Exhibit 10.6
LICENSE AND SUB-LICENSE AGREEMENT
This License and Sub-License Agreement (the "Agreement") is
entered into and made effective as of May 13, 2003, by and between BIOENVISION,
INC., a Delaware corporation ("Bioenvision"), and DECHRA PHARMACEUTICALS, PLC, a
corporation organized under the laws of the United Kingdom ("Dechra").
RECITALS
A. Bioenvision has entered into a Co-Development Agreement
with Stegram Pharmaceuticals Limited ("Stegram"), dated July 15, 1998, a true
and correct copy of which is attached hereto as Exhibit A (the "Co-Development
Agreement"), pursuant to which Stegram has granted to Bioenvision certain rights
and entitlements (including the marketing and development rights) in and to the
chemical compound known as trilostane, an inhibitor of 3a-hydroxysteroid
dehydrogenase, and methods of using trilostane.
B. Pursuant to the terms set forth in the Co-Development
Agreement, Bioenvision has the right under the Co-Development Agreement to grant
sublicenses.
C. Bioenvision has certain rights and entitlements, in its own
name, in and to trilostane and methods of using trilostane.
D. Dechra wishes to obtain from Bioenvision, and Bioenvision
wishes to grant to Dechra, a license of all of Bioenvision's rights and
entitlements (including without limitation the marketing and development
rights), within the territory of the United States and Canada, in and to the
chemical compound known as trilostane and methods of using trilostane, in each
case, solely with respect to animal health applications, on the terms and
conditions set forth herein.
NOW, THEREFORE, in consideration of the premises, the mutual
covenants and conditions set forth herein, and other good and valuable
consideration, the receipt and adequacy of which are hereby acknowledged,
Bioenvision and Dechra agree as follows:
1. Definitions.
1.1. Affiliate. The term "Affiliate" of Dechra shall mean any entity which
directly or indirectly controls, is controlled by or is under common control
with Dechra. The term "control" as used herein means the possession of the power
to direct or cause the direction of the management and the policies of an
entity, whether through the ownership of a majority of the outstanding voting
securities or by contract or otherwise.
1.2. FDA. The term "FDA" shall mean the United States Food and Drug
Administration, or any successor agency thereto.
1.3. Licensed Assets. The term "Licensed Assets" shall mean all of Bioenvision's
rights and entitlements (including without limitation the marketing and
development rights) in and to the chemical compound known as trilostane, in each
case, solely with respect to animal health applications, including the Licensed
Technology, Licensed Patents, Licensed Inventions, Licensed Improvements,
Licensed Technical Information, and all of
Bioenvision's rights and entitlements (including the marketing and development
rights) under the Co-Development Agreement, in each case solely with respect to
animal health applications and solely within the Licensed Territory and solely
with respect to the Licensed Field.
1.4. Licensed Field. The term "Licensed Field" shall mean, and is limited to,
the practice of the Licensed Patents, Licensed Inventions and Licensed Technical
Information, in each case, solely for use in animal health applications.
1.5. Licensed Improvement. The term "Licensed Improvement" shall mean those
unencumbered technology advances in the Licensed Technology made by or on behalf
of either or both of Bioenvision and Stegram during the term of the
Co-Development Agreement or the term of this Agreement that either (i) are
within the scope of, and would constitute an infringement of, any claim of a
Licensed Patent or (ii) use Licensed Technical Information, and are within the
Licensed Field.
1.6. Licensed Invention. The term "Licensed Invention" shall mean the Licensed
Technology that is related to, or necessary for the practice of, the Licensed
Technology for animal health applications as disclosed and claimed in one or
more Licensed Patents.
1.7. Licensed Patent. The term "Licensed Patent" shall mean any patent and
patent application, covering the Licensed Technology, Licensed Products,
Licensed Inventions or Licensed Improvements, patents to be issued pursuant
thereto, and all divisionals, continuations, continuations-in-part, reissues,
substitutions, or extensions thereof, or any patent issuing on a patent
application, filed after the "Effective Date" of the Co-Development Agreement,
which is included in the grant of license hereunder and any foreign counterparts
of the foregoing within the Licensed Territory, and including any "Patent" as
defined in the Co-Development Agreement.
1.8. Licensed Product. The term "Licensed Product" shall mean a product,
service, test, or information which is based upon or related to animal health
applications and is sold or provided for a fee and, but for the licenses granted
herein, would infringe one or more claims of a Licensed Patent, or was
discovered, developed, approved manufactured or marketed using a Licensed
Invention, Licensed Improvement or Licensed Technical Information.
1.9. Licensed Technical Information. The term "Licensed Technical Information"
shall mean (i) Technical Information as defined in the Co-Development Agreement,
based upon or solely related to animal health applications, and (ii)
unencumbered published or unpublished confidential and proprietary information
in the nature of research and development information, knowledge and technical
data, together with trade secrets relating to the Licensed Technology, including
any inventions in the possession of or belonging solely to Bioenvision on or
prior to the effective date of this Agreement which Bioenvision has the
obligation to include in this Agreement, or which comes into the possession of
Bioenvision during the term of this Agreement. Licensed Technical Information
shall include herein only that Licensed Technical Information which is
reasonably necessary for Dechra's practice of the Licensed Inventions or without
which such practice would constitute an infringement of Bioenvision's rights.
Licensed Technical Information includes only the above information which is
developed by or on behalf of Bioenvision or Stegram, or is generated pursuant to
research funded, in whole or in part, by Bioenvision.
1.10. Licensed Technology. The term "Licensed Technology" shall mean patented
and unpatented, patentable and unpatentable, proprietary technology related to a
dehydrogenase inhibitor and receptor blocker developed by or on behalf of either
or both of Bioenvision and Stegram, in each case, useable with respect to animal
health applications.
1.11. Licensed Territory. The term "Licensed Territory" shall mean the United
States of America, its territories and possessions, and the country of Canada.
1.12. Net Sales. The term "Net Sales" shall mean the aggregate invoice price of
all Licensed Products sold by Dechra or its Affiliates or sublicensees in the
Licensed Territory within the Licensed Field, less the following discounts and
offsets related thereto: tariffs, import or export duties, excise, value-added
and sales taxes, where such tariffs, duties or taxes are separately stated as
part of the sales price; customary trade, quantity and cash discounts actually
given; rebates and adjustments required by governmental entities and made
pursuant to governmental or private third-party health or medical insurance
programs; transportation, packaging, handling and freight charges where such are
separately stated as part of the sales price; and allowances or credits for
returns or rejections. In the event of a sale of a Licensed Product by Dechra to
an Affiliate of Dechra, and the subsequent resale of such Licensed Product by
such Affiliate, Net Sales shall be computed on the basis of such subsequent
resale. In the event that any Licensed Product is sold as a component of another
product, "Net Sales" shall mean the portion of such other product's invoice
price that is allocable to the Licensed Product based on the ratio of the
invoice price of the Licensed Product when sold separately to the invoice price
of such other product, or, in the absence of the invoice price of either the
Licensed Product or such other product, on the ratio of the cost of the Licensed
Product to the total cost of such other product. Net Sales in Canadian dollars
shall be converted into United States dollars at each time at which a
calculation of Net Sales is to be made under this Agreement.
1.13. Royalty Period. The term "Royalty Period" shall mean, in respect of any
month, either (a) the period of 12 months ending on the last day of the
immediately preceding month or, if shorter, (b) the period beginning on the most
recent Royalty Period Start Date provided in Section 3.5 and ending on the last
day of the immediately preceding month.
2. Grant.
2.1. Grant of License. Subject to the terms and conditions hereof, Bioenvision
hereby grants to Dechra and its Affiliates an exclusive license of the Licensed
Assets, including a sublicense under the Co-Development Agreement, free and
clear of all liens, encumbrances and claims other than those specifically set
forth in this Agreement. Such license shall include the right to make, use,
sell, offer for sale, import and distribute Licensed Products and to practice
methods and processes under the Licensed Patents, Licensed Inventions, Licensed
Improvements, Licensed Technology and Licensed Technical Information. For the
avoidance of doubt, Bioenvision agrees that the exclusivity of the license
granted to Dechra means that Bioenvision shall not practice, use or otherwise
exploit the Licensed Patents, Licensed Inventions, Licensed Improvements,
Licensed Technology or Licensed Technical Information in the Licensed Territory
for use in animal health applications (including making, using, selling,
offering for sale, importing or distributing a product, service, test, or
information), and that Bioenvision shall not grant a license to any party other
than Dechra to do any of the foregoing.
2.2. Sublicenses. The license granted to Dechra by Bioenvision under this
Agreement shall include the right to grant sublicenses. To the extent that any
such sublicense is a further sublicense of rights licensed to Bioenvision from
Stegram under the Co-Development Agreement, such further sublicense by Dechra
shall be in accordance with Article 7 of the Co-Development Agreement.
2.3. Licensed Technical Information. Bioenvision agrees to provide Dechra,
promptly after the execution of this Agreement by all parties and thereafter
during the term of this Agreement, copies of such documentation as Bioenvision
has in its possession from time to time relating to the Licensed Technical
Information.
3. Consideration.
In consideration of the grant of the licenses by Bioenvision
to Dechra hereunder, Dechra agrees to make the following payments to
Bioenvision:
3.1. Execution of Agreement. Upon the execution of this Agreement by both
Bioenvision and Dechra, and the receipt by both Bioenvision and Dechra of the
written consent to this Agreement by Stegram, Dechra shall
pay to Bioenvision in cash by wire transfer of immediately available funds an
amount equal to One million two hundred and fifty thousand United States Dollars
(US $1,250,000.00).
3.2. Submission of NADA. Upon Dechra's submission of its New Animal Drug
Application ("NADA") to the FDA for trilostane, Dechra shall pay to Bioenvision
in cash by wire transfer of immediately available funds an amount equal to seven
hundred and fifty thousand United States Dollars (US $750,000.00).
3.3. Receipt of NADA Approval and Licensed Patents.
3.3.1. If Dechra receives approval of its New Animal Drug Application ("NADA
Approval") from the FDA for trilostane prior to the issuance of a Licensed
Patent by the United States Patent and Trademark Office (the "USPTO") to either
Stegram or Bioenvision, then (a) Dechra shall pay to Bioenvision in cash by wire
transfer of immediately available funds an amount equal to Xxx Xxxxxxx Xxxx
Xxxxxxx Xxxxxxxx Xxxxxx Xxxxxx Dollars (US $1,500,000.00) and (b) Dechra shall
deposit with a mutually acceptable escrow agent (the "Escrow Agent") an amount
equal to Xxx Xxxxxxx Xxxx Xxxxxxx Xxxxxxxx Xxxxxx Xxxxxx Dollars (US
$1,500,000.00) (the "Escrowed Amount"). The Escrowed Amount shall be released to
Bioenvision, with the accumulated interest accrued thereon, net of the fees and
expenses of the Escrow Agent, upon the issuance of a Licensed Patent by the
USPTO.
3.3.2. If no Licensed Patent has been issued by the USPTO on or before the third
anniversary of the effective date of this Agreement, then an amount equal to US
$250,000 of the Escrowed Amount, with the pro rata share of the accumulated
interest accrued thereon, net of the fees and expenses of the Escrow Agent,
shall be released to Dechra. For each consecutive 90-day period thereafter, if
no Licensed Patent has been issued by the USPTO on or before the end of such
90-day period, then an amount equal to US $250,000 of the Escrowed Amount, with
the pro rata share of the accumulated interest accrued thereon, net of the fees
and expenses of the Escrow Agent, shall be released to Dechra, until either (i)
a Licensed Patent is issued by the USPTO or (ii) all of the Escrowed Amount,
with the accumulated interest accrued thereon, net of the fees and expenses of
the Escrow Agent, is released to Dechra, whichever shall first occur. If a
Licensed Patent is issued by the USPTO prior to the release of all of the
Escrowed Amount to Dechra as provided above, then upon the issuance of such
Licensed Patent: (a) the then remaining principal balance of the Escrowed Amount
shall be released to Bioenvision, with the accumulated interest accrued thereon,
net of the fees and expenses of the Escrow Agent, and (b) Dechra shall promptly
pay to Bioenvision the excess of $1,500,000 over the remaining principal balance
of the Escrowed Amount released to Bioenvision together with accumulated
interest thereon.
3.3.3. If Dechra receives a NADA Approval from the FDA for trilostane
simultaneously with or after the issuance of any Licensed Patent by the USPTO to
either Stegram or Bioenvision, then upon Dechra's receipt of the NADA Approval,
Dechra shall pay to Bioenvision in cash by wire transfer of immediately
available funds an amount equal to Three Million United States Dollars (US
$3,000,000.00).
3.4. Statement of Net Sales. Following the execution of this Agreement, Dechra
shall, by the 15th day of each month provide to Bioenvision a statement showing
in reasonable detail the Net Sales for the immediately preceding calendar month
with respect to Licensed Products sold by Dechra or its Affiliates or its
sublicensees, prepared in accordance with generally accepted accounting
principles in the United States (the "Monthly Total"). In addition, following
the execution of this Agreement and until such time, if any, as the Royalty rate
equals four percent as provided below, such monthly statement shall also show
such Net Sales for the Royalty Period ending on the last day of the immediately
preceding month (the "Rolling Annual Total").
3.5. Royalty Payments.
3.5.1. Until such time as the Rolling Annual Total is equal to or exceeds Ten
Million United States Dollars (US $10,000,000.00), Dechra shall not owe any
payments to Bioenvision other than those set forth in Sections 3.1, 3.2 and 3.3.
3.5.2. In respect of the month in which the Rolling Annual Total first equals or
exceeds $10 million, Dechra shall make a one-time payment to Bioenvision equal
to the sum of:
(a) Two Hundred Thousand United States Dollars (US
$200,000.00), plus
(b) Two percent of the amount by which the Rolling Annual
Total exceeds $10 million.
3.5.3. In respect of each month subsequent to the month described in Section
3.5.2, Dechra shall (subject to Sections 3.5.6 and 3.5.9 below) pay to
Bioenvision a royalty (the "Royalty") equal to two percent of the Monthly Total
for each such subsequent month.
3.5.4. The first day of the month immediately following the month described in
Section 3.5.2 shall be a new Royalty Period Start Date for purposes of
thereafter determining the Royalty Period and the Rolling Annual Total shall be
recalculated effective from such new Royalty Period Start Date.
3.5.5. In respect of the month in which the Rolling Annual Total first equals or
exceeds $15 million, Dechra shall, in addition to any payments due under
Sections 3.5.2 or 3.5.3, make a one-time payment to Bioenvision equal to one
percent of the amount by which the Rolling Annual Total exceeds $15 million.
3.5.6. In respect of each month subsequent to the month described in Section
3.5.5, and in lieu of any payment pursuant to Section 3.5.3 above, Dechra shall
thereafter (subject to Sections 3.5.8 and 3.5.9 below) pay to Bioenvision a
Royalty equal to three percent of the Monthly Total for each such subsequent
month.
3.5.7. The first day of the month immediately following the month described in
Section 3.5.5 shall be a new Royalty Period Start Date for purposes of
thereafter determining the Royalty Period and the Rolling Annual Total shall be
recalculated effective from such new Royalty Period Start Date.
3.5.8. In respect of the month in which the Rolling Annual Total first equals or
exceeds $20 million, Dechra shall, in addition to any payments due under
Sections 3.5.2, 3.5.3, 3.5.5 or 3.5.6, make a one-time payment to Bioenvision
equal to one percent of the amount by which the Rolling Annual Total exceeds $20
million.
3.5.9. In respect of each month subsequent to the month described in Section
3.5.8, and in lieu of any payment pursuant to Section 3.5.3 or 3.5.6 above,
Dechra shall thereafter pay to Bioenvision a Royalty equal to four percent of
the Monthly Total for each such subsequent month.
3.6. Illustrative Examples. For the avoidance of doubt, the application of
Section 3.5 is illustrated by the examples set forth in Exhibit B attached
hereto.
3.7. Statement of Royalty. Once the payment of Royalty by Dechra to Bioenvision
begins pursuant to Section 3.5, the monthly statement of Net Sales described in
Section 3.4 shall also include the calculation in reasonable detail of the
related Royalty owed by Dechra with respect to such Net Sales. In the event that
Bioenvision disagrees with Dechra's calculation of Net Sales, such dispute may
be resolved in accordance with the dispute resolution procedure set forth in
Section 12 below.
3.8. Renegotiation of Royalty Rates. The payment obligations under the license
granted to Dechra for the Licensed Assets shall continue throughout the term as
defined in this Agreement, but will be subject to good faith renegotiations upon
the occurrence of whichever of the following applies, unless this Agreement
shall have been earlier terminated: (a) the expiration of the last to expire of
the Licensed Patents applicable to the Licensed Field within any country in the
Licensed Territory; or (b) if no Licensed Patents have been issued within a
particular
country in the Licensed Territory that are applicable to the Licensed Field, the
abandonment of the last to be abandoned of any applications for Licensed Patents
in such country that are applicable to the Licensed Field. Such good faith
renegotiations shall take into account on a country-by-country or regional
basis, but shall not be limited to: (i) competition with the Licensed Products
within the Licensed Field; (ii) utilization, incorporation and value of Licensed
Technical Information within the Licensed Field; (iii) value of Licensed
Technical Information if no longer confidential or proprietary through no fault
of Dechra, or its Affiliates, sublicensees, contractors, financiers or any other
Dechra agents or the purchasers of Products or services from Dechra or its
Affiliates who have access to Licensed Technical Information; (iv) the
applicable contract or patent law; or (v) prior payment commitments.
If a Licensed Product incorporates inventions, patents or technical
information that are obtained from sources other than Bioenvision or Stegram,
the parties agree to negotiate in good faith a new Royalty rate to reflect the
combination of such third-party inventions, patents or technical information;
provided, however, the parties agree to use commercially reasonable efforts to
incorporate inventions., patents and technical information from Bioenvision
and/or Stegram in such Licensed Products.
4. Term and Termination.
4.1. Term. Unless terminated sooner in accordance with the provisions of this
Agreement, the term of the licenses granted to Dechra by Bioenvision shall
expire when the last of the Royalty obligations set forth herein has expired.
4.2. Rights Upon Termination. Upon termination of this Agreement, neither party
shall be released from any obligation that matured prior to the effective date
of such termination. Dechra and its Affiliates and any sublicensees may,
however, after the effective date of such termination, sell all Licensed
Products in inventory provided that Dechra shall pay to Bioenvision the
Royalties as required by Article 3 hereof and shall submit the reports required
by Article 3 hereof.
4.3. Termination Upon Default. If either party shall be in default of any
obligation hereunder, the other party may terminate this Agreement by giving
notice of termination by certified or registered mail to the party in default,
specifying the basis for termination. If within sixty (60) days after the
receipt of such notice of termination, the party in default shall remedy, in
good faith, the condition forming the basis for termination, such notice of
termination shall cease to be operative, and this Agreement shall continue in
full force.
4.4. Termination Upon Bankruptcy or Insolvency. Either party shall have the
right to terminate this Agreement if the other party shall cease to carry out
its business as related to the Licensed Products within the Licensed Field and
the Licensed Territory, become insolvent, file a voluntary petition in
bankruptcy, apply for or consent to the appointment of a trustee, receiver or
liquidator of its assets, seek relief under any law for the aid of debtors, or
fail to have an involuntary petition in bankruptcy dismissed within 60 days
after the filing thereof, other than any such case that was initiated, directly
or indirectly, by the party attempting to cancel this Agreement.
4.5. Notice of Imminent Bankruptcy. Each party shall inform the other party of
such party's intention to file a voluntary petition in bankruptcy or of such
party's knowledge of another's intention to file an involuntary petition in
bankruptcy, to be received, in the event of a party's voluntary petition in
bankruptcy, at least thirty (30) days prior to filing such a petition.
4.6. Survival. Notwithstanding anything else in this Agreement to the contrary,
the parties agree that Dechra's obligation to pay Bioenvision any payments or
other consideration accrued but unpaid prior to termination shall survive the
termination of this Agreement.
5. Records and Audits.
Dechra shall keep accurate records of all operations affecting payments
hereunder. Bioenvision shall have the right for it or its duly authorized agent
to audit and otherwise inspect all such records no more often than twice per
calendar year pursuant to not less than fifteen (15) calendar days prior written
notice, signed by Bioenvision, which audit shall be conducted at the offices of
Dechra during customary business hours. Information obtained by Bioenvision or
its authorized agent in such audits and inspections shall be deemed to be
Confidential Information of Dechra and subject to the provisions of Section 11.1
below.
6. Ownership of Intellectual Property.
Bioenvision and Dechra shall each retain full ownership of its own existing and
future intellectual property rights, including rights in the process of being
protected and rights conceived but not yet reduced to practice as of, or
subsequent to, the effective date of this Agreement.
7. Patent Prosecution and Infringement.
7.1. Bioenvision shall provide Dechra with copies of allowed patent
claims when such claims are allowed in the Licensed Field and in the
Licensed Territory for all Licensed Patents, Licensed Inventions and
Licensed Improvements licensed hereunder
7.2. Bioenvision shall provide Dechra with draft copies of all
correspondence and filings and related prosecution documents on the
Licensed Patents and Dechra shall promptly provide comments, if any, to
Bioenvision. Bioenvision shall confer with Dechra, and shall make
reasonable efforts to have Dechra's suggestions regarding prosecution
tactics and strategy adopted by Stegram with respect to Licensed
Patents that are licensed to Bioenvision from Stegram under the
Co-Development Agreement. Notwithstanding the foregoing, Dechra
acknowledges that, under the Co-Development Agreement, Stegram shall
have the right to take such actions as are reasonably necessary, in
Stegram's good faith judgment, to preserve all rights under such
Licensed Patents as are licensed to Bioenvision from Stegram under the
Co-Development Agreement and to maintain such Licensed Patents and
patent applications in the name of Stegram. As soon as practical,
subsequent to the filing of any prosecution document, Bioenvision shall
provide Dechra with a copy of the document. In addition, Bioenvision
shall provide Dechra with a copy of any official office action and
copies of responses and submissions filed by Bioenvision or filed by
Stegram and in the possession of Bioenvision.
7.3. Bioenvision shall inform Dechra at least forty-five (45) days
prior to any decision having as a result the failure to file, or the
abandonment of a Licensed Patent application or failure to maintain a
Licensed Patent licensed hereunder, so that Dechra may take over and
maintain such Licensed Patent in force in the name of Bioenvision or
Stegram, as the case may be.
7.4. In the event that Bioenvision decides not to pay patenting
expenses in any jurisdiction in the Licensed Territory, whether as
provided in Article 11 of the Co-Development Agreement or otherwise,
Bioenvision agrees to notify Dechra promptly of such decision. In such
event, Dechra may elect to maintain such Licensed Patent in force, in
the name of Bioenvision or Stegram, as the case may be.
7.5. Either party promptly shall notify the other party of any
suspected infringement by a third party of the Licensed Patents in the
Licensed Field and the Licensed Territory, and each party promptly
shall inform the other of any evidence of such infringement. Dechra
shall have the right to exercise, in the name and on behalf of
Bioenvision, the rights of Bioenvision under Article 12 of the
Co-Development Agreement with respect to infringements in the Licensed
Field and the Licensed Territory.
7.6. In the event that either party becomes aware of the institution by
a third party of any proceedings for the revocation of any Licensed
Patent in the Licensed Field and in any country in the Licensed
Territory, such party shall notify the other party promptly. Dechra
shall have the right to participate in any such proceeding at its own
expense, in its own name.
7.7. In the event that either party becomes aware of any claim by a
third party that the exercise by Dechra of its rights under the license
granted by Bioenvision constitutes an infringement of such third
party's rights, such party shall notify the other party promptly.
Dechra shall have the right to exercise, in the name and on behalf of
Bioenvision, the rights of Bioenvision under Article 14 of the
Co-Development Agreement.
7.8. In the event that Bioenvision obtains a legally assignable
ownership interest in any issued Licensed Patent in the Licensed
Territory which claims subject matter solely within the Licensed Field,
Bioenvision agrees, on the written request of Dechra and without
further consideration from Dechra, to assign to Dechra all of
Bioenvision's right, title and interest in and to such Licensed Patent,
and to execute such instruments as Dechra may reasonably request to
effect, perfect and record such assignment.
8. Representations; Acceptance of Liability.
8.1. Bioenvision represents that it has the right to grant to Dechra
all of the rights set forth as being granted to Dechra herein.
8.2. Bioenvision is unaware of any claims asserted against Bioenvision
or Stegram by any third parties with respect to patent infringement or
any other type of liability relevant to licensing or sublicensing of
the Licensed Patents, the Licensed Inventions, the Licensed
Improvements and the Licensed Technical Information, which have not
been disclosed to Dechra as of the effective date of this Agreement.
8.3. Bioenvision represents that it has full power, authority and legal
right to enter into this Agreement and to consummate the transactions
contemplated herein.
8.4. Dechra represents that it has full power, authority and legal
right to enter into this Agreement and to consummate the transactions
contemplated herein.
8.5. Dechra shall accept liability to the extent of the Licensed Field
and the Licensed Territory for or on account of any injury, loss or
damage, of any kind or nature sustained by, or any damage assessed or
asserted against, or any other liability incurred by or imposed upon
either party arising out of or in connection with or resulting from (i)
the production, use or sale of any Licensed Product by Dechra, its
Affiliates or its sublicensees, or (ii) the use by Dechra, its
Affiliates or its sublicensees of any technical information,
techniques, or practices disclosed by either party, or (iii) any
advertising or other promotional activities by Dechra, its Affiliates
or its sublicensees with respect to any of the foregoing. If a
sublicense is granted by Dechra to a third party that third party shall
accept all liability for any injury, loss or damage as set forth above,
in addition to Dechra remaining liable to Bioenvision for any and all
such liabilities.
9. Indemnification.
Dechra hereby agrees to indemnify, hold harmless and defend from
liability, to the extent of the Licensed Field and for the Licensed
Territory, Bioenvision and Stegram and their respective officers,
directors, representatives, agents and employees, from and against any
and all demands, claims, suits or actions of any character presented or
brought on account of any injuries, losses or damages sustained by any
person or property in consequence of (i) any act or omission of Dechra
or its agents, employees or subcontractors, or (ii) any liability,
except for any injuries, losses or damages that specifically result
from the negligence or willful misconduct of Bioenvision or Stegram.
The foregoing indemnity shall include but not be limited to court
costs, attorneys' fees, costs of investigation and costs of defense
associated with such demands, claims, suits or actions. The foregoing
indemnity shall apply only to the extent of the Licensed Field and in
the Licensed Territory.
10. Insurance.
Dechra shall maintain, during the term of this Agreement, reasonable
amounts of comprehensive general liability insurance, including
products liability insurance, with reputable and financially secure
insurance carriers to cover the activities of Dechra and its
Affiliates. Such insurance shall be written to cover claims incurred,
discovered, manifested, or made during or beyond the expiration or
termination of this Agreement during the period that any product,
process, or service, relating to, or developed pursuant to, this
Agreement is being commercially distributed or sold by Dechra or by a
sublicensee, Affiliate or agent of Dechra. Dechra shall furnish to
Bioenvision a certificate of insurance evidencing such coverage and
periodically, upon request, provide evidence that the coverage is still
in effect.
11. Confidentiality; Publication; Publicity.
11.1. In fulfilling their obligations under this Agreement, it may be
desirable or necessary for the parties to disclose to one another
certain of their Confidential Information. In the event of receipt of
such Confidential Information, the receiving party agrees to preserve
such information as confidential and not to disclose it to third
parties or to use it except in connection with this Agreement during
the term of this Agreement and for a period of five (5) years following
its termination. The foregoing obligations shall not apply to any
information that:
(a) is now in the public domain or becomes generally
available to the public through no fault of the
receiving party;
(b) is already known to, or in the possession of, the
receiving party as can be demonstrated by documentary
evidence;
(c) is disclosed to the receiving party on a
non-confidential basis by a third party having the
right to make such disclosure; or
(d) is independently developed by the receiving party as
can be demonstrated by documentary evidence.
In addition, to the extent reasonably necessary to
fulfill its obligations or exercise its rights under this
Agreement (i) a party may disclose Confidential Information to
its Affiliates, sublicensees, consultants, outside
contractors, research investigators and clinical
investigators, on a need-to-know basis on condition that such
persons or entities agree to be bound by the provisions of
this Agreement, (ii) a party or its Affiliates or sublicensees
may disclose Confidential Information to governmental or other
regulatory authorities to the extent that such disclosure is
reasonably necessary to obtain patents or regulatory
authorizations, provided the disclosing party shall request
confidential treatment thereof, and (iii) a party may disclose
Confidential Information as required by applicable law,
regulation or judicial process, provided that such party shall
give the other party (x) prior written notice thereof, (y)
adequate opportunity to object to any such disclosure or to
request confidential treatment thereof, and (z) shall take all
steps reasonably possible to minimize the disclosure to that
level mandated by law.
11.2. If either Bioenvision or Stegram desires to publish or present
the results of the Co-Development Program, Bioenvision shall provide a
copy of the manuscript of any proposed publication or presentation to
Dechra. Dechra shall then have fifteen (15) days to review and comment
on the manuscript or presentation, and Bioenvision agrees to delete any
information identified by Dechra as its trade secrets or Confidential
Information. In the event that Dechra determines that a Licensed Patent
application covering information contained in the proposed publication
or presentation should be filed, Bioenvision shall delay such
publication or presentation for up to thirty (30) days after the
fifteen (15) days described above to allow such filing to be made.
11.3. Each party shall provide the other party with the prior
opportunity to review and approve any press releases or similar public
announcements concerning this Agreement or clinical, regulatory and
commercial developments related to Licensed Products in the Licensed
Field and the Licensed Territory as soon as practicable, but in no
event later than 24 hours before an announcement is made. Neither party
shall not use the name of the other party or otherwise refer to any
organization related to the other party, except with the written
approval of the other party, such approval not to be unreasonably
withheld.
11.4. Each party shall provide the other party with the prior
opportunity to review and approve any press releases or similar public
announcements concerning this Agreement or clinical, regulatory and
commercial developments related to Licensed Products as soon as
practicable, but in no event later than 24 hours before an announcement
is made.
12. Dispute Resolution.
12.1. Exclusive Procedure. Any dispute arising out of or
relating to this Agreement, including the breach, termination or
validity hereof, shall be resolved in accordance with the procedure
specified in this article, which shall be the sole and exclusive
procedure for the resolution of any such disputes.
12.2. Negotiation Between Executives. The parties shall first
attempt in good faith to resolve any dispute arising out of or relating
to this Agreement promptly by negotiation between executives who have
authority to settle the controversy and who are at a higher level of
management than the persons with direct responsibility for
administration of this Agreement. Either party (the "Disputing Party")
may give the other party (the "Responding Party") written notice of any
dispute not resolved in the normal course of business. Such notice
shall include: (a) a statement of the Disputing Party's position and a
summary of arguments supporting that position, and (b) the name and
title of the executive who will represent the Disputing Party and of
any other person who will accompany the executive. Within fifteen (15)
days after delivery of the notice, the Responding Party shall respond
with (i) a statement of the Responding Party's position and a summary
of arguments supporting that position, and (ii) the name and title of
the executive who will represent the Responding Party and of any other
person who will accompany the executive. Within thirty (30) days after
delivery of the initial notice by the Disputing Party, the executives
of both parties shall meet at a mutually acceptable time and place, and
thereafter as often as they reasonably deem necessary, to attempt to
resolve the dispute. All reasonable requests for information made by
one party to the other party will be honored. All negotiations pursuant
to this section shall be confidential and shall be treated as
compromise and settlement negotiations for purposes of the rules of
evidence.
12.3. Mediation. If the dispute has not been resolved by
negotiation within sixty (60) days of the Disputing Party's initial
notice, or if executives of the parties failed to meet within thirty
(30) days
after delivery of the initial notice by the Disputing Party, the
parties shall endeavor to settle the dispute by mediation under the
then current Mediation Procedure of the CPR Institute for Dispute
Resolution. Unless otherwise agreed, the parties will select a mediator
from the CPR Institute Panels of Distinguished Neutrals. Each party
shall bear its own expenses (including attorneys' fees) and an equal
share of the expenses of the mediator and any fees of the CPR
Institute.
12.4. Arbitration. Any dispute arising out of or relating to
this Agreement, including the breach, termination or validity hereof,
which has not been resolved by the non-binding dispute resolution
procedure provided above within one hundred twenty (120) days after the
initiation of such procedure, shall be finally resolved by binding
arbitration in accordance with the then current CPR Institute Rules for
Non-Administered Arbitration by a sole arbitrator; provided, however,
that if either party refuses to participate in the non-binding dispute
resolution procedure provided above, then the other party may initiate
binding arbitration before expiration of such 120-day period. The
arbitrator shall be knowledgeable in the commercial, legal and
technical aspects of the subject matter of the dispute. Unless
otherwise agreed, the parties will select the arbitrator from the CPR
Institute Panels of Distinguished Neutrals. The arbitration shall be
conducted in either or both of New York, New York, and London, England,
as determined by the arbitrator. The arbitrator shall determine issues
of arbitrability but shall not be empowered to award injunctive relief
or damages in excess of compensatory damages and each party expressly
waives and forgoes any right to punitive, exemplary or similar damages
unless a statute requires the compensatory damages be increased in a
specific manner. Unless determined otherwise by the arbitrator, each
party shall bear its own expenses (including attorneys' fees) and an
equal share of the expenses of the arbitrator and any fees of the CPR
Institute. The arbitration shall be governed by the Federal Arbitration
Act, 9 U.S.C. xx.xx. 1-16, and judgment upon the award rendered by the
arbitrator may be entered by any court having jurisdiction.
12.5. Confidentiality. Except as required by law, the
existence, content and result of the mediation and arbitration shall be
held in confidence by the parties, their representatives, other
participants, the mediator and the arbitrator, each of whom shall be
bound by an appropriate written confidentiality agreement.
12.6. Tolling of Limitations Periods. All applicable statutes
of limitations and defenses based upon the passage of time shall be
tolled while the procedures specified in this article 12 are pending.
The parties shall take such action, if any, required to effectuate such
tolling.
13. Third-Party Beneficiary.
It is understood and agreed that Stegram is intended to be a
third-party beneficiary of this Agreement, and is entitled to
diligently enforce the same in its own name, notwithstanding any action
or inaction by Bioenvision with regard to the enforcement thereof, and
free from any claim, defense, setoff or other right of Dechra against
Bioenvision.
14. General Provisions.
14.1. Independent Contractors. The relationship between
Bioenvision and Dechra is that of independent contractors. Bioenvision
and Dechra are not joint venturers, partners, principal and agent,
master and servant, employer or employee, and have no other
relationship other than independent contracting parties. Bioenvision
and Dechra shall have no power to bind or obligate each other in any
manner, other than as is expressly set forth in this Agreement.
14.2. Entire Agreement; Modification. This Agreement sets
forth the entire agreement and understanding between the parties as to
the subject matter hereof. There shall be no amendments or
modifications to this Agreement, except by a written document which is
signed by both parties.
14.3. Force Majeure. The parties shall not be responsible for
failure to perform any of the obligations imposed by this Agreement
(except an obligation to pay money), provided the failure is not due to
negligence and provided such failure is caused by fire, storms, floods,
strikes, lockouts, accidents, war, terrorism, riots or civil
commotions, inability to obtain transportation or raw materials,
embargoes, any local, state, provincial or national regulation, law, or
restriction, seizure or acquisition of the technology or the Licensed
Products by any local, state, provincial or national government, or of
any agency thereof, or by reason of any compliance with a demand or
request for such Licensed Product for any purpose for national defense,
or any other cause or contingency beyond the reasonable control of said
party (whether or not of the same kind or nature as the causes or
contingencies above enumerated) shall not subject the party so failing
to any liability to the other.
14.4. Further Assurances. Each party shall execute any
instruments reasonably believed by the other party to be necessary to
implement the provisions of this Agreement.
14.5. Governing Law. This Agreement shall be construed and
enforced in accordance with the substantive laws of the State of New
York, without regard to the principles thereof regarding the choice of
law.
14.6. Headings. The headings for each article and section in
this Agreement have been inserted for convenience of reference only and
are not intended to limit or expand on the meaning of the language
contained in the particular article or section.
14.7. Severability. Should any one or more of the provisions
of this Agreement be held invalid or unenforceable by a court of
competent jurisdiction, it shall be considered severed from this
Agreement and shall not serve to invalidate the remaining provisions
thereof. The parties shall make a good faith effort to replace any
invalid or unenforceable provision with a valid and enforceable one
such that the objectives contemplated by them when entering this
Agreement may be realized.
14.8. No Waiver. Any delay in enforcing a party's rights under
this Agreement or any waiver as to a particular default or other matter
shall not constitute a waiver of such party's rights to the future
enforcement of its rights under this Agreement, excepting only as to an
express written and signed waiver as to a particular matter for a
particular period of time.
14.9. Marking. Dechra shall place in a conspicuous location on
any product or its packaging, which is made or sold under any Licensed
Patent coming within this Agreement, a patent notice in accordance with
the laws concerning the marking of patented articles. Dechra shall
include a marking provision similar to this section in every sublicense
granted pursuant to Article 2 above.
14.10. Attorneys' Fees. In the event of a dispute between the
parties hereto or in the event of any default hereunder, the party
prevailing in the resolution of any such dispute or default shall be
entitled to recover its reasonable attorneys' fees and other costs
incurred in connection with resolving such dispute or default.
14.11. Notices. Any notices required by this Agreement shall
be in writing, shall specifically refer to this Agreement and shall be
sent by registered or certified airmail, postage prepaid, or by fax,
telex or cable, charges prepaid, or by overnight courier, postage
prepaid and shall be forwarded to the respective addresses set forth
below unless subsequently changed by written notice to the other party:
For Bioenvision: Bioenvision, Inc.
000 Xxxxxxx Xxxxxx, Xxxxx 000
Xxx Xxxx, Xxx Xxxx 00000
Attention: Xxxxxxxxxxx X. Xxxx and Xxxxx X. Xxxx
Fax No.: (000) 000-0000
For Dechra: Dechra Pharmaceuticals, PLC
Dechra House
Jamage Industrial Estate
Talke Pits
Stoke-on-Trent ST7 1XW
Attention: Xxx Xxxx and Xx Xxxx
Fax No.: x00 (0) 0000 000000
Notice shall be deemed delivered upon the earliest of (i) when
received, (ii) five (5) days after deposit into the mail,
(iii) the date notice is sent via fax, telex or cable, or (iv)
two business days immediately following delivery to overnight
courier (except Sunday and holidays).
14.12. Compliance with Laws. Nothing contained in this
Agreement shall require or permit Bioenvision or Dechra to do any act
inconsistent with the requirements of any applicable law, regulation or
executive order as the same may be in effect from time to time.
14.13. Assignment. Dechra shall not assign any rights under
this Agreement not specifically transferable by its terms or not
permitted by Dechra's right to grant sublicenses hereunder, without the
prior written consent of Bioenvision, which consent shall not be
unreasonably withheld or delayed. Subject to the foregoing, this
Agreement shall be binding upon and inure to the benefit of any
successors in interest and assigns of Bioenvision and Dechra. Any such
successor or assignee of either party's interest shall expressly assume
in writing the performance of all the terms and conditions of this
Agreement to be performed by such party. If the Co-Development
Agreement is terminated for any reason, except breach of contract by
Stegram, this Agreement shall automatically transfer to Stegram insofar
as this Agreement grants to Dechra any sublicense under the
Co-Development Agreement, unless Dechra is in breach or default hereof,
and shall remain in full force and effect so long as Dechra performs
its obligations hereunder.
14.14. Counterparts. This Agreement may be executed in
counterparts, each of which shall be an original but all of which taken
together shall be one and the same instrument.
[The following page is the signature page.]
IN WITNESS WHEREOF, the parties have executed this Licensee and
Sub-License Agreement by their duly authorized representatives effective as of
the date first set forth above.
BIOENVISION, INC. DECHRA PHARMACEUTICALS, PLC
By /s/ Xxxxx X. Xxxx By /s/ Xxx X. Page
----------------------------------------- -----------------------------------------
Name: Xxxxx X. Xxxx Name: Xxx X. Page
-------------------------------------- --------------------------------------
Title: Director of Finance, Gen Counsel Title: Chief Executive
------------------------------------------- -------------------------------------
CONSENTED AND AGREED:
STEGRAM PHARMACEUTICALS LIMITED
By /s/ Xxxxxx Xxxxxxxx
-----------------------------------------------
Name: Xxxxxx Xxxxxxxx
-----------------------------------------------
Title: Director
-----------------------------------------------
EXHIBIT A
COPY OF CO-DEVELOPMENT AGREEMENT
BETWEEN BIOENVISION AND STEGRAM
EXHIBIT B
EXAMPLES OF ROYALTY CALCULATIONS
Illustration No. 1
Dechra begins to sell Licensed Products during Month 1. For the 12-month period
beginning on the first day of Month 1, and ending on the last day of Month 12,
the Rolling Annual Total of Net Sales equals US $9,500,000. In accordance with
Section 3.5.1, no Royalty payments are due from Dechra to Bioenvision with
respect such Net Sales.
For the 12-month period beginning on the first day of Month 2, and ending on the
last day of Month 13, the Rolling Annual Total of Net Sales equals US
$10,500,000. In Month 14, Dechra owes Bioenvision a Royalty payment under
Section 3.5.2 as follows:
$200,000 + [.02 x ($10,500,000 - $10,000,000)] = $200,000 + $10,000 = $210,000
In accordance with Section 3.5.4, the first day of Month 14 is a new "Royalty
Period Start Date" and the Rolling Annual Total is recalculated effective from
the beginning of Month 14.
In respect of Month 14 and each month thereafter, Dechra owes Bioenvision a
Royalty payment under Section 3.5.3 of 2% of the Monthly Total for such month
(subject to Sections 3.5.5 and 3.5.6 as shown in Illustration No. 2, and
Sections 3.5.8 and 3.5.9 as shown in Illustration No. 3).
Illustration No. 2
Assume the same facts as in Illustration No. 1.
For the six-month period beginning on the first day of Month 14, and ending on
the last day of Month 19, the Rolling Annual Total equals US $13,000,000. The
Royalty in respect of each of these months is 2% of the Monthly Total for each
such month. The Monthly Total for Month 20 equals US $4,000,000, so that the
Rolling Annual Total for the seven-month period beginning on the first day of
Month 14 and ending on the last day of Month 20 equals US $17,000,000. In Month
21, Dechra owes Bioenvision a Royalty payment under Section 3.5.5 as follows:
.02 x $4,000,000 + [.01 x ($17,000,000 - $15,000,000)] = $80,000
+ $20,000 = $100,000
In accordance with Section 3.5.7, the first day of Month 21 is a new "Royalty
Period Start Date" and the Rolling Annual Total is recalculated effective from
the beginning of Month 21.
In respect of Month 21 and each month thereafter, Dechra owes Bioenvision a
Royalty payment under Section 3.5.6 of 3% of the Monthly Total for such month
(subject to Sections 3.5.8 and 3.5.9 as shown in Illustration No. 3).
Illustration No. 3
Assume the same facts as in Illustration Nos. 1 and 2.
For the three-month period beginning on the first day of Month 21, and ending on
the last day of Month 23, the Rolling Annual Total equals US $16,000,000. The
Royalty in respect of each of these months is 3% of the Monthly Total for each
such month. The Monthly Total for Month 24 equals US $7,000,000, so that the
Rolling Annual Total for the four-month period beginning on the first day of
Month 21 and ending on the last day of Month 24 equals US $23,000,000. In Month
25, Dechra owes Bioenvision a Royalty payment under Section 3.5.8 as follows:
.03 x $7,000,000 + [.01 x ($23,000,000 - $20,000,000)] = $210,000 +
$30,000 = $240,000
In respect of Month 25 and each month thereafter, Dechra owes Bioenvision a
Royalty payment under Section 3.5.9 of 4% of the Monthly Total for such month,
without regard to the Rolling Annual Total thereafter.
