EXHIBIT 10.1
LICENSE AGREEMENT
THIS AGREEMENT is made as of April 11, 2000 (the "Effective Date"), by and
between MGI PHARMA, INC., a Minnesota corporation having its principal place of
business at Suite 110, 0000 Xxxx Xxx Xxxxxxxx Xxxx, Xxxxxxxxxxx, Xxxxxxxxx
00000-0000 ("MGI"); and CIBA Vision AG, a Novartis company, organized under the
laws of Switzerland having a place of business at Xxxxxxxxxxxx 00, XX-0000
Xxxxxx, Xxxxxxxxxxx ("CIBA Vision").
Recitals
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A. MGI has acquired certain rights, and developed certain data, relating to
the manufacture, use and sale of medicinal products in which a substance known
generically as pilocarpine hydrochloride is the active substance.
B. MGI has obtained from the United States Food and Drug Administration
("FDA") regulatory approval to market and sell pilocarpine hydrochloride as a
treatment for post-radiation xerostomia and xerostomia associated with Xxxxxxx'x
syndrome, and, through its previous licensee, has obtained additional marketing
authorizations in the Territory for xerophthalmia associated with Xxxxxxx'x
syndrome.
C. CIBA Vision possesses the resources, skill and experience required to
register, market and sell medicinal products incorporating pilocarpine
hydrochloride in such territory;
D. MGI has entered into an agreement with Merck KGaA (successor
organization to E. Merck) pursuant to which MGI has been granted the exclusive
right and license to refer to information contained in regulatory dossiers owned
by Merck KGaA for the purpose of obtaining marketing authorizations throughout
the world for certain medicinal products in which pilocarpine drug substance is
an active substance.
E. MGI is willing to grant to CIBA Vision, and CIBA Vision wishes to obtain
from MGI the right to register, market and sell such medicinal products in the
Territory, all upon and subject to the terms and conditions set forth in this
Agreement.
NOW THEREFORE, in consideration of the premises and the mutual covenants
hereinafter set forth, the parties hereto have agreed as follows:
Article 1
INTRODUCTORY PROVISIONS
1.1 Defined Terms. The following terms, when used in capitalized form
in this Agreement, shall have the meanings set forth below:
(a) "Adverse Experience Data" shall mean all data concerning any
serious or unexpected adverse effects, side-effects and
contraindications of any Licensed Product which come to the
attention of either Party or of any Sublicensee of either Party
and which is of such a nature and magnitude that it is required
under the laws of the United States or of any country in the
Territory to be collected, maintained and reported to Competent
Authority.
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(b) "Affiliate" when used with reference to either Party shall mean
any entity controlling, controlled by or under common control
with such Party. For purposes hereof, "control" shall mean
ownership, directly or indirectly, of more than fifty percent
(50%) of the securities having the right to vote for election of
directors, in the case of a corporation, and more than fifty
percent (50%) of the beneficial interest in the capital, in the
case of an entity other than a corporation.
(c) "Best Efforts" shall mean those efforts that would be made by a
reasonably prudent business person acting in good faith and in
the exercise of reasonable commercial judgment.
(d) "CIBA Vision Sublicensee" shall mean any entity to which CIBA
Vision has granted, a sublicense pursuant to Article 9.
(e) "Competent Authority" shall mean, in respect of any country, any
agency responsible for the issuance of Marketing Authorizations
for medicinal products marketed in that country.
(f) "Confidential Information" shall mean all information, including
but not limited to Proprietary Product Information, including any
information on the markets, customers, suppliers, patents or
patent applications, inventions, products, procedures, designs,
formulas, business plans, financial projections, organizations,
employees, consultants or any other similar aspects of a Party's
present or future business, the secrecy of which confers a
competitive advantage upon that Party.
(g) "Drug Master File" shall mean Type II Drug Master File No. 8453
on file with the FDA, any supplementary or successor drug master
file in respect of pilocarpine drug substance that may hereafter
be submitted by Merck KGaA to the FDA, or any corresponding drug
master file or similar file in respect of pilocarpine drug
substance that may hereafter be submitted by Merck KGaA to any
Competent Authority in any country other than the United States.
(h) "E. Merck Agreement" shall mean the Supply and License Agreement
dated as of March 19, 1992 between Merck KGaA and MGI.
(i) "Health Registration Dossier" shall mean all documentation which
is now or shall hereafter be on file with the FDA, or any
Competent Authority, which comprises the information and data
submitted to such agency in support of an application made by
either Party, or a Sublicensee of either Party, to such agency
for Marketing Authorization for any Licensed Product for
treatment of any Indication.
(j) "Indication" shall mean any medical condition or set of symptoms
for the treatment of which a medicinal product may be determined
to be useful.
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(k) "Know-How" shall mean all information and data, regardless of
form, which is necessary or useful (i) to the manufacture of the
Licensed Products or (ii) to the development or manufacture of
dose forms or means of delivery of the Licensed Products, and
which is owned, developed, acquired or otherwise licensable by
either Party or any Sublicensee of either Party during the term
of this Agreement.
(l) "Licensed Products" shall mean pharmaceutical products having as
an active substance pilocarpine and including any other forms and
strengths of pilocarpine for parenteral administration, as
described and defined in Exhibit A.
(m) "Marketing Authorization" shall mean any authorization which is
legally required under applicable laws, regulations or
administrative decisions to put a proprietary medicinal product
on the market in any country for use in treatment of any
Indication; including, without limitation, any governmental price
approval or reimbursement approved under a national health
insurance system.
(n) "MGI Sublicensee" shall mean any third party to which MGI shall
have granted a sublicense under the E. Merck Agreement or a
license to use Proprietary Product Information, Know-How or the
Trademark in respect of any country outside the Territory.
(o) "MAT" (or Moving Annual Total) shall mean total cumulative actual
Net Sales Revenue for any consecutive twelve (12) month period
starting with the first day of any month and running through the
last day of any calendar month twelve months later.
(p) "Net Sales Revenue" shall mean the total amount invoiced by CIBA
Vision to third parties for sale of Licensed Product in the
Territory, less (i) allowance or credit for returns, including
withdrawals and recalls; (ii) sales rebates allowed or paid;
(iii) volume and/or cash discounts to the extent that the same
are not reflected in the invoiced price; (iv) sales, value-added
and other taxes that are payable by the buyer and are included in
the invoiced price; (v) transportation, handling and insurance
costs that are payable by the buyer related to such sales and
separately identified and included in the invoice; and (vi)
customs duties related to sales made by the seller to its
customers if separately identified and included in the invoice.
(q) "Party" shall mean either of the two parties to this Agreement.
(r) "Patents" shall mean any and all patents under the laws of any
country or countries which are owned, acquired or otherwise
licensable by either Party or its Sublicensees during the term of
this Agreement and which are necessary or useful (i) to the
manufacture of the Licensed Products, (ii) to the development or
manufacture of dose forms or means of delivery of the Licensed
Products, or (iii) to the use of the Licensed Products in
conjunction with other products.
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(s) "Sublicensee" shall mean either an MGI Sublicensee or a CIBA
Vision Sublicensee.
(t) "Product Launch" shall mean, in respect of each country in the
Territory, the first commercial sale of the Licensed Products for
resale or use in such country.
(u) "Proprietary Product Information" shall mean (i) all information
and data now or hereafter contained in any Drug Master File or
Health Registration Dossier to which either Party, or any
Sublicensee of either Party, shall have the right under
applicable law, regulations and administrative decisions to
refer, to authorize third parties to refer and to prohibit third
parties from referring, for purposes of any application for
Marketing Authorization for any Licensed Product and (ii) all
other information and data now or hereafter in existence which
relates to the development, testing, manufacture, marketing or
use of any Licensed Product and which shall not have entered into
the public domain.
(v) "Supply Agreement" shall mean that certain Supply Agreement, in
the form set forth in Exhibit B hereto, entered into between MGI
and CIBA Vision contemporaneously with the execution of this
Agreement.
(w) "Supporting Data" shall mean all data and information in the
possession of either Party or Sublicensee relating to (i) the
pharmacological or toxicological properties of any Licensed
Product, (ii) pre-clinical or clinical testing and experience in
relation to any Licensed Product, which is not included in any
Health Registration Dossier and (iii) to the extent reasonably
required for purposes of any application for Marketing
Authorization, the chemical composition, manufacturing processes
and quality control testing of the Licensed Products.
(x) "Territory" shall mean the following countries as constituted on
the Effective Date, exclusive of any overseas territories,
departments or possessions of any of such countries: Albania,
Armenia, Austria, Azerbaijan, Belgium, Belarus, Bosnia and
Herzegovina, Bulgaria, Croatia, Cyprus, The Czech Republic,
Denmark, Estonia, Finland, France, Georgia, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Kazakhstan, Kyrgyzstan, Latvia,
Liechtenstein, Lithuania, Luxembourg, Macedonia, Malta, Moldova,
the Netherlands, Norway, Poland, Portugal, Romania, The Russian
Federation, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Tajikistan, Turkey, Turkmenistan, Ukraine, the United Kingdom,
Uzbekistan and Yugoslavia.
(y) "Trademark" shall mean the trademarks listed in Exhibit D for
each Country or as otherwise agreed on by both parties in
writing, and shall have the same meaning without regard to
whether such trademark is at any given time registered or
otherwise protected under the laws of any country.
1.2 Other Rules of Interpretation. Unless the context clearly
indicates otherwise, the following rules shall govern the interpretation of
this Agreement:
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(a) The definitions of all terms defined herein shall apply equally
to the singular, plural, and possessive forms of such terms.
(b) All references to "Sections," or "Exhibits" shall mean the
corresponding Sections of and Exhibits to this Agreement.
Article 2
LICENSE GRANT
2.1 License to Market and Sell. Subject to the terms and conditions of
this Agreement, MGI hereby grants to CIBA Vision an exclusive right and
license under all Patents, Know-How and Proprietary Product Information
which are or shall hereafter be owned, controlled or otherwise licensable
by MGI, upon and subject to the conditions under which MGI has or shall
have the right to grant such right and license, to apply for Marketing
Authorizations for Licensed Products in each country in the Territory and
to use, market, promote and sell Licensed Products in the Territory. Such
right and license includes, but is not limited to, a sublicense under the
rights and license granted to MGI under the E. Merck Agreement. The right
and license granted herein shall be further subject to the following terms
and conditions:
(a) Such right and license shall include the right of CIBA Vision to
refer to and/or otherwise use, in applications for Marketing
Authorization for Licensed Products in the Territory, to the Drug
Master File as well as any MGI Health Registration Dossier for
any Indication.
(b) Such right and license shall be exclusive to CIBA Vision, and MGI
shall not market, promote or sell Licensed Products within the
Territory or license, supply or otherwise assist any third party
to do so, except as expressly provided herein.
(c) Such right and license shall include the right to grant
sublicenses in accordance with Article 9.
(d) CIBA Vision acknowledges that it shall purchase all of its
requirements for the Licensed Products from MGI as the sole
supplier, on the terms set forth in the Supply Agreement;
provided, however, that its right and license hereunder shall
include the right to specify in its purchase orders for delivery
of Licensed Product which alternate manufacturer, previously
validated and approved as provided in the Supply Agreement, shall
be used by MGI to manufacture such order, as provided in such
Supply Agreement.
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2.2 License Grant-Back. CIBA Vision hereby grants to MGI an
irrevocable, nonexclusive, royalty-free right and license, with right of
sublicense, under (i) all Proprietary Product Information developed by CIBA
Vision or its Sublicensees during the term of this Agreement; and (ii) all
Patents and Know-How conceived and reduced to practice by CIBA Vision or
its Sublicensees during the term of this Agreement in connection with the
use, sale or manufacture of Licensed Products, except for Patents and
Know-How developed by CIBA Vision or its Sublicensees without use of MGI
Confidential Information, as shown by reasonable proof; to apply for
Marketing Authorizations for the Licensed Products in respect of each
country outside the Territory, for all Indications, to market, promote and
sell the Licensed Products in each country outside the Territory pursuant
to such Marketing Authorizations and to manufacture or have manufactured
Licensed Products anywhere in the world. Such right and license shall
include the right to refer, in any application for Marketing Authorization
for the Licensed Products in respect of any country outside the Territory,
to any and all Health Registration Dossiers which CIBA Vision shall
establish with Competent Authorities in the Territory.
2.3 MGI Health Registration Dossiers. MGI shall provide or cause to be
provided to CIBA Vision complete and accurate copies of all documentation
contained in each Health Registration Dossier for the Licensed Products, as
of the Effective Date, within thirty (30) days after MGI's receipt of the
payment provided for in Section 5.1. MGI shall thereafter update such
information to CIBA Vision with any additional documentation it may add to
such Health Registration Dossiers, within thirty (30) days after the date
on which it was submitted to the FDA or other Competent Authority, subject
to Section 2.5. In addition, MGI will furnish or cause to be furnished to
CIBA Vision any information contained in the Drug Master File that is
required to be furnished to any Competent Authority, upon and subject to
the terms and conditions of the E. Merck Agreement.
2.4 CIBA Vision Health Registration Dossiers. CIBA Vision shall
provide to MGI complete and accurate copies of all documentation contained
in CIBA Vision's or its Sublicensee's Health Registration Dossier, within
reasonable time, but no more than sixty (60) days. CIBA Vision shall
thereafter update such information to MGI with any additional documentation
it or any CIBA Vision Sublicensee may add to such Health Registration
Dossiers, within thirty (30) days after the date on which it was submitted
to the respective Competent Authority, subject to Section 2.5.
2.5. Adverse Experience Data Information. Both Parties agree to
mutually exchange, in English, all information relating to the safety of
the Licensed Product (including publications from/in their respective
Territory) in a manner consistent with FDA and ICH guidelines, enabling
both Parties to fully meet their obligations towards regulatory authorities
and to enable them to continuously assess the Licensed Products' safety
profile. Case reports shall be exchanged in a type-written CIOMS or
FDA-3500 format. CIBA Vision will maintain its own Safety Database for the
Territory. Copies of Adverse Experience Data shall be forwarded in English
by facsimile or courier as quickly as may be necessary to permit the
recipient to comply with any applicable legal requirements and within
(i) seven (7) days for fatal or life threatening cases,
(ii) ten (10) days for all other serious events,
(iii) quarterly for all non-serious events,
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after such Adverse Experience data is acquired but in no event later than
the date on which such Adverse Experience Data is provided to any Competent
Authority. All adverse events received by MGI, a Marketing Authorization
Holder (MAH) of Salagen Tablets in the United States, will be relayed to
CIBA Vision and to all other authorized MAH partners outside the Territory
in concert with approved FDA and ICH Guidelines and Regulations. CIBA
Vision shall from time to time provide MGI with a written list of the MAHs
in each country in the Territory to which CIBA Vision will be relaying all
Adverse events.
The details and timelines for the exchange of pharmacovigilance information
will be outlined in a separate agreement between the pharmacovigilance
departments of both parties.
2.6 Other Information and Data. Each Party shall provide to the other
Party complete and accurate copies of all documentation containing
Supporting Data, Clinical Study Reports or other Study Reports, and other
data relating to the Licensed Products, which is prepared or acquired by
such Party or any of its respective Sublicensees during the term of this
Agreement.
2.7. English Translation. Both parties shall take best efforts to
provide any information to the other in English. In case a document needs
to be translated exclusively for one party's needs, the same party shall
bear the costs of such translation.
Article 3
MARKET DEVELOPMENT
3.1 Regulatory Approvals and Product Launch. Attached hereto as
Exhibit C is a list of the Marketing Authorizations received for the
Licensed Products as of the Effective Date. CIBA Vision shall prepare and
submit to MGI, within thirty (30) days of the Effective Date, a written
plan for obtaining other Marketing Authorizations for the Licensed Products
in the Territory. CIBA Vision shall submit to Health Authorities all other
applications and supporting data and information that may be necessary to
obtain any other Marketing Authorizations for the Licensed Products in the
Territory in accordance with the approved plan. In particular, CIBA Vision
shall use its Best Efforts, where commercially reasonable, to obtain,
maintain and renew such Marketing Authorizations for the Licensed Products
in each country in the Territory. CIBA Vision shall provide MGI with
written semi-annual reports of its progress in obtaining and maintaining
such Marketing Authorizations, due at marketing meetings according to
section 4.4. CIBA Vision shall also use its Best Efforts, where
commercially reasonable and justifiable, to launch Licensed Products in
each country in the Territory after obtaining Marketing Authorization.
3.2 Mutual Assistance. Each of the Parties shall use its Best Efforts
to provide such assistance as the other Party shall reasonably request for
purposes of obtaining Marketing Authorizations for the Licensed Products,
as follows:
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(a) Each Party shall make its personnel available, both in person and
by telephone, for reasonable periods of time, to advise personnel
of the other Party in connection with its applications for
Marketing Authorization for the Licensed Products. Where such
assistance will require travel of the Party requested to provide
such assistance, the requesting Party shall notify the other
Party of its need therefor at least fifteen (15) days in advance
of the day on which it desires such personnel to be made
available to it, provided that, should unusual circumstances
arise such that either Party requires immediate assistance
hereunder, the other Party shall use its Best Efforts to provide
such assistance without regard to such notice requirement.
(b) The scope of the cooperation between the Parties hereunder shall
include collaboration and assistance in (i) interpretation of any
Health Registration Dossier or other Supporting Data provided by
either Party to the other, (ii) and review of regulatory
documentation and submissions prepared by the other Party.
(c) Each Party shall bear the expenses of its own personnel engaged
in the cooperative efforts provided for in this Section 3.2.
However, it is the intent of the Parties that the scope and
duration of such efforts shall not be such as to require the
hiring of additional personnel or as to conflict with the
efficient operation of either Party's other business. In the
event that more extensive cooperation may be required than can be
achieved in a manner consistent with these criteria, the Parties
will jointly consider possible cost-sharing or other mutually
beneficial solutions.
3.3 Coordination of Testing and Trials. The Parties shall keep one
another fully and currently informed as to all tests and trials that they
intend to carry out for purposes of compliance with regulatory requirements
and shall cooperate in the design of such tests and trials in order to
ensure to the maximum possible extent that duplication of effort will be
avoided, and, that the results will be suitable for filing both with the
FDA and with Competent Authorities in the Territory and will otherwise be
usable for purposes of meeting all applicable regulatory requirements.
Without limiting the generality of the foregoing, the Parties shall use
their Best Efforts to ensure that all clinical trials of the Licensed
Products that they shall undertake after the Effective Date shall be
designed and conducted in accordance with good clinical practices and good
laboratory practices as established for both the United States and the
European Community. Except as otherwise agreed, however, supporting trials
conducted by CIBA Vision in Europe shall be required to meet European
requirements only.
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Article 4
MARKETING
4.1 Promotion and Marketing. CIBA Vision shall commit adequate funding
and use its Best Efforts to fund and support Product Launch, marketing and
sale of Licensed Products throughout the Territory. Within thirty (30) days
after the Effective Date and thereafter each calendar year during the term
of this Agreement within the budget timelines as agreed by both parties,
CIBA Vision shall provide MGI with an annual plan and budget, detailing its
proposed marketing of the Licensed Products in the Territory, on a
country-by-country basis, during the upcoming year. MGI shall be entitled
to review and comment on such plan. In addition, by January 20 of each
calendar year during the term of this Agreement, CIBA Vision shall provide
MGI with a report comparing its actual performance against the annual plan
and budget for the previous calendar year.
4.2 Competing Products. CIBA Vision agrees that it will not, and will
require its Sublicensees not to, during the term of this Agreement develop
or cause to be developed, market, promote or sell within the Territory any
other medicinal product other than Licensed Product with the same mechanism
of action, namely the stimulation of the activity of the exocrine glands by
agonism on cholinergic receptors, and oral administration.
4.3 Assistance by MGI. MGI shall provide reasonable assistance to CIBA
Vision by providing marketing information and sales training materials
relating to the Licensed Products, whether generated by MGI or its
Sublicensees. In addition, MGI shall invite a reasonable number of CIBA
Vision's sales personnel to attend any MGI sales training programs on the
Licensed Products. CIBA Vision shall bear the travel and living expenses
for such of its personnel and any incremental training costs.
4.4 Meetings. Representatives of CIBA Vision and MGI shall meet on a
semi-annual basis, alternating between meeting sites in Europe and the
United States, to discuss CIBA Vision's promotional and marketing efforts
relating to the Licensed Products in the Territory, as well as MGI's
corresponding efforts in the United States.
4.5 Compliance with Laws. CIBA Vision shall ensure that the marketing,
promotion and sale of the Licensed Products complies with the conditions
and requirements of an applicable Marketing Authorizations, and with all
other applicable legal and regulatory requirements in the Territory.
Article 5
LICENSE FEES AND ROYALTIES
5.1 License Fees. CIBA Vision shall pay to MGI a license fee, to be
paid as follows:
(a) one and one half million US Dollars (US$ 1,500,000), within five
(5) business days after CIBA Vision is enabled, as a wholesaler,
to sell Licensed Product in the United Kingdom with the UK Health
Authorities (hereinafter MCA) having approved the 12-month shelf
life extension (36 months) to all existing inventory.
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(b) one and one half million US Dollars (US$ 1,500,000), within five
(5) business days after (i) Global Pharm Inc. has been approved
as a new manufacturer by MCA and (ii) all necessary documents
have been provided to CIBA Vision and/or the MCA in order to
effect a change of the Marketing Authorization Holder in the U.K.
5.2 Milestone Payments. CIBA Vision shall pay to MGI in the following
milestone payments within thirty (30) days of the occurrence of the
applicable milestone
Milestone Payment Milestone Event
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US$ 1,000,000 Net Sales Revenues for Licensed Products
reach US$ 5 Million on a MAT basis, but
not due before January 1, 2002
US$ 1,000,000 Net Sales Revenues for Licensed Products
reach US$ 10 million on a MAT basis, but
not due before January 1, 2003
US$ 1,000,000 Net Sales Revenues for Licensed Products
reach US$ 15 million on a MAT basis, but
not due before January 1, 2004
US$ 1,000,000 Cumulative Net Sales Revenues for
Licensed Products reach US$ 35 million,
but not due before January 1, 2005
5.3 Royalties. In addition to the license fees and the milestone
payments provided for under Sections 5.1 and 5.2, CIBA Vision shall pay to
MGI royalties of twenty percent (20%) of Net Sales Revenue on Licensed
Products. Such royalty rate shall be reduced to eight percent (8%) on a
country-by-country basis if and when a generic substitute for the Licensed
Products is sold in a country in the Territory and CIBA Vision loses 20% or
more within previous twenty-four (24) months (on a moving basis), anytime
after the introduction of the generic product in that country. CIBA Vision
shall be entitled to specify delivery of Licensed Product from the approved
manufacturer of Licensed Product with the lower cost. In the event the
higher cost manufacturer is selected, such higher cost will be borne
entirely by CIBA Vision.
5.4 Minimum Sales. In each calendar year, CIBA Vision agrees to sell
the following minimum amounts of the Licensed Products:
Year Minimum Net Sales Revenues
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2000 No Minimum Sales
2001 Euro 2 million
2002 Euro 4 million
2003 Euro 5 million
Thereafter Euro 5 million in each calendar year.
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If CIBA Vision fails to sell the above minimum amounts, and such failure is
not due to insufficient supply by MGI under the Supply Agreement for
whatever reason, MGI may, at its option and effective upon forty-five (45)
days written notice to CIBA Vision, as the sole remedy, convert this
Agreement and the licenses granted under section 2 (but not the Trademark
license according to section 8) to non-exclusive. CIBA Vision's obligations
under this Section 5.4 shall be reduced, country-by-country, on a pro rata
basis (in accordance to the country relative weight as indicated in Exhibit
F) if and when a generic substitute for the Licensed Products is sold in
any country in the Territory.
5.5 Reports. CIBA Vision shall provide to MGI, on or before the date
which shall be forty-five (45) days after the end of each calendar quarter
during the term of this Agreement, a report which shall show Net Sales
Revenue for such calendar quarter by country and the calculation of the
royalties payable. If actual Net Sales Revenue of any Sublicensee for that
quarter is unavailable at the time such quarterly report is due, CIBA
Vision shall include in its report for that quarter a good faith estimate
of such Net Sales Revenue, and an appropriate adjustment for the difference
between the actual and estimated Net Sales Revenue shall be made in the
report for the following quarter, with a corresponding adjustment in the
amount of royalties payable in respect of that quarter.
5.6 Exchange Rates. All payments related to Milestones and Royalties
shall be made in US Dollar currency. For purposes of determining the amount
of Net Sales Revenue during any calendar month, the total of all sales in
each other currency during such month shall be converted into US Dollar
currency at the rate in effect at the close of the last business day of the
month, as reported by the Wall Street Journal.
5.7 Books and Records. During the term of the Agreement and for three
(3) years thereafter, CIBA Vision shall keep accurate and complete records
showing all sales of Licensed Products by CIBA Vision and its Sublicensees.
Such records shall include all information necessary to verify the total
amount and computation of earned royalties hereunder, and shall be open to
inspection and audit, during reasonable business hours, to the extent
necessary to verify the amount of such royalties. Such inspection and audit
shall be conducted at the request and expense of MGI by an independent
Certified Public Accountant appointed by MGI and reasonably acceptable to
CIBA Vision. In the normal course, such inspection and audit shall be made
not more often than once in each calendar year. Such Certified Public
Accountant shall undertake a confidentiality obligation to CIBA Vision
permitting it to disclose to MGI, and only MGI, the amount of the royalties
due hereunder, and no other information. MGI shall bear the costs of any
such inspection and audit; provided that if any inspection and audit
reveals an underpayment of more than five percent (5%), CIBA Vision shall
reimburse MGI for its out-of-pocket costs for such inspection and audit.
5.8 Taxes. All payments to be made by CIBA Vision will be paid from
its place of business in Switzerland to MGI in the United States pursuant
to this Agreement, and represent net amounts that MGI is entitled to
receive, and shall not be subject to withholding or deduction for any
reason whatever. In the event that such payments become subject to duties,
taxes or charges of whatever kind or nature levied by any country other
than the United States, such payments shall be increased to such an extent
as to allow MGI to receive the net amounts due under this Agreement.
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5.9 Payments.
(a) All amounts related to goods shall be payable according to the
terms agreed on in the Supply Agreement (Exhibit B).
(b) All amounts related to royalties payable for any calendar quarter
under Section 5.3 shall be due on the same date as the report
relating to that quarter, as provided in that section 5.5.
(c) All amounts related to License Fees and Milestone payments shall
be due on the dates and in the currencies as indicated in section
5.1 and 5.2.
(d) Each such payment shall be made by wire transfer to the account
of the Party receiving same at a bank designated in writing by
that Party from time to time. Any overdue amounts hereunder shall
bear interest at the rate of twelve percent (12%) per annum, or
the maximum legal interest rate, whichever is lower.
Article 6
INDEMNIFICATION
6.1 Product Liability Claims. Each of the Parties shall indemnify and
hold harmless the other Party, its Affiliates and its Sublicensees from and
against all liabilities, damages, losses, costs and expenses (including
reasonable attorneys' fees) arising out of claims, suits or proceedings
brought by third parties wherein it is alleged that personal injury or
death has resulted from use of the Licensed Product, as follows:
(a) MGI shall indemnify and hold harmless CIBA Vision, its Affiliates
and its Sublicensees if and to the extent that any such claim,
suit or proceeding is based upon alleged or actual (i)
negligence, gross negligence or willful misconduct of or
attributable to MGI in connection with the conduct of preclinical
or clinical testing of any Licensed Product; (ii) negligence,
gross negligence or willful misconduct of or attributable to MGI,
E. Merck, or any contractor of MGI in the manufacture of any
Licensed Product supplied by MGI to CIBA Vision or any of its
Sublicensees; (iii) failure of any Licensed Product supplied by
MGI to CIBA Vision or any of its Sublicensees to conform to the
Product Release Specifications (as defined in the Supply
Agreement) for such Licensed Products or to comply with the
warranties as set forth in the Supply Agreement or with
applicable laws, regulations or administrative decisions; or (iv)
failure of MGI to comply with any provision of this Agreement,
the Supply Agreement or with any applicable laws, regulations
and/or administrative decisions relating to the Licensed
Products; or otherwise arises from the sale or provision of any
Licensed Product by MGI to any third party, except to the extent
subject to indemnification by CIBA Vision pursuant to Section
6.1(b).
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(b) CIBA Vision shall indemnify and hold harmless MGI, its Affiliates
and its Sublicensees if and to the extent that any such claim,
suit or proceeding is based upon alleged or actual (i)
negligence, gross negligence or willful misconduct of or
attributable to CIBA Vision or any of its Sublicensees in
connection with the conduct of any pre-clinical or clinical
testing of any Licensed Product; (ii) negligence, gross
negligence or willful misconduct of or attributable to CIBA
Vision or any of its Sublicensees in the promotion, marketing,
packaging, labeling or sale of any Licensed Product, whether or
not supplied by MGI or (iii) failure of CIBA Vision or any of its
Sublicensees to comply with any provision of this Agreement or
with any applicable laws, regulations and/or administrative
decisions relating to the Licensed Products; or otherwise arises
from the sale or provision of any Licensed Product by CIBA Vision
or its Sublicensees to any third party, except to the extent
subject to indemnification by MGI pursuant to Section 6.1(a).
(c) Whenever either Party shall become aware of a claim, suit or
proceeding in respect of which such Party or any of its
Sublicensees shall be entitled to indemnification under the
provisions of this Agreement, such Party shall give notice in
writing to the other Party, shall permit the other Party to
assume control of the defense or settlement of the matter, and
shall provide, at the expense of the other Party, all authority,
information and assistance which the other Party shall reasonably
request for purposes thereof.
6.2 Further Indemnification. Notwithstanding any other provision
hereof, each Party agrees to indemnify and hold harmless the other Party
from and against any loss, liability, damage or expense (including
reasonable attorney's fees) which the other Party shall suffer, sustain or
become subject to as a direct and proximate result of (i) any gross
negligence or willful misconduct on the part of employees or agents of the
indemnifying Party, its Affiliates or any of its Sublicensees, (ii) any
breach of any covenant or agreement of the indemnifying Party contained in
this Agreement, or (iii) any misrepresentations by the indemnifying Party
in or in connection with this Agreement.
6.3 Subrogation. In the event that either Party shall have indemnified
the other Party under Section 6.1 or Section 6.2, the indemnifying Party
shall be subrogated to the rights of the indemnified Party against any
third party, and such indemnified Party hereby assigns to the indemnifying
Party all claims, causes of action and other rights which the indemnified
Party may then have against any third party, including Sublicensees and, in
the case of MGI, Merck KGaA, or against any contract manufacturer of
Licensed Products supplied under the Supply Agreement, with respect to the
claim, suit or proceeding. Conversely, and without in any way limiting the
obligation of either Party to indemnify the other Party as herein provided,
to the extent that either Party shall fail to perform its indemnification
obligations under Section 6.1 or Section 6.2, such Party owing a duty of
indemnification hereby assigns to the other Party all claims, cause of
action and other rights which the Party owing such duty may then have
against any third party, including Sublicensees and, in the case of MGI,
Merck KGaA, or against any contract manufacturer of Licensed Products
supplied under the Supply Agreement, with respect to the claim, suit or
proceeding.
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6.4 Insurance. Both parties shall procure and maintain adequate
insurance or equivalent coverage in order to be able to cover claims under
this agreement. Upon request, each party shall provide proof of adequate
coverage to the other party.
Article 7
CONFIDENTIALITY
7.1 Non-Use and Non-Disclosure. Each Party acknowledges and agrees
that all the other Party's Confidential Information is confidential and
proprietary to the disclosing Party. Each Party shall not use or disclose
to any third party the other Party's Confidential Information for any
purpose other than as permitted or required hereunder. Each Party shall
take the same reasonable measures necessary to prevent any disclosure by
its employees, agents, contractors, or consultants of the other Party's
Confidential Information as it applies to the protection of its own
Confidential Information.
7.2 Marking. To be entitled to protection as Confidential Information,
all MGI or CIBA Vision documents containing that Party's Confidential
Information shall be appropriately and clearly marked as "Proprietary,"
"Secret," "Confidential," or other words to similar effect. If a disclosure
of Confidential Information is made orally, as in a meeting, the disclosing
Party shall indicate the nature of that information at the time of its
disclosure and shall confirm such designation in writing within ten (10)
days of the date of such disclosure to the receiving Party.
7.3 Exclusions. Information shall not be considered Confidential
Information hereunder if it:
(a) was already in the possession of the receiving Party prior to its
receipt from the disclosing Party, as shown by the receiving
Party's books and records;
(b) is, or becomes, part of the public knowledge or literature
through no fault, act or omission of the receiving Party,
provided, Proprietary Product Information shall not be deemed to
have entered the public domain by reason of its having been filed
with any Competent Authority;
(c) is, or becomes, available to the receiving party from a source
other than the disclosing party, which source has rightfully
obtained the same information and has no obligation of
confidentiality to the disclosing party with respect to it;
(d) is made available on an unrestricted basis by the disclosing
Party to a third party unaffiliated with the disclosing Party; or
(e) is required to be revealed pursuant to law; provided, however,
the receiving Party which is under any such requirement of law
shall give reasonable notice to the disclosing Party of such
requirement and shall cooperate with the disclosing Party in
reasonable legal efforts to limit or mitigate any such revelation
so as to preserve the proprietary nature of any Confidential
Information contained therein.
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7.4 Duration; Surviving Obligation. Each Party's obligations of
non-use and non-disclosure of the other Party's Confidential Information
shall apply during the term of this Agreement and shall also survive for a
period of five (5) years after its termination for any reason.
Article 8
TRADEMARK LICENSE
8.1 License Grant. MGI hereby grants to CIBA Vision an exclusive,
royalty-free right and license, during the term of this Agreement, to use
the Trademark in connection with the marketing, promotion, advertising and
sale or other distribution of the Licensed Products within the Territory
and for no other purpose. Such right and license shall include the right to
grant sublicenses in accordance with Article 9. In the event that the
execution and filing of one or more registered user agreements is required
in connection with the license grant to CIBA Vision or the sublicensing of
any Sublicensee of CIBA Vision under the laws of any country in the
Territory, CIBA Vision shall cause such an agreement to be executed and
filed and provide MGI with evidence of such filing, and MGI shall sign such
documents and otherwise cooperate as necessary to facilitate the filing of
any such agreement.
8.2 Quality Standards. All Licensed Products sold under the Trademark
by CIBA Vision or its Sublicensees, or Co-promotion Partners, shall comply
with reasonable standards adhered to by MGI in its own manufacture and sale
of Licensed Products, which standards shall be provided to CIBA Vision in
writing as soon as feasible, and in any event prior to the filing by CIBA
Vision or its Sublicensees, of the first application for Marketing
Authorization of the Licensed Products in the Territory. Any subsequent
changes in such standards shall be provided to CIBA Vision in writing
sufficiently in advance to permit CIBA Vision reasonably to comply. In
particular, and without limiting the generality of the foregoing, the
following terms and conditions shall apply:
(a) Upon request by MGI, CIBA Vision shall provide MGI with samples
of Licensed Products bearing the Trademark, as well as copies of
all materials, including but not limited to brochures,
professional literature, packaging and consumer instructions,
which are created or intended for use by CIBA Vision or any of
its Affiliates in the advertising, promotion, marketing or sale
of Licensed Products, for examination and testing to verify
compliance with the standards of this Section 8.2. CIBA Vision
shall also permit MGI, at reasonable times, to examine stocks of
Licensed Products held by it or its Sublicensees to verify
compliance with such standards. MGI shall notify CIBA Vision in
writing CIBA Vision shall take reasonable steps to correct the
problem in consultation with MGI.
(b) If MGI notifies CIBA Vision in writing of any nonconformity with
such standards in the Licensed Products sold by CIBA Vision or
its Sublicensees, CIBA Vision shall take all reasonable steps or
measures necessary to ensure that such products are brought into
compliance with the applicable standards.
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8.3 Use of Trademark. CIBA Vision shall market the Licensed Products
under the Trademark; provided, however that if the Trademark is unavailable
or unusable in a particular country in the Territory, the Parties shall
mutually agree on a suitable alternative. In addition, all packages in
which Licensed Products are to be sold to consumers shall, where legally
permissible, bear a legend, stating that Licensed Products are "Sold by
[CIBA Vision or Sublicensee] under License from MGI PHARMA, INC.". CIBA
Vision shall provide to MGI samples of packages bearing the Trademark.
8.4 Registration and Approvals. Attached hereto as Exhibit D is a list
of the registrations and pending applications for registration for the
Trademarks. MGI shall have the sole right to file applications for
trademark registration, and to maintain registrations and pending
applications for the Trademarks in the Territory. However, if MGI fails to
file for a trademark application or to maintain a trademark registration or
pending application in a country in the Territory for more than thirty (30)
days after a respective request by CIBA Vision, CIBA Vision shall have the
right to file for such trademark application or to maintain the trademark
registration or pending application in the name of MGI, and at reasonable
and customary costs to be paid by MGI.
8.5 Reservation of Rights. CIBA Vision acknowledges MGI's proprietary
rights in and to the Trademark, subject to the licenses granted pursuant to
this Agreement. CIBA Vision acknowledges that nothing in this Agreement
shall constitute a grant of any license or right in or to any trademarks,
tradenames or logotypes owned by MGI other than the Trademark. CIBA Vision
shall not adopt, use or register any words, phrases or symbols which are
identical to or confusingly similar to the Trademark and shall not use the
Trademark as part of its corporate or trade name, or in combination with
any other trademark or trade name or permit any third party to do so.
8.6 Infringements. CIBA Vision shall promptly notify MGI upon becoming
aware of any use in the Territory by any third party of the Trademark or of
any similar xxxx which may constitute an infringement or passing off of the
Trademark. MGI shall have the first right, at its option, to institute
proceedings against third party infringers in respect of infringements
occurring in the Territory. If MGI elects not to institute such proceedings
within a period of thirty (30) days after its discovery of the
infringement, CIBA Vision shall have the right at its option to do so. MGI
shall have the exclusive right in its sole discretion to institute
proceedings against third party infringers in respect of infringements
occurring outside the Territory. Each Party shall cooperate fully with the
other Party in connection with any such proceedings against third-party
infringers, provided that all expenses of such proceedings shall be borne
by the Party instituting the same and any damages which may be awarded or
agreed upon in settlement of such action shall accrue to such Party.
Article 9
SUBLICENSES
9.1 Sublicense Rights. CIBA Vision shall have the right to sublicense
its rights hereunder and shall notify MGI of any sublicense agreement.
9.2 Terms and Conditions of Sublicense Agreements. Each sublicense
agreement with a CIBA Vision Sublicensee shall include terms insuring the
protection of MGI's rights under this Agreement.
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Article 10
FORCE MAJEURE
10.1 Definition and Notice. "Force Majeure" shall mean any event, not
existing as of the Effective Date and not reasonably within the control of
the Parties as of such date, which, in whole or in material part, prevents
or makes commercially unreasonable one Party's performance of its
obligations under this Agreement. Force Majeure shall include, without
limitation: fire, storm, earthquake, flood, acts of State or other
governmental action, war or civil unrest, strikes, and prolonged shortage
of energy or any other supplies. A Party affected by an event of Force
Majeure shall promptly provide the other Party with written notice
describing the event, its cause and foreseeable duration, and its possible
consequences upon performance under this Agreement.
10.2 Suspension of Performance. After an affected Party has given
notice under Section 10.1, that Party shall be relieved of any liability
under this Agreement, except for the obligation to pay amounts due and
owing, but only to the extent and only for so long as the Force Majeure
prevents performance. The other Party may likewise suspend the performance
of all or part of its obligations, except for the obligation to pay any
amounts due and owing, to the extent that such suspension is commercially
reasonable.
10.3 Termination. If the period of Force Majeure continues for more
than one (1) year, either Party may terminate this Agreement upon giving
notice to the other Party without incurring liability other than the
obligation to make payments due to such date.
Article 11
TERM AND TERMINATION
11.1 Term of Agreement. The term of this Agreement shall commence on
the Effective Date and unless earlier terminated in accordance with the
provisions of Article 11, shall continue in full force and effect until the
twelfth (12th) anniversary of the Effective Date. Thereafter the term of
this Agreement shall automatically be extended for additional two (2) year
terms, unless written notice of termination is given by one party. Notice
of intent to terminate on the anniversary of the original term or any
subsequent extension shall be provided no later than 180 days prior to such
anniversary date.
11.2 Termination.
(a) Either Party shall have the right to terminate this Agreement by
written notice to the other Party with immediate effect:
(i) If such other Party (the "breaching party") is in
material breach of its obligations under this Agreement and has
failed to cure such breach within sixty (60) days after its
receipt of written notice thereof from the non-breaching party in
the case of breach of any obligation to make payment as and when
due hereunder, or within ninety (90) days after its receipt of
such written notice in the case of breach of any other material
obligation hereunder.
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(ii) At any time in the event that the other Party has filed
a petition of any type as to its bankruptcy or insolvency, been
declared bankrupt, become insolvent, made an assignment for the
benefit of creditors, gone into liquidation or receivership, or
had a trustee or receiver appointed.
(b) CIBA Vision shall be entitled to terminate this Agreement with
immediate effect if the Supply Agreement is terminated and CIBA
Vision has not been supplied with Licensed Product by for a
period of more than on hundred eighty (180) days.
11.3 Effect of Termination or Expiration. Upon any termination or
expiration of this Agreement; the following provisions shall apply:
(a) Termination or expiration of this Agreement shall not release
either Party from the obligation to make payment of all amounts
then or thereafter due and payable to the other Party hereunder.
(b) The licenses granted to CIBA Vision hereunder shall terminate on
the effective date of such termination; provided, however, that
notwithstanding any such termination or expiration, CIBA Vision
and its Sublicensees shall have the right to sell any remaining
inventory of Licensed Products in the ordinary course of business
and subject to the payment of royalties hereunder. CIBA Vision
shall transfer to MGI all Marketing Authorizations, Health
Registration Dossiers and any other materials prepared for
purposes of or in connection with applications for Marketing
Authorization in the Territory, whether or not such materials
shall have been submitted to any Competent Authority, as promptly
as possible, and shall take such other steps as may be necessary
or useful in order to permit MGI to pursue each existing
application or a substitute application with the minimum possible
loss of the lead-time acquired by reason of CIBA Vision's
application. In addition, within sixty (60) days after the
termination or expiration of this Agreement, CIBA Vision shall
furnish MGI with a list of all of CIBA Vision's customers to whom
it sold Licensed Products in the last year prior to such
termination.
(c) Subject to its rights to sell remaining inventory, upon any
termination or expiration, CIBA Vision shall cease and desist
from use of the Trademark in any manner. CIBA Vision hereby
grants to MGI in the event of such termination or expiration,
full power of attorney, with the right of substitution, to
cancel, revoke or withdraw any governmental registration or
authorization permitting CIBA Vision to use the Trademark in the
Territory and agrees to provide such further documentation and
assistance as MGI may reasonably request in connection therewith.
(d) The Parties' respective rights and obligations under Article 6
(Indemnification) shall survive termination or expiration of this
Agreement. The Parties' respective rights and obligations under
Article 7 (Confidentiality) shall survive termination or
expiration for a period of three (3) years following expiration
of this Agreement.
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(e) Such termination shall be without prejudice to any other remedies
to which the Parties may be entitled in respect of breach of this
Agreement.
Article 12
LIMITATION OF LIABILITY
12.1 Limitation of Liability. EXCEPT FOR ANY BREACH OF SECTION 4.2
(LOYALTY) OR ARTICLE 7 (CONFIDENTIALITY) OR PERSONAL INJURY, IN NO EVENT
SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY HEREUNDER FOR ANY SPECIAL,
INDIRECT, INCIDENTAL OR CONSEQUENTIAL LOSSES OR DAMAGES, EVEN IF SUCH PARTY
SHALL HAVE BEEN ADVISED IN ADVANCE OF THE POSSIBILITY OF SUCH POTENTIAL
LOSS OR DAMAGE.
Article 13
DISPUTE RESOLUTION
13.1 Negotiation. The Parties agree to consult and negotiate in good
faith to try to resolve any dispute, controversy or claim that arises out
of or relates to this Agreement. Except as provided in Section 13.2, no
formal dispute resolution shall be used by either Party unless and until
the chief executive officers of each Party shall have attempted to meet in
person to achieve such an amicable resolution.
13.2 Reservation for Litigation. Notwithstanding Section 13.3 below,
each Party expressly reserves the right to seek judicial relief (including,
without limitation, an injunction or other preliminary relief) from a court
of competent jurisdiction.
13.3 Arbitration. Subject to the reservation of the Parties under
Section 13.2 above, any dispute, controversy or claim that arises out of or
relates to this Agreement that is not resolved under Section 13.1 shall be
settled by final and binding arbitration in accordance with the
International Arbitration Rules of the American Arbitration Association
("AAA") in effect on the Effective Date, as modified by Section 13.4 below.
Judgment upon the award rendered by the arbitrators may be entered in any
court of competent jurisdiction. The place of arbitration shall be
Minneapolis, Minnesota, U.S.A. The arbitration shall be conducted in the
English language by three (3) neutral arbitrators selected by mutual
agreement of the Parties or, if that is not possible within thirty (30)
days of the initial demand for such arbitration, by the AAA. At least one
(1) arbitrator shall have knowledge of and experience in the ethical
pharmaceutical industry, and at least one (1) arbitrator shall have
knowledge of and experience in international law and technology licensing.
13.4 Special Rules. Notwithstanding any provision to the contrary in
the AAA's International Arbitration Rules, the Parties hereby stipulate
that any arbitration hereunder shall be subject to the following special
rules:
(a) The arbitrators may not award or assess punitive damages against
either Party; and
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(b) Each Party shall bear its own costs and expenses of the
arbitration and one-half (1/2) of the fees and costs of the
arbitrators, subject to the power of the arbitrators, in their
sole discretion, to award all such reasonable costs, expenses and
fees to the prevailing Party.
Article 14
REPRESENTATIONS AND WARRANTIES
14.1 By MGI. MGI hereby represents and warrants to CIBA Vision as
follows:
(a) MGI has been duly organized and is validly existing as a
corporation in good standing under the laws of the State of
Minnesota, with corporate power to conduct any lawful business
activity. MGI has the corporate power and authority to enter into
this Agreement and the Supply Agreement and to consummate the
transactions contemplated by this Agreement and the Supply
Agreement.
(b) The execution, delivery and performance of this Agreement and the
Supply Agreement, and the consummation of the transactions
contemplated by this Agreement and the Supply Agreement, by MGI
have been duly and validly authorized by all requisite corporate
action. This Agreement and the Supply Agreement have been duly
executed and delivered by MGI and constitute the legal, valid and
binding obligations of MGI, enforceable against MGI in accordance
with their respective terms, except as enforceability thereof may
be limited by bankruptcy, insolvency, reorganization or other
similar laws relating to or affecting the rights of creditors
generally, and by general principles of equity.
(c) The execution, delivery and performance of this Agreement and the
Supply Agreement, and the consummation of the transactions
contemplated by this Agreement and the Supply Agreement, by MGI
do not conflict with or result in any breach of any of the
provisions of, constitute a default under, result in a violation
of, or require any authorization, consent (except as may have
been obtained), approval, exemption or other action by or notice
to any court or governmental body, under the provisions of MGI's
Restated Articles of Incorporation or bylaws or any indenture,
mortgage, lease, loan agreement, license or other agreement or
instrument to which MGI is a party, or of any law, statute, rule
or regulation or order, judgment or decree to which MGI is
subject.
(d) MGI has received no notice from E. Merck that it is in material
breach of any of its obligations under the E. Merck Agreement;
and MGI is in compliance in all material respects with the E.
Merck Agreement.
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(e) It is the owner of, or is otherwise entitled to provide to CIBA
Vision and to authorize CIBA Vision to use in the manner
contemplated in this Agreement, all information and data,
including but not limited to any applicable Drug Master Files
and/or Health Registration Dossiers, which it shall provide to
CIBA Vision under and for purposes of this Agreement. Such
warranty shall be deemed to have been reaffirmed, upon each
delivery of information and/or data hereunder, by MGI.
(f) To the best knowledge of MGI, and after diligent research by MGI
with respect to the countries listed in Exhibit D, the use,
marketing, promotion and sale of the Licensed Products under the
Trademark in those countries do not infringe any third party
Patents and/or Trademark rights.
14.2 By CIBA Vision. CIBA Vision hereby represents and warrants to MGI
as follows:
(a) CIBA Vision has been duly organized and is validly existing as a
corporation under the laws of Switzerland, with full corporate
power to conduct the business contemplated by this Agreement and
the Supply Agreement. CIBA Vision has the corporate power and
authority to enter into this Agreement and the Supply Agreement
and to consummate the transactions contemplated by this
Agreement.
(b) The execution, delivery and performance of this Agreement and the
Supply Agreement, and the consummation of the transactions
contemplated by this Agreement and the Supply Agreement, by CIBA
Vision have been duly and validly authorized by all requisite
corporate action. This Agreement and the Supply Agreement have
been duly executed and delivered by CIBA Vision and constitute
the legal, valid and binding obligations of CIBA Vision,
enforceable against CIBA Vision in accordance with their
respective terms, except as enforceability thereof may be limited
by bankruptcy, insolvency, reorganization or other similar laws
relating to or affecting the rights of creditors generally, and
by general principles of equity.
(c) The execution, delivery and performance of this Agreement and the
Supply Agreement, and the consummation of the transactions
contemplated by this Agreement and the Supply Agreement, by CIBA
Vision do not conflict with or result in any breach of any of the
provisions of, constitute a default under, result in a violation
of, or require any authorization, consent (except as may have
been obtained), approval, exemption or other action by or notice
to any court or governmental body, under the provisions of CIBA
Vision's Articles of Association or any indenture, mortgage,
lease, loan agreement, license or other agreement or instrument
to which CIBA Vision is a party, or of any law, statute, rule or
regulation or order, judgment or decree to which CIBA Vision is
subject.
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(d) It is the owner of, or is otherwise entitled to provide to MGI
and to authorize MGI to use in the manner contemplated in this
Agreement, all information and data, including but not limited to
any applicable Drug Master Files and/or Health Registration
Dossiers, which it shall provide to MGI under and for purposes of
this Agreement. Such warranty shall be deemed to have been
reaffirmed, upon each delivery of information and/or data
hereunder, by CIBA Vision.
Article 15
ADDITIONAL COVENANTS OF MGI
E. Merck Agreement. During the term of this Agreement, MGI agrees fully to
comply with its obligations and to diligently enforce its rights under the E.
Merck Agreement to the extent necessary to preserve its exclusive rights in the
Territory thereunder and to preserve its rights to the supply of pilocarpine
drug substance, except to the extent that such compliance is dependent upon CIBA
Vision and its Sublicensee or is commercially unreasonable. MGI agrees to
provide CIBA Vision with copies of any amendments to or modifications of the E.
Merck Agreement which may be proposed from time to time, sufficiently in advance
of execution to allow CIBA Vision a reasonable time to comment. MGI shall not
terminate the E. Merck Agreement, or agree to any amendment to or modification
of the E. Merck Agreement which may adversely affect any rights of CIBA Vision
under this Agreement or the ability of MGI to perform its obligations under this
Agreement, without the prior written consent of CIBA Vision, which consent shall
not unreasonably be withheld.
Article 16
MISCELLANEOUS
16.1 Entire Agreement. This Agreement, including Exhibits A through F
attached hereto and incorporated as an integral part of this Agreement, and
the Supply Agreement constitute the entire agreement of the Parties with
respect to the subject matter hereof, and supersede all previous agreements
by and between the Parties as well as all proposals, oral or written, and
all prior or contemporaneous negotiations, conversations or discussions
between the Parties related to this Agreement.
16.2 Relationship. The Parties are independent contractors and shall
not be deemed to have formed any partnership, joint venture or other
relationship. Neither Party shall make, or represent to any other person
that it has the power or authority to make, any financial or other
commitment on behalf of the other Party.
16.3 Assignment. Subject to section 9 of this agreement, neither Party
shall have the right to assign or otherwise transfer its rights and
obligations under this Agreement except with the prior written consent of
the other Party, provided that a successor in interest by merger, operation
of law, assignment, purchase or otherwise of substantially all of the
business and assets of either Party shall acquire all rights and
obligations of such Party hereunder without any such consent.
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16.4 Notices; Language. Except as may be otherwise provided in this
Agreement, any notice, demand or request given, made or required to be made
shall be in writing and shall be effective, unless otherwise provided
herein, when received after delivery by (a) registered air mail, postage
prepaid; (b) facsimile with electronic confirmation of receipt; or (c) a
reputable international courier such as Federal Express or DHL at the
addresses set forth below or to any other address that a Party specifies in
writing. All reports, notices and communications required or permitted
hereunder shall be in the English language.
If to MGI: MGI PHARMA, INC.
0000 Xxxx Xxx Xxxxxxxx Xxxx
Xxxxxxxxxxx, XX 00000-0000
XXX
Facsimile 000-000-0000
Attention: Legal Department
With copy to: Xxxxxx & Xxxxxxx LLP
000 Xxxxx Xxxxx Xxxxxx
Xxxxxxxxxxx, Xxxxxxxxx 00000
Facsimile: 000-000-0000
Attention: Xxx Xxxxx, Corporate Counsel
If to CIBA Vision: CIBA Vision AG
Xxxxxxxxxxxx 00
XX-0000 Xxxxxx
Xxxxxxxxxxx
Facsimile: 41-1-862 03 85
Attention: Head Ophthalmic Business Unit
With copy to: Legal Department
Facsimile: 41-1-862 03 84
16.5 Governing Law. This Agreement shall be governed by, and
interpreted and construed in accordance with, the law of the State of
Minnesota, USA, excluding Minnesota's choice of law rules.
16.6 Amendment. This Agreement may not be modified or amended, in
whole or in part, except by written agreement signed by both Parties.
16.7 Severability. If one or more of the provisions of this Agreement
is subsequently declared invalid or unenforceable, this Agreement shall be
treated as though that provision were not in this Agreement, and this shall
not affect the validity or enforceability of the remaining provisions of
this Agreement (unless those provisions that are invalidated or
unenforceable are clearly material and inseparable from the other
provisions). The Agreement as modified shall be applied and construed to
reflect substantially the good faith intent of the Parties and to achieve
the economic effects originally intended by the terms hereof.
16.8 Counterparts. This Agreement shall be executed in two or more
counterparts , and each such counterpart shall be deemed an original
hereof.
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16.9 Waiver. No failure by either Party to take any action or assert
any right hereunder shall be deemed to be a waiver of such right in the
event of the continuation or repetition of the circumstances giving rise to
such right.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed
as of the Effective Date.
MGI PHARMA, INC. CIBA VISION AG
By /s/ Xxxxxxx X. Xxxxxxx By /s/ Xxxx von Bidder
------------------------------------- -------------------
Xxxxxxx X. Xxxxxxx Xxxx von Bidder
President and Chief Executive Officer President, Ophthalmic
Business Unit
By /s/ Xxxxxx X. Xxxxxxx By /s/ Xxxxx Xxxxxx
------------------------------------- ----------------
Xxxxxx X. Xxxxxxx, Vice President Xxxxx Xxxxxx, Vice President
Manufacturing & International Business Development and
Operations Licensing
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