EXHIBIT 2.6
DEVELOPMENTAL COLLABORATION AGREEMENT
This DEVELOPMENTAL COLLABORATION AGREEMENT ("Agreement"), dated as of July
8, 1998 is entered into by and between Xxxxxx Healthcare Corporation, a Delaware
corporation having a place of business at 0000 Xxxx Xxxx Xxxx, Xxxxxxxxx,
Xxxxxxxx 00000 ("Baxter") and UroGen Corp., a Delaware corporation having its
principal place of business at 00000 Xxxxxx Xxx, Xxxxx X, Xxx Xxxxx, Xxxxxxxxxx
00000 ("UroGen").
RECITALS
X. Xxxxxx and UroGen have entered into that certain Asset Purchase
Agreement dated as of February 28, 1998, as amended by that certain Amendment to
Asset Purchase Agreement dated as of May 27, 1998, between Baxter and UroGen (as
so amended, the "Asset Purchase Agreement") pursuant to which Baxter has agreed
to sell the Mini-Ad Vector Technology (as that capitalized term is defined in
the Asset Purchase Agreement) to UroGen as well as other property related to the
research, development, manufacture, use and sale of Mini-Ad Vector Products (as
that capitalized term is defined in the Asset Purchase Agreement).
B. UroGen has appointed Baxter as its exclusive worldwide distributor of,
and Baxter has agreed to distribute, products utilizing the Mini-Ad Vector
Technology for the treatment of blood clotting disorders in humans relating to
hemophilia A pursuant to the terms of that certain Distribution Agreement
between Baxter and UroGen of even date herewith (the "Distribution Agreement")
X. Xxxxxx and UroGen wish to collaborate to develop products utilizing
the Mini-Ad Vector Technology for the treatment of blood clotting disorders in
humans relating to hemophilia A (such products are hereafter referred to,
individually and collectively, as "Collaboration Product(s)"), subject to the
terms and conditions of this Agreement.
AGREEMENT
NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein, Baxter and UroGen hereby agree as follows:
1. DEFINITIONS.
1.1 Terms Defined in Preamble and Recitals: As used herein, all
capitalized terms defined in the Preamble and Recitals of this Agreement shall
bear the meanings ascribed to such terms as set forth therein.
1.2 Terms Defined in Asset Purchase Agreement: Unless otherwise defined
herein, all capitalized terms shall have the meanings ascribed to such terms as
set forth in the Asset Purchase Agreement.
1.3 Other Terms: As used herein, the following capitalized terms shall
have the following meanings:
"Adjusted Interest(s)" means each of the UroGen Interest and the Baxter
Interest, respectively, as adjusted pursuant to Section 3.5(c) of this
Agreement.
"Affiliate" of a Party shall mean any entity (i) which directly or
indirectly through one or more intermediaries Controls, is Controlled by, or is
under common Control with, the Party or (ii) fifty percent (50%) or more of the
voting capital stock (or in the case of an entity which is not a corporation,
fifty percent (50%) or more of the equity interest) of which is beneficially
owned or held by a Party or any of such Party's Subsidiaries. The term
"Control" means the possession, directly or indirectly, of the power to direct
or cause the direction of the management and policies of an entity (other than a
natural person), whether through the ownership of voting capital stock, by
contract or otherwise.
"Baxter Funding" means all funds advanced by Baxter to UroGen under the
Credit Agreement during the Baxter Funding Period pursuant to Section 3.5(a) of
this Agreement.
"Baxter Funding Period" means the period beginning on the date of this
Agreement through and including the date of the IND Milestone.
"Baxter Interest" means [ * ]%.
"Deadlock" means a deadlock of the Management Board on any matter coming
before the Management Board for a vote.
"Development Work" is defined in Section 3.1(a) of this Agreement.
"Dispute" means any claim or controversy arising out of or relating to the
execution, interpretation or performance of this Agreement (including the
validity, scope and enforceability of the provisions contained in Section 27)
and/or the Parties' legal obligations to each other.
"Event of Insolvency" shall mean, with respect to any Party, that:
(1) A receiver, conservator, custodian, liquidator or trustee of the Party
or of all or any of the property of the Party, is appointed by court
order and such order remains in effect for more than ninety (90) days;
or an order for relief is entered under the federal bankruptcy laws
with respect to the Party; or any of the material property of the
Party is sequestered by court order and such order remains in effect
for more than ninety (90) days; or a petition is filed against the
Party under the bankruptcy, reorganization, arrangement, insolvency,
readjustment of debt, dissolution or liquidation law of any
jurisdiction, whether now or hereafter in effect, and is not dismissed
within ninety (90) days after such filing;
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(2) The Party files a petition in voluntary bankruptcy or seeking relief
under any provision of any bankruptcy, reorganization, arrangement,
insolvency, readjustment of debt, dissolution or liquidation law of
any jurisdiction, whether now or hereafter in effect, or consents to
the filing of any petition against it under any such law; or
(3) The Party makes an assignment for the benefit of its creditors or
consents /to the appointment of a receiver, conservator, custodian,
liquidator or trustee of the Party (or of all or any part of its
property).
"FDA" means the United States Food and Drug Administration.
"Fully Loaded Cost" means, for either Party, such Party's cost of
manufacturing, performing or acquiring any items or services, in accordance with
generally accepted accounting principles, consistently applied ("GAAP"), and,
with respect to each Party, in accordance with such Party's normal accounting
policies, all consistently applied, including any royalties payable by such
Party in connection with manufacturing, performing or acquiring any items or
services. Fully Loaded Cost shall not include general corporate allocations or
other allocations which are not directly related to the manufacture, performance
or acquisition of the item or service, however designated. In the event any
item is acquired or any service is provided for a Party from or by an Affiliate
of such Party, the cost of acquiring such items or services shall be deemed to
mean such Affiliate's actual cost of manufacturing, performing or acquiring such
items or services in accordance with the principles set forth in this definition
of "Fully Loaded Cost." Current costs of developing any items or services shall
be included in Fully Loaded Cost, but in no event shall any historic development
costs which arise or accrue prior to the date of this Agreement be included in
Fully Loaded Cost.
"Funding" means the UroGen Funding and/or the Baxter Funding.
"IND Budget" means the budget approved by the Management Board, as adjusted
by the Management Board from time to time, for developing Collaboration
Product(s) during the Baxter Funding Period.
"IND Milestone" means the date on which the treatment of the first patient
under an Initial New Drug Application for a Collaboration Product commences in a
Phase I Clinical Trial.
"Interest" means the Baxter Interest and/or the UroGen Interest, as the
context requires.
"Management Board" means the Management Board created pursuant to Section
3.2 hereof.
"Mini-Ad Vector Technology" means (a) technology developed by Baxter and
relating to adenoviral vectors for gene therapy which has been (i) licensed to
UroGen pursuant to the Seller License Agreement and/or (ii) transferred to
UroGen pursuant to the Asset Purchase Agreement and (b) any Intellectual
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Property Rights developed, licensed or acquired by UroGen (and/or Affiliates of
UroGen) relating to adenoviral vectors for gene therapy.
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"Milestones" means, collectively, the IND Milestone and the Qualifying
Regulatory Approval Milestone.
"Party" or "Parties" means, individually or collectively (as the context
requires) UroGen and/or Baxter.
"Qualifying Regulatory Approval" means Regulatory Approval in (i) the
United States; or (ii) Japan; or (iii) in at least two of the following five
European nations: France, Germany, Italy, Spain and the United Kingdom.
"Qualifying Regulatory Approval Milestone" means the Qualifying Regulatory
Approval of a Collaboration Product.
"Regulatory Approval" means (i) in the United States, approval from the FDA
and any other United States governmental authority (or agency or other political
subdivision thereof) necessary for the right to market, sell or distribute the
Collaboration Product(s), in the United States to the public at large, (ii)
outside the United States, an analogous order by a non-United States
governmental authority (or agency or other political subdivision thereof)
necessary for the right to market, sell or distribute, and the right to be paid
or reimbursed for, the Collaboration Product(s), in that country (other than the
United States), to the public at large.
"UroGen Funding" means all monetary contributions or payments by UroGen
towards or on behalf of the Development Work required to be paid by UroGen under
this Agreement during the UroGen Funding Period, other than any such funds
expended by UroGen where the source of such funds is Baxter Funding.
"UroGen Funding Period" means the period beginning on the first day
following the date of the IND Milestone through and including the date of the
Qualifying Regulatory Approval Milestone.
"UroGen Interest" means [ * ]%.
2. TERM OF AGREEMENT. The term of this Agreement (the "Term") shall
expire on the earlier to occur of (a) a Qualifying Regulatory Approval or (b)
either Baxter or UroGen giving the other Party hereto written notice of
termination of the Term of the Agreement at least thirty (30) days prior to the
effective date of termination (or, if an Event of Insolvency occurs after the
delivery of the notice of termination, or has occurred and is continuing as of
the date of the notice of termination, with respect to a non-terminating Party,
the effective date of termination of the Term shall occur immediately as of the
date of delivery of the terminating Party's notice of termination to the non-
terminating Party).
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3. DEVELOPMENT WORK.
3.1 Responsibility for Development Work:
(a) During the Term, UroGen:
i. shall be responsible for the overall Development Work (as that
term is defined below); and
ii. shall use at least commercially reasonable efforts to develop the
Collaboration Product(s) and to achieve the Milestones, including
but not limited to conducting any clinical trials and performing
any regulatory work which it is required to perform (the
"Development Work"), pursuant to the terms and conditions of this
Agreement and subject to the direction of the Management Board.
(b) Notwithstanding any provision of this Agreement to the contrary, for a
period equal to the longer of the term of this Agreement or the term of the
Distribution Agreement, UroGen shall not, in any form or manner, directly or
indirectly, on its own behalf or in combination with others, anywhere in the
world:
(i) develop, manufacture, market, sell, distribute, acquire or license; or
(ii) provide services to (including, but not limited to consulting
services), or become interested in (as a stockholder, joint venturer,
partner, licensor, member, principal, agent, independent contractor,
trustee, lender of money or in any other relation or capacity whatsoever,
except as a holder of securities of a corporation whose securities are
publicly traded, and then only to the extent of owning not more than two
percent (2%) of any class or series of the issued and outstanding
securities of such corporation), any individual, corporation, limited
liability company, partnership, limited partnership, limited liability
partnership, trust or unincorporated association, or a government or any
agency or political subdivision thereof, which develops, manufactures,
markets, sells, distributes, acquires or licenses;
any products utilizing the Mini-Ad Vector Technology for the treatment of blood
clotting disorders in humans except for the Collaboration Products.
(c) It is understood and accepted that UroGen and Baxter have interests in
other business ventures which may be in conflict with the activities of the
Development Work and that nothing in this Agreement, subject to Section 3.1(b)
above and the Distribution Agreement, shall limit the current or future business
activities of UroGen or Baxter with respect to such activities, whether or not
such activities are competitive with those of the Development Work or the other
Party hereto.
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3.2 Management Board:
(a) Purpose and Constitution.
(i) The purpose of the Management Board will be to facilitate the
overall relationship of the Parties under this Agreement and to manage the
direction and implementation of the Development Work. The product
components, biological elements, product confirmations, product design and
product requirements for Collaboration Product(s) recommended by the
Management Board shall not be deemed finalized until they are approved by
UroGen. The Management Board shall meet from time to time as appropriate,
but no less frequently than quarterly during each calendar year,
alternating between the offices of the Parties, unless the Parties shall
agree otherwise. The Management Board shall review and approve technical
milestones, budgets, funding, reimbursement and resource allocations.
(ii) Subject to Sections 27 and 8.2 below, the Management Board will
consist of representatives from each of UroGen and Baxter, and each Party
shall select not less than one (1) and up to three (3) representatives to
serve as its designated members of the Management Board. Regardless of the
number of representatives serving as designated members of the Management
Board for each Party, each of Baxter and UroGen shall have one (1) vote on
any issue presented to the Management Board for a vote.
(iii)Subject to Sections 27 and 8.2 below, in the event that any
member of the Management Board designated pursuant to Section 3.2(a)(ii) is
unable to serve, or once having commenced to serve, is removed or withdraws
from the Management Board (a "Withdrawing Member of the Management Board"),
such Withdrawing Member of the Management Board's replacement (the
"Substitute Member of the Management Board") on the Management Board will
be designated by the Party which selected the Withdrawing Member of the
Management Board; provided that, subject to Sections 27 and 8.2 below, a
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member of the Management Board designated pursuant to Section 3.2(a)(ii)
may only be removed by the Party entitled to designate such member of the
Management Board pursuant to Section 3.2(a)(ii).
(iv) In the event a Party chooses not to designate any member(s) of
the Management Board, such membership(s) shall not otherwise be filled and
the size of the Management Board shall be correspondingly reduced until
such time as such Party elects to designate such member(s) in accordance
with this Agreement.
(v) The Parties agree that no action shall be taken at any meeting of
the Management Board unless (aa) each member of the Management Board shall
receive at least three (3) business days' notice of such meeting or shall
waive such notice in writing and the unanimous consent of Baxter and UroGen
is given approving such action at such meeting of the Management Board or
(bb) a unanimous written consent of the Management Board
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authorizing such action is obtained prior to the taking of such action at
such meeting of the Management Board.
(b) Development Work Committees. To assist the Management Board in its
work, the Management Board may, from time-to-time, at its sole discretion,
create project committees, including Management Board and non-Management Board
members (each, a "Development Work Committee"). Each Development Work
Committee shall only have that authority specifically granted to it by the
Management Board, and may not be granted any authority which exceeds that of the
Management Board. A Development Work Committee may be created to oversee the
Development Work or a specific aspect or the Development Work.
(c) Voting. Except as provided in Section 3.2(d) below, all decisions of
the Management Board shall be made by unanimous consent or unanimous written
consent of Baxter and UroGen. In the event that a Party ceases to participate in
the Development Work pursuant to Section 8.2, that Party's rights with respect
to the management of the Development Work, representation on the Management
Board, and right of approval of decisions of the Management Board shall cease.
(d) Certain Material Transactions. The sale, pledge, hypothecation,
license, transfer or other disposition of UroGen Intellectual Property (as that
term is defined in Section 4 below) to any entity other than UroGen or Baxter,
which would adversely affect the performance of UroGen's obligations or any of
Xxxxxx'x rights under the Distribution Agreement or this Agreement, will require
approval by Baxter before the Management Board and/or UroGen may authorize such
transactions.
(e) Confidential Information. At the request of UroGen, Baxter shall cause
any of its officers, directors, employees, agents and representatives (other
than the Hired Designated Employees, as that capitalized term is defined in the
Asset Purchase Agreement) (the "Baxter Representatives") to whom UroGen
Confidential Information (as that capitalized term is hereinafter defined) will
be disclosed through their participation on the Management Board and/or the
Development Work Committees, to execute an agreement (which is reasonably
acceptable to Baxter and UroGen) containing substantially the same terms and
conditions as are set forth in Sections 1 through 7, inclusive, of that certain
Confidentiality and Non-Solicitation Agreement, dated as of September 17, 1997
(the "Confidentiality Agreement"), by and between Baxter and UroGen (attached
hereto as Exhibit B) with respect to such UroGen Confidential Information. For
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the purposes of this Agreement, the term "UroGen Confidential Information" shall
mean Confidential Information (as that capitalized term is defined in the
Confidentiality Agreement) of UroGen which is disclosed by UroGen to any of the
Baxter Representatives, in connection with their participation on the Management
Board and/or the Development Work Committees, in a tangible form which is marked
as "Confidential" at the time it is so delivered. Except as is set forth in this
Section 3.2(e), or as may otherwise be required by applicable law, Baxter and
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the Baxter Representatives shall have no other obligations relating to any
confidential information of UroGen and the Parties agree that the continuing
obligations of each Party with respect to Confidential Information under the
Confidentiality Agreement shall be limited to any such Confidential Information
disclosed by a
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Disclosing Party to a Receiving Party (as those capitalized terms are defined in
the Confidentiality Agreement) prior to the date of this Agreement.
3.3 Budget, Funding and Milestones: The technical milestones/benchmarks,
budget and timetable for the Development Work will be submitted by UroGen to the
Management Board for review and approval from time-to-time during the
Development Work with the intent that the Parties move expeditiously and
effectively toward development of the Collaboration Product(s) and the
achievement of the Milestones. Notwithstanding anything contained in this
Agreement to the contrary, however, from the date of this Agreement until
achievement of the Qualifying Regulatory Approval Milestone, Baxter and UroGen
will use at least commercially reasonable efforts to mutually agree in good
faith on the milestones/benchmarks, budget and timetable for the Development
Work.
3.4 Delivery of Information: During the term of the Development Work,
UroGen shall promptly deliver to Baxter all material data and information (and
with respect to patentable Intellectual Property Rights, after establishing
invention records and filing patent applications) developed pursuant to the
Development Work relating to the Collaboration Product(s).
3.5 Funding:
(a) Baxter Funding. Subject to the terms and conditions set forth in this
Agreement, Baxter will fund the Approved Expenses of UroGen with respect to the
Development Work to be incurred during the Baxter Funding Period at UroGen's
Fully Loaded Cost by making advances of such funds with respect to each three
(3) month period during the Baxter Funding Period pursuant to the Credit
Agreement, which funding shall constitute "Baxter Funding", as follows:
(i) UroGen shall, with respect to each three (3) month period during the
Baxter Funding Period, deliver its request for funding for such three (3)
month period to Baxter at least thirty (30) days in advance of the
beginning of the applicable three (3) month period; and
(ii) Subject to the terms and conditions set forth in this Agreement,
Baxter will thereupon make advances under the Credit Agreement pursuant to
UroGen's request for funding prior to the start of the applicable three (3)
month period.
For the purposes of this Agreement, the term "Approved Expenses" shall mean
those expenditures made or to be made by UroGen with respect to research,
development and other activities which specifically relate to the Development
Work and which are contemplated by, and fall within, the Development Work
budgets approved by the Management Board for such three (3) month period less
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any unexpended funds funded by either Baxter or UroGen as part of the Baxter
Funding or the UroGen funding, respectively, for prior periods.
(b) UroGen Funding. Subject to the terms and conditions set forth in this
Agreement, UroGen will fund the Approved Expenses of UroGen with respect to the
Development Work
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incurred during the UroGen Funding Period at UroGen's Fully Loaded Cost, which
funding shall constitute "UroGen Funding".
(c) Adjusted Interest. (i) From the date hereof through the end of the
Baxter Funding Period, in the event that Baxter declines to pay any portion of
its funding obligations under Section 3.5(a), for the purposes of determining
Xxxxxx'x Adjusted Interest under this Agreement, the Baxter Interest will be
adjusted (and UroGen's Adjusted Interest will be correspondingly adjusted) on an
annual basis in arrears in proportion to its share of the total Funding pursuant
to the following formula (provided, however, that in no event shall (aa) the
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UroGen Adjusted Interest be less than [ * ]% nor more than [ * ]%, nor shall
(bb) the Baxter Adjusted Interest be less than [ * ]% nor more than [ * ]%):
Xxxxxx'x Adjusted Interest = ((A / B) x C) x 100
UroGen's Adjusted Interest = 100% - Xxxxxx'x Adjusted Interest
where:
A = the dollar amount actually funded to UroGen by Baxter pursuant to
Section 3.5(a) above through such calendar year;
B = the aggregate Approved Expenses for Developmental Work during the
Baxter Funding Period through such calendar year; and
C = the Baxter Interest, expressed as a decimal.
In the event that UroGen does not request funding from Baxter for any
calendar year during the Baxter Funding Period up to the level of the
Approved Expenses for that calendar year, neither Xxxxxx'x Interest nor
UroGen's Interest will be adjusted according to the preceding formula with
respect to the difference between the level of the Approved Expenses for
that calendar year and the amount of funding requested by UroGen for that
calendar year. On the last day of the Baxter Funding Period Xxxxxx'x
Adjusted Interest and UroGen's Adjusted Interest, each as adjusted by this
Section 3.5(c)(i), shall be fixed until and unless Xxxxxx'x Adjusted
Interest or UroGen's Adjusted Interest is adjusted pursuant to Section
3.5(c)(ii) below.
(ii) From the first day of the UroGen Funding Period through the end of
the UroGen Funding Period, in the event that UroGen declines to pay any
portion of its funding obligations under Section 3.5(b), for the purposes
of determining UroGen's Adjusted Interest under this Agreement, UroGen's
Adjusted Interest (as adjusted pursuant to Section 3.5(c)(i) above) will
be adjusted (and Xxxxxx'x Adjusted Interest will be correspondingly
adjusted) on an annual basis in arrears in proportion to its share of the
total Funding pursuant to the following formula (provided, however, that in
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no event shall (aa) the UroGen Adjusted Interest be less than [ * ]% nor
more than [ * ]%, nor shall (bb) the Baxter Adjusted Interest be less than
[ * ]% nor more than [ * ]%):
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UroGen's Adjusted Interest = ((A / B) x C) x 100
Xxxxxx'x Adjusted Interest = 100% - UroGen's Adjusted Interest
where:
A = the dollar amount actually funded by UroGen pursuant to Section
3.5(b) above from the beginning of the UroGen Funding Period
through such calendar year;
B = the aggregate Approved Expenses for Developmental Work during the
UroGen Funding Period through such calendar year; and
C = the UroGen Adjusted Interest fixed as of the last day of the
Baxter Funding Period pursuant to Section 3.5(c)(i) above,
expressed as a decimal.
On the earlier to occur of (i) the last day of the UroGen Funding
Period or (ii) the date of termination of this Agreement, and thereafter,
the Adjusted Interest of each Party for the purposes of calculating the
Purchase Price Percentage under the Distribution Agreement shall be fixed
at such Party's Adjusted Interest as of the earlier to occur of (i) the
last day of the UroGen Funding Period or (ii) the date of termination of
this Agreement.
(iii) In the event that during the annual budget approval process for the
Development Work by the Management Committee and/or UroGen, either Baxter
or UroGen proposes to fund the Development Work in excess of the
Development Work budgets approved by the Management Committee during the
Baxter Funding Period ("Baxter Funding Period Excess Funding"), Baxter will
have the first option (for a period of fifteen (15) days from the date the
Baxter Funding Period Excess Funding is proposed) to elect to provide the
Baxter Funding Period Excess Funding as part of the Baxter Funding pursuant
to Section 3.5(a) above and, if Baxter elects not to exercise its option,
UroGen will then have the option (for a period of fifteen (15) days from
the date of expiration of Xxxxxx'x option) to elect to provide the Baxter
Funding Period Excess Funding (which amount, if paid by UroGen, shall be
treated as Approved Expenses for the purposes of the calculations in
Section 3.5(a) above for the Baxter Funding Period). In the event that
during the annual budget approval process for the Development Work by the
Management Committee and/or UroGen, either Baxter or UroGen proposes to
fund the Development Work in excess of the Development Work budgets
approved by the Management Committee during the UroGen Funding Period
("UroGen Funding Period Excess Funding"), UroGen will have the first option
(for a period of fifteen (15) days from the date the UroGen Funding Period
Excess Funding is proposed) to elect to provide the UroGen Funding Period
Excess Funding as part of the UroGen Funding pursuant to Section 3.5(b)
above and, if UroGen elects not to exercise its option to provide the
UroGen Funding Period Excess Funding, Baxter will then have the option (for
a period of fifteen (15) days from the date of expiration of UroGen's
option) to elect to provide the UroGen Funding Period Excess Funding (which
amount, if paid by Baxter, shall be treated as Approved Expenses for the
purposes of the calculations in Section 3.5(b) above for the UroGen Funding
Period).
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(iv) Upon a Change of Control of UroGen, Xxxxxx'x obligation to provide any
Baxter Funding under this Agreement or the Credit Agreement will terminate,
Xxxxxx'x Adjusted Interest for the Baxter Funding Period under Sections
3.5(a) and 3.5(c)(i) will become fixed at its then current level as of the
date of the Change of Control (subject to increase pursuant to Section
3.5(c)(ii)), the Baxter Funding Period will terminate, and the UroGen
Funding Period will commence. For the purposes of this Agreement, the term
"Change of Control" shall mean that a stockholder of UroGen (including any
Affiliates of such stockholder), other than Baxter, shall Control fifty
percent (50%) or more of the Total Voting Power (as that capitalized term
is defined in the Investors' Agreement) at any time.
(v) For purposes of illustration, an example of the operation of the
formulae in Sections 3.5(c)(i) through 3.5(c)(iv) above is set forth in
Exhibit A attached hereto.
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(d) Costs of Management Board. Each Party shall bear its own expense with
respect to participation on the Management Board and any Development Work
Committees, including travel expenses for meetings, which costs will not be
included in the Funding of either Party.
(e) Limitation on Baxter Funding. Notwithstanding any provision of this
Agreement to the contrary, Baxter shall not be obligated to fund more than one
Collaboration Product at a time during the Baxter Funding Period and any refusal
by Baxter to fund more than one Collaboration Product at a time during the
Baxter Funding Period shall not constitute a breach of this Agreement, a
termination of this Agreement by Baxter under Section 2, an election by Baxter
to cease participation under Section 8.1, nor a failure by Baxter to advance any
Baxter Funding.
(f) Cessation of Funding. In the event that either Party fails to make any
advances or payments with respect to their respective Funding obligations
hereunder, such failure to Fund shall be deemed an election to cease
participation pursuant to Section 8.1 hereof.
3.6 Testing And Regulatory Expenses: All expenses incurred by UroGen in
connection with any research, development, testing or Regulatory Approval whose
primary function is other than developing the Collaboration Product(s) or
achieving the Milestones, shall be borne solely by UroGen and shall not be
considered reimbursable expenses or Funding covered by this Agreement.
4. OWNERSHIP OF COLLABORATION PRODUCT(S), PATENTS AND KNOW-HOW. As
between Baxter and UroGen, subject to the Seller License Agreement UroGen shall
own any and all (a) unpatented inventions, data, processes, compositions,
techniques and other technical data and (b) material subject to protection as
trade secrets or as patentable or copyrightable ideas, which UroGen or its
employees, agents or representatives may conceive, invent or discover, either
solely or jointly with another or others (including Baxter), during the Term of
this Agreement in conjunction with the Development Work (collectively, together
with the Intellectual Property Assets, the "UroGen Intellectual Property") and
all Collaboration Product(s). Subject to the Seller License Agreement, Baxter
shall not make any use of, or have any rights or interests in, any UroGen
Intellectual Property
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or Collaboration Product(s) without the prior written approval of UroGen except
as otherwise set forth in this Agreement, the Asset Purchase Agreement or the
other Transaction Documents.
5. PROSECUTION OF PATENT RIGHTS.
5.1 UroGen Patents: Subject to the Seller License Agreement and during
the term of the Seller License Agreement and this Agreement, UroGen shall have
the obligation to timely prepare, file, prosecute and maintain, at UroGen's
direction and expense, all patents, and any applications, extensions,
continuations, divisions, reissues and reexaminations thereof (collectively,
"Patent(s)"), on UroGen Intellectual Property. Whenever possible, UroGen shall
file internationally under the Patent Cooperation Treaty and/or the European
Patent Convention in order to minimize expenses. At a minimum, UroGen shall
prepare, file, prosecute and maintain all Patents on UroGen Intellectual
Property in the United States, Canada, the member nations of the European Union,
Japan, and in any other Baxter Region (as that capitalized term is defined in
the Distribution Agreement) where UroGen has elected to obtain regulatory
approval pursuant to Section 6.1(b) of the Distribution Agreement. The
reasonable expenses of preparing, filing, prosecuting and maintaining Patents
with respect to the UroGen Intellectual Property in the United States, Canada,
the member nations of the European Union, Japan, in any other Baxter Region (as
that capitalized term is defined in the Distribution Agreement) where UroGen has
elected to obtain regulatory approval pursuant to Section 6.1(b) of the
Distribution Agreement, and all other countries that are agreed to by Baxter and
UroGen in writing, shall be Approved Expenses. If UroGen elects not to prepare,
file, prosecute and/or maintain any Patent on UroGen Intellectual Property in
any Baxter Region (as that capitalized term is defined in the Distribution
Agreement) where UroGen has elected not to obtain regulatory approval pursuant
to Section 6.1(b) of the Distribution Agreement and where Baxter has elected to
assume regulatory responsibility (or to pay UroGen to obtain such regulatory
approval) pursuant to Section 6.1(b) of the Distribution Agreement, upon
Xxxxxx'x election to prepare, file, prosecute and/or maintain such Patent on
UroGen Intellectual Property in that Baxter Region on behalf of UroGen: UroGen
shall cooperate with and assist Baxter in preparing, filing, prosecuting and/or
maintaining such Patent on UroGen Intellectual Property in that Baxter Region,
including providing Baxter any and all information and documentation necessary
in order for Baxter to prepare, file, prosecute and/or maintain such Patent on
UroGen Intellectual Property in that Baxter Region on behalf of UroGen (any
costs UroGen may incur in connection therewith shall be funded by Baxter as
Baxter Funding Period Excess Funding or UroGen Funding Period Excess Funding, as
applicable, pursuant to Section 3.5(c)(iii)). After assuming responsibility for
preparing, filing, prosecuting and/or maintaining such Patent on UroGen
Intellectual Property in that Baxter Region, Baxter may elect at any time to
withdraw from such responsibility for such jurisdiction. Except as set forth in
this Section 5.1, or unless such filings in other countries are agreed to by the
Parties in writing, such other country filings shall not be made.
5.2 Prior Art; Review And Comment: Each Party shall cooperate with the
other to ensure that all prior art that is pertinent to the examination of any
Patent on UroGen Intellectual Property is brought to the attention of the other
Party. The Parties to this Agreement shall have the right to review and comment
on substantive documents prepared in connection with the preparation, filing,
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prosecution and maintenance of any Patent on UroGen Intellectual Property prior
to the filing of such papers; however, such review and comment shall be
performed expeditiously so as not to negatively affect patent rights and shall
be at each party's own cost and expense.
5.3 Third Party Licenses and Product Clearances: UroGen shall be
responsible for obtaining (at its cost and expense), and shall use at least
commercially reasonable efforts to obtain: (a) licenses or sublicenses of any
Intellectual Property Rights of third parties (other than Intellectual Property
Rights relating to Factor VIII genes) which may be necessary or advisable to the
prosecution of the Development Work and/or to fully exploit the Collaboration
Products; and (b) product clearances with respect to Collaboration Products.
6. TRADEMARKS.
6.1 Baxter Trademarks: UroGen shall not make any use of, or have any
rights or interests in, any Baxter trademark except as otherwise permitted in
the Transaction Documents without the prior written approval of Baxter.
6.2 UroGen Trademarks: Subject to the Seller License Agreement, Baxter
shall not make any use of, or have any rights or interests in, any UroGen
trademark except as otherwise permitted in the Transaction Documents without the
prior written approval of UroGen.
7. USE OF CONSULTANTS. The Parties contemplate that from time to time
during the term of this Agreement third party technical consultants may be
employed by either Party in connection with the development of the Collaboration
Product(s). Xxxxxx'x prior written consent to the utilization of specific
consultants shall be required in the event that UroGen desires to retain a third
party technical consultant for consultation relating to the treatment of blood
clotting disorders in humans. The Parties agree that information designated as
confidential by either Party may be disclosed by UroGen to such consultants
provided that Baxter is given reasonable notice of the circumstances and nature
of the intended disclosure and that the disclosure is limited to information
necessary to enable the technical consultant to provide technical consulting
services. The consultant will be required to sign an agreement with UroGen
committing the consultant to protect such confidential information.
8. CESSATION OF DEVELOPMENT WORK.
8.1 Cessation: Prior to the occurrence of the Qualifying Regulatory
Approval Milestone, either Party may unilaterally cease all participation in all
Development Work under this Agreement by thirty (30) days prior written notice
of its election to cease participation to the other Party. In the event that a
Party gives a notice of termination of the Agreement pursuant to Section 2(b)
above, fails to make any advances or payments with respect to its Funding
obligations (i.e., funds $0 with respect to its aggregate Funding obligations),
or gives a notice of cessation of participation pursuant to this Section 8.1,
the other Party (the "Remaining Party") shall have the right to proceed with the
independent development of the Collaboration Product(s) at its own expense. In
the event Baxter
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gives notice of termination to UroGen pursuant to this Section 8.1, effective as
of the date of termination Xxxxxx'x obligations to provide Baxter Funding shall
immediately terminate. In addition, in the event that the Seller License
Agreement terminates without a concurrent transfer of the Intellectual Property
Assets to UroGen pursuant to the terms and conditions of the Seller License
Agreement and the Asset Purchase Agreement (the "License Termination Date"),
Xxxxxx'x obligations to UroGen under this Agreement will automatically terminate
without notice to UroGen or any third party effective on the License Termination
Date, UroGen will be deemed to have elected to have unilaterally ceased all
participation in all Development Work under this Agreement as of the License
Termination Date, and Baxter will be deemed to be the "Remaining Party" as of
the License Termination Date (but shall have no obligation with respect to the
independent development of the Collaboration Product(s)). Upon any such
cessation of participation in the Development Work:
(a) If the Remaining Party is Baxter, then at Xxxxxx'x election by written
notice to UroGen: (i) UroGen shall grant an exclusive royalty-free license to
all rights, title and interest of UroGen with respect to the UroGen Intellectual
Property and to the Collaboration Product(s), including the exclusive right to
develop, make, use, market, sell and distribute such Collaboration Product(s),
throughout the world in perpetuity; (ii) UroGen shall, at UroGen's cost, use at
least commercially reasonable efforts to effect a transfer of UroGen's then
existing technology (including know-how) to Baxter as may be, and to the extent,
necessary for Baxter to make, use and sell the Collaboration Products within the
Field of Distribution (as that capitalized term is defined in the Distribution
Agreement); and (iii) UroGen shall cooperate with and assist Baxter in Xxxxxx'x
regulatory efforts, including providing Baxter access to any and all information
and documentation necessary in order for Baxter to assume regulatory
responsibility, as may be necessary as a result of the license described in
clause (i) above and the transfer of technology described in clause (ii) above
(any costs UroGen may incur in such cooperation or assistance shall be borne by
Baxter at UroGen's Fully Loaded Cost); or
(b) If the Remaining Party is UroGen, then at UroGen's election by written
notice to Baxter: (i) all ownership rights, marketing rights and licenses of
Baxter to the Collaboration Product(s) developed or being developed under the
Development Work (including under the Distribution Agreement), shall terminate
and fully vest in UroGen and UroGen shall have the sole right to use, market,
sell and distribute such Collaboration Product(s) throughout the world; and (ii)
Baxter shall, at Xxxxxx'x cost, use at least commercially reasonable efforts to
license or sublicense to UroGen, on a royalty-free (except for royalties payable
to third parties, which shall be paid by UroGen), world-wide, and non-exclusive
basis, any of Xxxxxx'x then existing Intellectual Property Rights to the use of
adenoviral vectors for the treatment of blood clotting disorders in humans
relating to hemophilia A as have been provided to UroGen prior to termination of
Xxxxxx'x participation in the Development Work in perpetuity (or in the event of
a sublicense of third party Intellectual Property Rights, for the remaining term
of Xxxxxx'x license from such third party).
8.2 Composition of Management Board on Cessation: In the event that a
Party ceases participation in the Development Work under this Agreement pursuant
to Section 8.1 above, such Party's designated members of the Management Board
shall be deemed to have resigned from the
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Management Board effective with the effective date of such notice and such Party
shall have no further right to designate any members of the Management Board or
to participate in the management of the Development Work.
9. COMPLIANCE WITH REGULATORY REQUIREMENTS.
9.1 Regulatory Requirements: Except as otherwise provided in this
Agreement, and except for those regulatory responsibilities allocated to Baxter
pursuant to the Distribution Agreement, UroGen shall be responsible for meeting
all regulatory requirements and for obtaining reimbursement pertaining to the
manufacturing, marketing, sales, distribution and utilization of the
Collaboration Product(s), including such requirements as are necessary for
Regulatory Approval, in the United States, Canada, the member nations of the
European Union, and Japan. Subject to the terms and conditions of the
Distribution Agreement, UroGen's regulatory responsibilities will also be
applicable to each country, state, region or locality in which Baxter either
markets, sells and distributes or plans to market, sell and distribute the
Collaboration Product(s). UroGen's regulatory responsibilities shall include
conducting any necessary clinical trials to gather safety and effectiveness data
to support marketing applications to FDA or other governmental or quasi-
governmental authorities in the United States, Canada, the member nations of the
European Union, and Japan, and any other country, state, region or locality
where UroGen may be responsible for compliance with such regulatory requirements
pursuant to the terms and conditions of the Distribution Agreement. During the
term of this Agreement, Xxxxxx'x obligations with respect to compliance with
regulatory requirements shall be as set forth in Section 6.1 of the Distribution
Agreement.
9.2 Regulatory Actions: During the term of this Agreement, UroGen shall be
responsible for all regulatory actions, and Baxter will cooperate and assist
UroGen with any regulatory action, pursuant to the terms and conditions set
forth in Section 6.2 of the Distribution Agreement.
10. BOOKS AND RECORDS.
10.1 Records: UroGen shall keep full, detailed and accurate books of
account of the Development Work in accordance with GAAP, including identifying
costs and expenses (including, but not limited to, Approved Expenses) incurred
and paid in connection with the Development Work. Books of account maintained by
UroGen shall be kept at its principal place of business.
(a) As soon as available after the end of each calendar month, and in any
event within 30 days thereafter, unaudited statements of Funding, cash flow,
costs, expenses, Approved Expenses, and operations of the Development Work for
such month and for the calendar year to the end of such month, along with an
estimate of costs and expenses to be incurred during the following six months,
all in reasonable detail and prepared according to GAAP, subject to changes
resulting from normal year-end audit adjustments, certified by the chief
financial officer of UroGen, and a comparison between the actual financial
figures for such monthly accounting period, the comparable figures for the prior
calendar year (if any), and the comparable figures included, as applicable, in
the then
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current budget for the Development Work approved by the Management Board for
such monthly accounting period, with an explanation of any material differences
between them;
(b) As soon as available after the end of each calendar year, and in any
event within 120 days thereafter, audited statements of Funding, cash flow,
costs, expenses, Approved Expenses, and operations of the Development Work for
such calendar year, setting forth in each case in comparative form the figures
for the previous calendar year (if any), all in reasonable detail, accompanied
by an unqualified opinion on such financial statements of a firm of independent
public accountants of nationally recognized standing selected by the Management
Board that such financial statements fairly present the financial position of
the Development Work being reported upon at the end of such calendar year and
the results of the Development Work's operations and cash flows for such
calendar year in conformity with GAAP; and
(c) With reasonable promptness, such other data, reports and information
as from time to time Baxter and/or the Management Board may reasonably request.
10.2 Retention: Books and records required to be maintained by UroGen
hereunder shall be retained for at least three (3) years after the expiration of
the Term.
10.3 Audit: Either Party may audit the books and records of the other
for the purpose of determining compliance with the terms of this Agreement. The
auditing Party may use independent outside auditors (who may participate fully
in such audit). In the event that an audit is proposed with respect to
information which the Party to be audited wishes not to disclose to the auditing
Party ("Restricted Information"), then on the written demand of the Party to be
audited the individuals conducting the audit with respect to the Restricted
Information will be limited to the auditing Party's independent auditors. In
such event, the Party to be audited shall pay the costs of the independent
auditors conducting such audit, but only with respect to that portion of the
audit relating to the Restricted Information. Such independent auditors shall
enter into an agreement with the Parties hereto, on terms that are agreeable to
both Parties hereto, under which such independent auditors shall agree to
maintain the confidentiality of the information obtained during the course of
such audit and establishing what information such auditors will be permitted to
disclose in reporting the results of any audit of Restricted Information. Any
such audit shall be conducted during regular business hours in a manner that
does not interfere unreasonably with the operations of the Party to be audited.
The audits conducted by any Party under the provisions of this Agreement shall
not, in the aggregate, be conducted more than once in any twelve (12) month
period unless the next preceding audit disclosed a failure to conform to the
terms of this Agreement or unless the facility received a Form FDA-483 in the
twelve (12) months following any audit. Subject to the foregoing limitations,
any such audit shall be conducted when requested by notice given not less than
thirty (30) days prior to the commencement of the audit.
11. REPRESENTATIONS AND INDEMNITIES. For the purposes of this Agreement,
the following respective representations of the Parties set forth in Sections
11.1 and 11.3 below shall be
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deemed to be made as of the date of this Agreement and shall be deemed to be
remade as of the date of each and every Funding hereunder:
11.1 UroGen Representations: UroGen represents and warrants that:
(a) UroGen is a corporation duly incorporated, validly existing and in
good standing under the laws of the state of its incorporation. UroGen has the
corporate power and authority to execute, deliver and perform this Agreement;
(b) The execution, delivery and performance by UroGen of this Agreement
has been duly authorized by all requisite corporate action and will not violate
any provision of law applicable to, any order of any court or other agency of
government applicable to, or the articles/certificate of incorporation or the
by-laws of, UroGen. This Agreement has been duly executed and delivered by
UroGen and constitutes its legal, valid and binding obligation, enforceable
against UroGen in accordance with its terms, except as such enforceability may
be limited by bankruptcy, insolvency, reorganization, moratorium or other
similar laws and equitable principles relating to creditors rights generally and
by general principles of equity, regardless of whether considered at law or in
equity;
(c) Neither the execution and delivery of this Agreement, nor the
performance of the obligations of UroGen hereunder shall result in a violation,
breach or event of default (or any event or condition which with notice or the
passage of time or both would constitute an event of default) of or with respect
to any agreement, mortgage, indenture or order of any court of competent
jurisdiction binding upon UroGen or upon the property of UroGen;
(d) It is party to no contract materially adverse to the obligations
undertaken and rights granted in this Agreement;
(e) The execution of this Agreement and delivery of this Agreement to
Baxter and the performance of its terms does not conflict with the terms of any
agreement to which UroGen is bound;
(f) UroGen has no current agreements with other parties for the
development of the Collaboration Product(s); and
(g) Except as disclosed in Schedule 3.7(F) or Schedule 3.7(G) of the Asset
--------------- ---------------
Purchase Agreement, and except for the Biologics, (i) UroGen is not aware that
there now exists any use, by a third party, of any Intellectual Property which
violates any Intellectual Property Right of UroGen in the UroGen Intellectual
Property; (ii) to UroGen's knowledge, no infringement of any material
Intellectual Property Right of any other person or entity has occurred or
results in any way from the use, manufacture and sale of the UroGen Intellectual
Property or Collaboration Products; and (iii)
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no claim of any infringement by UroGen of any material Intellectual Property
Right of any other person or entity has been made, asserted or threatened in
writing against UroGen relating to any of the UroGen Intellectual Property.
UroGen makes no representation or warranty with respect to the infringement of
third party Intellectual Property Rights by the Biologics.
11.2 UroGen Indemnification -- Representations And Warranties: UroGen
shall indemnify Baxter for, and hold it harmless from, any liability, loss,
expense or cost (including attorney's fees) incurred by, or any claim or
judgement against, Baxter as a result of any breach by UroGen of any of the
foregoing representations and warranties. In addition, UroGen shall, during the
term of this Agreement, indemnify Baxter pursuant to the terms and conditions of
Section 12 of the Distribution Agreement.
11.3 Baxter Representations: Baxter represents and warrants to UroGen
that as of the date of this Agreement:
(a) Baxter is a corporation duly incorporated, validly existing and in
good standing under the laws of the state of its incorporation. Baxter has the
corporate power and authority to execute, deliver and perform this Agreement;
(b) The execution, delivery and performance by Baxter of this Agreement
has been duly authorized by all requisite corporate action and will not violate
any provision of law applicable to, any order of any court or other agency of
government applicable to, or the articles/certificate of incorporation or the
by-laws of, Baxter. This Agreement has been duly executed and delivered by
Baxter and constitutes its legal, valid and binding obligation, enforceable
against Baxter in accordance with its terms, except as such enforceability may
be limited by bankruptcy, insolvency, reorganization, moratorium or other
similar laws and equitable principles relating to creditors rights generally and
by general principles of equity, regardless of whether considered at law or in
equity;
(c) Neither the execution and delivery of this Agreement, nor the
performance of the obligations of Baxter hereunder shall result in a violation,
breach or event of default (or any event or condition which with notice or the
passage of time or both would constitute an event of default) of or with respect
to any agreement, mortgage, indenture, or order of any court of competent
jurisdiction binding upon Baxter or upon the property of Baxter;
(d) It is party to no contract materially adverse to the obligations
undertaken in this Agreement;
(e) The execution of this Agreement and delivery of this Agreement to
UroGen and the performance of its terms does not conflict with the terms of any
agreement to which Baxter is bound; and
(f) Baxter has no current agreements with other parties for the
development of the Collaboration Product(s).
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11.4 Baxter Indemnification -- Representations And Warranties: Baxter
shall indemnify UroGen for, and hold it harmless from, any liability, loss,
expense or cost (including attorney's fees) incurred by, or any claim or
judgement against, UroGen as a result of a breach by Baxter of the foregoing
representations and warranties.
12. INFRINGEMENT.
12.1 Defense Of Third Party Infringement Suits: In the event that a third
party shall xxx either Party alleging that the manufacture, use or sale of
Collaboration Product(s), or any part thereof, infringes a patent of such third
party, then UroGen shall control the defense and bear the costs and expenses of
such suit (in such event, UroGen shall be the "Controlling Party"); provided,
--------
however, that in the event that UroGen, for whatever reason, fails to defend any
-------
such third party suit, Baxter shall have the right to assume control of the
defense and bear the costs and expenses of such suit (in such event, Baxter
shall be the "Controlling Party"). Either Party shall have the right, in the
event that it is not the Controlling Party, to participate at its own expense in
the defense of any such action with counsel of its own selection. The
Controlling Party will consult with the Management Board with respect to all
material decisions and actions taken by the Controlling Party in connection with
any such suit (to the extent possible, prior to making or taking any such
decisions or actions) and the other Party shall provide reasonable cooperation
in the defense of such suit and furnish all evidence in its control (at the
Controlling Party's expense based on the other Party's Fully Loaded Cost
therefor). The Controlling Party shall not enter into any settlement that
materially affects the other Party's rights or interests under this Agreement,
the Distribution Agreement or otherwise without the other Party's prior written
consent, which consent shall not be unreasonably withheld.
12.2 Third Party Royalty Expenses: If the Management Board shall approve
the payment to a third-party of royalty payments with respect to any license
relating to the development of the Collaboration Product(s) or any portion
thereof, then such royalty payments shall be paid by UroGen and included in the
determination of UroGen's Fully Loaded Costs with respect to the development of
the Collaboration Product(s) or any portion thereof.
12.3 Suits For Infringement By Others: In the event Baxter or UroGen
becomes aware of any actual or threatened infringement by a third party of the
UroGen Intellectual Property, that Party shall promptly notify the Management
Board and the Management Board shall determine the most appropriate action to
take. Baxter will cooperate with UroGen in pursuing or otherwise resolving each
charge of infringement. UroGen will bear all costs and expenses of pursuing any
claims of infringement, including attorneys fees in connection with any such
suit. In the event that UroGen, for whatever reason, fails to pursue any actual
or threatened infringement by a third party of the UroGen Intellectual Property,
Baxter shall have the right (but not the obligation) to pursue such claims of
infringement at UroGen's expense based on Xxxxxx'x Fully Loaded Cost therefor.
Either Party shall have the right, in the event that it is not the Party
controlling such infringement action, to participate at its own expense in any
such suit with counsel of its own selection. Any award of damages or other
recovery attributable to the infringement of the UroGen Intellectual Property
shall be retained by UroGen. The Party controlling such suit for infringement
shall not enter into any
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settlement that materially affects the other Party's rights or interests under
this Agreement, the Distribution Agreement or otherwise without the other
Party's prior written consent, which consent shall not be unreasonably withheld.
13. FOREIGN CURRENCY CONVERSION. Where calculations of a Party's Fully
Loaded Cost relate to currency other than United States dollars, all such
calculations shall be made pursuant to Xxxxxx'x then current accounting policies
and practices, as consistently applied.
14. WITHHOLDING TAXES. Where required to do so by applicable law, Baxter
shall withhold taxes required to be paid to a taxing authority on account of any
payments to UroGen hereunder, and Baxter shall furnish UroGen with satisfactory
evidence of such withholding and payment in order to permit UroGen to obtain a
tax credit or other such relief as may be available under applicable laws.
Baxter shall cooperate with UroGen in obtaining exemption from withholding taxes
wherever available under applicable law.
15. FORCE MAJEURE. Neither Party to this Agreement shall be liable for
delay or failure in the performance of any of its obligations hereunder if such
delay or failure is due to causes beyond its reasonable control, including acts
of God, fires, earthquakes, strikes and labor disputes, acts of war, civil
unrest or intervention of any governmental authority, but any such delay or
failure shall be remedied by such Party as soon as is reasonably possible.
16. LIMITATION OF LIABILITY. IN NO EVENT, WHETHER AS A RESULT OF BREACH
OF CONTRACT, TORT LIABILITY (INCLUDING NEGLIGENCE), OR OTHERWISE, SHALL EITHER
PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, PUNITIVE, EXEMPLARY,
CONSEQUENTIAL OR LIQUIDATED DAMAGES OR LOST PROFITS UNDER THIS AGREEMENT OR
RELATING TO THE SUBJECT MATTER HEREOF, EXCEPT WHERE DAMAGES ARE AWARDED TO A
THIRD PARTY AGAINST AN INDEMNIFIED PARTY.
17. FOREIGN GOVERNMENT APPROVAL OR REGISTRATION. If this Agreement or
any associated transaction is required by the law of any nation to be either
approved or registered with any governmental authority, or any agency or
political subdivision thereof, UroGen shall assume all legal obligations to do
so, except where (i) the failure to obtain approval or registration shall not
------------
adversely affect the material rights and/or obligations of UroGen and/or Baxter
with respect to this Agreement or any associated transaction, and (ii) the
---
failure to obtain approval or registration shall not result in any liability or
culpability of Baxter under, or with respect to the violation of, any applicable
law.
18. NOTICES. All notices required under this Agreement shall be in
writing, and all such notices and other written communications (including
purchase orders) shall be delivered either by hand, by a nationally recognized
overnight delivery service (with delivery charges prepaid), by first class,
registered or certified United States mail (postage prepaid), or by facsimile
transmission (provided that in the case of facsimile transmission, a
confirmation copy of the notice shall be
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delivered by hand, by a nationally recognized overnight delivery service (with
delivery charges prepaid), or by first class, registered or certified United
States mail (postage prepaid) within two (2) days of facsimile transmission),
addressed to each Party as follows:
If to Baxter,
such notices shall be delivered to: Xxxxxx Healthcare Corporation
0000 Xxxx Xxxx Xxxx
Xxxxxxxxx, Xxxxxxxx 00000
Attention: President - Venture Management
Associate General Counsel
Facsimile: 000-000-0000
If to UroGen,
such notices shall be delivered to: UroGen Corp.
00000 Xxxxxx Xxx, Xxxxx X
Xxx Xxxxx, Xxxxxxxxxx 00000
Attention: President
Facsimile: 000-000-0000
or such other address as any such Party may designate in writing and delivered
to the other Party hereto pursuant to this Section 18. All such notices or
other written communications shall be deemed to have been received by the
addressee if delivered by: hand or by a nationally recognized overnight
delivery service (with delivery charges prepaid) at the time of delivery; by
first class, registered or certified United States mail (postage prepaid), three
(3) business days after delivery thereof to the United States Postal Service; or
by facsimile transmission, at the time of transmission.
19. CHOICE OF LAW AND JURISDICTION. This Agreement shall be governed by
and construed in accordance with the internal laws of the State of California,
without application of conflicts of law principles, and, subject to Section 27
below, each Party hereby submits to the jurisdiction and venue of any state or
federal court in the State of California. To the extent permissible by law,
each of the Parties hereby waives, releases and agrees not to assert, and agrees
to cause its Affiliates to waive, release and not assert, any rights such Party
or its Affiliates may have under any foreign law or regulation that would be
inconsistent with the terms of this Agreement as governed by California law.
20. PROVISIONS CONTRARY TO LAW/SEVERABILITY. In performing this
Agreement, the Parties hereto shall comply with all applicable laws. Nothing in
this Agreement shall be construed so as to require the violation of any law, and
wherever there is any conflict between any provision of this Agreement and any
applicable law, the applicable law shall prevail. In the event any provision of
this Agreement conflicts with any applicable law or is otherwise determined by
an arbitrator or court having valid jurisdiction thereof to be unenforceable,
the affected provision of this Agreement shall be deemed to have been modified
to the extent necessary so as not to conflict with
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the applicable law or to be unenforceable or, if such modification is not
possible, such provision shall be deemed to have been deleted here from, without
affecting, impairing or invalidating the remaining provisions of this Agreement.
21. ENTIRE AGREEMENT. This Agreement, together with any schedules
attached hereto, constitutes the entire agreement between the Parties as to the
subject matter hereof, and all prior negotiations, representations, agreements
and understandings are merged into, extinguished by and completely expressed by
this Agreement.
22. WAIVERS AND MODIFICATIONS. The failure of any Party to insist on
the performance of any obligation hereunder shall not be deemed to be a waiver
of such obligation. Waiver of any breach of any provision hereof shall not be
deemed to be a waiver of any other breach of such provision or any other
provision. No waiver, modification, release or amendment of any obligation
under or provision of this Agreement shall be valid or effective unless in
writing signed by the Party to be bound by such waiver, modification, release or
amendment.
23. ASSIGNMENT. UroGen may not assign its rights or obligations under
this Agreement without the prior written consent of Baxter, unless such
assignment occurs in connection with a Change of Control of UroGen and the
assignee assumes all of the duties and obligations of UroGen under this
Agreement and the Distribution Agreement. Baxter may assign its rights and
obligations hereunder to any Affiliate of Baxter without prior notice to or
consent of UroGen. No Party hereto may assign any of its rights or obligations
under this Agreement, unless and to the extent expressly permitted by this
Section 23. Subject to the foregoing, this Agreement shall inure to the benefit
of and be binding on the Parties' permitted successors and assigns.
24. INDEPENDENT PARTIES. By virtue of this Agreement, neither Party
constitutes the other as its agent (except as may otherwise be expressly
provided herein), partner, joint venturer, or legal representative and neither
Party has express or implied authority to bind the other in any manner
whatsoever.
25. DISBURSEMENTS. Unless otherwise agreed between the Parties, all
disbursements from one Party to another under this Agreement shall be paid on or
before the due date by wire transfer to the bank account specified in writing by
the Party receiving the disbursement.
26. COUNTERPARTS. This Agreement may be executed in any number of
counterparts with the same effect as if all Parties had signed the same
document. All such counterparts shall be deemed an original, shall be construed
together, and shall constitute one and the same instrument.
27. DISPUTE RESOLUTION.
27.1 Provisional Remedies: The procedures specified in this Section 27
shall be the sole and exclusive procedures for the resolution of Deadlocks and
Disputes; provided, however, that a
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Party, without prejudice to these procedures, may seek a preliminary injunction
or other provisional relief with respect to a Dispute if, in its sole judgment,
such action is deemed necessary to avoid irreparable damage or to preserve the
status quo. During such action, the Parties will continue to participate in good
faith in the procedures specified in this Section 27.
27.2 Negotiations Between Executives: Within ten (10) days of the
occurrence of a Deadlock or delivery of a written notice by one Party to the
other Party of a Dispute, the Parties will cause, respectively, an executive
officer of UroGen designated by UroGen and an executive of Baxter designated by
Baxter, to meet and by good faith negotiations attempt to resolve such Deadlock
or Dispute. In the event that the Parties fail to resolve a Deadlock pursuant to
this Section 27.2 within thirty (30) days of the occurrence of the Deadlock, the
final decision with respect to the Deadlock shall be made solely by UroGen
reasonably taking into account the interests of both Parties. In the event that
the Parties fail to resolve a Dispute pursuant to this Section 27.2 within
thirty (30) days after one Party delivering written notice of the Dispute to the
other Party, the Dispute shall be submitted to and shall be resolved by
arbitration pursuant to Section 27.3 below.
27.3 Arbitration: In the event that a Dispute is not resolved between the
Parties pursuant to the procedures of, and time periods specified in, Section
27.2 above, such Dispute shall be finally settled by arbitration administered by
JAMS/Endispute in accordance with the provisions of its Comprehensive
Arbitration Rules and Procedures and the United States Federal Arbitration Act,
as modified below:
(a) The arbitration shall be heard by a panel of three (3) independent
and impartial arbitrators, all of whom shall be selected from a list of
neutral arbitrators supplied by JAMS/Endispute. From such list, each of
Baxter and UroGen shall select one (1) arbitrator, and the arbitrators so
selected shall select a third. The panel shall designate one (1) among them
to serve as chair.
(b) The arbitration proceedings shall be conducted: (a) if notice
demanding arbitration is delivered by UroGen to Baxter, in Xxxx County,
Illinois, or (b) if notice demanding arbitration is delivered by Baxter to
UroGen, in San Diego County, California.
(c) Any Party may seek interim or provisional remedies under the Federal
Rules of Civil Procedure and the United States Federal Arbitration Act as
necessary to protect the rights or property of the Party pending the
decision of the arbitrators.
(d) The Parties shall allow and participate in limited discovery for the
production of documents and taking of depositions, which shall be conducted
in accordance with the Comprehensive Arbitration Rules and Procedures of
JAMS/Endispute. All discovery shall be completed within sixty (60) days
following the filing of the answer or other responsive pleading.
Unresolved discovery disputes shall be brought to the attention of the
chair of the arbitration panel and may be disposed of by the chair.
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(e) Each Party shall have up to fifty (50) hours to present evidence and
argument in a hearing before the panel of arbitrators provided that the
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chair of the panel of arbitrators may establish such longer times for
presentations as the chair deems appropriate.
(f) The arbitration award shall be rendered by the arbitrators within
fifteen (15) business days after conclusion of the hearing of the matter,
shall be in writing and shall specify the factual and legal basis for the
award. Judgment thereon may be entered in any court having jurisdiction
thereof.
(g) The arbitrators are empowered to order money damages in compensation
for a Party's actual damages, specific performance or other appropriate
relief to cure a breach; provided, however, that the arbitrators will have
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no authority to award special, punitive or exemplary damages, or other
money damages that are not measured by the prevailing Party's actual
damages.
27.4 Performance During Dispute: Subject to Sections 2 and 8.1 above, each
Party is required to continue to perform its obligations under this Agreement
pending final resolution of any dispute arising out of or relating to this
Agreement, unless to do so would be commercially impossible or impractical under
the circumstances.
27.5 Costs of Arbitration: The Party which is found to have been more at
fault in a dispute arbitrated under this Section 27 shall be responsible for
paying the costs and expenses, including reasonable attorney's fees, which the
other Party has incurred in such arbitration.
28. RULES OF CONSTRUCTION. In this Agreement, unless a clear contrary
intention appears:
(a) The singular number includes the plural number and vice versa;
(b) Reference to any Party includes such Party's permitted successors and
assigns;
(c) Reference to any gender includes the other gender;
(d) Reference to any Section, Exhibit or Schedule means such section of
this Agreement, exhibit to this Agreement or schedule to this Agreement, as
the case may be, and references in any section or definition to any clause
means such clause of such section or definition;
(e) "Herein," "hereunder," "hereof," "hereto," and words of similar
import shall be deemed references to this Agreement as a whole and not to
any particular section or other provision of this Agreement;
(f) "Including" (and with the correlative meaning "include") means
including without limiting the generality of any description preceding such
term;
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(g) Relative to the determination of any period of time, "from" means
"from and including," "to" means "to but excluding" and "through" means
"through and including";
(h) Reference to any law (including statutes and ordinances) means such
law as amended, modified, codified or reenacted, in whole or in part, and
in effect from time to time, including rules and regulations promulgated
thereunder;
(i) Accounting terms used herein shall have the meanings historically
attributed to them by GAAP;
(j) In the event of any conflict between any of the provisions of the
body of this Agreement and any exhibit or schedule hereto, the provisions
of the body of this Agreement shall control;
(k) The headings contained in this Agreement have been inserted for
convenience of reference only, and are not to be used in construing this
Agreement; and
(l) Any rule of construction or interpretation which might otherwise
require this Agreement to be construed or interpreted against either Party
shall not apply to any construction or interpretation hereof.
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IN WITNESS WHEREOF, the Parties have duly executed this Agreement as of the
date first set forth above.
XXXXXX HEALTHCARE CORPORATION UROGEN CORP.
By: /s/ Xxxxxx X. Xxxxxxx By: /s/ Xxxx X. Xxxxxxx
-------------------------------- --------------------------------
Name: Xxxxxx X. Xxxxxxx Name: Xxxx X. Xxxxxxx
Title: President, Venture Management Title: President and Chief Executive
Officer
EXHIBIT A
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EXAMPLE OF THE OPERATION OF THE FORMULAE IN SECTIONS 3.5(C)(I) THROUGH
3.5(C)(IV)
ILLUSTRATION 1: For the purposes of this illustration, assume that:
. The Baxter Funding Period begins at 12:01 am on January 1, 1999;
. In Year 1 of the Baxter Funding Period (year end 1999), UroGen
requests funding equal to budgeted Approved Expenses for Year 1 and
Baxter pays full amount of request ($[ * ]);
. In Year 2 of the Baxter Funding Period (year end 2000), UroGen
requests $[ * ], $[ * ] less than the budgeted Approved Expenses for
Year 2 ($[ * ]) and Baxter pays full amount of request;
. In Year 3 of the Baxter Funding Period (year end 2001), UroGen
requests $[ * ] in funding, $[ * ] in excess of budgeted Approved
Expenses for Year 3 ($[ * ]), and Baxter pays $[ * ] (electing to pay
the excess under Section 3.5(c)(iii));
. In Year 4 of the Baxter Funding Period (year end 2002), UroGen
requests $[ * ] in funding, $[ * ] in excess of budgeted Approved
Expenses for Year 4 ($[ * ]), and Baxter only pays $[ * ] (electing
not to pay the excess) and UroGen pays $[ * ] (electing to pay the
excess under Section 3.5(c)(iii));
. In Year 5 of the Baxter Funding Period (year end 2003), UroGen
requests funding equal to budgeted Approved Expenses for Year 5
($[ * ]) and Baxter pays only $[ * ] ($[ * ] less than amount
requested);
. The Baxter Funding Period terminates at midnight on December 31,
2003;
. The UroGen Funding Period begins at 12:01 am on January 1, 2004;
. In Year 1 of the UroGen Funding Period (year end 2004), UroGen funds
full amount of budgeted Approved Expenses for Year 1 ($[ * ]);
. In Year 2 of the UroGen Funding Period (year end 2005), UroGen funds
$[ * ], $[ * ] less than the budgeted Approved Expenses for Year 2
($[ * ]);
. In Year 3 of the UroGen Funding Period (year end 2006), Baxter
proposes $[ * ] in funding, $[ * ] in excess of budgeted Approved
Expenses for Year 3 ($[ * ]), UroGen declines to pay the excess and
Baxter elects to pay, and pays, the $[ * ] excess under Section
3.5(c)(iii));
. The UroGen Funding Period terminates at midnight on December 31,
2006.
Accordingly, the Adjusted Interests of Baxter and UroGen as of the end of each
year of the Baxter Funding Period and as of the end of each year of the UroGen
Funding Period will be as follows:
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ILLUSTRATION 1
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TIME PERIOD CALCULATION OF BAXTER ADJUSTED CALCULATION OF UROGEN ADJUSTED
BAXTER ADJUSTED INTEREST UROGEN ADJUSTED INTEREST
INTEREST INTEREST
--------------------------------------------------------------------------------------------------------
END OF YEAR 1 OF (([ * ] / [ * ]) x [ * ]% 100% - [ * ]% [ * ]%
BAXTER FUNDING [ * ]) x 100
PERIOD
--------------------------------------------------------------------------------------------------------
END OF YEAR 2 OF (([ * ] / [ * ]/1/)x [ * ]% 100% - [ * ]% [ * ]%
BAXTER FUNDING [ * ]) x [ * ]
PERIOD
--------------------------------------------------------------------------------------------------------
END OF YEAR 3 OF (([ * ] / [ * ]) x [ * ]% 100% - [ * ]% [ * ]%
BAXTER FUNDING [ * ]) x 100
PERIOD
--------------------------------------------------------------------------------------------------------
END OF YEAR 4 OF (([ * ] / [ * ]/2/)x [ * ]% 100% - [ * ]% [ * ]%
BAXTER FUNDING [ * ]) x [ * ]
PERIOD
--------------------------------------------------------------------------------------------------------
END OF YEAR 5 OF (([ * ] / [ * ]) x [ * ]% 100% - [ * ]% [ * ]%
BAXTER FUNDING [ * ]) x 100
PERIOD
--------------------------------------------------------------------------------------------------------
FINAL FIXED [ * ]% [ * ]%
ADJUSTED INTERESTS
AT END OF BAXTER
FUNDING PERIOD
--------------------------------------------------------------------------------------------------------
END OF YEAR 1 OF [ * ]% - [ * ]% [ * ]% (([ * ] / [ * ]) x [ * ]%
UROGEN FUNDING [ * ]) x 100
PERIOD
--------------------------------------------------------------------------------------------------------
END OF YEAR 2 OF [ * ]% - [ * ]% [ * ]% (([ * ] / [ * ]) x [ * ]%
UROGEN FUNDING [ * ]) x 100
PERIOD
--------------------------------------------------------------------------------------------------------
END OF YEAR 3 OF [ * ]% - [ * ]% [ * ]% (([ * ] / [ * ]/3/)x [ * ]%
UROGEN FUNDING [ * ]) x 100
PERIOD
--------------------------------------------------------------------------------------------------------
__________________
/1/ See first sentence of final paragraph of Section 3.5(c)(i).
/2/ Pursuant to Section 3.5(c)(iii), for the purposes of the calculation
under Section 3.5(c)(i) UroGen's payment of the $[ *] in excess of
Approved Expenses is treated as part of the accumulated Approved
Expenses.
/3/ Pursuant to Section 3.5(c)(iii), for the purposes of the calculation
under Section 3.5(c)(ii) Xxxxxx'x payment of the $[ * ] in excess of
Approved Expenses is treated as part of the accumulated Approved
Expenses.
-ii-
--------------------------------------------------------------------------------------------------------
ILLUSTRATION 1
--------------------------------------------------------------------------------------------------------
TIME PERIOD CALCULATION OF BAXTER ADJUSTED CALCULATION OF UROGEN ADJUSTED
BAXTER ADJUSTED INTEREST UROGEN ADJUSTED INTEREST
INTEREST INTEREST
--------------------------------------------------------------------------------------------------------
FINAL FIXED [ * ]% [ * ]%
ADJUSTED INTERESTS
AT END OF UROGEN
FUNDING PERIOD
--------------------------------------------------------------------------------------------------------
ILLUSTRATION 2: For the purposes of this illustration, assume that the facts
are the same as in Illustration 1 above except that the Agreement terminates on
the License Termination Date pursuant to Section 8.1 of the Agreement at the end
of Year 3 of the Baxter Funding Period - thereafter Xxxxxx'x Adjusted Interest
and UroGen's Adjusted Interest will remain fixed at [ * ]% and [ * ]%
respectively pursuant to the last paragraph of Section 3.5(c)(ii).
ILLUSTRATION 3: For the purposes of this illustration, assume that the facts
are the same as in Illustration 1 above except that in Year 3 of the Baxter
Funding Period a Change of Control occurs with respect to UroGen - thereupon
Xxxxxx'x Adjusted Interest and UroGen's Adjusted Interest will become fixed at
[ * ]% and [ * ]% respectively pursuant to Section 3.5(c)(iv), the Baxter
Funding Period will terminate, the UroGen Funding Period will commence, and each
of Xxxxxx'x Adjusted Interest and UroGen's Adjusted Interest will thereafter be
adjusted pursuant to Section 3.5(c)(ii).
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EXHIBIT B
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CONFIDENTIALITY AGREEMENT
Please see attached.
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