thereof. Any
such sublicense shall conform to the terms hereof, and Pharmacia shall be
responsible for the performance by its sublicensees of all obligations imposed
under the terms of this Agreement.
2.3 MARKETING AND DISTRIBUTION RIGHTS AND OBLIGATIONS. Pharmacia shall
have the exclusive worldwide right to market and distribute the Licensed
Products. Pharmacia agrees, at its own expense, to use diligent efforts to
market the Licensed Products.
2.4 NO OTHER RIGHTS. Except as otherwise expressly provided in this
Agreement, under no circumstances shall a party hereto, as a result of this
Agreement, obtain any ownership interest in or other right to any technology,
know-how, patents, pending patent applications, products or biological materials
of the other party, including items owned, controlled or developed by the other
party, or transferred by the other party to said party, at any time pursuant to
this Agreement. Without limitation of the foregoing, Pharmacia shall obtain no
rights to the trademarks StaphVAX or 336 or any variation thereof.
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2.5 NO OTHER OBLIGATIONS. Except as otherwise expressly provided in
this Agreement or as set forth on Exhibit B, Nabi shall have no obligations to
Pharmacia with respect to the development and commercialization of Licensed
Products.
ARTICLE 3. EFFORTS DURING DEVELOPMENT PHASE
3.1 DILIGENT EFFORTS OF PHARMACIA. During the Development Phase and
thereafter, Pharmacia agrees, at its own expense, to use commercially reasonable
efforts to perform research, preclinical development and clinical development
with respect to Licensed Products and to seek and use its best commercially
reasonable efforts to obtain Final Market Approvals, where necessary, for
Licensed Products throughout the world. Pharmacia shall use its best
commercially reasonable efforts to commence commercial sales of Licensed Product
on a country-by-country basis at the earliest practicable date. Pharmacia shall
have sole responsibility for filing and obtaining registrations for all Licensed
Products and shall have sole rights to any such registrations which it obtains.
Pharmacia shall have the sole right to determine which markets to seek
registration except that it shall seek registration in [***].
3.2 INFORMATION EXCHANGE, REPORTS. During the Development Phase and
thereafter, Pharmacia shall keep Nabi informed as to its progress related to the
Licensed Products, summarizing results of all preclinical or clinical studies or
tests performed by Pharmacia or its Affiliates and sublicensees. Attached hereto
as Exhibit C is the initial development plan. Once every six months following
the Effective Date, Pharmacia shall provide Nabi an updated development plan and
a detailed report describing Pharmacia's progress during the preceding twelve
months with respect to Pharmacia's efforts under this Agreement. As soon as is
reasonably practicable following delivery of each such plan and report,
representatives of the parties shall meet to discuss each such plan and report.
The site of the meetings shall be alternatively selected by Nabi and Pharmacia.
These reports are solely for Nabi informative use to monitor the work on
Pharmacia. These reports are to be maintained as confidential disclosures.
3.3 RIGHT TO USE DATA. Pharmacia shall provide Nabi full access to all
of its notes, data and other information relating to Licensed Products in the
Field on a confidential basis. Pharmacia shall maintain all information and data
which Pharmacia generates during the course of preclinical and clinical trials
conducted during the Development Phase, and Pharmacia shall grant Nabi a
perpetual, non-exclusive, worldwide, royalty-free license to any such
information or data, including the right to sublicense outside the Field,
subject to the confidentiality provisions of Article 6. In the event this
Agreement is terminated other than by Pharmacia pursuant to Section 9.2.1, Nabi
shall retain such license and shall have unrestricted access to and use of such
information and data for any purpose, including any regulatory purpose.
3.4 ATTENDANCE AT REGULATORY MEETINGS. Pharmacia will inform Nabi, with
reasonable prior notice, of all meetings between its representatives and
regulatory authorities regarding marketing approval of the Licensed Products.
Nabi shall have the right to have a representative present at all important
meetings if appropriate. Pharmacia will be solely responsible for the conduct of
the meeting.
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ARTICLE 4. PAYMENTS
4.1 LUMP SUM PAYMENTS. In consideration of the license and technical
materials provided hereunder, Pharmacia shall compensate Nabi by paying to Nabi
by wire transfer within five (5) business days after the Effective Date the sum
of [***].
Upon achievement of each of the milestones set forth below, Pharmacia
shall make the corresponding payment stated below:
MILESTONE PAYMENT
(a) Completion of the proof of concept study in [***]
dairy cattle and the affirmative decision by
Pharmacia to move forward with development
of a first Licensed Product in the Field or
[***], whichever first occurs
(b) If Pharmacia elects to move forward with [***]
development of a first Licensed Product in
the Field following completion of the proof
of concept study, final [***] filing for
mastitis vaccine which constitutes a
Licensed Product, provided that if such
filing is not made by [***], Pharmacia shall
make a penalty payment of [***] to Nabi and
upon such payment shall have no further
payment obligation under this clause (b)
(c) First Final Market Approval for a Licensed [***]
Product in [***]
(d) [***] filing for mastitis vaccine which [***]
constitutes a Licensed Product
(e) First Final Market Approval for a Licensed [***]
Product in [***]
(f) First Final Market Approval for a Licensed [***]
Product in [***]
(g) First Final Market Approval for a Licensed [***]
Product in [***]
Within five (5) business days following the occurrence or successful
completion, as the case may be, of each of the milestones set forth above or
following the date the penalty payment becomes due under clause (b) above,
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Pharmacia shall pay to Nabi the corresponding milestone payment set forth above
in United States dollars by wire transfer. Payments made by Pharmacia to Nabi
pursuant to this Section 4.1 are not refundable under any circumstances and will
not be credited against royalty payments due to Nabi pursuant to Section 4.2.
4.2 ROYALTIES. Following the First Commercial Sale of a Licensed
Product, Pharmacia will pay, on a calendar quarterly basis, without offset or
deduction except as set forth in Section 1.11, a royalty in the amounts set
forth below on Net Sales of the Licensed Product during the previous quarter.
4.2.1 ROYALTY CALCULATION; MINIMUMS. In consideration of the
licenses granted to Pharmacia, Pharmacia shall pay to Nabi a royalty at the
rates set forth on Exhibit D of the Net Sales of the Licensed Products sold by
Pharmacia, its Affiliates and/or sublicensees; PROVIDED, HOWEVER, that:
(a) subject to the provisions of Section 5.1.2, for each of
the [***] periods beginning three months after Pharmacia, its
Affiliates and/or its or their sublicensees shall have received its
first Final Market Approval for a Licensed Product in [***] (the "[***]
Period"), Pharmacia shall pay to Nabi royalties of at least [***]
PROVIDED, HOWEVER, that if the product previously identified by
Pharmacia and Nabi has achieved worldwide sales measured in U.S.
dollars of at least [***] for a [***] Period, then for each subsequent
[***] Period Pharmacia's minimum royalty obligation under this (a)
shall be reduced to [***];
(b) subject to the provisions of Section 5.1.2, in addition to
the minimum royalty obligation set forth in (a) above, for each of the
[***] periods beginning three months after Pharmacia, its Affiliates
and/or its or their sublicensees shall have received its first Final
Market Approval for a Licensed Product in [***] (the "[***] Period"),
Pharmacia shall pay to Nabi further royalties of at least [***]
PROVIDED, HOWEVER, that if the product previously identified by
Pharmacia and Nabi has achieved worldwide sales measured in U.S.
dollars of at least [***] for a [***] Period, then for each subsequent
[***] Period Pharmacia's minimum royalty obligation under this (b)
shall be reduced to [***];
(c) upon expiration of each of the [***] periods set forth in
(a) and (b) above, Pharmacia shall continue to make annual minimum
royalty payments to Nabi in amounts to be agreed upon by Pharmacia and
Nabi acting in good faith;
(d) notwithstanding the provisions of (a) and (b) above, in
the event the market share of a product competitive with a Licensed
Product that is offered and sold by a third party is [***] or greater
(i) in [***] the minimum royalty set forth in (a) above shall be
renegotiated in good faith and (ii) in [***] the minimum royalty set
forth in (b) above shall be renegotiated in good faith;
(e) notwithstanding the provisions of (a) and (b) above,
Pharmacia shall have no obligation to make minimum royalty payments in
the event Nabi elects not to take action against an alleged infringer
of the Patent Rights in the Field or any action taken by Nabi against
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the alleged infringer is unsuccessful and in either such event sales of
Licensed Products are materially and adversely affected by sales of the
alleged infringing product; and
(f) notwithstanding the provisions of (a) and (b) above, in
the event sales of Licensed Products are materially and adversely
affected during the [***] periods set forth in (a) and (b) above,
despite Pharmacia's best documented diligent efforts, because
regulatory, technical or supply limitations limit production and sales,
Nabi shall in good faith agree to appropriately reduce the minimum
royalty payment for [***], as appropriate, for the period in question.
4.2.2 ROYALTY PAYMENT REPORTS, EXCHANGE RATES. During the term
of this Agreement following the First Commercial Sale of a Licensed Product,
Pharmacia shall within forty five (45) days after each calendar quarter pay to
Nabi the royalties due under the Agreement for such quarter and furnish to Nabi
a written quarterly report showing: (i) the gross sales of the Licensed Products
sold by Pharmacia, its Affiliates, and its sublicensees during the reporting
period and the calculation of Net Sales from such gross sales; (ii) the royalty
due thereon; (iii) withholding taxes, if any, required by law to be deducted in
respect of such royalties; and (iv) the exchange rates used in determining the
amount of United States dollars. All sales in currencies other than United
States dollars shall be converted into United States dollars calculated at the
exchange rate published in THE WALL STREET JOURNAL on the last day of the
calendar quarter. If no royalty is due for any royalty period hereunder,
Pharmacia shall so report. Pharmacia shall keep complete and accurate records in
sufficient detail to properly reflect all gross sales and Net Sales and to
enable the royalties payable hereunder to be determined. Any royalty payment for
the fourth quarter of a [***] Period or [***] Period shall include an amount
sufficient to satisfy the minimum royalty obligation under Section 4.2.1.
4.2.3 AUDITS. Upon the written request and ample advance
notice (30 days) of Nabi, Pharmacia shall permit an internal auditor or
independent public accountant selected by Nabi and acceptable to Pharmacia which
acceptance shall not be unreasonably withheld or delayed, to have access during
normal business hours to such records of Pharmacia as may be reasonably
necessary to verify the accuracy of the royalty reports described herein, in
respect of any calendar year ending not more than thirty-six (36) months prior
to the date of such request. All such verifications shall be conducted at Nabi's
expense and not more than once in each calendar year. In the event such Nabi
representative concludes, providing sufficient evidence that additional
royalties were owed to Nabi during such period, the additional royalty shall be
paid by Pharmacia within thirty (30) days of the date Nabi delivers to Pharmacia
such representative's written report so concluding. The fees charged by such
representative shall be paid by Nabi unless the audit discloses that the
royalties payable by Pharmacia for the audited period are underpaid by more than
[***], in which case Pharmacia shall pay the reasonable fees and expenses
charged by such representative and a further amount equal to the amount of the
additional royalty. Any overpay will be refundable or credited against future
royalties. Pharmacia shall include in each Third Party sublicense granted by it
pursuant to this Agreement a provision requiring the sublicensee to make reports
to Pharmacia, to keep and maintain records of sales made pursuant to such
8
sublicense and to grant access to such records by Nabi's representatives to the
same extent required of Pharmacia under this Agreement. Nabi agrees that all
information subject to review under this Section 4.2.3 or under any sublicense
agreement is confidential and that Nabi shall cause its representatives to
retain all such information in confidence.
4.2.4 FOREIGN ROYALTIES. If royalties are due Nabi hereunder
for sales of Licensed Products in a country in which, by reason of currency
regulations or taxes of any kind, it is impossible or illegal for Pharmacia, its
Affiliates and/or sublicensees to transfer royalty payments to Nabi for Net
Sales in that country, such royalties shall be deposited in whatever currency is
allowable by the person or entity not able to make the transfer for the benefit
or credit of Nabi in an accredited bank in that country that is acceptable to
Nabi.
4.2.5 INTEREST ON LATE PAYMENTS. Any payments by Pharmacia to
Nabi that are not paid on or before the fifth business day after the date such
payments are due under this Agreement shall bear interest at the lower of (a)
the maximum rate permitted by applicable law and (b) two (2) percentage points
above the prime rate of interest reported from time to time by THE WALL STREET
JOURNAL, calculated on the number of days payment is delinquent.
ARTICLE 5. INTELLECTUAL PROPERTY
5.1 FILING, PROSECUTION AND MAINTENANCE OF PATENT RIGHTS.
5.1.1 PROSECUTION AND MAINTENANCE. Nabi shall be responsible
at its expense for the filing, prosecution and maintenance of the Patent Rights
in its own name, keeping Pharmacia informed.
5.1.2 ABANDONMENT; FAILURE TO PAY. Nabi agrees that it will
not abandon the prosecution of any patent applications included within the
Patent Rights nor shall it fail to make any payment or fail to take any other
action necessary to maintain a patent under the Patent Rights unless it has
notified Pharmacia in sufficient time for Pharmacia to assume such prosecution
or make such payment. If Nabi elects not to continue to seek or maintain patent
protection on any patent or patent application included in the Patent Rights and
subject to any prior rights Nabi may hereafter grant to Third Parties, [***].
Nabi will advise Pharmacia of all decisions taken with respect to any such
election in a timely manner in order to allow Pharmacia to protect its rights
under this Section 5.1.2.
5.1.3 COOPERATION. Each party shall make available to the
other party (or to the other party's authorized attorneys, agents or
representatives), its employees, agents or consultants to the extent reasonably
necessary or appropriate to enable the appropriate party to file, prosecute and
maintain patent applications and resulting patents as set forth in this Section
5.1 for periods of time reasonably sufficient for such party to obtain the
assistance it needs from such personnel. Where appropriate, each party shall
sign or cause to have signed all documents relating to said patent applications
or patents at no charge to the other party.
5.2 INFRINGEMENT BY OTHERS.
5.2.1 PROSECUTION BY NABI. Nabi and Pharmacia shall each
promptly notify the other in writing of any alleged or threatened infringement
of patents or patent applications included in the Patent Rights in the Field
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licensed hereunder to Pharmacia of which they become aware, and the parties
shall consult concerning the action to be taken. Nabi shall have the right, but
not the obligation, to prosecute at its own expense any such infringement. Any
recovery or damages derived from such action shall belong to Nabi.
5.2.2 PROSECUTION BY PHARMACIA. If, within thirty (30) days or
shorter as may be necessary to protect Pharmacia's right to seek immediate
injunctive relief, after Nabi first becomes aware of any infringement of the
Patent Rights in the Field, Nabi declines to prosecute such infringement or
fails to cause such infringement to terminate or to bring or diligently
prosecute a suit or action to compel termination, if Nabi so elects in writing,
Pharmacia shall have the right, but not the obligation, to bring such suit or
action to compel termination at the sole expense of Pharmacia. In such event,
Pharmacia shall have the right, if Nabi is a legally indispensable party, to
bring such suit or action in the name of Nabi. Nabi shall have the right to join
any such suit or action brought by Pharmacia at Nabi's expense. Any recovery or
damages derived from such action shall first be used to reimburse the parties
for all legal expenses relating to the suit and thereafter shall [***]. No
settlement, consent, judgment or other voluntary final disposition of the suit
may be entered into without the consent of Nabi, which consent shall not
unreasonably be withheld.
5.3 DECLARATORY ACTIONS. In the event that a declaratory judgment
action alleging invalidity or non-infringement of any of the Patent Rights shall
be brought against Pharmacia, Pharmacia shall notify Nabi in writing, and the
parties shall consult concerning the action to be taken. Nabi, at its sole
option, shall have the right, within thirty (30) days after commencement of such
action, to intervene, take over and duly prosecute the sole defense of the
action at its own expense. Pharmacia shall have no obligation to defend any such
action, but Pharmacia shall have the right, at its own expense, to join in the
defense of any such suit or action.
5.4 INFRINGEMENT ACTION AGAINST PHARMACIA. In the event that a suit or
action is brought against Pharmacia alleging infringement of any third-party
patent right as a result of the exercise of Pharmacia's rights under Section
2.1, Pharmacia shall have the exclusive right to defend such suit or action at
its sole expense. Nabi will confer with and assist Pharmacia, at Nabi's expense,
in the conduct or settlement of such defense. Nabi shall have the right to be
represented in such suit or action by advisory counsel at its expense. Pharmacia
shall not have the right to settle any such suit or action without the prior
written consent of Nabi if as a result of such settlement Nabi would be
obligated to make any payment, assume any obligation, part with any property or
interest therein, be subject to any injunction or order, grant any license or
other right under the Patent Rights, or acknowledge the invalidity of any of the
Patent Rights. Any recovery or damages obtained by Pharmacia in relation to any
counterclaim or the like filed by Pharmacia in such suit shall be applied first
in satisfaction of any expenses and legal fees of Pharmacia relating to the
suit. Any recovery or damages still remaining shall [***].
5.5 COOPERATION. In any infringement suit either party may institute to
enforce or defend the Patent Rights or in which either party defends claims of
infringement of third-party patents pursuant to this Agreement or in any
declaratory judgment action defended by a party, the other party shall, at the
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request of the party initiating or defending such suit, cooperate at its expense
in all respects and, to the extent possible, have its employees testify when
requested and make available relevant records, papers, information, samples and
the like. Pharmacia's cooperation in any suit initiated by Nabi shall be at
Nabi's expense. Nabi's cooperation in any suit initiated by Pharmacia shall be
at Pharmacia's expense.
5.6 IMPROVEMENTS. Pharmacia hereby grants to Nabi a non-exclusive,
worldwide, royalty-free license, including the right to sublicense, to all
Improvements directly related to Nabi Technology for all purposes. If Pharmacia,
its Affiliates and/or its and their sublicensees develop or acquire Improvements
not directly related to Nabi Technology, such Improvements shall be promptly
disclosed to Nabi in reasonable detail and [***]. In the event this Agreement is
terminated other than by Pharmacia pursuant to Section 9.2.1, [***].
5.7 ADDITIONAL AGREEMENT. Pharmacia shall have the right to test
vaccines using Nabi Technology and Patent Rights in staphylococcal disease in
[***] to attempt to demonstrate successful proof of concept in [***]. If
Pharmacia has successfully demonstrated proof of concept in [***] and decides to
move forward, Pharmacia shall pay to Nabi the sum of [***] and Pharmacia and
Nabi shall in good faith negotiate the terms of an exclusive licensing agreement
substantially similar to this Agreement for the field of prevention and
treatment of S. AUREUS infections in [***]. In such event, the milestone events
and all payments and the royalty rates shall be based upon then-prevailing
market rates and terms.
5.8 OTHER TECHNOLOGY. (a) In the event that subsequent to the Effective
Date, Nabi develops or acquires (with the right to sublicense) new technology
which has application in the field of veterinary medicine, subject to the
provisions of Section 5.8(b) Nabi shall offer to negotiate in good faith with
Pharmacia rights to such technology in such field. If the parties are unable to
reach agreement in principle on terms within sixty (60) days after Nabi has made
the offer and to execute and deliver definitive agreements within ninety (90)
days after Nabi has made the offer, Nabi shall be free thereafter to take
whatever action it determines with respect to such technology with no further
obligation to Pharmacia.
(b) Notwithstanding the provisions of Section 5.8(a), in the
event that subsequent to the Effective Date, Nabi develops or acquires (with the
right to sublicense) new technology which is specific to the treatment, control
or prevention of S. AUREUS infections in dairy cattle and proposes to transfer
such technology to a Third Party, Nabi shall notify Pharmacia in writing and set
forth in reasonable detail the nature of such technology and the principal terms
of such proposed transfer. Such offer shall constitute an offer to transfer such
technology on such terms to Pharmacia. Pharmacia shall have the right to accept
such offer within sixty (60) days after Nabi has made the offer. If such offer
has not been accepted by Pharmacia in writing within sixty (60) days after Nabi
has made such offer or definitive agreements with respect to such offer have not
been executed and delivered within ninety (90) days after Nabi has made such
offer, Nabi shall be free to transfer the new technology to the Third Party on
terms no less favorable to Nabi than those offered to Pharmacia.
ARTICLE 6. CONFIDENTIALITY
6.1 NONDISCLOSURE OBLIGATIONS.
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6.1.1 GENERAL. Except as otherwise provided in this Article 6,
during the term of this Agreement and for a period of five (5) years thereafter,
both parties shall maintain in confidence and use only for purposes specifically
authorized under this Agreement (i) information and data received from the other
party resulting from or related to the development of the Licensed Products and
(ii) all information and data not described in clause (i) but supplied by the
other party under this Agreement. For purposes of this Article 6, information
and data described in clause (i) or (ii) shall be referred to as "Information".
6.1.2 LIMITATIONS. To the extent it is reasonably necessary or
appropriate to fulfill its obligations or exercise its rights under this
Agreement, a party may disclose to its Affiliates, sublicensees, consultants,
outside contractors and clinical investigators, Information it is otherwise
obligated under this Section 6.1 not to disclose on a need-to-know basis on
condition that such entities or persons agree to keep the Information
confidential for the same time periods and to the same extent as such party is
required to keep the Information confidential; and a party or its sublicensees
may disclose such Information to government or other regulatory authorities to
the extent that such disclosure is reasonably necessary to obtain patents or
authorizations to conduct clinical trials of, and to commercially market, the
Licensed Products. The obligation not to disclose Information shall not apply to
any part of such Information that: (i) is or becomes part of the public domain
other than by unauthorized acts of the party obligated not to disclose such
Information or its Affiliates or sublicensees; (ii) can be shown by written
documents to have been disclosed to the receiving party or its Affiliates or
sublicensees by a Third Party, provided such Information was not obtained by
such Third Party directly or indirectly from the other party under this
Agreement pursuant to a confidentiality agreement; (iii) prior to disclosure
under this Agreement, was already in the possession of the receiving party or
its Affiliates or sublicensees, provided such Information was not obtained
directly or indirectly from the other party under this Agreement pursuant to a
confidentiality agreement; (iv) can be shown by written documents to have been
independently developed by the receiving party or its Affiliates without breach
of any of the provisions of this Agreement; or (v) is disclosed by the receiving
party pursuant to interrogatories, requests for information or documents,
subpoena, civil investigative demand issued by a court or governmental agency or
as otherwise required by law, provided that the receiving party notifies the
other party immediately upon receipt thereof and provided further that the
disclosing party furnishes only that portion of the Information which it is
advised by counsel is legally required.
6.2 TERMS OF THIS AGREEMENT. Except as provided in Section 10.7 hereof,
Nabi and Pharmacia each agree not to disclose any terms or conditions of this
Agreement to any Third Party without the prior consent of the other party,
except as required by applicable law or pursuant to a confidentiality agreement
no less restrictive than this Article 6. If either party determines that it is
required to file with the Securities and Exchange Commission or other
governmental agency this Agreement for any reason, such party shall request
confidential treatment of such portions of this Agreement, as it and the other
party shall together determine. Notwithstanding the foregoing, prior to
execution of this Agreement, Nabi and Pharmacia shall agree upon the substance
of information that can be used as a routine reference in the usual course of
business to describe the terms of this transaction, and Nabi and Pharmacia may
disclose such information, as modified by mutual agreement from time to time,
without the other party's consent.
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6.3 PUBLICATIONS.
6.3.1 PROCEDURE. Both parties recognize the mutual interest in
obtaining patent protection for inventions, which arise under this Agreement. In
the event that employees or consultants or any other Third Party under contract
to Nabi or Pharmacia wishes to make a publication (including any oral disclosure
made without obligation of confidentiality) relating to work performed under
this Agreement in the Field (the "Publishing Party"), the Publishing Party shall
transmit to Nabi or Pharmacia a copy of the proposed written publication at
least thirty (30) days prior to submission for publication, or an abstract of
such oral disclosure at least thirty (30) days prior to submission of the
abstract or the oral disclosure, whichever is earlier. Nabi and Pharmacia shall
have the right (a) to propose modifications to the publication for patent
reasons, (b) to request a delay in publication or presentation in order to
protect patentable information, or (c) to request that the information be
maintained as a trade secret and, in such case, the Publishing Party shall not
make such publication.
6.3.2 DELAY. If Nabi requests a delay as described in Section
6.3.1(b), the Publishing Party shall delay submission or presentation of the
publication for a period of ninety (90) days to enable patent applications
protecting rights in such information to be filed.
6.3.3 RESOLUTION. Upon the receipt of written approval of
Nabi, the Publishing Party may proceed with the written publication or the oral
presentation.
6.4 INJUNCTIVE RELIEF. The parties hereto understand and agree that
remedies at law may be inadequate to protect against any breach of any
provisions of this Article 6 by either party or their employees, agent, officers
or directors or any other person acting in concert with it or on its behalf.
Accordingly, each party shall be entitled to the granting of injunctive relief
by a court of competent jurisdiction against any action that constitutes any
such breach of this Article 6, without any requirement to post a bond.
ARTICLE 7. REPRESENTATIONS AND WARRANTIES
7.1 MUTUAL REPRESENTATIONS. Nabi and Pharmacia each represent and
warrant to the other as follows:
7.1.1 ORGANIZATION. It is a corporation duly organized,
validly existing and is in good standing under the laws of the jurisdiction of
its incorporation and has all requisite power and authority, corporate or
otherwise, to execute, deliver and perform this Agreement.
7.1.2 AUTHORIZATION. The execution, delivery and performance
by it of this Agreement has been duly authorized by all necessary corporate
action and does not violate any provision of any law, rule, regulation, order,
writ, judgment, injunction, decree, determination or award presently in effect
having applicability to it or any provision of its charter documents or any
agreement or other instrument or obligation to which it is bound or its assets
are subject.
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7.1.3 BINDING AGREEMENT. This Agreement is a legal, valid and
binding obligation of it enforceable against it in accordance with its terms and
conditions.
7.1.4 NO INCONSISTENT OBLIGATION. Except as provided in
Section 2.3, it is not under any obligation to any person, or entity,
contractual or otherwise, that is conflicting or inconsistent in any respect
with the terms of this Agreement or that would impede the diligent and complete
fulfillment of its obligations.
7.2 LIMITATIONS
7.2.1 DISCLAIMER OF WARRANTY. Except as provided in Section
7.1, the rights granted by Nabi herein are provided WITHOUT REPRESENTATION OR
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER
WARRANTY OR REPRESENTATION, EXPRESS OR IMPLIED. NABI MAKES NO REPRESENTATION OR
WARRANTY THAT EXERCISE OF THE RIGHTS GRANTED IN THIS AGREEMENT WILL NOT INFRINGE
ANY THIRD-PARTY OR OTHER PROPRIETARY RIGHT. NABI ASSUMES NO RESPONSIBILITY
WHATSOEVER WITH RESPECT TO THE PATENT RIGHTS OR NABI TECHNOLOGY, OR THE USE
THEREOF, OR THE MANUFACTURE, POSSESSION, USE, MARKETING, SALE OR OTHER
DISPOSITION, BY PHARMACIA OR ANYONE ELSE, OF LICENSED PRODUCT(S). Without
limitation of the generality of this Section, nothing contained herein or in the
Patents Rights or Nabi Technology shall be construed as extending any
representation or warranty with respect to any of the foregoing or the results
to be obtained thereby.
7.2.2 DISCLAIMER OF CERTAIN DAMAGES. IN NO EVENT WILL NABI BE
LIABLE TO PHARMACIA OR ANY OTHER PARTY, REGARDLESS OF THE CAUSE OR THEORY OF
ACTION (WHETHER CONTRACT, TORT INCLUDING WITHOUT LIMITATION STRICT LIABILITY AND
NEGLIGENCE, OR OTHERWISE) FOR ANY INCIDENTAL, SPECIAL, PUNITIVE, CONSEQUENTIAL
OR OTHER EXTRAORDINARY DAMAGES RESULTING FROM OR ARISING UNDER THIS AGREEMENT
INCLUDING WITHOUT LIMITATION THE EXERCISE OF THE RIGHTS GRANTED IN THIS
AGREEMENT, THE USE OF PATENT RIGHTS OR NABI TECHNOLOGY, OR THE MANUFACTURE, SALE
OR USE OF LICENSED PRODUCTS UNLESS THE DAMAGES ARE CAUSED BY NABI'S WILLFUL AND
MALICIOUS MISCONDUCT
7.2.3 FURTHER LIMITATIONS. Nothing in this Agreement shall be
construed as:
(a) a warranty or representation by Nabi as to the validity or
scope of any Patent Rights; or
(b) a warranty or representation that anything made, used,
sold or otherwise disposed of under the rights granted in this
Agreement is or will be free from infringement of a third-party patent
or other proprietary right; or
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(c) a warranty or representation that any of the Nabi
Technology has not been, or may not hereafter be, developed
independently by a Third Party; or
(d) conferring by implication, estoppel or otherwise any
license or other right under patents or technology of Nabi except for
activities within the Field.
ARTICLE 8. INDEMNITY
8.1 PHARMACIA INDEMNITY OBLIGATIONS. Pharmacia agrees to defend,
indemnify and hold Nabi, its Affiliates and their respective directors,
officers, employees and agents harmless against any and all claims, suits,
losses, judgments, liabilities, damages, costs and fees (including but not
limited to reasonable attorneys' fees) and expenses resulting from or arising
out of (a) the breach by Pharmacia of its representations and warranties in
Article 7 or any other breach of this Agreement; (b) actual or asserted
violations of any applicable law or regulation by Pharmacia, its Affiliates or
sublicensees by virtue of which the Licensed Products manufactured, distributed
or sold shall be alleged or determined to be adulterated, misbranded, mislabeled
or otherwise not in compliance with such applicable law or regulation; (c)
claims for bodily injury, death or property damage attributable to the
manufacture, distribution, sale or use of the Licensed Products by Pharmacia,
its Affiliates or sublicensees; or (d) a recall ordered by a governmental
agency, or required by a confirmed failure, of Licensed Products manufactured,
distributed, or sold by Pharmacia, its Affiliates or sublicensees and to the
extent not caused by the willful misconduct of Nabi.
8.2 NABI INDEMNITY OBLIGATIONS. Nabi agrees to defend, indemnify and
hold Pharmacia, its Affiliates and their respective directors, officers,
employees and agents harmless against any and all claims, suits, losses,
judgments, liabilities, damages, costs, fees (including but not limited to
reasonable attorneys' fees) and expenses resulting from or arising out of the
breach by Nabi of its representations and warranties in Article 7 or any other
breach of this Agreement not caused by the willful misconduct of Pharmacia.
8.3 PROCEDURE. A party or any of its Affiliates or their respective
employees or agents (the "Indemnitee") that intends to claim indemnification
under this Article 8 shall promptly notify the other party (the "Indemnitor") of
any loss, claim, damage, liability or action in respect of which the Indemnitee
intends to claim such indemnification, and the Indemnitor shall assume the
defense thereof with counsel mutually satisfactory to the parties; PROVIDED,
HOWEVER, that an Indemnitee shall have the right to retain its own counsel, with
the fees and expenses to be paid by the Indemnitor, if representation of such
Indemnitee by the counsel retained by the Indemnitor would be inappropriate due
to actual or potential differing interests between the Indemnitee and the
Indemnitor. The indemnity agreement in this Article 8 shall not apply to amounts
paid in settlement of any loss, claim, damage, liability or action if such
settlement is effected without the consent of the Indemnitor, which consent
shall not be withheld unreasonably. The failure to deliver notice to the
Indemnitor within a reasonable time after the commencement of any such action
shall not relieve the Indemnitor of any liability to the Indemnitee under this
Article 8. The Indemnitee and its employees and agents shall cooperate fully
with the Indemnitor and its legal representatives in the investigation of any
action, claim or liability covered by this indemnification. In the event that an
Indemnitee claims indemnity from the Indemnitor and the Indemnitor is finally
15
held liable to indemnify the Indemnitee, the Indemnitor shall additionally be
liable to pay the reasonable legal costs and attorneys' fees incurred by the
Indemnitee in establishing its claim for indemnity.
8.4 INSURANCE. Pharmacia shall carry and maintain at its expense during
the term of the Agreement, appropriate insurance coverage of the kind and with
liability limits acceptable to Nabi to protect itself and Nabi from and against
any and all claims or liabilities which may arise directly or indirectly as a
result of its performance under this Agreement. A certificate evidencing
adequate insurance coverage and any renewal thereof shall be provided to Nabi
upon request of Nabi.
ARTICLE 9. EXPIRATION AND TERMINATION
9.1 EXPIRATION. Unless this Agreement is sooner terminated in
accordance with the provisions of this Article 9, the term of Pharmacia's
obligation of royalty payments pursuant to Section 4.2 hereof shall cease [***]
(a) with respect to royalties calculated on the basis of Section 1 of Exhibit B,
[***] or (b) with respect to royalties calculated on the basis of Section 2 of
Exhibit B, [***] after the date of the Agreement in the country in which the
sales occur. [***].
9.2 TERMINATION.
9.2.1 TERMINATION BY EITHER PARTY. Subject to the provisions
of Section 9.2.2, this Agreement may be terminated by either party (i) by reason
of a material breach if the breaching party fails to remedy such breach within
ninety (90) days after written notice thereof by the non-breaching party or (ii)
upon bankruptcy, insolvency, dissolution or winding up of the other party.
9.2.2 INTELLECTUAL PROPERTY LICENSE SURVIVAL DURING
BANKRUPTCY. All rights and license rights granted under or pursuant to this
Agreement are, and shall otherwise be deemed to be, for purposes of Section
365(n) of the U.S. Bankruptcy Code, licenses of rights to "intellectual
property" as defined under Section 101(52) of the U.S. Bankruptcy Code. The
parties agree that each party, as a licensee of such rights under this Agreement
shall retain and may fully exercise all of its rights and elections under the
U.S. Bankruptcy Code, subject to performance by the other party of its
preexisting obligations under this Agreement.
9.2.3 TERMINATION BY PHARMACIA. [***].
9.2.4 TERMINATION BY NABI. This Agreement may be terminated by
Nabi by written notice to Pharmacia if (i) Pharmacia fails to make any royalty
or other payment within ten (10) business days after such payment becomes
payable and such failure is not remedied within ten (10) days after notice
thereof from Nabi, (ii) Pharmacia is in breach of its obligations under Sections
2.3 or 3.1 hereof or (iii) Pharmacia fails to make the full annual minimum
royalty payment for a twelve-month period agreed upon pursuant to Section
4.2.1(c) or to agree upon an annual minimum royalty payment as contemplated by
Section 4.2.1(c), in each case for any reason whatsoever, including, without
limitation, as a result of a renegotiation, reduction or elimination of the
annual minimum royalty as provided in Sections 4.2.1(d), 4.2.1(e) and 4.2.1(f)
or in Section 5.1.2. Pharmacia shall cease to have any rights under Section 2.1
16
with respect to [***] if Pharmacia fails to make minimum royalty payments of at
least [***] for a [***] period covered by Section 4.2.1(a) or to have any rights
under Section 2.1 with respect to [***] if Pharmacia fails to make minimum
royalty payments of at least [***] for a [***] period covered by Section
4.2.1(b), in each case for any reason whatsoever, including, without limitation,
as a result of a renegotiation, reduction or elimination of the annual minimum
royalty as provided in Sections 4.2.1(d), 4.2.1(e) and 4.2.1(f) or in Section
5.1.2. The failure by Pharmacia to expend by [***] at least [***] in U.S.
dollars for the development and commercialization of Licensed Products shall be
conclusively deemed to be a breach of Section 3.1 hereof.
9.3 SURVIVAL. The provisions of Articles 5, 6, 7 and 8 and Sections
3.3, 4.1 (with regard to milestone payments due and unpaid), 4.2 (with respect
to royalties accrued but not yet paid and with respect to Sections 4.2.2, 4.2.3,
4.2.4 and 4.2.5), 9.4, 10.11 and this Section 9.3 shall survive the expiration
or termination of this Agreement.
9.4 NON-LIMITATION OF RIGHTS. Termination of this Agreement pursuant to
Section 9.2 shall not be exclusive or prejudicial to any other rights or
remedies of the non-defaulting party on account of the defaulting party's breach
or default under this Agreement.
ARTICLE 10. MISCELLANEOUS
10.1 FORCE MAJEURE. Neither party shall be held liable or responsible
to the other party nor be deemed to have defaulted under or be in breach of this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected party, including but not limited to fire,
floods, embargoes, war, acts of war (whether war is declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other labor
disturbances, act of God or acts, omissions or delays in acting by any
governmental authority or the other party; PROVIDED, HOWEVER, that the party so
affected shall use reasonable commercial efforts to avoid or remove such causes
of nonperformance, and shall continue performance hereunder with reasonable
dispatch whenever such causes are removed. Either party shall provide the other
party with prompt written notice of any delay or failure to perform that occurs
by reason of FORCE MAJEURE. The parties shall mutually seek a resolution of the
delay or the failure to perform as noted above.
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10.2 ASSIGNMENT. This Agreement may not be assigned or otherwise
transferred by either party without the prior written consent of the other
party; PROVIDED, HOWEVER, that either party may, without such consent, assign
its rights and obligations under this Agreement (i) in connection with a
corporate reorganization, to any Affiliate, all or substantially all of the
equity interest of which is owned and controlled by such party or its direct or
indirect parent corporation, or (ii) in connection with a merger, consolidation
or sale of substantially all of such party's assets to an unrelated Third Party
or a sale to an unrelated Third Party of all or a substantial portion of its
business of which the transaction contemplated hereby is a part; PROVIDED,
HOWEVER, that such party's rights and obligations under this Agreement shall be
assumed in writing by its successor in interest in any such transaction. Any
purported assignment in violation of the preceding sentence shall be void. Any
permitted assignee shall assume all obligations of its assignor under this
Agreement.
10.3 SEVERABILITY. Each party hereby agrees that it does not intend to
violate any public policy, statutory or common laws, rules, regulations, treaty
or decision of any government agency or executive body thereof of any country or
community or association of countries. Should one or more provisions of this
Agreement be or become invalid, the parties hereto shall substitute, by mutual
consent, valid provisions for such invalid provisions which valid provisions in
their economic effect are sufficiently similar to the invalid provisions that it
can be reasonably assumed that the parties would have entered into this
Agreement with such valid provisions. In case such valid provisions cannot be
agreed upon, the invalidity of one or several provisions of this Agreement shall
not affect the validity of this Agreement as a whole, unless the invalid
provisions are of such essential importance to this Agreement that it is to be
reasonably assumed that the parties would not have entered into this Agreement
without the invalid provisions.
10.4 NOTICES. Any consent, notice or report required or permitted to be
given or made under this Agreement by one of the parties hereto to the other
shall be in writing, delivered personally or by facsimile (and promptly
confirmed by telephone, personal delivery or courier) or courier, postage
prepaid (where applicable), addressed to such other party at its address
indicated below, or to such other address as the addressee shall have last
furnished in writing to the addressor and shall be effective upon receipt by the
addressee.
If to Nabi: Nabi Biopharmaceuticals
0000 Xxxx xx Xxxxxxxx Xxxxxxxxx, X.X.
Xxxx Xxxxx, XX 00000
Attention: Xxxx X. Xxxx, Esq.
Senior Director and General Counsel
Telephone: 000 000-0000
Telecopy: 000 000-0000
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WITH A COPY TO:
Xxxxxx XxXxxxxxx & Fish LLP
World Trade Center West
000 Xxxxxxx Xxxxxxxxx
Xxxxxx, XX 00000-0000
Attention: Xxxxxxxxxxx Xxxxxxxxx, Esq.
Telephone: 000 000-0000
Telecopy: 000-000-0000
If to Pharmacia: Pharmacia Corp
Pharmacia Animal Health 0000 Xxxxxxx Xxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attention: Xxxxxx Xxxxxxx, Esq.
Assistant General Counsel
Telephone: 000 000 0000
Telecopy: 269-833- 2600
10.5 APPLICABLE LAW. This Agreement shall be governed by and construed
in accordance with the laws of the State of Delaware, without giving effect to
the choice of laws provisions thereof, PROVIDED, HOWEVER, that the scope,
validity and enforceability of patents shall be determined in accordance with
the applicable laws of the countries in which such patents have been issued.
10.6 DISPUTE RESOLUTION.
10.6.1 GOOD FAITH ATTEMPT TO RESOLVE. The parties hereby agree
that they will attempt in good faith to resolve any controversy or claim arising
out of or relating to this Agreement promptly by negotiations.
10.6.2 ARBITRATION. If the parties are unable to resolve the
matter through negotiations, the parties shall submit the dispute to
arbitration. The arbitration shall be held in accordance with the Commercial
Arbitration Rules of the American Arbitration Association (the "Arbitration
Rules") as the Arbitration Rules then exist by one or more arbitrators appointed
in accordance with the Arbitration Rules. The arbitration shall take place in
Boca Raton, Florida if initiated by Pharmacia or New York City, N.Y. if
initiated by Nabi. Each party shall have the right to take discovery of the
other party by any or all methods provided in the Federal Rules of Civil
Procedure. The arbitrator may, upon request, exclude any evidence not made
available to the other party pursuant to a proper discovery request from being
used in the arbitration. Any decision or award resulting from the arbitration
provided for herein shall be final and binding on the parties hereto. Judgment
upon the arbitrator's award may be entered in any court of competent
jurisdiction. Under no circumstances shall either party be obliged to use
arbitration to reconcile Nabi patent issues.
10.6.3 RIGHT TO SEEK INJUNCTIVE RELIEF. Notwithstanding the
foregoing provisions of this Section 10.6, either party has the right to bring
suit in a court of competent jurisdiction against the other party for (i) any
breach of such other party's duties of confidentiality pursuant to Article 6 of
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this Agreement and (ii) any infringement of its own proprietary rights by the
other party.
10.6.4 NO OTHER PROCEEDINGS. The parties agree not to
institute any litigation or other proceedings against each other in connection
with this Agreement except as provided in this Section 10.6 unless this
Agreement otherwise provides.
10.7 PUBLIC ANNOUNCEMENTS. The parties agree that press releases and
other announcements to be made by either of them in relation to this Agreement
shall be subject to the written consent of the other party, which consent shall
not be unreasonably withheld or delayed, except to the extent otherwise required
by law. Except to the extent required by law, no disclosure will discuss terms
or scope of this Agreement.
10.8 ENTIRE AGREEMENT. This Agreement, together with the Exhibits
hereto, contains the entire understanding of the parties with respect to the
subject matter hereof. All express or implied agreements and understandings,
either oral or written, heretofore made are expressly merged in and made a part
of this Agreement. This Agreement may be amended, or any term hereof modified,
only by a written instrument duly executed by both parties hereto.
10.9 HEADINGS. The captions to the several Articles and Sections hereof
are not a part of this Agreement, but are merely guides or labels to assist in
locating and reading the several Articles and Section hereof.
10.10 INDEPENDENT CONTRACTORS. It is expressly agreed that Nabi and
Pharmacia shall be independent contractors and that the relationship between the
two parties shall not constitute a partnership, joint venture or agency. Neither
Nabi nor Pharmacia shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on the other, without the prior consent of the other party to do so.
10.11 AGREEMENT NOT TO SOLICIT. During the first three years of this
Agreement, Pharmacia and its Affiliates shall not hire any employee of Nabi, or
any person who had been an employee of Nabi within [***] of the date of hire,
who is or was actively involved in the development or commercialization of the
Patent Rights or Nabi Technology [***]; PROVIDED, HOWEVER, that nothing
contained in this Section 10.11 shall prohibit Pharmacia or any of its
Affiliates from hiring a person responding to a general advertisement for
employment.
10.12 EXPORTS. The parties acknowledge that the export of technical
data, materials, or products is subject to the exporting party receiving any
necessary export licenses and that the parties cannot be responsible for any
delays attributable to export controls, which are beyond the reasonable control
of either party. Nabi and Pharmacia agree not to export or re-export, directly
or indirectly, any information, technical data, the direct product of such data,
samples or equipment received or generated under this Agreement in violation of
any applicable export control laws or governmental regulations. Nabi and
Pharmacia agree to obtain similar covenants from their licensees, sublicensees
and contractors with respect to the subject matter of this Section 10.12.
20
10.13 WAIVER. The waiver by either party hereto of any right hereunder
or the failure to perform or of a breach by the other party shall not be deemed
a waiver of any other right hereunder or of any other breach or failure by said
other party whether of a similar nature or otherwise.
10.14 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.
10.15 INTERPRETATION. The parties acknowledge and agree that: (i) each
party and its counsel reviewed and negotiated the terms and provisions of this
Agreement and has contributed to its revision; (ii) the rule of construction to
the effect that any ambiguities are resolved against the drafting party shall
not be employed in the interpretation of this Agreement; and (iii) the terms and
provision of this agreement shall be construed fairly as to all parties hereto
and not in favor of or against any party, regardless of which party was
generally responsible for the preparation of this Agreement.
10.16 IDENTIFICATION OF PATENT RIGHTS; PATENT MARKING. Where
appropriate, all packaging and documentation for the Licensed Products shall
include a notation acknowledging Nabi's patent rights in the Licensed Products.
Pharmacia shall xxxx, and cause its Affiliates and sublicensees to xxxx, all
Licensed Products made, sold or used under this Agreement, or their containers,
in accordance with the applicable patent marking laws of each country in which
such Licensed Products are to be sold or offered for sale.
IN WITNESS WHEREOF, the parties have executed this Agreement as of the
date first set forth above.
NABI BIOPHARMACEUTICALS PHARMACIA AND UPJOHN COMPANY
By: /s/ XXXXXX X. XXXXXX By: /s/ XXXXXX XXXX
----------------------------- -----------------------------------
Title: President and Chief Title: President, Pharmacia
Operating Officer Animal Health
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