Exhibit 4.6(b)
THE CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST
IN ACCORDANCE WITH RULE 24B-2 OF THE SECURITIES AND EXCHANGE ACT OF 1934, AS
AMENDED. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN ***.
LICENSE AGREEMENT
By and between
BRITANNIA PHARMACEUTICALS, LIMITED
Redhill, Surrey
United Kingdom
and
MYLAN PHARMACEUTICALS, INC.
Morgantown, West Virginia, U.S.A.
Execution Copy
11/24/99
INDEX
1. Interpretation and Definitions
2. Due Diligence Period; Completion of Development; Clinical Trial; Product
Registration
3. Grant of License; License Fees
4. Royalty
5. Trademarks and Trade Names; Patent Infringement
6. Representations and Warranties
7. Confidentiality
8. Marketing Obligation; Indemnity
9. Term of License Agreement
10. Termination
11. Specific Performance; Force Majeure
12. Further Assistance
13. Assignment
14. Choice of Law
15. Notices
16. Miscellaneous
AGREEMENT
THIS AGREEMENT effective this 29th day of November, 1999, by and between;
BRITANNIA PHARMACEUTICALS, LIMITED, a U.K. limited liability company whose
principle place of business is 00-00 Xxxxxxxx Xxxx, Xxxxxxx, Xxxxxx XX0 0XX,
Xxxxxxx (hereinafter referred to as "Britannia"); and
MYLAN PHARMACEUTICALS, INC., a corporation organized and existing under the laws
of the State of West Virginia, United States of America, having its principal
offices at 000 Xxxxxxxx Xxxxx Xxxx, Xxxxxxxxxx, Xxxx Xxxxxxxx, 00000 X.X.X.
(Hereinafter referred to as "Mylan")
RECITALS
A. Britannia and Dow Hickham Pharmaceuticals Inc., a wholly-owned subsidiary
of Mylan, previously entered into an agreement dated August 30, 1995 (the
"1995 Agreement") concerning a product containing apomorphine hydrochloride
for the treatment of Xxxxxxxxx'x Disease. The 1995 Agreement has been
terminated.
B. Britannia's request for Orphan Drug Designation by the United States Food
and Drug Administration ("FDA") for the Product was granted under the U. S.
Orphan Drug Act on April 22, 1993 (as hereinafter defined, the "Orphan Drug
Designation"); and said Orphan Drug Designation (#91-575) subsequently was
transferred to Mylan on January 14, 1999.
C. Britannia has developed certain know-how regarding the registration,
manufacturing and marketing of the Product (as hereafter defined, the
"Know-How"), and is developing other forms of the Product for intranasal
and other routes of administration.
D. Prior to the execution hereof, Mylan has conducted a customary "due
diligence" review of information within the control of Britannia relating
to the Product, the Orphan Drug Designation, and the
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Know-How which Mylan deemed necessary and relevant to the transactions
contemplated by this Agreement.
E. Mylan filed an Investigative New Drug exemption (the "IND") for the Product
on March 14, 1997, and is proceeding to conduct the research and testing
necessary to filing a NDA for the Product.
F. Britannia, desires to xxxxx Xxxxx an exclusive license to manufacture,
promote, use, distribute, sell and otherwise commercially exploit the
Product under the Know-How in the United States, and under the Know-How in
Canada and Mexico (as hereafter defined, the United States, Canada and
Mexico shall constitute the "Territory") and Mylan desires to receive such
license.
NOW THEREFORE, in consideration of the mutual promises set forth herein, the
parties hereto hereby agree as follows:
1. INTERPRETATION AND DEFINITIONS
As used herein, the following terms shall have the respective meanings set
forth below:
1.1 "Affiliate" shall mean any person or legal entity controlling,
controlled by or under common control with the person or legal entity
with respect to whom such status is at issue.
1.2 "Best Efforts" shall mean such commercially reasonable efforts,
resources and expertise as a reasonably prudent business person
experienced in and knowledgeable of such matters as the kind and
character contemplated herein would exercise under the circumstances.
1.3 "Commencement Date" shall mean the date on which this Agreement has
been signed by both parties.
1.4 "Contract Year" shall mean the period beginning on the date of
introduction of the Product by Mylan in the Territory and ending
December 31 of the following year and, for each
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subsequent Contract Year, the successive calendar year or portion
thereof during the term of this Agreement.
1.5 "Field of Use", when used in connection with the Product in the ampule
dosage form, shall mean the treatment of Xxxxxxxxx'x disease; when
used in connection with Improvements made by Britannia, shall mean the
treatment of Xxxxxxxxx'x disease and treatment of any other ailment
for which Improvements are indicated; and, when used in connection
with Improvements made by Mylan, shall mean only treatment of
Xxxxxxxxx'x disease.
1.6 "Improvements" shall mean new dosage forms or other modifications
(including new uses outside the Field of Use) to the Product developed
by either party.
1.7 "Know-How" shall mean all methods, processes, techniques, products,
machines, materials, compositions, technology, information, data,
results of tests, studies, analyses and expertise possessed now and in
the future by Britannia or any Affiliate of Britannia, or developed
after the Commencement Date by Mylan or any Affiliate of Mylan, which
are useful in, and specifically related to, making, marketing or using
the Product or packaging that is uniquely designed or suited for the
Product, and shall include, without limitation, pharmacology,
toxicology, drug stability, manufacturing and formulation
methodologies and techniques, analytical technologies and clinical or
non-clinical safety and efficacy studies. It is understood and agreed
that the "Know-How" does not include any know-how or confidential
information relating to the Pen as defined in the 1995 Agreement.
1.8 "NDA" shall mean a New Drug Application filed with the United States
Food and Drug Administration in respect of the Product for the
Indication, and all amendments and supplements thereto.
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1.9 "Net Sales" shall mean: The gross amount invoiced for the Product in
arm's length transactions with bona fide customers who are not
Affiliates or Sublicensees of Mylan, less
(a) quantity and/or normal and customary cash discounts actually
allowed or taken;
(b) freight, postage, insurance, duties and taxes (not including
sales or income taxes payable by Mylan) invoiced as separate
items by Mylan;
(c) credits, rebates and/or adjustments allowed or given by reason of
Product expiration dating, rejections or returns, retroactive
price reductions or programs with wholesalers or other
distributors or resellers according to which they are entitled to
chargeback rebates, credits or adjustments upon their sales to
customers; and
(d) rebates, administrative fees, reimbursements or similar payments
to or for Medicaid or any other government programs (whether
mandatory or voluntary), hospitals, health maintenance
organizations, insurance carriers, buying groups or other
entities in connection with the purchase or utilization of the
Product.
1.10 "Net Selling Price" during any period shall mean the amount obtained
by dividing Net Sales of the Product sold by Mylan during such period
by the number of units of the Product sold which comprise such Net
Sales.
1.11 "Non-Exclusive" shall mean, when used in connection with a specific
grant of rights to the Product, that the granting party (i) shall
retain for itself and its Affiliates the ability to use such granted
rights, and (ii) shall have the ability to authorize its Affiliates or
third parties (in addition to the grantee of such specific rights) to
use such granted rights, in the Territory and Field of use covered by,
and for the time of, the grant.
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1.12 "Orphan Drug Designation" shall mean the FDA's act of granting a
request by Britannia for designation of the Product as intended for a
rare disease or condition pursuant to 21 USC 360 bb; which said
Designation subsequently was transferred to Mylan.
1.13 "Orphan Drug Rights" shall mean the rights of exclusivity which will
be granted by the FDA to Mylan upon approval of the Product for
marketing in the United States pursuant to 21 USC 360 cc.
1.14 "Product" shall mean a pharmaceutical product containing apomorphine
hydrochloride in the following dosage forms:
(a) 2 ml. and 5ml. glass ampules and other containers with the same
or different volumes for subcutaneous injection; and
(b) Improvements developed by Britannia and incorporated under the
License in accordance with Section 3.3 below.
It is understood and agreed that "Product" does not include the "Pen"
as defined in the 1995 Agreement.
1.15 "Quarter" shall refer to the quarterly periods ending March 31, June
30, September 30 and December 31.
1.16 "Specifications" shall mean the specifications for the Product set
forth in an approved NDA or other regulatory approvals for the Product
in the Territory, as the same may be amended from time to time in
writing and agreed between the parties.
1.17 "Territory" shall mean the United States of America, its territories
and possessions (including the freely-associated Commonwealth of
Puerto Rico), Canada and Mexico.
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1.18 "U.K. License" shall mean the license for the Product dated August,
1993 granted by the Medicines Control Agency in the United Kingdom,
and all amendments and supplements thereto.
2. DUE DILIGENCE PERIOD; COMPLETION OF DEVELOPMENT; CLINICAL TRIAL; PRODUCT
REGISTRATION
2.1 Mylan shall use its Best Efforts to obtain FDA approval of the NDA for
the Product and to secure and maintain the registration applications
for the Product in Canada and Mexico.
2.2 Britannia agrees to use its Best Efforts to assist Mylan in the
completion of development work necessary for FDA approval of the NDA
and in the preparation and filing of the other registrations for the
Product in the Territory. Out-of-pocket expenses for the NDA and other
Product registrations, including any additional clinical studies,
filing fees, and other expenses associated with the completion,
preparation and filing of the NDA and the other Product registrations,
shall be borne by Mylan. All product registrations shall be owned by
Mylan and shall be submitted in Mylan's name.
3. GRANT OF LICENSE; LICENSE FEES.
3.1 In consideration for the payment of the license fees provided by
Section 3.2 hereunder and subject to the terms and conditions hereof,
Britannia hereby grants Mylan and Mylan hereby accepts an Exclusive
right under the Know-How and the Orphan Drug Designation, to
manufacture, market, promote, use, distribute, sell and otherwise
commercially exploit the Product in the Field of Use in the Territory
(such rights are hereinafter referred to as the "License"). Mylan
shall have the right to sublicense the rights granted hereunder,
provided that the terms and conditions of such sublicense shall not be
inconsistent with the terms and conditions of this Agreement and each
such sublicense (except to an Affiliate of Mylan) shall be subject to
the prior written approval of Britannia, which
6
approval shall not be unreasonably withheld. It is understood and
agreed that any purported sublicense by Mylan in violation of this
Section 3.1 shall be invalid.
3.2 In consideration for the rights granted to Mylan pursuant to Section
3.1 hereof, Mylan hereby agrees to pay the following additional
license fees to Britannia:
(a) U.S. $*** (*** United States Dollars) upon approval by the FDA of
the NDA with Orphan Drug Rights;
(b) U.S. $*** (*** United States Dollars) upon the one year
anniversary of first commercial sale of the Product in the
Territory.
3.3 The License granted hereby shall be deemed to include all Improvements
to the Product, subject to the following terms and conditions:
(a) Improvements developed by Britannia shall become part of the
License granted to Mylan under Section 3.1 of this Agreement
without further milestone payments by Mylan provided that Mylan
shall deliver to Britannia, without charge, a copy of the
regulatory package for such Improvement in the form in which it
is filed in the U.S. and other countries in the Territory; Mylan
shall have the obligation to complete regulatory trials and
register Improvements developed by Britannia whenever it is
commercially reasonable to do so;
(b) Improvements developed by Mylan within the Field of Use shall be
offered to Britannia on an exclusive basis for all countries
outside the Territory;
(c) Mylan shall have the right to make, use and sell the Product in
the Territory under the Improvements developed by Mylan within
the Field of Use, provided that
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it shall pay to Britannia a royalty of *** percent (***%) on Net
Sales of such Product;
(d) Improvements developed by Mylan outside the Field of Use shall be
offered to Britannia on an exclusive basis in the U.K. only.
Mylan shall retain all other rights outside the U.K.; and
(e) Mylan shall have the right to make, use and sell Improvements
without obligations to Britannia other than those established
under Subsections 3.3(b), (c) or (d) above.
Improvements developed by Mylan shall be offered to Britannia under subsections
(b) and (d) in exchange for a royalty of *** percent of Net Sales of such
Improvement and the parties shall enter into an agreement containing the same
terms and conditions in respect of such Improvement as apply to the Product
under this Agreement. Such Improvements shall be disclosed in writing to
Britannia and Britannia shall have a period not to exceed *** from
date of written disclosure in which to exercise its rights under this Section.
For purposes of this Section 3.3, Improvements developed by Mylan's parent
company, Mylan Laboratories, or its Affiliates shall be deemed to be
Improvements developed by Mylan. The term "developed" as used herein shall mean
reduced to practice such that the party offered the Improvement is able to
determine whether such Improvement would be useful or marketable. The work
required to bring the Improvement to market for regulatory purposes, including
clinical trials necessary for approval, shall remain the responsibility of each
party in its respective territory.
4. ROYALTY
In consideration of the grant of license hereinabove set forth, Mylan shall
pay to Britannia a Royalty of ***% of Net Sales for the first *** of the term of
this Agreement and a royalty of ***% of Net Sales thereafter for the remainder
of the term of this Agreement as set forth in Section 9 hereof. Such royalty
shall be paid on a calendar quarterly basis, in arrears, within sixty (60) days
of the end of the quarter in which the royalty is earned.
8
5. TRADEMARKS AND TRADE NAMES; PATENT INFRINGEMENT
5.1 Mylan shall be responsible for the selection, registration and
maintenance of any trademark or name under which Mylan may choose to
market the Product and its Improvements. Mylan shall own all
trademarks and trade names pursuant to which Mylan may determine to
market the product and its Improvements in the territory.
5.2 (a) Britannia and Mylan agree to notify the other in writing of (i)
any alleged infringement or potential infringement of the Orphan
Drug Rights, or patents on Improvements; or (ii) any information
or allegations affecting the validity of the Orphan Drug
Designation, or patents on Improvements promptly after becoming
aware of the same.
(b) Britannia shall have the option of conducting any litigation with
respect to alleged infringement of patents on any Improvements
developed by Britannia. Should Britannia decide to conduct the
litigation, Britannia shall control the conduct of the litigation
and Mylan shall reasonably cooperate with Britannia in such
litigation. Provided, however, should Britannia, for any reason,
decline to conduct the litigation, Mylan shall have the right to
conduct such litigation and, in such event, Britannia shall
reasonably cooperate with Mylan in such litigation.
Notwithstanding which party conducts the litigation, Mylan and
Britannia shall equally share the cost of such litigation and any
proceeds therefrom shall be apportioned, pro rata, between Mylan
and Britannia based upon the damage sustained by either party,
respectively, and/or the benefit which inures to each as the
result of the litigation. The allocation by a court or other
competent tribunal having jurisdiction shall be binding on the
parties. If the matter is not determined by a court or other
tribunal or, if the court or tribunal
9
does not make such an allocation, or if the matter is resolved by
settlement or other mechanism, the parties shall negotiate in
good faith to agree on an appropriate allocation.
(c) Britannia and Mylan, each at the request of the other and at
their own expense, shall assist each other and cooperate in any
action taken, other than direct financial assistance, against an
alleged infringer or potential infringer.
5.3 Britannia agrees to defend (or settle) at its own expense, any action
in the nature of patent infringement asserted against Mylan by reason
of the marketing and sale of the Product pursuant to the Orphan Drug
Rights, patents on Britannia's Improvements and/or the Know-How and to
indemnify Mylan against any cost, loss or expense (including
reasonable attorneys fees and disbursements) incurred in connection
therewith. Any such indemnification shall be provided in the manner
and subject to the terms of Sections 8.3 and 8.4 hereof, provided that
Britannia shall only be responsible for direct costs, damages and
expenses arising from a matter as to which indemnification is required
by this Section (including, without limitation, license fees paid
hereunder and other costs and expenses directly attributable to such
matter) and shall not be responsible for lost profits or consequential
damages (such as loss of corporate good will generally) arising with
respect thereto. Notwithstanding the preceding provisions of this
Section 5.3, Mylan shall be responsible for the first $*** in costs
and expenses attributable to any matter as to which indemnity is to be
provided under this Section 5.3.
6. REPRESENTATIONS AND WARRANTIES
6.1 Britannia hereby represents and warrants to Mylan as follows:
10
(a) The execution and delivery by Britannia of this Agreement and the
performance by Britannia of its obligations hereunder have been
duly authorized by all necessary corporate action on the part of
Britannia, and do not conflict with the terms of any other
contract, agreement, arrangement or understanding to which
Britannia is a party.
(b) Britannia has not received notice nor is it aware of any claim of
ownership invalidity or patent infringement asserted by any third
party (including, without limitation, by employees, consultants
or other personnel) against Britannia in respect of the Know-How.
(c) Britannia has the right to grant an exclusive license under the
Know-How in accordance with the terms and conditions hereof.
(d) Britannia has provided, or otherwise made available, to Mylan,
whether requested or not, all relevant or material information
and data concerning the Product, Orphan Drug Designation, the
Know-How and the ability of Britannia to perform hereunder.
(e) To Britannia's knowledge and belief, all information provided or
to be provided by Britannia hereunder, as far as it is or shall
be known by Britannia, is true, complete and accurate.
(f) To Britannia's knowledge and belief, there are no pending or
threatened actions, suits, proceedings, investigations, inquiries
or judgements, decrees, injunctions, awards, or orders involving,
or related to, any matters set forth herein or rights granted
hereunder.
6.2 Mylan hereby represents and warrants to Britannia as follows:
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(a) The execution and delivery by Mylan of this Agreement and the
performance by Mylan of its obligations hereunder have been duly
authorized by all necessary corporate action on the part of Mylan
and do not conflict with the terms of any other contract,
agreement, arrangement or understanding to which Mylan is a
party.
(b) Mylan has received from Britannia such information with respect
to the Product, Orphan Drug Designation and the Know-How as Mylan
has deemed necessary and relevant in connection with the
transactions contemplated by this Agreement, and Mylan has had
the opportunity to ask questions of and receive answers from
persons acting on behalf of Britannia as Mylan has deemed
necessary to verify the information so obtained. The foregoing
shall not be deemed a limitation upon any representation or
warranty of Britannia set forth herein. This representation shall
come into effect upon expiration of the Due Diligence Period
referred to in Section 2.1 provided Mylan has not terminated this
Agreement in accordance with that Section.
6.3 Each of Mylan and Britannia hereby covenant with each other as
follows:
(a) Mylan shall disclose to Britannia and Britannia shall disclose to
Mylan, in each case within five (5) business days, all reports or
other knowledge ("Safety Data") they may from time to time
possess with respect to "adverse drug experiences" (as defined in
regulations promulgated by applicable regulatory authorities),
mislabeling, stability failures or microbiological contamination
with respect to the product (whether occurring inside or outside
the Territory). With respect to "serious adverse drug
experiences" as defined in the U.S. legislation in 21 CFR Section
312.32 and Section 314.80 and in applicable sections of the laws
of the countries comprising the Territory, each party shall
disclose to the other such Safety Data within
12
two (2) business days of receipt of notification of such event.
The content of such disclosure shall comply with applicable
regulations. Each party shall promptly deliver to the other all
correspondence which such party may receive from regulatory
authorities in jurisdictions where such party has rights to
market the product, except for procedural, non-substantive
communications which do not relate to the safety or efficacy of
the Product.
7. CONFIDENTIALITY
7.1 For purposes of this Agreement, the term "Confidential Information"
shall mean any information (whether or not reduced to writing) which
either party shall possess in relation to the development,
formulation, manufacture, testing, marketing or distribution of any
Product (including Improvements developed by Mylan) except for any
information which:
(a) is available to the public generally other than as a result of
disclosure by either party;
(b) is known to a party prior to disclosure by the other party and
such other party can prove it by written evidence or other
competent proof; or
(c) becomes known to a party by a source other than the other party,
which source is legally entitled to make such disclosure.
7.2 Britannia and Mylan shall keep in strictest confidence all
Confidential Information and shall not disclose such Confidential
Information to any third person except employees, consultants or other
agents who need to receive such Confidential Information for the
purpose of achieving an objective of this Agreement and who are bound
by obligations
13
of confidentiality with respect thereto, as necessary in connection
with the transactions provided for or contemplated hereby, or as may
otherwise be required by law. Each such party shall exercise all
necessary precautions to safeguard the secrecy of Confidential
Information and to prevent the unauthorized disclosure thereof.
7.3 Subject to Sections 7.1 and 7.2, Mylan (and Mylan's permitted
sublicensees) shall have the right to use all Confidential Information
hereafter developed by Britannia for use in marketing the product in
the Territory and for developing Improvements but for no other
purpose.
7.4 The provisions of this Article 7 shall survive expiration or
termination of this Agreement for any reason and shall remain in
effect for a period of seven (7) years following the date of the last
sale of Product or any Improvement by Mylan hereunder.
8. MARKETING OBLIGATION; INDEMNITY
8.1 At all times during the term hereof following the Commencement Date,
Mylan will use its Best Efforts, subject to compliance with all
applicable laws and regulations, to register, promote and market the
Product in the Territory. Mylan agrees to market the Product in a
commercially reasonable manner.
8.2 Britannia shall indemnify and hold Mylan harmless from and against any
direct costs, expenses (including, without limitation, reasonable
attorneys fees) or damages (hereinafter referred to as "Claims") which
arise from breach by Britannia of any of its representations,
covenants, warranties or obligations set forth herein, except to the
extent such Claims are caused by the negligence or willful misconduct
of Mylan. Mylan shall indemnify and hold Britannia harmless from and
against any Claims which arise from the breach by Mylan of any of its
representations, covenants, warranties or
14
obligations set forth herein or from the marketing, sale or
distribution of the Product by Mylan and its Affiliates, except to the
extent such Claim was caused by or arises from: (i) the negligence or
willful misconduct of Britannia; or (ii) any matter as to which
Britannia has agreed to indemnify Mylan hereunder. The person
obligated to provide indemnity pursuant to this Section 8.2 is
hereinafter referred to as the "Indemnifying Party".
8.3 Promptly after the receipt by any party hereto of notice of (a) any
claim or (b) the commencement of any action or proceeding, such party
will, if a claim with respect thereto is to be made against any party
obligated to provide indemnification pursuant to Section 8.2 hereof,
give such Indemnifying Party written notice of such claim or the
commencement of such action or proceeding. Such Indemnifying Party
shall have the right, at its option, to compromise or defend, at its
own expense and by its counsel, any such matter involving the asserted
liability of the party seeking such indemnification. Such notice, and
the opportunity to compromise or defend, shall be a condition
precedent to any liability of the Indemnifying Party under the
indemnification provisions of Section 8.2. In the event that any
Indemnifying Party shall undertake to compromise or defend any such
asserted liability, it shall promptly notify the party seeking
indemnification of its intention to do so, and the party seeking
indemnification agrees to cooperate fully with the Indemnifying party
and its counsel in the compromise of, or defense against, any such
asserted liability. In any event, the indemnified party shall have the
right, at its own expense, to participate in the defense of such
asserted liability, provided that the Indemnifying Party's counsel
shall make all final decisions concerning the defense or compromise or
settlement of such litigation.
8.4 Each of the parties hereto shall be entitled to be represented at any
proceedings brought by the other party under this Article 8 by its own
counsel, at its own expense, and shall
15
cooperate fully with the other party in any such proceeding, provided
it is adequately reimbursed for its out-of-pocket costs and expenses,
excluding attorneys' fees.
8.5 Mylan at all times under this Agreement shall maintain product
liability insurance protecting itself and Britannia (naming Britannia
as an additional insured) against any Claims for which Mylan is
required to indemnify Britannia hereunder. The insurance coverage
shall be in such amounts, covering such risks as are appropriate, in
accordance with sound business practice and Mylan's obligations under
this Agreement, but, in any event in amounts ***.
In connection with its obligations hereunder, Mylan, upon request,
shall furnish proof of such insurance to Britannia.
9. TERM OF LICENSE AGREEMENT
9.1 Subject to the provisions of Section 11, this Agreement shall remain
in effect until the last to expire of the following terms:
(a) Expiration of the Orphan Drug Rights;
(b) The last to expire of any patents issued or licensed to Britannia
for an Improvement or, if there are no such patents, for a period
of *** from the date of first commercial sale of the
Product in the Territory subject to a right by Mylan to renew for
additional consecutive terms of *** each by giving
notice in writing to Britannia of its intent to renew not less
than six (6) months prior to the end of the initial or any
renewal term.
9.2 Upon the expiration of the term of this Agreement, Mylan shall have a
royalty-free, Non-Exclusive, paid-up license to market, promote, use,
sell and distribute the Product under the Trademarks in the Territory.
16
9.3 No expiration of the term of this Agreement shall relieve either party
of obligations accrued to such date of expiration or of obligations
which continue by the terms hereof beyond such expiration.
10. TERMINATION
10.1 In the event of any default by either party in the performance of any
of the terms and conditions of this Agreement, the other party may
terminate this agreement upon ninety (90) days written notice;
provided, however, that (i) if during such ninety (90) day period the
party against whom the default is claimed cures default, (ii) if such
breach cannot be cured within such ninety (90) day period, such person
takes reasonable steps to commence and proceeds diligently thereafter
to cure such default and, in fact, cures such default within a
reasonable period of time, or (iii) if such default is cured in any
other manner satisfactory to the other party as a substitute for full
performance, then this Agreement will continue in full force and
effect until it expires as provided in Section 9.
10.2 In the event that this Agreement is terminated by either party as a
result of the default of the other party, the obligations of
confidentiality set forth in Section 7 shall survive and continue to
bind the defaulting party, and in all other respects the rights and
obligations of the non-defaulting party shall be determined in
accordance with the provisions of this Agreement.
11. SPECIFIC PERFORMANCE; FORCE MAJEURE
11.1 Each party agrees that a violation by it of any of its covenants and
undertakings contained in this Agreement will cause irreparable injury
to the other, and that such other party shall be entitled, in addition
to any other rights and remedies it may have hereunder at law or at
equity, to an injunction or similar
17
equitable remedy enjoining and restraining any such violation or
threatened violation thereof.
11.2 Neither Britannia nor Mylan shall be held liable or in default for
failure of performance for any cause beyond its reasonable control
including, for example, Acts of God, declared or undeclared war, fire,
flood, interruption of transportation, embargo, insurrections,
accident, explosion, governmental laws, orders, regulations, or
restrictions, any strike, lockout or other labor troubles interfering
with the production or transportation of the Product.
12. FURTHER ASSURANCES
Each of the parties shall, from time to time during the term of this
Agreement, upon request by the other, execute and deliver all such further
documents or instruments as may be required in order to give effect to the
purpose and intent of this Agreement. Without limiting the generality of the
foregoing, the obligations of the parties hereunder are undertaken with a
principal objective of complying with all pertinent provisions of applicable
laws, orders and regulations relating to the manufacture, use or sale of
pharmaceutical products, and the parties shall take all necessary action as may
be required to comply with such provisions.
13. ASSIGNMENT
This Agreement shall be binding upon and inure to the benefit of the
parties hereto and their respective assignees and successors in interest. In
addition, except to the extent of the sublicensing permitted by Section 3.1,
neither party shall assign its rights or obligations hereunder, except with the
consent of the other party, which consent shall not be unreasonably withheld.
14. CHOICE OF LAW
This Agreement shall be governed by, and construed in accordance with, the
internal laws of the State of Delaware, without giving effect to its principles
of conflicts of laws.
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15. NOTICES
Any such notice, request or other communication required or permitted by
this Agreement to be given by either party to the other shall be in writing and
either mailed by registered or certified mail, return receipt requested, by
express delivery service or by facsimile transmission, addressed to such party,
Attention: The Chief Executive Officer, at its address indicated above or to
such party previously may have designated by like written notice. Notice shall
be deemed to have been given upon receipt. Facsimile transmission numbers for
the parties are as follows:
If to Mylan: (000) 000-0000
If to Britannia: (44) (0) 000 000 000
16. MISCELLANEOUS
16.1 This agreement constitutes the entire agreement between the parties
with respect to the subject matter hereof and supersedes all prior
written or oral agreements or understandings regarding the subject
matter hereof or in conflict with its terms.
16.2 Except as otherwise provided in Section 11.1, any disputes arising
with respect to the interpretation or enforcement of, or claims with
respect to, any provision hereof shall be submitted in the first
instance to the parties' respective Chief Executive Officers.
16.3 No modification or waiver of any of the terms of this Agreement shall
be deemed valid unless it is in writing and signed by the party
against whom such modification is sought to be enforced. The failure
of either party to insist upon the strict performance of any term of
this Agreement or the waiver by either party of any breach under this
Agreement shall not prevent the subsequent strict enforcement of such
term nor be deemed a waiver of any subsequent breach.
19
16.4 In the event any court declares illegal or unenforceable, as written
or applied, any provision of this Agreement, the balance of such
provision and this Agreement shall continue in full force and effect
as if such provision had been deleted or made inapplicable to the
situations to which such provision cannot be legally applied.
16.5 Neither party shall publicly disclose the subject matter or terms and
conditions hereof without the prior consent of the other, except to
the extent of disclosure which either party may be required to make by
law or regulation.
IN WITNESS WHEREOF, the parties hereto have executed this agreement as of
the day and year first written above.
BRITANNIA PHARMACEUTICALS, LIMITED
By:
------------------------------------
MYLAN PHARMACEUTICALS INC.
By:
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AMENDMENT TO LICENSE AGREEMENT BETWEEN
BRITANNIA PHARMACEUTICALS, LIMITED
AND
MYLAN PHARMACEUTICALS INC.
DATED NOVEMBER 24, 1999
The Parties agree to amend the above referenced agreement as follows:
1. Section 3.3(a) shall be deleted and replaced with the following:
3.3(a) Improvements developed by Britannia shall become part of the License
granted to Mylan under Section 3.1 of this Agreement without further
milestone payments by Mylan provided that Mylan shall by written
notice elect to accept rights to the relevant Improvement *** the
date of written disclosure of such Improvement by Britannia and
provided that Mylan shall deliver to Britannia, without charge, a
copy of the regulatory package for such Improvement in the form in
which it is filed in the U.S. and other countries in the Territory;
Mylan shall have the obligation to complete regulatory trials and
register Improvements developed by Britannia and accepted by Mylan
as aforesaid whenever it is commercially reasonable to do so;
2. Revise Page 8 Line 14 as follows:
By inserting the sentence:
"All Improvements shall be disclosed in writing and each party shall have a
period *** the date of written disclosure to exercise
its rights under this Section 3.3"
In place of the sentence:
"Such improvements shall be disclosed in writing to Britannia and Britannia
shall have a period *** the date of written disclosure in which to exercise
its rights under this Section"
Signed and Accepted:-
MYLAN PHARMACEUTICALS INC. BRITANNIA PHARMACEUTICALS LTD.
BY: BY:
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TITLE: TITLE:
DATE: DATE:
