EXHIBIT 10.13
5-AZACYTIDINE LICENSE AGREEMENT
DATED AS OF JUNE 7, 2001
BETWEEN:
PHARMION CORPORATION, having an address of 0000 Xxxxxxxxx Xxxx,
Xxxxxxx, Xxxxxxxx 00000,
("Pharmion Corporation"), and
PHARMION GMBH, a wholly owned subsidiary of Pharmion Corporation having
an address of Xxxxxxxxxxxxxxxxxx 0, XX 000, XX 4010 Basel, Switzerland,
("Pharmion GmbH" and, together with Pharmion Corporation, "Pharmion")
AND:
PHARMACIA & UPJOHN COMPANY, having an address of 000 Xxxxx 000X,
Xxxxxxx, Xxx Xxxxxx 00000,
("Pharmacia")
WHEREAS:
A. Pharmacia has developed and owns a chemical entity
and pharmaceutical product formulation known as 5-azacytidine (defined below),
and Pharmacia has previously conducted, and /or facilitated the conduct of Phase
II/III clinical studies for the treatment of myelodysplastic Syndrome ("MDS")
with 5-azacytidine, as well as other clinical studies with 5-azacytidine;
B. Pharmion has developed U.S. and international
regulatory, marketing and information technology capabilities for the purpose of
developing, marketing and selling pharmaceutical products discovered by third
parties;
C. The parties hereto have agreed that Pharmacia will
grant to Pharmion an exclusive worldwide license to the 5-azacytidine Technology
(as defined below) and all related Data (as defined below) for all therapeutic
and diagnostic applications, but with an option for Pharmacia to participate in
the development, manufacture, marketing, distribution, promotion, and sale and
use in any manner of the Product (as defined below) at a later date;
D. Pharmion Corporation shall acquire the rights granted
hereunder, and shall discharge the obligations hereunder, relating to North
America, and Pharmion GmbH shall acquire the rights granted hereunder, and shall
discharge the obligations hereunder, relating to the rest of the world;
E. The obligations of Pharmion Corporation and Pharmion
GmbH hereunder shall be joint and several; and
F. The parties wish to enter into this Agreement (as
defined below) to set out the terms and conditions of their agreement with
respect to the development and Commercialization (as defined below) of the
Product and the licenses and other rights granted with respect thereto.
NOW THEREFORE THIS AGREEMENT WITNESSES that in consideration of the
mutual covenants contained in this Agreement and other good and valuable
consideration, the receipt and sufficiency of which is acknowledged, the parties
hereto agree as follows:
1. DEFINITIONS, SCHEDULES AND INTERPRETATION
1.1 DEFINED TERMS. In this Agreement, unless the context
otherwise requires:
(a) "ADVERSE DRUG REACTION REPORTS" shall mean reports
concerning or alleging side-effects, injury, significant failure of expected
pharmacological action, toxicity or sensitivity reaction including unexpected or
increased frequency or severity thereof, associated with commercial or clinical
uses, studies, investigations or tests on animals or human beings of the
Product, whether or not determined to be attributable to the Product or to any
other pharmaceuticals.
(b) "AFFILIATE" means, at any time, any person, company
or legal entity then directly or indirectly controlled by, controlling or under
common control with the Party with respect to which the term is associated,
where "control" means:
(i) The ownership, whether direct or indirect,
of 50% or more of the shares of the Party with respect to which the
term is associated, or
(ii) In the absence of ownership of 50% or more
of the shares of the Party with respect to which the term is associated
or in the case of a non-corporate entity, the ability to direct or
cause the direction of the management and policies of the Party with
respect to which the term is associated.
(c) "AGREEMENT" shall mean this 5-azacytidine License
Agreement dated as of June 7, 2001 between Pharmion and Pharmacia (including all
Schedules attached hereto), as the same may be amended, modified or supplemented
from time to time.
(d) "APPROVAL" means any and all licenses, permits,
certificates of authority, authorizations, approvals (including, without
limitation, any applicable governmental price and reimbursement approvals),
registrations, and similar consents granted or issued by any Governmental or
Regulatory Authorities and necessary for the importation, exportation,
development, manufacture, distribution, sale, marketing, promotion, storage,
transport or use in any manner of the Product.
(e) "BUSINESS DAY" shall mean a day, other than Saturday
or Sunday, on which banks are open for business in New York, New York.
(f) "CGMP" shall mean all laws, guidelines and
regulations applicable to the manufacture of the Product within the respective
Country of Sale, including the current Good
Manufacturing Practice regulations as promulgated under Federal Food, Drug and
Cosmetic Act (21 CFR), as the same may be amended , modified or supplemented
from time to time, or similar manufacturing guidelines and regulations
applicable outside the United States.
(g) "COMMERCIALIZATION PLANS" means all marketing plans
retained by Pharmacia, if any, relating to the proposed marketing and sale of
5-azacytidine, together with all available sales and financial projections, if
any, related to such marketing plans, developed by Pharmacia during the three
years prior to the date of this Agreement.
(h) "COMMERCIALIZE" AND "COMMERCIALIZATION" mean the
manufacture, distribution, promotion, marketing, sale, export, import, storage
and use of the Product in any manner related to providing the Product in Final
Form (as defined below).
(i) "CONFIDENTIAL INFORMATION" shall have the meaning set
forth in paragraph 8.1.
(j) "COUNTRY OF SALE" means the country where the Product
is being sold to unaffiliated customers.
(k) "DATA" means all information owned by Pharmacia and
contained in or arising from clinical study protocols, and results of clinical
studies conducted, for 5-azacytidine in any form or formulation, including,
without limitation, Regulatory Data.
(l) "CRITICAL DECISION PERIOD" means the 75- day period
specified in paragraph 7.3.
(m) "DROPPED PRODUCT LICENSE" means the license to
develop and Commercialize the Product ( including, without limitation, the right
to use any and all trademarks and tradenames of the Product) as specified in
paragraphs 10.4 and 10.5.
(n) "DROPPED PRODUCT OPTION" means the exclusive,
irrevocable option from Pharmion to Pharmacia to use commercially reasonable
efforts to negotiate in good faith the Dropped Product License as specified in
paragraph 10.4.
(o) "EFFECTIVE DATE" means the date of this Agreement,
written at the start of this Agreement.
(p) "FDA" means the United States Food and Drug
Administration.
(q) "FINAL FORM" means a finally finished and packaged
form of the Product suitable for ultimate consumer use.
(r) "FIRST COMMERCIAL SALE" means, with respect to each
Country of Sale, the first sale of the Product to an unaffiliated customer in
such Country of Sale after the Governmental or Regulatory Authorities within
such country have granted all applicable Approvals, if any.
(s) "5-AZACYTIDINE" means the proprietary chemical entity
known as 5-azacytidine having the Structure set forth in SCHEDULE B attached to
this Agreement.
(t) "5-AZACYTIDINE TECHNOLOGY" means all information and
know-how developed by or on behalf of Pharmacia or its Affiliates, or acquired
by Pharmacia or its Affiliates, prior to the Effective Date, whether or not
patented, with respect to 5-azacytidine, including, without limitation,
information which describes or identifies 5-azacytidine, the proprietary
synthetic processes for 5-azacytidine, methods of use of 5-azacytidine,
formulations for 5-azacytidine, all information and results of laboratory,
preclinical and clinical studies conducted by or on behalf of Pharmacia with
respect to 5-azacytidine in any form or formulation and all other Data and any
and all Commercialization Plans. Without limiting the foregoing, the
"5-azacytidine Technology" includes the Pharmacia Patents, if any.
(u) "GOVERNMENTAL OR REGULATORY AUTHORITY" shall mean any
court, tribunal, arbitrator, authority, agency, department, bureau, commission,
official or other instrumentality of the U.S., any foreign country or
multinational organization or any domestic or foreign state, province, county,
city or other political subdivision.
(v) "IND" means an Investigational New Drug application
filed with the FDA seeking authority to test a product in human clinical
studies.
(w) "JOINT DEVELOPMENT AND PROMOTION AGREEMENT" means the
agreement to be negotiated and entered into by Pharmion and Pharmacia pursuant
to paragraph 7.4 regarding the continued development and Commercialization of
the Product in the event that Pharmacia exercises the Participation Option (as
defined below).
(x) "LIABILITIES" means any and all liabilities, claims,
losses, damages, costs, fines, fees, penalties, deficiencies and expenses
(including, without limitation, interest, court costs and reasonable fees of
attorneys).
(y) "NDA" means a New Drug Application pursuant to 21
U.S.C. Section 505 (b)(1) and any amendments or supplements thereto, filed with
the FDA, or any successor application or procedure, seeking Approval for the
Product, or any similar application, amendment, supplement, successor
application or procedure filed in any other country to the Governmental or
Regulatory Authorities charged with responsibility for regulating approval to
market a product for the treatment of humans.
(z) "NDA FILING NOTICE" means written notice from
Pharmion to Pharmacia delivered pursuant to paragraph 7.2, whereby Pharmion
notifies Pharmacia that the FDA has accepted for filing an NDA for the Product.
(aa) "NET SALES" means the actual gross invoiced sales
price of the Product billed to unaffiliated customers, less:
(i) To the extent such amounts are included in
the invoiced sales price, actual credited allowances and/or
charge-backs for spoiled, damaged, out-dated and returned Product,
(ii) Quantity and other trade discounts and early
settlement discounts (where such discounts are effectively
non-discretionary and are given as a matter of course) actually allowed
and taken,
(iii) Sales, value-added and other direct taxes
incurred (except for taxes based on Pharmion's income),
(iv) Customs duties and surcharges and other
governmental charges incurred in connection with the exportation or
importation of the Product, and
(v) Legally mandated rebates.
(bb) "OPTION EXPIRY DATE" means the date specified in the
first sentence of paragraph 7.3.
(cc) "ORALLY AVAILABLE PRODUCT" means any orally available
therapeutic formulation of the Product.
(dd) "PARTICIPATION OPTION" means the exclusive,
irrevocable option granted by Pharmion to Pharmacia pursuant to paragraph 7.1,
the exercise of which permits Pharmacia to participate with Pharmion in the
continued development and Commercialization of the Product on the terms and
conditions set out in Section 7.
(ee) "PARTICIPATION OPTION EXERCISE NOTICE" means written
notice from Pharmacia to Pharmion of the exercise by Pharmacia of the
Participation Option, pursuant to paragraph 7.3.
(ff) "PHARMACIA" means Pharmacia & Upjohn Company (a party
to this Agreement).
(gg) "PHARMACIA PATENTS" means:
(i) The patents and patent applications listed
in SCHEDULE A to this Agreement,
(ii) Any and all continuations,
continuations-in-part, divisionals, reissues, re-examinations or
improvements of or to the aforesaid patents and patent applications
listed in clause (i),
(iii) All foreign applications and patents
corresponding to the patents and patents applications listed in clauses
(i) and (ii) above which have been or may be filed and which directly
relate to 5-azacytidine,
(iv) Any supplementary protection certificates or
equivalent patent term extension rights which directly relate to
5-azacytidine, its manufacture or use, and
(v) Author certificates, inventor certificates,
utility certificates, certificates of addition, re-filings, renewals,
patents of addition, extensions,
substitutions, confirmations, registrations or revalidations which
directly relate to 5-azacytidine, its manufacture or use, or additions
of or to any of the above which directly relate to 5-azacytidine, its
manufacture or use, and all foreign counterparts of the above which
directly relate to 5-azacytidine, its manufacture or use.
(hh) "PHARMACIA REPRESENTATIVE" means the one
representative of Pharmacia on Pharmion's Project Management Team (as defined
below).
(ii) "PHARMION" means, collectively, Pharmion Corporation
and Pharmion GmbH (each a party to this Agreement).
(jj) "PRODUCT" means any and all Pharmion therapeutic or
diagnostic formulations of 5-azacytidine in Final Form (including Orally
Available Product).
(kk) "PRODUCT PATENTS" means:
(i) Any and all patent applications and patents
filed by or on behalf of, and/or issued to Pharmion or its Affiliates
either prior to or during the Term (as defined below) or licensed in by
Pharmion, which contain claims covering inventions which are necessary
or useful for the development or Commercialization of the Product or
the Final Form of the Product,
(ii) Any and all continuations,
continuations-in-part, divisionals, reissues, re-examinations or
improvements of or to the patents and patent applications listed in
clause (i) above,
(iii) All foreign applications and patents
corresponding to the patents and patent applications listed in clauses
(i) and (ii) above,
(iv) Any supplementary protection certificates or
equivalent patent term extension rights which relate to the patents and
patent applications listed in clauses (i) and (ii) above and
(v) Author certificates, inventor certificates,
utility certificates, certificates of addition, re-filings, renewals,
patents of addition, extensions, substitutions, confirmations,
registrations or revalidations which relate to the Product or the Final
Form of the Product, its formulation, manufacture or use or additions
of or to any of the above and all foreign counterparts of the above .
Notwithstanding the foregoing, the "Product Patents" exclude all 5-azacytidine
Technology and Pharmacia Confidential Information.
(ll) "PRODUCT TECHNOLOGY" means all information and
know-how developed by or on behalf of Pharmion or its Affiliates, or acquired by
Pharmion or its Affiliates, prior to or during the Term, whether or not
patented, with respect to the Product, including, without limitation,
information which describes or identifies the Product, proprietary synthesis
processes for the Product, methods of use of the Product, formulations for the
Product and all information and results of laboratory, preclinical and clinical
studies conducted by or on behalf of Pharmion
or its Affiliates with respect to the Product in any form or formulation. The
"Product Technology" includes any and all Product Patents, but excludes all
5-azacytidine Technology and Pharmacia Confidential Information.
(mm) "PROJECT MANAGEMENT TEAM" means Pharmion's project
management team for the development and Commercialization of the Product.
(nn) "PUBLICATION" means any proposed publication or other
such public disclosure, written or oral, concerning or relating to the
5-azacytidine Technology.
(oo) "REGULATORY DATA" means all regulatory submissions
made by Pharmacia with respect to 5-azacytidine with Governmental or Regulatory
Authorities in any part of the world prior to the Effective Date, all
correspondence with such Governmental or Regulatory Authorities relating to any
such submissions and all notes of verbal communications from such Governmental
or Regulatory Authorities relating to such submissions; provided, however, that
"Regulatory Data" shall not include any proprietary or confidential information
of any third party. Without limiting the generality of the foregoing,
"Regulatory Data" shall include any data or submissions filed by Pharmacia to
obtain "orphan drug" status or other similar special product approvals.
(pp) "RULES" means the Commercial Arbitration Rules of the
American Arbitration Association.
(qq) "STRUCTURE" means the chemical structure for
5-azacytidine as set forth in Schedule B.
(rr) "TERM" means the term of this Agreement, as more
specifically set out at paragraph 10.1.
(ss) "THIRD PARTY CLAIM" means a claim made or any
litigation or other proceeding or action brought or threatened by any claimant
(other than any Affiliate of a Party) not a party to this Agreement.
(tt) "TRADEMARK NOTICE" means written notice from Pharmion
to Pharmacia pursuant to paragraph 6.4 regarding Pharmion's top choices for each
trademark or trade name for the Product.
(uu) "VALID CLAIM" means a claim of an issued unexpired
patent included within the Pharmacia Patents, if any, which has not been held
permanently revoked, unenforceable or invalid by a decision of a court or other
government agency of competent jurisdiction, un-appealable or unappealed within
the time allowed for appeal, and which has not been admitted to be invalid or
unenforceable.
1.2 ADDITIONAL DEFINITIONS. Any words defined elsewhere
in this Agreement shall have the particular meaning assigned thereto.
1.3 SCHEDULES. The following are the schedules to this
Agreement and are incorporated into and deemed to form a part of this Agreement:
SCHEDULE A - Pharmacia Patents and Patent Applications
SCHEDULE B - Chemical Structure of 5-azacytidine
SCHEDULE C - Quantities of 5-azacytidine Material to be
Transferred to Pharmion
SCHEDULE D - Insurance
1.4 OTHER INTERPRETIVE PROVISIONS. In this Agreement,
unless the context otherwise requires:
(a) TENSE/GENDER - Words denoting the singular shall
include the plural and vice versa and the masculine gender shall include the
feminine gender and neuter and vice versa;
(b) AMENDMENTS - Reference to any statute, law, rule,
regulation or document shall be a reference to that statute, law, rule,
regulation or document and all amendments, consolidations, modifications or
reenactments thereof from time to time;
(c) NUMBERS - Where numbers are referred to in full as
well as in figures, the full description shall prevail over the actual figures
in the event of any inconsistencies; and
(d) PARTY - Pharmacia and Pharmion may be referred to
herein individually as a "Party" or collectively as the "Parties". For purposes
of this Agreement, Pharmion Corporation and Pharmion GmbH, together, shall
constitute a "Party" under this Agreement and the obligations of Pharmion
Corporation and Pharmion GmbH under this Agreement shall be joint and several.
In addition, all notices and/or consents required to be given to or by Pharmion
under this Agreement and all amounts required to be paid to or by Pharmion under
this Agreement shall be deemed to be duly given to or received by, or duly paid
to or by, Pharmion if duly given to or received by, or duly paid to or by,
either Pharmion Corporation or Pharmion GmbH.
2. LICENSE GRANTS
2.1 GRANT OF LICENSE TO THE 5-AZACYTIDINE TECHNOLOGY.
Pharmacia hereby grants to Pharmion, and Pharmion hereby accepts, an exclusive
worldwide license to use the 5-azacytidine Technology to develop and
Commercialize the Product for all therapeutic and diagnostic applications.
2.2 FURTHER ASSURANCES. Subject to the terms and
conditions of this Agreement, each of the Parties agrees to use its commercially
reasonable efforts to take, or cause to be taken, all actions and to do, or
cause to be done, all things necessary or desirable to consummate the
transactions contemplated by this Agreement, including, without limitation,
using their respective commercially reasonable efforts to cause the National
Cancer Institute ("NCI") and the Cancer and Leukemia Group - B ("CLGB") to
transfer to Pharmion the right to use their respective proprietary and/or
confidential information relating to 5-azacytidine.
2.3 SUB-LICENSES
(a) CONTRACT MANUFACTURING SUB-LICENSE -Pharmion shall
have the right at any time during the Term of this Agreement to sub-license
rights under this Agreement to one or more contract manufacturers for the
purposes of permitting such manufacturer(s) to make the
Product for Pharmion. Any such contract manufacturers shall be reasonably
satisfactory to Pharmacia.
(b) NO SUB-LICENSES BEFORE EXPIRY OF THE PARTICIPATION
OPTION - Except as provided in subparagraph 2.3(a), Pharmion shall not have the
right, without the prior written consent of Pharmacia, to grant sub-licenses
under this Agreement until after expiry of the Participation Option.
(c) RIGHT TO SUB-LICENSE - Subject to the provisions of
subparagraphs 2.3(a) and (b), Pharmion shall have the right to sub-license any
of the rights under this Agreement, subject to the following terms and
conditions:
(i) NOTICE - Pharmion shall provide notice in
writing to Pharmacia of any sub-licenses granted under this Agreement.
(ii) NO RELIEF - Sub-licensing shall not relieve
Pharmion of any obligations (financial or other) under this Agreement
and Pharmion shall make all required payments to Pharmacia as if the
sublicensed activities were conducted by Pharmion.
(iii) SIMILAR PROVISIONS - Pharmion shall ensure
that each sub-license contains all of the same payment, reporting,
record keeping, audit and liability provisions as are contained in this
Agreement, which provisions shall allow access and audits by Pharmacia
as if the sub-licensee had contracted directly with Pharmacia.
(iv) COMPULSORY SUB-LICENSES - Notwithstanding
the provisions of clauses (ii) and (iii) above, if Pharmion is required
pursuant to law to grant a sub-license of its rights under this
Agreement to a government or third party in a country where Pharmion is
selling or offering for sale the Product, Pharmion will use reasonable
commercial efforts to negotiate a sub-license that complies with the
terms of this subparagraph 2.3(c). The Parties acknowledge and agree
that it may not be possible for Pharmion to negotiate a complying
sub-license, and in this case, Pharmion will negotiate and/or enter
into a sub-license on the best terms and conditions as Pharmion is able
to negotiate. In this situation, Pharmacia and Pharmion will reasonably
agree on the compensation that will accrue to each Party under such
compulsory sub-license.
2.4 RESERVED RIGHTS. All rights not specifically granted
under this Agreement to Pharmion are reserved to Pharmacia.
2.5 NONCOMPETE. During the Term, Pharmion and its
Affiliates shall not directly or indirectly develop, license, manufacture,
distribute, promote, market, sell, export, import or use in any manner any
product if such activity would adversely and materially affect the sale of the
Product.
2.6 PRIORITY. Pharmion shall give as high a priority to
the development and commercialization of the Product as it would to promising
compounds originating from its own research. Pharmion shall diligently pursue
development and Commercialization efforts with respect to the Product and shall
use all commercially reasonable efforts to devote adequate
personnel and other resources to develop and Commercialize the Product with a
view to obtaining all applicable Approvals as quickly as possible.
3. ROYALTIES
3.1 PARTICIPATION OPTION NOT EXERCISED. If Pharmacia does
not exercise the Participation Option set forth in Section 7, Pharmion shall pay
Pharmacia, on a country-by-country basis, a royalty of twenty percent (20%) of
Net Sales of the Product in each Country of Sale for the longer of the period
of:
(i) The date of the First Commerical Sale of the
Product (which shall be the date of invoice of the first such sale) in
such Country of Sale through the date of the last to expire of the
Valid Claims in such Country of Sale; or
(ii) ten (10) years from the date of First
Commercial Sale (which shall be the date of invoice of the first such
sale) in such Country of Sale;
provided, however, that if the Data (including, without limitation all
information and data obtained by NCI and/or CLGB in connection with
5-azacytidine) are deemed insufficient by the FDA to support an approval of the
Product as a treatment for MDS patients or any sub-group of MDS patients (other
than any refinements and/or minor supplements to the Data or Class 1
re-submissions required or requested by the FDA to obtain FDA approval) and
Pharmion must conduct another Phase III clinical trial for such indication prior
to initial FDA approval, then the royalty rate shall be eight percent (8%) of
Net Sales; and provided, further, that if a product containing 5-azacytidine is
sold in a similar formulation to the Product in any Country of Sale as a generic
drug or branded generic drug, then from and after the date that such generic
product has attained a greater than 10% market share in such Country of Sale (as
determined by evidence provided by Pharmion and satisfactory to Pharmacia), the
royalty rate in such Country of Sale shall be five percent (5%) of Net Sales.
Notwithstanding the foregoing, the royalty rate on Net Sales of Orally Available
Product in each Country of Sale shall be five percent (5%). In the event that
Pharmion is required to pay any royalty to NCI and/or CLGB in connection with
Pharmion's use of any NCI or CLGB information and/or data related to
5-azacytidine and required for FDA approval of the NDA for the Product, Pharmion
and Pharmacia agree to reasonably negotiate appropriate changes to the royalty
payments hereunder.
3.2 PARTICIPATION OPTION EXERCISED. If the Parties
execute the Joint Development and Promotion Agreement, Pharmion will not be
obligated to pay any royalty payments to Pharmacia pursuant to this Section 3
after the date of such execution.
3.3 NET SALES CALCULATION. The Parties acknowledge and
agree that any part of Net Sales received by Pharmion that is computed in a
currency other than United States dollars will be translated into United States
dollars at the average of the exchange rate applicable on the last business day
of the month prior to the month of such Net Sales, and the exchange rate
applicable on the last business day of the month in which such Net Sales were
made, in each case, as published in the United States edition of the Wall Street
Journal.
3.4 WITHHOLDING TAX. Any tax (other than any tax based on
Pharmion's income) which Pharmion is required by law to pay or withhold from
royalty payments to be made to
Pharmacia under this Agreement shall be deducted from the amount otherwise due;
provided that, in regard to any such deduction, Pharmion shall give Pharmacia
such assistance as may be reasonably requested by Pharmacia to enable or assist
Pharmacia to claim exemption therefrom or a reduction thereof and shall provide
Pharmacia with an official tax certificate as soon as possible. Proof of all
withholding tax payments in form satisfactory to Pharmacia shall be provided by
Pharmion to Pharmacia as evidence of such payments.
3.5 INVOICES FOR ROYALTIES. If requested by Pharmion,
Pharmacia shall submit a written invoice addressed to Pharmion for each royalty
payment to be made by Pharmion under this Agreement. Pharmacia shall submit
these written invoices to Pharmion promptly upon receipt of the quarterly
royalty report from Pharmion as specified in subparagraph 4.1(b).
3.6 ROYALTY CALCULATION AND PAYMENT.
(a) TIMING - During the Term, royalties for the sale of
the Product shall be calculated and paid by Pharmion to Pharmacia quarterly, and
shall be due (i) as to Net Sales within the United States, not later than 45
days following the end of each calendar quarter and (ii) as to Net Sales outside
the United States, not later than 90 days following the end of each calendar
quarter; provided, however, that if any such royalties are not paid when due,
Pharmion shall pay to Pharmacia interest on such overdue amount for the period
from and including the due date to but excluding the date on which such amount
(royalty and interest) is paid to Pharmacia in full. The interest rate payable
by Pharmion to Pharmacia on such overdue amount shall be equal to the lesser of
(i) the prime commercial lending rate as announced by Citibank N.A. at its
principal office in New York, New York and (ii) the maximum rate permitted by
applicable law.
(b) CURRENCY OF PAYMENT - All royalties shall be payable
by Pharmion to Pharmcia in immediately available funds in United States currency
by wire transfer to an account designated in writing by Pharmacia.
3.7 NO OTHER ROYALTIES. The royalties set out in this
Section 3 are the only royalties payable by Pharmion to Pharmacia (or to any
Pharmacia licensor) in connection with the licenses granted under paragraph 2.2
of this Agreement.
3.8 ROYALTY REDUCTION AS PER THIS AGREEMENT. The Parties
acknowledge and agree that all of the royalty payment provisions of this Section
3 are subject to the provisions of paragraph 9.6 of this Agreement.
3.9 PAID UP LICENSES. At the time of expiry of the
periods for the payment of royalties on the sale of the Product in each Country
of Sale as set out in this Section 3, Pharmion shall have a fully paid-up right
and license under paragraph 2.2 in such Country of Sale with respect to the
Product.
4. REPORTS AND RECORD KEEPING
4.1 REPORTS. During the Term, Pharmion shall have the
following reporting requirements to Pharmacia:
(a) PROGRESS REPORTS - Pharmion shall submit semi-annual
progress reports to Pharmacia, such reports to summarize in reasonable detail
Pharmion's progress with development and Commercialization of the Product during
each six-month period. These reports shall be delivered to Pharmacia no later
than 45 days after each six-month period. The Parties agree that the first such
report shall be delivered to Pharmacia not later than 45 days after June 30,
2001. In addition, Pharmion shall provide to a limited number of Pharmacia
personnel physical access (by telephone, facsimile, e-mail and through personal
visits) at reasonable times during regular business hours to a reasonable number
of Pharmion personnel who are knowledgeable about such progress reports and who
will provide such Pharmacia personnel with additional information about such
progress reports, as reasonably requested by Pharmacia.
(b) ROYALTY REPORTS - After First Commercial Sale in any
Country of Sale and for the remainder of the Term, Pharmion shall submit
quarterly payment reports to Pharmacia (as to Net Sales within the United
States, not later than 45 days following the end of each calendar quarter and,
as to Net Sales outside the United States, not later than 90 days following the
end of each calendar quarter, in each case at the same time as it transfers to
Pharmacia the royalty payments due and payable for such quarter). Such reports
shall include, but not be limited to:
(i) An accounting of Net Sales for the Product
in each Country of Sale (in United States currency) on a country-by-
country basis and the calculation of Net Sales from the gross revenues
for the Product in each Country of Sale, and
(ii) An accounting of worldwide Net Sales (in
United States currency) and the calculation of the royalty amounts
owing to Pharmacia pursuant to Section 3 (in United States currency),
including, if applicable, the exchange rates used in determining the
royalty amounts due in United States currency.
4.2 RECORD KEEPING. Pharmion shall keep complete and
accurate written financial and accounting records with respect to Sections 3 and
4 of this Agreement, in accordance with generally accepted accounting practices
and consistently applied across all Pharmion products, sufficient for Pharmacia
to ascertain and verify the accuracy and completeness of the accounting and the
amounts owing pursuant to this Agreement. Pharmion shall preserve these written
records for a period of at least six years after creation of such records.
4.3 AUDITS. Not more than once per year during the Term,
Pharmion shall permit independent auditors (chosen by Pharmacia and reasonably
acceptable to Pharmion) to inspect, copy and abstract Pharmion's books, records
and accounts and all or any part of its operations and activities as may be
necessary to determine the completeness and accuracy of the reports and payments
made or required to be made under this Agreement. Pharmacia shall give
reasonable notice to Pharmion of its request for an audit pursuant to this
provision, and such audit shall be conducted during normal business hours.
Pharmacia shall be responsible for the cost of such audit; provided, however,
that if the independent auditors conducting such audit conclude that the royalty
payments made hereunder were understated by an amount in excess of five percent
(5%) during any calendar year, Pharmion will pay the cost of such audit. If such
audit determines that additional payments were owed during such period, Pharmion
shall pay the
additional amounts to Pharmacia not later than 45 days after the date of the
delivery of the audit report to Pharmion. The Parties acknowledge and agree that
the confidentiality provisions of Section 8 will apply to audits conducted
pursuant to this paragraph 4.3 and Pharmacia shall ensure that its auditors
(including all audit personnel working on the audit) are bound by
confidentiality provisions at least equivalent to the confidentiality provisions
of Section 8.
5. PHARMACIA OBLIGATIONS
5.1 TECHNOLOGY TRANSFER. To the extent not already
provided by Pharmacia to Pharmion, promptly after execution of this Agreement,
Pharmacia shall disclose and make available to Pharmion the 5-azacytidine
Technology, and all documentation retained by it relating to the 5-azacytidine
Technology sufficient to enable Pharmion to exercise its rights and perform its
obligations under this Agreement. In addition, during the Term, Pharmacia shall
provide to a limited number of Pharmion personnel physical access (by telephone,
facsimile, email and through personal visits) at reasonable times during regular
business hours to a reasonable number of Pharmacia personnel (at Pharmion or
Pharmacia facilities) and to materials and information pertaining to the
5-azacytidine Technology, as more specifically set out below:
(a) PHARMACEUTICAL DEVELOPMENT - For the first six months
after the Effective Date, Pharmacia will use its reasonable efforts to provide
ongoing assistance to Pharmion pharmaceutical development personnel with respect
to 5-azacytidine material to be supplied by Pharmacia to Pharmion pursuant to
paragraph 5.2, if any, including the provision of documentation certifying cGMP
compliance of the 5-azacytidine material to be supplied to Pharmion,or, to the
extent 5-azacytidine is manufactured by a third party, to provide reasonable
assistance to Pharmion in monitoring of the synthesis, production and cGMP
compliance of such third party. Pharmion estimates that the assistance required
from Pharmacia under this subparagraph 5.1(a) should not be more than two days
initially and then some periodic questions, but in no event exceeding in total
20 person-hours of Pharmacia time.
(b) REGULATORY - For the first 12 months after the
Effective Date, Pharmacia will use its reasonable efforts to provide ongoing
assistance (not to exceed 20 person-hours of Pharmacia time) to Pharmion
regulatory personnel in the form of answering questions that may arise from time
to time with respect to the IND filed for 5-azacytidine. As well, for a period
of 12 months after the filing by Pharmion of its IND (and the European
equivalent) for the Product, Pharmacia will use its reasonable efforts to
provide ongoing assistance (not to exceed 20 person-hours of Pharmacia time) to
Pharmion regulatory personnel in the form of assisting with questions that the
FDA or other Governmental or Regulatory Authorities may have on Pharmion's IND
(and the European equivalent). The Pharmacia assistance required by Pharmion
regulatory personnel pursuant to this subparagraph 5.1(b) shall not exceed a
total of 40 person-hours. In addition to the foregoing, if requested by
Pharmion, and to the extent permissable by the FDA or any similar Governmental
or Regulatory Authorities outside the United States, Phamacia will cooperate
reasonably with Pharmion in the transfer of any IND (and the European
equivalent) for 5-azacytidine to Pharmion. If such transfer is not permitted,
Pharmacia will provide reasonable assistance to Pharmion to allow Pharmion to
cross-reference any IND (and the European equivalent) pertaining to
5-azacytidine from any IND (or European equivalent) filed by Pharmion for the
Product.
(c) MANUFACTURING - For the first 24 months after the
Effective Date, Pharmacia will use reasonable efforts to provide three days per
calendar quarter (excluding travel time) of consultation and advice from
Pharmacia personnel to Pharmion's manufacturing personnel (not to exceed a total
of approximately 180 person-hours of assistance during such period). From time
to time during this 24 month period, Pharmion manufacturing personnel will
request this consultation and advice from Pharmacia and the assistance will be
provided at times agreeable to the Pharmion and Pharmacia personnel, both acting
reasonably. The support to be provided by Pharmacia to the Pharmion
manufacturing personnel under this subparagraph 5.1(c) shall be from Pharmacia
personnel knowledgeable with the chemical synthesis of 5-azacytidine, if any,
who can assist Pharmion with the transfer of the chemical synthesis of
5-azacytidine from Pharmacia to a third party contract manufacturer chosen by
Pharmion in accordance with subparagraph 2.3(a).
All out-of-pocket costs associated with all personnel visits under this
paragraph 5.1 shall be reimbursed by Pharmion to Pharmacia, unless otherwise
agreed by the Parties, and all such visits shall be at mutually agreeable times,
both Parties acting reasonably.
5.2 MATERIAL TRANSFER. As soon as practicable after the
Effective Date and in any event no later than 21 Business Days after the
Effective Date, Pharmacia shall transfer to Pharmion existing quantities of
5-azacytidine compound, if any, previously synthesized in accordance with cGMP
processes by or on behalf of Pharmacia and in Pharmacia's possession as more
specifically set out in SCHEDULE C.
5.3 NO FURTHER RESEARCH BY PHARMACIA. Except in the event
of exercise by Pharmacia of the Participation Option, the Parties acknowledge
and agree that Pharmacia shall have no obligation to conduct further research or
development in connection with 5-azacytidine under this Agreement.
6. PHARMION OBLIGATIONS
6.1 DEVELOPMENT ACTIVITIES. Except in the event of
exercise by Pharmacia of the Participation Option, Pharmion shall have sole
responsibility and liability for obtaining all Approvals necessary to develop
and Commercialize the Product in each Country of Sale. In addition, Pharmion
shall have sole responsibility and discretion, and shall use all commercially
reasonable efforts at its sole cost and expense, to develop and Commercialize
the Product, including, without limitation:
(a) CLINICAL - Conduct human clinical trials of the
Product as Pharmion determines are reasonable, necessary or desirable;
(b) REGULATORY - Obtain all applicable Approvals for the
Product;
(c) PRODUCT AND MANUFACTURING PROCESS DEVELOPMENT -
Develop (and/or contract out for) a manufacturing and process development
package for the Product as Pharmion determines is reasonable, necessary or
desirable; and
(d) MARKET - Subject to paragraph 2.6, Commercialize the
Product in such regions, at such prices and on such other terms and conditions
as Pharmion determines are reasonable, necessary or desirable.
Notwithstanding the above development and Commercialization provisions of this
paragraph 6.1, but subject to paragraph 2.6, Pharmion shall not be obligated to
undertake any particular activity and shall not be obligated to continue
development and Commercialization of the Product. Notwithstanding any other
provision of this Agreement, in the event that the date of the First Commercial
Sale of the Product (which shall be the date of invoice of the first such sale)
shall not have occurred during the five (5) year period immediately succeeding
the Effective Date, then, upon thirty (30) days prior written notice to
Pharmion, Pharmacia may terminate this Agreement, and the provisions of
paragraph 10.3 shall thereafter apply.
6.2 PHARMACIA REPRESENTATIVE. During the Term and prior
to the Option Expiry Date, Pharmion shall permit the Pharmacia Representative to
participate, as a non-voting member, on Pharmion's Project Management Team.
Pharmacia acknowledges that Pharmion's preference is that the Pharmacia
Representative be a project management employee. Except for the acknowledgment
set out above, Pharmacia shall be solely responsible for the designation of the
Pharmacia Representative and shall be solely responsible for any expenses of the
Pharmacia Representative in connection with the Pharmacia Representative's
participation on the Project Management Team. Pharmion will ensure that written
notice of Project Management Team meetings are given to the Pharmacia
Representative, but will not be obligated to alter Project Management Team
meetings or activities to accommodate the schedule of the Pharmacia
Representative. Pharmion will provide to the Pharmacia Representative all
documents and other materials distributed or otherwise made available to any
other members of the Project Management Team. The Pharmacia Representative shall
continue to participate on the Project Management Team after the Option Expiry
date if Pharmacia exercises the Participation Option; provided, however, that
Pharmion shall have no further obligation to permit the Pharmacia Representative
to participate on the Project Management Team under this paragraph 6.2 after the
Option Expiry Date if Pharmacia does not exercise the Participation Option.
6.3 EXPENSES. Except in the event of the Parties
executing the Joint Development and Promotion Agreement, Pharmion shall be
solely responsible for all costs and expenses of the development and
Commercialization of the Product.
6.4 TRADEMARKS.
(a) PHARMION'S RESPONSIBILITY - During the Term, except
as set out below at subparagraph 6.4(b), Pharmion shall be responsible for, in
its sole discretion and at its sole expense, prosecution and maintenance of the
trademarks and trade names for the Product.
(b) NOTICE TO PHARMACIA - Pharmion agrees that it will
give Trademark Notice to Pharmacia, notifying Pharmacia of Pharmion's top
choices (not to exceed five) for a trademark or trade name for the Product. If
Pharmacia has a preference for the choice of trademark or trade name for the
Product, Pharmacia shall provide written notification of this preference within
45 days of receipt of such Trademark Notice. Pharmion will reasonably consider
Pharmacia's input into the choice of each trademark or trade name for the
Product.
Pharmion is not obligated to chose any trademark or trade name recommended by
Pharmacia, but agrees that it will not choose a trademark or trade name to which
Pharmacia has a reasonable objection.
Pharmion shall have no further obligation to consult with Pharmacia under this
paragraph 6.4 after the Option Expiry Date if Pharmacia does not exercise the
Participation Option.
6.5 NO OTHER CONSULTATION REQUIRED. Except as provided in
this Agreement, in the event Pharmacia does not exercise the Participation
Option, any additional consultation between Pharmion and Pharmacia with respect
to development of the Product will be from time to time on an as needed basis,
where and when appropriate and as the Parties may mutually agree and neither
Party will be obligated to discuss or consult with the other Party on Product
development matters.
7. PARTICIPATION OPTION
7.1 GRANT OF PARTICIPATION OPTION. Pharmion hereby grants
the Participation Option to Pharmacia, as specified in this Section 7. The
Participation Option may be exercised by Pharmacia as set out in paragraph 7.3.
7.2 DELIVERY OF NDA FILING NOTICE. Promptly after its
filing with the FDA of its first NDA for the Product, Pharmion shall deliver to
Pharmacia the NDA Filing Notice.
7.3 OPTION EXERCISE PERIOD. Pharmacia may exercise the
Participation Option at any time up to and including the Option Expiry Date
which shall be the date occurring 75 days after the date of receipt by Pharmacia
of (i) the NDA Filing Notice and (ii) all preclinical, clinical, regulatory,
manufacturing, financial, marketing, royalty and other data relating to the
Product, including photocopies of documentation pertaining to the development
and Commercialization of the Product in order to assist Pharmacia to make its
decision with respect to the Participation Option. Pharmacia may exercise the
Participation Option by giving the Participation Option Exercise Notice to
Pharmion.
(a) INFORMATION SHARING - During the Critical Decision
Period, Pharmion shall promptly disclose and make available to Pharmacia such
information as Pharmacia may reasonably request. In addition, during the
Critical Decision Period, Pharmion will provide physical access (by telephone,
facsimile, email and through personal visits) for a reasonable number of
Pharmacia personnel to all materials and information pertaining to the Product
and, during any Pharmacia visit, Pharmion personnel will be available to respond
to inquiries with respect to the Product. All visits by Pharmacia shall be at
the expense of Pharmacia and shall be at mutually agreeable times, both Parties
acting reasonably. Notwithstanding the above provision for information sharing
and access, Pharmacia acknowledges and agrees that its requests for information
and access under this subparagraph 7.3(a) will be reasonable and will not unduly
interfere with Pharmion personnel's other day to day work obligations.
Notwithstanding the generality of the foregoing, the Parties acknowledge and
agree that Pharmacia has the right during the Critical Decision Period to audit
Pharmion's books, records and accounts and all or any part of Pharmion's
operations and activities as may be reasonably requested by Pharmacia for
Pharmacia to gather the information it requires during the Critical
Decision Period. Pharmacia acknowledges that if it does not exercise the
Participation Option, Pharmion's obligation to share information and provide
access to Pharmacia under this subparagraph 7.3(a) will expire after the Option
Expiry Date. If Pharmacia exercises the Participation Option, Pharmion's
obligation to share information and provide access to Pharmacia under this
subparagraph 7.3(a) will continue throughout the six-month period for
negotiation of the Joint Development and Promotion Agreement as set forth in
paragraph 7.4.
7.4 NEGOTIATION PERIOD.
(a) NEGOTIATION - If Pharmacia gives the Participation
Option Exercise Notice to Pharmion, Pharmion Corporation and Pharmacia shall
have six months from the date of receipt by Pharmion of the Participation Option
Exercise Notice to negotiate in good faith the Joint Development and Promotion
Agreement. Such agreement will contain provisions:
(i) calling for Pharmacia promptly to reimburse
Pharmion for fifty percent (50%) of Pharmion's fully allocated cost
(determined in accordance with United States generally accepted
accounting principles and further specified in the Joint Development
and Promotion Agreement) for the development and Commercialization of
the Product during the Term of this Agreement through the date of
execution of the Joint Development and Promotion Agreement,
(ii) providing for the equal sharing of all
profits and losses derived from the distribution and sale of the
Product and all costs and expenses of the continued development and
Commercialization of the Product, in each case on a 50:50 basis between
Pharmacia and Pharmion, and
(iii) providing for such other terms and
conditions as would typically be found in agreements between
pharmaceutical companies for the joint development and co-promotion of
a product.
Pharmion will continue to share Product data and other information (as set out
at subparagraph 7.3(a) above) with Pharmacia during such six-month negotiation
period.
(b) FAILURE TO REACH AGREEMENT - If during such six-month
negotiation period of the Joint Development and Promotion Agreement, Pharmion
Corporation and Pharmacia fail to reach agreement on any term or condition of
the Joint Development and Promotion Agreement, the Parties shall submit the
dispute to the Chief Executive Officer of Pharmion Corporation and [the Senior
Vice President, Corporate Licensing] of Pharmacia who shall meet with respect to
such dispute and who shall thereafter negotiate in good faith with each other to
resolve such dispute.
8. CONFIDENTIALITY AND PUBLICATION
8.1 CONFIDENTIALITY; EXCLUSIONS. All data, information,
documents and other proprietary materials transmitted by a Party hereto to the
other Party in connection with this Agreement, including without limitation, all
Data, 5-azacytidine Technology, Product Technology, and all other scientific,
technical and clinical data, information reports, financial or business reports
and forecasts and information gathered, generated or transferred by a Party to
the other Party during the course of this Agreement shall be deemed confidential
(hereinafter, "Confidential Information"). Each Party hereto shall hold in
confidence all Confidential Information received from the other Party and shall
not disclose any such Confidential Information to any third party pursuant
hereto; provided, however, that the confidentiality obligations of this Section
8 shall not extend to information which:
(a) PUBLIC DOMAIN - Is now or later made known to the
public through no fault of the receiving Party of its obligations under this
Agreement;
(b) RECEIVED FROM A THIRD PARTY - Is received by the
receiving Party from a third party not under an obligation of confidentiality to
the disclosing Party regarding such information;
(c) INDEPENDENTLY DEVELOPED - Is independently developed
by the receiving Party or its Affiliates (as evidenced by written records)
without reliance on information provided by the disclosing Party; or
(d) REQUIRED DISCLOSURE - Is required to be disclosed by
law, regulation, order, decree or subpoena or other legal process; provided,
that the receiving Party has used reasonable efforts to obtain a protective
order or other applicable protection against further disclosure of such
Confidential Information.
8.2 OBLIGATION OF CONFIDENTIALITY. Each Party shall use
the same degree of care (and in any event not less than reasonable care) to
safeguard the confidentiality of the other Party's Confidential Information that
it uses to protect its own Confidential Information.
8.3 PUBLICATION. Without limiting the confidentiality
provisions of this Section 8, neither Party shall publish, in written or oral
form, a Publication concerning or relating to the 5-azacytidine Technology,
without the express written consent of the other Party. Any proposed Publication
by a Party shall be provided by such Party to the other Party at least 60 days
prior to submission for publication. Such other Party shall review the proposed
Publication and shall inform the publishing Party within the 60 day period
whether or not it consents to the proposed Publication. In any event,
Publication shall only occur with the written consent of the other Party, which
consent shall not be unreasonably withheld. Contributions by either Party shall,
at such Party's request, be acknowledged in any Publication.
8.4 ANNOUNCEMENTS/PROMOTION. Pharmion and Pharmacia agree
that neither Party will make any press releases, announcements or create any
publicity regarding the existence or subject matter of this Agreement or release
any advertising, promotional or sales literature which mentions the name of the
other Party or discloses any terms or condition of, or subject matter of, this
Agreement without the prior written consent of the other Party (which consent
shall not be unreasonably withheld). It is acknowledged and agreed by the
Parties that at such time as shares of Pharmion stock become publicly traded
Pharmion may be required by applicable law, statute, rule or regulation to file
this Agreement with the U.S. Securities and Exchange Commission in connection
with its reporting obligations; provided that, unless otherwise agreed to in
writing by Pharmacia, Pharmion will seek confidential treatment for the
provisions of this Agreement.
8.5 PERMITTED DISCLOSURES. Nothing in this Section 8 is
intended to prohibit a receiving Party from disclosing information to any
Governmental or Regulatory Authorities as required by applicable law, statute,
rule or regulation for securing applicable Approvals for the Product, or to
patent agents or attorneys and government patent offices as required by
applicable law, statute, rule or regulation for securing applicable patents in
connection with this Agreement.
8.6 RETURN OF INFORMATION. Upon expiration or termination
of this Agreement, the receiving Party will upon request from the disclosing
Party promptly return to the disclosing Party all Confidential Information of
the disclosing Party in the receiving Party's possession, as well as all written
information and materials that incorporate such Confidential Information;
provided, however, that the receiving Party may keep one (1) copy of such
Confidential Information, or as required by any applicable laws, statutes, rules
or regulations, subject to the confidentiality provisions contained herein.
9. PATENT PROSECUTION, MAINTENANCE AND ENFORCEMENT
9.1 PHARMACIA PATENTS - PROSECUTION AND MAINTENANCE.
(a) PHARMACIA'S RESPONSIBILITY - During the Term, except
as set out below at subparagraph 9.1(b), Pharmacia shall be responsible for, in
its sole discretion and at its sole expense, prosecution and maintenance of any
and all Pharmacia Patents.
(b) NOTICE TO PHARMION - Pharmacia shall notify Pharmion
in writing of its intentions with regard to ceasing prosecution or maintenance
of patent protection for any Pharmacia Patent not less than 45 days prior to any
such cessation to allow Pharmion to continue prosecuting or maintaining the
patent protection at its own discretion and expense, in which case Pharmacia at
Pharmion's expense, will execute such documents and otherwise cooperate with
Pharmion as may be necessary to perfect and maintain such patent protection.
9.2 PRODUCT PATENTS - PROSECUTION AND MAINTENANCE.
(a) PHARMION'S RESPONSIBILITY - During the Term, except
as set out below at subparagraph 9.2(b), Pharmion shall be responsible for, in
its sole discretion and at its sole expense, prosecution and maintenance of the
Product Patents.
(b) NOTICE TO PHARMACIA - Pharmion shall notify Pharmacia
in writing of its intentions with regard to ceasing prosecution or maintenance
of patent protection for any Product Patent not less than 45 days prior to such
cessation to allow Pharmacia to continue prosecuting or maintaining the patent
protection at its own discretion and expense, in which case, Pharmion at
Pharmacia's expense, will execute such documents and otherwise cooperate with
Pharmacia as may be necessary to perfect and maintain such patent protection.
9.3 PHARMACIA PATENTS - INFRINGEMENT.
(a) NOTICE - Each of Pharmion and Pharmacia agrees that
during the Term it will promptly notify the other Party in the event that it
becomes aware of any infringement or potential infringement of any Pharmacia
Patents.
(b) PHARMACIA TO PROSECUTE - Pharmacia agrees that during
the Term it will, at Pharmacia's sole cost and expense, protect its interests in
the Pharmacia Patents from infringement by third parties and that it will
prosecute infringers of the Pharmacia Patents or otherwise act to eliminate
infringement of the Pharmacia Patents by third parties when, in the sole
judgment and discretion of Pharmacia, such action is necessary, proper and
justified. If Pharmacia fails to prosecute or otherwise act to eliminate such
infringement, Pharmacia shall give notice in writing to Pharmion of its election
not to bring a claim or suit or take action, within ten (10) days following such
election, and of the circumstance of such infringement or unauthorized use,
including such evidence of infringement as Pharmacia may possess and the numbers
of Pharmacia Patents so infringed. Pharmion may, but is not required to, (i)
obtain a discontinuance of the alleged infringing operation or unauthorized use
or, (ii) bring any claim, suit or action against such third party within six (6)
months of the date of receipt by Pharmion of the aforesaid notice. Any claim,
suit or action by Pharmion shall be either in the name of Pharmion, or in the
name of Pharmacia, or jointly by Pharmion and Pharmacia, as may be required by
the law of the forum.
9.4 PRODUCT PATENTS - INFRINGEMENT.
(a) PHARMION TO PROSECUTE - Pharmion agrees that during
the Term it will, at Pharmion's sole cost and expense, protect its interests in
the Product Patents from infringement by third parties and that it will
prosecute infringers of the Product Patents or otherwise act to eliminate
infringement of the Product Patents when, in the sole judgment and discretion of
Pharmion, such action is necessary, proper and justified. If Pharmion fails to
prosecute or otherwise act to eliminate such infringement, Pharmion shall give
notice in writing to Pharmacia of its election not to bring a claim or suit or
take action, within ten (10) days following such election, and of the
circumstance of such infringement or unauthorized use, including such evidence
of infringement as Pharmion may possess and the numbers of Product Patents so
infringed. Pharmacia may, but is not required to, (i) obtain a discontinuance of
the alleged infringing operation or unauthorized use or, (ii) bring any claim,
suit or action against such third party within six (6) months of the date of
receipt by Pharmion of the aforesaid notice. Any claim, suit or action by
Pharmacia shall be either in the name of Pharmacia, or in the name of Pharmion,
or jointly by Pharmion and Pharmacia, as may be required by the law of the
forum.
(b) NOTICE - Each of Pharmacia and Pharmion agrees that
during the Term it will promptly notify the other Party if it becomes aware of
any infringement or potential infringement of any Product Patents.
9.5. COSTS AND EXPENSES. It is understood and agreed that
the Party to this Agreement that institutes any claim, suit or action in
accordance with paragraphs 9.1, 9.2, 9.3 or 9.4 shall bear solely all costs and
expenses associated therewith and shall be entitled to retain and keep any and
all sums received, obtained, collected or recovered whether by judgment,
settlement or otherwise, as a result of such claim, suit or action. In addition,
with respect to any such claim, suit or action, the Party that did not institute
such claim, suit or action shall render all reasonable assistance to the other
Party that did institute such claim, suit or action (at such other Party's cost
and expense) including, but not limited to, executing all documents as may be
reasonably requested by such other Party.
9.6 THIRD PARTY PATENTS. Each Party hereto shall notify
the other Party promptly in the event of the receipt of notice of any action,
suit or claim alleging infringement by 5-azacytidine or the Product, or the
manufacture or use thereof, of any patent held by a third party and the Parties
shall meet to discuss how to respond to any such action, suit or claim. In the
event such alleged infringement involves 5-acytidine, or the manufacture or use
thereof, Pharmacia, upon request of Pharmion, shall retain counsel reasonably
satisfactory to Pharmion to represent Pharmion and shall pay the fees and
expenses of such counsel related to such proceeding. In any such proceeding,
Pharmion shall have the right to retain its own counsel, but the fees and
expenses of such counsel shall be at the expense of Pharmion unless (i)
Pharmacia and Pharmion shall have mutually agreed to the retention of such
counsel or (ii) the named parties to any such proceeding (including any
impleaded parties) include both Pharmacia and Pharmion and representation of
both Parties by the same counsel would be inappropriate due to actual or
potential differing interests between them. All such fees and expenses shall be
reimbursed as they are incurred. Pharmacia shall not be liable for any
settlement of any proceeding effected without its written consent.
In the event such alleged infringement involves the Product, or the
manufacture or use thereof, Pharmion, upon request of Pharmacia, shall retain
counsel reasonably satisfactory to Pharmacia to represent Pharmacia and shall
pay the fees and expenses of such counsel related to such proceeding. In any
such proceeding, Pharmacia shall have the right to retain its own counsel, but
the fees and expenses of such counsel shall be at the expense of Pharmacia
unless (i) Pharmion and Pharmacia shall have mutually agreed to the retention of
such counsel or (ii) the named parties to any such proceeding (including any
impleaded parties) include both Pharmion and Pharmacia and representation of
both Parties by the same counsel would be inappropriate due to actual or
potential differing interests between them. All such fees and expenses shall be
reimbursed as they are incurred. Pharmion shall not be liable for any settlement
of any proceeding effected without its written consent.
Notwithstanding any other royalty payment provision of this Agreement,
in the event that any such action, suit or claim results in a determination by a
court of competent jurisdiction of infringement of the intellectual property
rights of a third party, and results in the payment of royalties or other
compensation by Pharmion to such third party, Pharmion may reduce its royalty
payments to Pharmacia after the date of determination of such infringement, the
reduction to be in the amount equal to one-half of the royalties or other
compensation paid to such third party, up to a maximum of one-half the royalties
payable to Pharmacia under Section 3 with respect to the Country(ies) of Sale
for which payments are being made to such third party.
10. TERM AND TERMINATION
10.1 TERM. The Term shall continue on a country-by-country
basis in each Country of Sale and shall commence on the Effective Date and end
on the later of:
(i) the expiration date of the last Valid Claim
in such Country of Sale; and
(ii) the date of expiry of the ten-year period
commencing on the date of the First Commercial Sale (which shall be the
date of invoice of the first such sale) in such Country of Sale;
unless earlier terminated pursuant to paragraph 10.2.
10.2 EARLY TERMINATION. This Agreement may be terminated
prior to expiry of the Term in any of the circumstances set out in this
paragraph 10.2:
(a) EXERCISE OF THE PARTICIPATION OPTION - If Pharmacia
exercises the Participation Option, this Agreement shall terminate on the
effective date of the Joint Development and Promotion Agreement.
(b) BANKRUPTCY, ETC. - If a Party becomes bankrupt or
insolvent, petitions any judicial body under any bankruptcy or insolvency laws,
or has any proceeding commenced against it for insolvency, bankruptcy or
liquidation and such proceeding is not dismissed within 60 days, the other Party
may terminate this Agreement by providing not less than ten days written notice
to such Party.
(c) PHARMION TERMINATION - Pharmion will have the right
to arbitrarily terminate this Agreement for any or no reason by providing 120
days notice in writing to Pharmacia.
(d) PHARMACIA TERMINATION - Except as provided in the
last sentence of paragraph 6.1 and in subparagraphs 10.2(a) and 10.2(b) above,
Pharmacia will have the right to terminate this Agreement only in the event of
material breach by Pharmion of any of its representations, warranties or
obligations under this Agreement (including, without limitation, nonpayment of
any royalties due to Pharmacia in accordance with Section 3 and which are not
then being disputed in good faith) by providing 45 days prior notice in writing
to Pharmion. Pharmion shall have the opportunity to cure such breach within the
45 day period to avoid termination of this Agreement. In the event that payment
of any royalty amount is being disputed in good faith, such dispute shall be
submitted to the Chief Executive Officer of Pharmion Corporation and the Senior
Vice President, Licensing of Pharmacia for resolution. If such Parties fail to
resolve such dispute within 60 days following such submission, such dispute
shall be submitted for arbitration pursuant to section 12.
10.3 EFFECT OF EARLY TERMINATION. In any of the situations
set out in paragraph 10.2, this Agreement shall end as of the effective date of
the termination and Pharmion shall have no further right to develop or
Commercialize the Product pursuant to this Agreement and all licensing rights
and interests and sublicensing rights and interests granted by Pharmacia to
Pharmion pursuant to paragraph 2.2 of this Agreement shall terminate.
Notwithstanding early termination of this Agreement and provided the Product
poses no safety issues, Pharmion shall be permitted for a period of six months
following the effective date of the termination to sell off its existing
inventory of Product subject to the payment of royalties as set forth in Section
3. Except as set forth in this paragraph 10.3, early termination of this
Agreement shall not affect any rights or obligations of either Party accrued
prior to the effective date of the termination, including, without limitation:
(a) PROPRIETARY PROPERTY - Rights to its proprietary
property (including without limitation, all its Confidential Information)
generated pursuant to this Agreement prior to the effective date of the
termination.
(b) CONFIDENTIALITY AND PUBLICATION - The confidentiality
provisions of Section 8 which shall survive for a period of five years after the
effective date of the termination.
(c) INDEMNIFICATION - The indemnity provisions of
paragraphs 11.5 through 11.11, inclusive.
10.4 DROPPED PRODUCT OPTION. Pharmion hereby grants to
Pharmacia the Dropped Product Option. Except as provided in paragraph 10.5, the
terms of the Dropped Product License shall be reasonably negotiated between the
Pharmion Corporation and Pharmacia at the time of exercise of the Dropped
Product Option, but may include, without limitation, access to proprietary
information with respect to the Product generated under this Agreement. The
Dropped Product Option may be exercised at any time during the period commencing
on the effective date of the termination of this Agreement pursuant to
subparagraph 10.2(b) and expiring 6 months after the effective date of the
termination. If the Dropped Product Option is not exercised within this 6 month
period, and the Parties do not reasonably agree in writing to extend such
period, the Dropped Product Option shall expire and the Parties shall have no
further rights or obligations under this paragraph 10.4. The period for
negotiation of the Dropped Product License shall be 6 months from the effective
date of the termination of this Agreement and during this negotiation period
both Parties will use commercially reasonable efforts to negotiate and complete
the Dropped Product License (the total period for exercise of the Dropped
Product Option and negotiation and completion of the Dropped Product License
shall be 6 months from the effective date of the termination of this Agreement
and the Parties may use this period for exercise of the Dropped Product Option
or such negotiation of the Dropped Product License, in Pharmacia's discretion).
If the Parties, acting reasonably, do not reach agreement on and execute the
Dropped Product License during such negotiation period and the Parties do not
reasonably agree in writing to extend the negotiation period, Pharmion shall use
commercially reasonable efforts to assign or sublicense its rights and
obligations under this Agreement to a third party, subject to Pharmacia's prior
written consent which shall not be unreasonably withheld. If Pharmion is unable
to assign or sublicense such rights and obligations within 90 days following the
end of such negotiation period, the Parties will have no further rights or
obligations under this paragraph 10.4 and the rights granted by Pharmacia to
Pharmion pursuant to paragraph 2.1 shall become non-exclusive rights to use the
5-azacytidine Technology in accordance with this Agreement.
10.5 DROPPED PRODUCT RIGHT. In the event of early
termination of this Agreement by Pharmacia pursuant to paragraph 10.2(c) or
paragraph 10.2(d), Pharmion shall automatically grant the Dropped Product
License, which shall be an exclusive, worldwide, royalty-free and fully paid-up,
irrevocable license (including the right to sub-license) to Pharmacia, at no
costs, fees or expenses to Pharmacia, to develop and Commercialize the Product
for all therapeutic and diagnostic applications, and including the use of all
trademarks and tradenames and all Confidential Information (including, without
limitation, all Product Technology) with respect to the Product generated under
this Agreement prior to the effective date of termination. No further
documentation will be required to make this Dropped Product
License effective but both Parties agree to use reasonable efforts to execute
such relevant documents deemed necessary by Pharmacia to give effect to this
paragraph 10.5.
10.6 EXPIRY OF THE TERM. As set out in paragraph 3.10, at
the expiry of the periods for the payment of royalties on the sale of the
Product in each Country of Sale pursuant to Section 3, Pharmion shall have fully
paid-up rights and licenses in each such Country of Sale under this Agreement.
Expiration of this Agreement shall not affect these fully paid-up rights and
licenses and shall not affect the following provisions which will survive
expiration of this Agreement at expiry of the Term:
(a) PROPRIETARY PROPERTY - A Party's rights to
proprietary property of such Party generated pursuant to this Agreement prior to
expiry of this Agreement.
(b) CONFIDENTIALITY AND PUBLICATION - The confidentiality
and publication provisions of Section 8 shall survive expiry of this Agreement
for a period of five years.
(c) INDEMNIFICATION - The indemnity provisions of
paragraphs 11.5 through 11.11, inclusive.
11. REPRESENTATIONS. WARRANTIES AND INDEMNIFICATION
11.1 PHARMACIA'S REPRESENTATIONS. Pharmacia represents and
warrants to Pharmion as follows:
(a) INCORPORATION AND ORGANIZATION - Pharmacia is a
corporation duly incorporated and organized, validly existing and in good
standing under the laws of its jurisdiction of incorporation.
(b) CORPORATE POWER - Pharmacia has all requisite
corporate power and capacity to own its property and assets and to carry on its
business as now being conducted by it and as presently contemplated to be
conducted by it.
(c) AUTHORITY - Pharmacia has due and sufficient right
and authority and has taken all action necessary to enter into this Agreement on
the terms and conditions set forth in this Agreement and to carry out the terms
of this Agreement.
(d) VALID OBLIGATIONS - This Agreement constitutes a
valid obligation of Pharmacia, legally binding on it and enforceable in
accordance with its terms, subject to applicable bankruptcy, insolvency,
moratorium, reorganization or similar laws, from time to time in effect,
affecting creditor's rights generally.
(e) OWNERSHIP OF 5-AZACYTIDINE TECHNOLOGY - Pharmacia
owns or has the right to use the 5-azacytidine Technology and has the right to
grant the license to the 5-azacytidine Technology as set out in paragraph 2.1 of
this Agreement.
(f) NO CONFLICTING AGREEMENTS - It is not under any
obligation (contractual or otherwise) to any third party that conflicts with or
is inconsistent with the provisions of this
Agreement or impedes its ability to grant the license rights of this Agreement
or to carry out its obligations under this Agreement.
(g) NO INFRINGEMENT - As of the Effective Date, Pharmacia
has not been notified by a third party that the use of the 5-azacytidine
Technology to manufacture, use or sell 5-azacytidine infringes the proprietary
rights of such third party.
11.2 NO REPRESENTATION. Except as expressly set out at
subparagraph 11.1(g) above, Pharmacia makes no representation or warranty
whatsoever that the exercise of the rights and licenses granted to Pharmion
under this Agreement will not infringe any patents of third parties. In
addition, EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, PHARMACIA MAKES NO
OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO 5-AZACYTIDINE, INCLUDING
THE MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, OR WITH RESPECT TO THE
ACCURACY OR COMPLETENESS OF THE 5-AZACYTIDINE TECHNOLOGY OR ANY OTHER DATA,
INFORMATION OR REGISTRATION MATERIAL TRANSFERRED TO PHARMION UNDER THIS
AGREEMENT AND/OR PREVIOUSLY SUBMITTED TO ANY REGULATORY AGENCY IN ANY COUNTRY.
ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE
IMPLIED WARRANTIES AND MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OF
5-AZACYTIDINE, ARE DISCLAIMED BY PHARMACIA.
11.3 PHARMION'S REPRESENTATIONS. Each of Pharmion
Corporation and Pharmion GmbH represents and warrants to Pharmacia as follows:
(a) INCORPORATION AND ORGANIZATION - It is a corporation
duly incorporated and organized, validly existing and in good standing under the
laws of the state of its incorporation or organization.
(b) CORPORATE POWER - It has all requisite corporate
power and capacity to own its property and assets and to carry on its business
as now being conducted by it and as presently contemplated to be conducted by
it.
(c) AUTHORITY - It has due and sufficient right and
authority and has taken all action necessary to enter into this Agreement on the
terms and conditions set forth in this Agreement and to carry out the terms of
this Agreement.
(d) VALID OBLIGATIONS - This Agreement constitutes its
valid obligation, legally binding on it and enforceable in accordance with its
terms, subject to applicable bankruptcy, insolvency, moratorium, reorganization
or similar laws, from time to time in effect, affecting creditor's rights
generally.
(e) NO CONFLICTING AGREEMENTS - It is not under any
obligation (contractual or otherwise) to any third party that conflicts with or
is inconsistent with the provisions of this Agreement or impedes its ability to
carry out its obligations under this Agreement.
11.4 LIMITATIONS ON LIABILITY. Pharmion acknowledges and
agrees that Pharmacia will not be liable to Pharmion, successors or assigns of
Pharmion, or to any third party with respect to:
(a) USE OF THE TECHNOLOGY - Any claim arising from use of
the 5-azacytidine Technology by Pharmion or its sub-licensees;
(b) PRODUCT - Any claim arising from the development or
Commercialization of 5-azacytidine or the Product by or on behalf of Pharmion or
its sub-licensees; or
(c) OTHER DAMAGES - Any claim by Pharmion for loss of
profits, loss or interruption of business, or for indirect, incidental, special
or consequential damages of any kind.
Each Party will be liable for the performance of its obligations under this
Agreement and for the veracity of its representations and warranties contained
in this Agreement.
11.5 INDEMNIFICATION. Except as set out below, Pharmion
agrees to defend, protect, indemnify and hold harmless Pharmacia and its
Affiliates, and its officers, directors, employees and agents against any and
all Liabilities arising from any claim, suit or action arising out of or related
to the development or Commercialization of the Product by or on behalf of
Pharmion and/or arising out of or related to Pharmion's use of the 5-azacytidine
Technology in any manner. The indemnity set out in this paragraph 11.5 shall not
apply to any Liabilities:
(a) GROSS NEGLIGENCE - To the extent arising out the
gross negligence or willful misconduct of Pharmacia; or
(b) BREACH OF REPRESENTATIONS - To the extent arising out
of a material breach by Pharmacia of its representations and warranties
contained in this Agreement.
11.6 NOTICE OF CLAIM. Subject to paragraph 11.7, in the
event that Pharmacia asserts a claim for indemnification under paragraph 11.5,
Pharmacia shall give reasonably prompt written notice to Pharmion specifying the
facts constituting the basis for such claim and the amount, if known, of such
claim.
11.7 NOTICE OF THIRD PARTY CLAIMS. If Pharmacia asserts a
claim for indemnification under paragraph 11.5 because of a Third Party Claim,
Pharmacia shall give reasonably prompt written notice thereof to Pharmion, but
in no event more than seven (7) days after the Third Party Claim is actually
known to Pharmacia.
11.8 FAILURE TO GIVE NOTICE. Failure to give the notice
required by paragraphs 11.6 and/or 11.7 shall be deemed a waiver by Pharmacia of
its claim for indemnification under this Agreement but only to the extent that
such delay materially prejudices Pharmion's ability to defend any claim, suit or
action related to such claim for indemnification.
11.9 ACTIONS RE: THIRD PARTY CLAIM. Pharmion shall have
the right to investigate Third Party Claims and, upon written notice to
Pharmacia, and using counsel reasonably satisfactory to Pharmacia, to secure,
contest or settle the Third Party Claim; provided that Pharmacia may participate
voluntarily, at its own expense, in any Third Party Claim through
representatives and counsel of its own choice; provided, further that Pharmacia
may choose its own counsel (at Pharmion's expense) if representation by counsel
retained by Pharmion would be inappropriate due to actual or potential differing
interests between Pharmion and Pharmacia. Except as expressly provided in
paragraph 11.10, Pharmacia shall not settle or compromise any Third Party Claim
for which it seeks indemnification under paragraph 11.5 without the prior
written consent of Pharmion (which consent will not be unreasonably withheld)
unless the litigation or other proceeding was instituted against Pharmacia and
Pharmion has not taken control of the defense of the Third Party Claim after
notification of such claim as set out above in paragraph 11.7.
11.10 OTHER INDEMNITY PROVISIONS. Except as otherwise
provided in these indemnity provisions, Pharmion shall bear all costs of any
Third Party Claim and shall indemnify and hold Pharmacia harmless against and
from all Liabilities of the Third Party Claim. Unless and until Pharmion elects
to defend or settle the Third Party Claim, Pharmacia shall have the full right,
at its option, to defend or settle the Third Party Claim and Pharmion shall
reimburse Pharmacia promptly for the amount of the costs, fees and expenses, if
any, of defending the Third Party Claim. The failure of Pharmion to respond in
writing to Pharmacia's notice with respect to a Third Party Claim within 20 days
after receipt of the notice shall be deemed an election not to defend the Third
Party Claim. If Pharmion does not assume the defense of any Third Party Claim,
including any litigation or other proceeding resulting from the Third Party
Claim or if representation by counsel retained by Pharmion would be
inappropriate due to actual or potential differing interests between Pharmion
and Pharmacia:
(a) PHARMACIA MAY DEFEND - Pharmacia may defend against
the Third Party Claim in such manner as it may deem appropriate, including, but
not limited to, settling the Third Party Claim, after giving notice of the same
to Pharmion, on such terms as Pharmacia may deem appropriate; and
(b) PHARMION MAY PARTICIPATE - Pharmion shall be entitled
to participate in (but not to control) the defense of the Third Party Claim,
with its own counsel at its own expense. If Pharmion thereafter seeks to
question the manner in which Pharmacia defended the Third Party Claim or the
amount or nature of any settlement, Pharmion shall have the burden to prove by a
preponderance of the evidence that Pharmacia did not defend or settle the Third
Party Claim in a reasonably prudent manner.
11.11 INFORMATION SHARING FOR THE INDEMNITY. The Parties to
this Agreement shall make available to each other all relevant information in
their possession relating to any Third Party Claim and shall cooperate in the
defense of all Third Party Claims.
12. DISPUTE RESOLUTION
12.1 ARBITRATION. Any dispute arising out of or relating
to this Agreement, or any alleged breach of this Agreement, shall be settled by
binding arbitration in accordance with the Rules, except as modified by this
Section 12. Each arbitration shall be conducted by three arbitrators, consisting
of one arbitrator chosen by each Party and the third arbitrator chosen by the
first two. In the event that the first two arbitrators are not able to agree
upon and chose a third arbitrator, the third arbitrator shall be appointed in
accordance with the Rules. The
arbitration proceeding shall be conducted in the English language in New York,
New York, unless the Parties agree in writing to conduct the arbitration in
another location. The costs of arbitration, including administrative and
arbitrators' fees, shall be shared equally by the Parties. Each Party shall bear
its own costs and attorneys' and witness' fees.
12.2 ARBITRATION DECISION. The arbitration decision shall
be binding and not appealable to any court in any jurisdiction. The prevailing
Party may enter the arbitration decision in any court specified in paragraph
13.7.
12.3. PROVISIONAL REMEDIES. Each Party has the right before
or during arbitration to seek and obtain from the appropriate court provisional
remedies including, without limitation, attachment, preliminary injunction and
replevin, to avoid irreparable harm, maintain the status quo or preserve the
subject matter of arbitration. Notwithstanding the foregoing, each Party waives
its right to trial of any issue by jury.
13. MISCELLANEOUS
13.1 CURRENCY. The Parties agree that, unless otherwise
indicated, all dollar amounts referred to in this Agreement are in United States
currency.
13.2 FURTHER ASSURANCES. The Parties agree to execute such
further documents and do such further acts as may be necessary to implement and
carry out the intent of this Agreement.
13.3 INUREMENT. The Parties agree that in all situations,
including, without limitation, in the case of a takeover or merger of either
Party, this Agreement shall inure to the benefit of and be binding upon each of
them, their successors and permitted assigns and all of their employees and
agents.
13.4 ASSIGNMENT. Except as set out below and in paragraph
10.4, the Parties agree that this Agreement and the rights, duties and
obligations of the Parties under this Agreement shall not be assigned by either
of them without the prior written consent of the other Party, and any attempt to
assign the rights, duties or obligations without this consent will be of no
effect; provided, however, that Pharmion GmbH may assign its rights, duties and
obligations to Pharmion Corporation after written notice to Pharmacia. This
provision shall not operate to restrict Pharmion's ability to grant sub-licenses
pursuant to the provisions of paragraph 2.3. As well, either Pharmion
Corporation or Pharmacia may, without the prior written consent of the other
Parties, assign this Agreement as a whole to:
(a) SURVIVING CORPORATION - A surviving corporation in
the event of a merger or consolidation between such Party and the surviving
corporation;
(b) ASSETS - An entity that purchases all or
substantially all of the assets of such Party and assumes all of the obligations
of such Party under this Agreement; or
(c) AFFILIATES - Any entity that is an Affiliate of such
Party as of the Effective Date;
provided, further,that in the event of subparagraph (c) above, such Party shall
continue to remain liable for the performance of all its obligation under this
Agreement unless otherwise agreed by the Parties in writing.
13.5 NOTICE. The Parties agree that any notice required to
be given under this Agreement shall be in writing and shall be delivered
personally or by overnight courier to the addresses set forth on page 1 of this
Agreement or by facsimile transmission (receipt confirmed), in each case to the
attention of the following persons:
(a) IF TO PHARMION - Attn.: Xxxxxxx Xxxxxxx, President
and Chief Executive Officer, Fax No. (000) 000-0000;
(b) IF TO PHARMACIA - Attn.: Senior Vice President,
global Licensing, Fax No.: (000) 000-0000, with a copy to Attn: General Counsel,
Fax No.: (000) 000-0000;
or to such other addresses and persons as may from time to time be notified in
writing by the Parties in accordance with this paragraph 13.5. Any notice
delivered personally or by overnight courier shall be deemed to have been given
and received at the time of delivery. Any notice delivered by facsimile
transmission shall be deemed to have been given and received on the next
Business Day following the date of transmission.
13.6 SEVERANCE. The Parties agree that if a provision of
this Agreement is wholly or partially invalid, this Agreement shall be
interpreted as if the invalid provision had not been a part hereof.
13.7 GOVERNING LAW; JURISDICTION. The Parties agree that
this Agreement shall be governed by and construed in accordance with the laws of
the State of New York. Subject to Section 12, each Party agrees and hereby
submits to the exclusive jurisdiction of the courts located in the State of New
York or in the United States District Court for the Southern District of New
York with respect to any dispute arising under or in connection with this
Agreement, and each Party hereby waives any objection it may now have or
hereafter have to such jurisdiction or the laying of venue in such courts.
13.8 RECITALS/SCHEDULES. The Parties agree that the
recitals and the schedules to this Agreement and all other instruments
supplementary to this Agreement are incorporated into this Agreement and form an
integral part of this Agreement.
13.9 ENTIRE AGREEMENT. The Parties agree that the
provisions contained in this Agreement constitute the entire agreement between
the Parties with respect to the subject matter and supersede all previous
communications, representations and agreements (whether verbal or written)
between the Parties with respect to the subject matter hereof.
13.10 PRODUCT RECALLS. After the Effective Date and unless
otherwise provided in the Joint Development and Promotion Agreement, in the
event, (i) any Governmental or Regulatory Authorities in any Country of Sale
issues a request, directive or order for the recall, withdrawal or field
correction of the Product, (ii) a court of competent jurisdiction in any Country
of Sale orders such recall, withdrawal or field correction, or (iii) Pharmion
shall reasonably determine that there should be such a recall, withdrawal or
field correction in any
Country of Sale (in which case, Pharmion shall notify the appropriate
Governmental or Regulatory Authorities), then Pharmion shall (x) provide
Pharmacia with written notice within five (5) Business Days of such request,
order or determination, (y) initiate all appropriate investigations, and (z)
take all appropriate corrective actions surrounding any such recall, withdrawal
or field correction. Pharmion shall be solely responsible for all costs and
expenses related to or arising from any recall, withdrawal or field correction
of the Product that occurs after the Effective Date.
13.11 MEDICAL/SCIENTIFIC PRODUCT INQUIRIES. After the
Effective Date and unless otherwise provided in the Joint Development and
Promotion Agreement, (i) Pharmion shall be solely responsible for responding to
all medical questions and inquiries relating to the Product in each Country of
Sale and (ii) in conjunction with the marketing and sale of the Product in a
Country of Sale, Pharmion shall be solely responsible for providing (A) medical,
technical and scientific information concerning the Product to healthcare
professionals, managed care organizations, sales representatives, medical
publishers, consumers, patient assistance programs and others that may request
such information, and (B) after-hours coverage to address emergency requests for
medical, technical and such scientific information concerning the Product.
13.12 ADVERSE MEDICAL EVENTS AND COMPLAINTS. After the
Effective Date and unless otherwise provided in the Joint Development and
Promotion Agreement, Pharmion shall have the sole authority and responsibility
for the handling of any adverse drug experience involving the Product in each
Country of Sale, and shall be solely responsible for complying with all
applicable Governmental or Regulatory Authorities reporting requirements,
including without limitation, Adverse Drug Reaction Reports, in each Country of
Sale regarding adverse drug events.
13.13 INDEPENDENT PARTIES. This Agreement shall not be
deemed to create any partnership, joint venture or agency relationship between
the Parties. Each Party shall act hereunder as an independent contractor.
13.14 WAIVER. Any term or condition of this Agreement may
be waived at any time by the Party that is entitled to the benefit thereof, but
no such waiver shall be effective unless set forth in a written instrument duly
executed by or on behalf of the Party or Parties waiving such term or condition.
No waiver by any Party of any term or condition of this Agreement, in any one or
more instances, shall be deemed to be or construed as a waiver of the same or
any other term or condition of this Agreement on any future occasion. All
remedies, either under this Agreement or by law or otherwise afforded, will be
cumulative and not alternative.
13.15 FORCE MAJEURE. A Party shall not lose any rights
hereunder or be liable to any other Party for damages or losses on account of
failure to perform by the defaulting Party if the failure is caused by any acts
of God, acts of government, war, fire, explosion, flood, earthquake, embargo,
labor dispute or any other similar force majeure events beyond the reasonable
control of such Party; provided, however, that the Party claiming any such force
majeure event has exerted all reasonable efforts to avoid such force majeure
event and has given prompt notice to the other Party of such force majeure
event. The Party giving such notice shall
be excused from its obligations hereunder as it is disabled from performing for
so long as it is disabled; provided, that such Party shall commence and continue
to take reasonable and diligent actions to cure and remedy such force majeure
event; provided, further that if such Party is unable to cure and remedy such
force majeure event within one (1) year of such notice, this Agreement shall
terminate in accordance with paragraph 10.3. In the event of any such force
majeure event, the Parties shall meet promptly to determine an equitable
solution to the effects of such force majeure event. The Term shall not be
extended by any force majeure event.
13.16 INSURANCE. Pharmion Corporation and Pharmion GmbH
shall, as of the Effective Date , obtain and keep in force throughout the Term
of this Agreement and for a period of five (5) years from the date of expiration
or termination of this Agreement, policies of insurance from carriers reasonably
acceptable to Pharmacia providing coverage as specified in Schedule D. The
obligation to maintain insurance after the expiration or termination of this
Agreement shall only apply with respect to insurance policies that are on a
"claims-made" basis. Pharmion shall submit a certificate of such insurance
(which shall include, without limitation, such information as set forth in
Schedule D) to Pharmacia not later than thirty (30) days after the Effective
Date of this Agreement.
13.17 CAPTIONS. The Parties agree that the captions
appearing in this Agreement have been inserted for reference and as a matter of
convenience only and in no way define, limit or enlarge the scope or meaning of
this Agreement or any provision.
13.18 AMENDMENTS. Any amendment, modification or supplement
to this Agreement shall only be effective if such amendment, modification or
supplement is in writing and is signed by Pharmion and by Pharmacia.
13.19 COUNTERPARTS. This Agreement may be executed in
facsimile counterparts, each of which shall be deemed to be an original and both
of which together shall constitute one and the same Agreement.
IN WITNESS WHEREOF the Parties have executed this Agreement as of the
day and year first written above.
PHARMION CORPORATION PHARMACIA & UPJOHN COMPANY
By: /s/ Xxxxxxx X. Xxxxxxx By: /s/ Xxxxxxx X. Xxxxx
------------------------------- ---------------------------
Name: Xxxxxxx X. Xxxxxxx Name: X. Xxxxx
Title: President and CEO Title: Group VP, Oncology
PHARMION GMBH
By: /s/ Xxxxxxx X. Xxxxxxx
--------------------------------
Name: Xxxxxxx X. Xxxxxxx
Title: President
