EXHIBIT 2.3
DISTRIBUTION AGREEMENT
This DISTRIBUTION 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).
X. Xxxxxx has agreed to collaborate with UroGen 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)")
pursuant to the terms of that certain Developmental Collaboration Agreement
between Baxter and UroGen of even date herewith (the "Development Agreement").
C. UroGen desires that Baxter market, sell and distribute all
Collaboration Products, as described herein and subject to the terms hereof.
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:
A. "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.
B. "Baxter Region" means, individually and collectively, the
geographical regions of (1) Western and Eastern Europe; (2) North America
(United States and Canada); (3) Japan; and (4) the rest of the world; provided,
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however, that Xxxxxx'x marketing plans may from time to time further divide
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"Baxter Regions" into individual nations or other smaller geographical regions
for the purposes of such marketing plans.
C. "FDA" means the United States Food and Drug Administration.
D. "Field of Distribution" means the market for products
utilizing the Mini-Ad Vector Technology for the treatment of blood clotting
disorders in humans relating to hemophilia A.
E. "First Equity Milestone" shall mean that point in time when
UroGen treats the first patient under an Initial New Drug Application in a Phase
I clinical trial, as such capitalized terms are defined by the FDA from time to
time.
F. "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,
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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.
G. "Mini-Ad Vector Technology" means (a) technology developed
by Seller 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 Property Rights developed, licensed or acquired by UroGen (and/or
Affiliates of UroGen) relating to adenoviral vectors for gene therapy.
H. "Product(s)" means any product or products utilizing the
Mini-Ad Vector Technology for use in the Field of Distribution, including
ancillary products relating thereto and/or used for the delivery or
administration of products utilizing the Mini-Ad Vector Technology in the Field
of Distribution to patients or customers.
I. "Purchase Price Percentage" means UroGen's Adjusted Interest
(as such term is defined in the Development Agreement), but in no event shall
UroGen's Purchase Price Percentage be less than [ * ]% or more than [ * ]%.
J. "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 Products, in the United States to the public at
large, or (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 Products, in that country (other than the United States),
to the public at large.
K. "Standard Average Price" shall mean an amount equal to the
average price paid by Baxter for a Product during the first three calendar
quarters of the preceding calendar year. For the first year of sales for any
Product, the Standard Average Price for such Product shall be determined by the
mutual agreement of the parties hereto.
2. TERM OF AGREEMENT.
2.1 Duration: The term of this Agreement (the "Term"), unless
earlier terminated as provided below, shall be the longer of (i) ten (10) years
from the date of Regulatory Approval of the first Collaboration Product in the
United States or (ii) the expiration of the last to expire of any existing
patents anywhere in the world or patents issued anywhere in the world as a
result of existing patent applications on the Mini-Ad Vector Technology listed
on Schedule 3.7(C) of the Asset Purchase Agreement which have issued on or
before ten (10) years from the date of Regulatory Approval of the first
Collaboration Product in the United States. The Term may be extended upon the
mutual written agreement of the parties.
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2.2 Early Termination: A non-breaching party may terminate this
Agreement if any of the following events (each is herein referred to as a
"Material Breach") occur:
A. A party fails to pay any amount owing under this Agreement,
on the date(s) specified for such payment and such failure shall continue for
sixty (60) days after written notice of such failure by the other party to this
Agreement;
B. A party shall default in the performance of or compliance
with any covenant contained in this Agreement (other than a failure to make a
payment described in Section 2.2(A) above or a default the liability for which
is excused under Sections 4.3, 4.4 or 13 hereof) which default shall continue
uncured beyond the applicable grace period therefor or, if no grace period is
specified therefor, such default shall continue uncured for sixty (60) days
after written notice of such default by the other party to this Agreement;
C. A receiver, conservator, custodian, liquidator or trustee of
a party, or of all or any of the property of a 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 a
party; or any of the material property of a party is sequestered by court order
and such order remains in effect for more than ninety (90) days; or a petition
is filed against a 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;
D. A 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
E. A 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; or
X. Xxxxxx provides notice to UroGen of Xxxxxx'x election to
cease participation in all Development Work (as such term is defined in the
Development Agreement) in accordance with Section 8.1 of the Development
Agreement and UroGen elects by written notice to Baxter to terminate Xxxxxx'x
ownership rights, marketing rights and licenses to Collaboration Product(s)
being developed under the Development Work in accordance with the terms of
Section 8.1(b) of the Development Agreement.
3. APPOINTMENT. Subject to the terms and conditions contained in this
Agreement, UroGen appoints Baxter as its exclusive worldwide marketing, sales
and distribution entity for the Products. Baxter accepts such appointment.
Notwithstanding any provision of this Agreement to the contrary, for a period
equal to the longer of (i) the Term of this Agreement or
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(ii) the term of the Development 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
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.
4. MANUFACTURE AND SUPPLY.
4.1 Obligation to Supply: UroGen shall exercise its commercially
reasonable efforts to manufacture and supply the Products or make reasonably
satisfactory arrangements for the manufacture and supply of the Products for
Baxter. UroGen shall make the commercially reasonable investment required to
enable it to manufacture and supply or make satisfactory arrangements for the
same, as required to perform its obligations under this Agreement. UroGen, or
its contract manufacturer, shall comply with all of the applicable regulations
of the country of manufacture and the country of sale as related to the
production of the Products (for example, Quality System Regulation ("QSR") of
the FDA).
4.2 Changes to Contract Suppliers, Manufacturers or Specifications:
UroGen may change contract suppliers, contract manufacturers or the
specifications of Products, provided that any such change has been presented for
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review and approval by Baxter at least ninety (90) days before it becomes
effective, and has been approved by Baxter, which approval shall not be
unreasonably withheld and notice of such approval (or disapproval, as the case
may be) shall be given to UroGen within thirty (30) days of Xxxxxx'x receipt of
a request from UroGen for such change. UroGen will be responsible for obtaining
any required Regulatory Approval with respect to such changes and will be
responsible for all costs associated with such change, including without
limitation, the cost of field upgrades.
4.3 Forecasting:
(a) After receiving Regulatory Approval, thirty (30) days prior to
the beginning of each calendar quarter during the term of this Agreement, Baxter
shall provide UroGen with a rolling twelve (12) month forecast of the orders it
expects to place for the
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Products during the next twelve (12) months. The forecast for the first quarter
of each such forecast shall constitute a firm purchase order by Baxter for the
number of units of Products forecast for such quarter (the "Baxter Purchase
Order"). The forecast for any given calendar quarter may not vary from the
forecast for the immediately preceding calendar quarter by more than twenty
percent (20%), nor may any Baxter Purchase Order for any given calendar quarter
vary by more than twenty percent (20%) from the prior forecast for such calendar
quarter. Twelve (12) months after receiving Regulatory Approval, the parties
hereto shall review and may mutually agree to adjust the twenty percent (20%)
level of variance permitted for (i) any given calendar quarter from the
immediately preceding calendar quarter under this Section 4.3(a), and (ii) any
Baxter Purchase Order from the prior forecast for such calendar quarter under
this Section 4.3(a). Before Regulatory Approval is received, Baxter shall
provide UroGen with a forecast based on the reasonably assumed date of
Regulatory Approval, but such forecast shall not be effective until Regulatory
Approval is actually received, and shall be effective only for thirty (30) days
after receipt of Regulatory Approval, whereupon Baxter shall provide UroGen with
a new forecast. The parties shall cooperate in good faith in creating and
providing other, longer range, forecasts which shall be used in budget planning
for the parties.
(b) In the event that Baxter fails to purchase the amounts specified
in the Baxter Purchase Orders for two (2) consecutive calendar quarters, the
parties shall agree to a remedial marketing plan which will reestablish the
appropriate amounts of Xxxxxx'x purchases under the Baxter Purchase Orders. In
the event that Baxter fails to purchase the amounts specified in the Baxter
Purchase Orders for three (3) consecutive calendar quarters, (i) Xxxxxx'x
purchase obligation shall be fixed at the minimum quarterly purchase amount
applicable to the then current Baxter Purchase Order and such purchase
obligation will remain in place for the period during which Baxter fails to meet
its quarterly purchase obligations with respect to Baxter Purchase Orders
(including such third consecutive calendar quarter) and (ii) the parties shall
also agree to a remedial marketing plan which will reestablish the appropriate
amounts of Xxxxxx'x purchases. The above mentioned penalties for failure to
purchase the forecast amounts shall not take effect until twelve (12) months
after Regulatory Approval, although Baxter shall make commercially reasonable
efforts to meet the forecast level of purchases during such twelve (12) month
period.
(c) At such time as Baxter resumes meeting its quarterly purchase
obligations under the Baxter Purchase Orders, Baxter shall no longer be subject
to the requirements of clauses (i) and (ii) of Section 4.3(b) above, and for the
purposes of determining compliance with this Section 4.3, calculation of
consecutive calendar quarters in which Baxter fails to purchase the amounts
specified in the Baxter Purchase Orders shall begin again at zero. If Baxter
complies with all of its obligations under Section 4.3(b), the remedial actions
by Baxter detailed in clauses (i) and (ii) of Section 4.3(b) above shall be the
sole and exclusive remedy available to UroGen for Xxxxxx'x failure to purchase
the amounts specified in the Baxter Purchase Orders. Further, if Baxter complies
with all of its obligations under Section 4.3(b), Xxxxxx'x failure to purchase
the amounts specified in the Baxter Purchase Orders shall not be deemed a
default by Baxter in its performance under this Agreement which would permit
termination of this Agreement pursuant to Section 2.2(A).
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4.4 Fill Rate Commitment:
(a) Upon Regulatory Approval and for a period of twelve (12) months
thereafter, UroGen shall make commercially reasonable efforts to maintain an
overall first delivery "fill rate" on Baxter Purchase Orders for Products of [*]
%. Thereafter, UroGen shall maintain an overall first delivery fill rate on
Baxter Purchase Orders of at least [ * ]%, or such other amount to which the
parties may mutually agree in writing, based on their experience during the
first twelve (12) months following Regulatory Approval. For the purpose of this
Agreement, "fill rate" shall be defined as lines of product shipped on the date
specified in the Baxter Purchase Order, divided by lines of product ordered,
times 100. Fill rate will be monitored by UroGen and Baxter. The fill rate
commitment established pursuant to this Section may be adjusted by mutual
written agreement of the parties hereto during the Term as may be appropriate to
reflect actual manufacturing experience.
(b) In the event that UroGen fails to meet its fill rate for two (2)
consecutive calendar quarters, the parties shall mutually agree to a remedial
plan to handle back orders of the Products and to assist UroGen in
reestablishing the targeted fill rate. In the event that UroGen fails to meet
its fill rate for three (3) consecutive calendar quarters, (i) UroGen's Purchase
Price Percentage shall drop to its minimum level of [ * ]% for any period in
which it fails to meet its fill rate (including such third consecutive calendar
quarter) and (ii) the parties shall also agree to a remedial plan to handle back
orders and assist UroGen in reestablishing the targeted fill rate. The above
mentioned penalties for failure to meet the applicable fill rates shall not take
effect until twelve (12) months after Regulatory Approval, although UroGen shall
make commercially reasonable efforts to meet the applicable fill rates during
such twelve (12) month period.
(c) At such time as UroGen resumes meeting its overall fill rate on
Xxxxxx'x orders for Products, UroGen shall no longer be subject to the
requirements of clauses (i) and (ii) of Section 4.4(b) above, and for the
purposes of determining compliance with this Section 4.4, calculation of
consecutive calendar quarters in which UroGen fails to meet its overall fill
rate on Xxxxxx'x orders for Products shall begin again at zero. If UroGen
complies with all of its obligations under Section 4.4(b), the remedial actions
by UroGen detailed in clauses (i) and (ii) of Section 4.4(b) above shall be the
sole and exclusive remedy available to Baxter for UroGen's failure to meet its
overall fill rate on Xxxxxx'x orders for Products. Further, if UroGen complies
with all of its obligations under Section 4.4(b), UroGen's failure to meet its
overall fill rate on Xxxxxx'x orders for Products shall not be deemed a default
by UroGen in its performance under this Agreement which would permit termination
of this Agreement pursuant to Section 2.2(A).
4.5 Discontinuance of Product Line: If UroGen wishes to discontinue a
product line which includes any Products, the parties will negotiate appropriate
closure conditions, in accordance with Section 4.6 below.
4.6 Assignment of Rights: In the event UroGen elects to abandon
and/or discontinues substantially all efforts to develop or market (or to have
developed or marketed) the Products or any of them (the "Discontinued
Products"), UroGen shall xxxxx Xxxxxx an exclusive,
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worldwide, royalty-free license under the Mini-Ad Vector Technology to make,
have made, use and sell, in such Product Field or sub-field, those Discontinued
Products. The term of such license shall be equal to the term of the
Distribution Agreement. In addition, in the event UroGen elects to abandon
and/or discontinues substantially all efforts to develop or market (or have
developed or marketed) any products utilizing the Mini-Ad Vector Technology
outside of the Field of Distribution ("Discontinued Products Outside of the
Field"), UroGen shall xxxxx Xxxxxx an exclusive, worldwide license under the
Mini-Ad Vector Technology to make, use and sell the Discontinued Products
Outside of the Field. Baxter shall pay UroGen a royalty under such license of no
less than [ * ] percent ([ * ]%) of sales of such Discontinued Products Outside
of the Field, the actual amount of which to be negotiated by the parties hereto.
After granting Baxter either or both of such licenses, (a) sales of Discontinued
Products or Discontinued Products Outside of the Field shall not be included in
net receipts for the purpose of determining the UroGen Price under Section 5.1
hereof or for the purpose of determining the Standard Average Price and (b)
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, and any costs
UroGen may incur in such cooperation or assistance shall be borne by Baxter at
UroGen's Fully Loaded Cost. Any royalty obligations to third parties with
respect to Discontinued Products or Discontinued Products Outside the Field
which are assigned or otherwise transferred to Baxter shall be paid by Baxter
after such assignment or transfer. The terms and conditions of such licenses
shall be negotiated by UroGen and Baxter, bargaining in good faith, and
documented in a written agreement, signed by authorized representatives of both
parties.
5. PURCHASE OF PRODUCT.
5.1 Product Sales: Baxter is solely responsible for establishing the
price of the Products for sale to customers. Baxter will pay UroGen the "UroGen
Price", as such term is hereafter defined, for the Products and payment for such
Products shall be made in accordance with Section 5.4. The UroGen Price will be
an amount equal to the product of the Purchase Price Percentage times net
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receipts from sales of Products by Baxter for that quarter (i.e., gross receipts
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net of any stamp, sales, transfer, use or similar taxes, freight, shipping or
customs duties costs). However, regardless of the applicable Purchase Price
Percentage under the Development Agreement, the UroGen Price shall never be less
than the sum of (a) UroGen's Fully Loaded Cost (excluding royalty payments made
as set forth in clause (c) below) for the Products Baxter has sold during such
calendar quarter plus (b) [ * ] percent ([ * ]%) of such Fully Loaded Cost, plus
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(c) any third party royalty payments UroGen may be required to pay, in
accordance with Section 5.8 hereof (the "UroGen Price Floor").
5.2 Managed Care/Capitated Sales: If Baxter sells Products to
customers in the managed care market on a "capitated" basis (i.e., customers are
charged on a per patient per year basis rather than on a per unit of product
basis), the parties shall negotiate in good faith a commercially reasonable,
appropriate and equitable allocation of the capitated fee between Baxter and
UroGen in lieu of applying the Purchase Price Percentage to the capitated fee.
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5.3 "Minimal" or "No Charge" Sales Transactions with Customers:
Baxter may, from time to time, agree to make specified Products available to
customers with a minimal charge or at no charge, as part of an advertising and
promotion program. Baxter shall be responsible for developing and approving any
such program, provided, however, that Baxter shall pay UroGen's Fully Loaded
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Cost for Products made available to customers in accordance with this Section
5.3.
5.4 Payment and Shipping Terms: UroGen shall xxxx Xxxxxx as of the
end of each month the Standard Average Price for Products shipped to customers
during the month. Baxter shall pay such invoices within sixty (60) days of
Xxxxxx'x receipt thereof. At the end of each calendar quarter, Baxter shall
reconcile the difference between the Standard Average Price paid for Products
shipped during that quarter and the actual price of such Products as determined
in accordance with Section 5.1 hereof. Baxter shall deliver to UroGen within
thirty (30) days of the end of each quarter a written report (a "Reconciliation
Report") detailing its reconciliation of the difference between the Standard
Average Price and the actual price of Products shipped during such quarter. If
Baxter has paid UroGen more than the actual price payable by Baxter for the
Products shipped during a calendar quarter pursuant to Sections 5.1 through 5.3,
inclusive (the "Owed Amount"), UroGen shall refund to Baxter within thirty (30)
days of the date of the Reconciliation Report the difference between the Owed
Amount and the Standard Average Price for such Products. If Baxter has paid
UroGen less than the Owed Amount for the Products shipped during a calendar
quarter, Baxter shall pay to UroGen within thirty (30) days of the date of the
Reconciliation Report the difference between the Owed Amount and the Standard
Average Price for such Products. Any dispute with respect to such a
reconciliation shall be resolved in accordance with the terms of Section 24
hereof. Products are to be shipped FCA (INCOTERMS) to Xxxxxx'x destination
designated in the purchase order. Xxxxxx'x designated destination may include a
Baxter facility or a customer's facility. Unless otherwise agreed in writing,
Baxter shall designate the shipper, pay all freight charges and will obtain and
pay for any necessary import licenses, authorizations or documentation for
shipments of Products outside the United States. UroGen shall pay all costs
associated with delivering the Products to the designated shipper and will
obtain and pay for any necessary export licenses, authorizations or
documentation for shipments of Products outside the United States. The parties
will cooperate with one another as necessary to meet appropriate export/import
regulations.
5.5 Acceptance of Shipment/Return of Goods: Baxter may inspect or
audit the Products for integrity and adherence to the product specifications.
If any of the Products of a continuous production run or shipment (a "Lot") fail
to meet UroGen's warranties or to conform to product specifications, Baxter
shall notify UroGen in writing within 120 days, and thereafter Baxter may reject
such Lot and, at Xxxxxx'x option and at UroGen's expense, Baxter shall receive a
credit, refund or replacement for such Products. If UroGen so requests, Baxter
will return any such Products to UroGen at UroGen's expense.
5.6 Controlling Document: UroGen shall acknowledge receipt of each
Baxter purchase order in writing within ten (10) business days after receipt
thereof and confirm delivery dates to destinations specified by Baxter. Subject
to Sections 4.3 and 4.4, all sales of Products
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shall be subject to the terms and conditions of this Agreement and, to the
extent they specify quantities, destinations and delivery dates, to Baxter
purchase orders. This Agreement shall not be subject to the terms, conditions or
provisions of any business form of Baxter or UroGen and any purchase order of
Baxter or any confirmation of UroGen is subject to this Agreement.
5.7 Baxter shall provide quarterly (or, to the extent Baxter
customarily generates such sales reports on a monthly basis, monthly) sales
reports as customarily generated by Baxter with standard detailing of the sales
volume. These reports shall be delivered to UroGen within thirty (30) days after
the end of each quarter (or, to the extent Baxter customarily generates such
sales reports on a monthly basis, each month).
5.8 Royalty Payments: Baxter shall pay any third party patent
royalty payments associated with any license obtained by Baxter for the benefit
of UroGen and required for the sale of Products incorporating the Factor VIII
gene. UroGen shall be responsible for paying any and all other third party
royalty payments necessary in order to manufacture and distribute the Products.
The cost of such third party royalty payments shall not be factored into the
calculation of UroGen's Fully Loaded Cost, but the cost of such third party
royalty payments shall be part of the UroGen Price Floor in accordance with
Section 5.1 hereof.
6. COMPLIANCE WITH REGULATORY REQUIREMENTS.
6.1 Regulatory Requirements:
(a) Except as provided below, and except for those regulatory
responsibilities allocated to Baxter pursuant to the other Transaction Documents
between UroGen and Baxter, UroGen shall be responsible for obtaining regulatory
approval for the sale of Products, meeting regulatory requirements, including,
without limitation, regulatory approval of promotional materials, and for
obtaining reimbursement pertaining to the manufacturing, marketing, sales,
distribution and utilization of the Products. UroGen's regulatory obligations
are applicable to each country, state, region or locality in which Baxter either
markets, sells and distributes or plans to market, sell and distribute the
Products. To assist UroGen in meeting this obligation, Baxter shall be diligent
in advising UroGen of its plans to enter, remain active, or depart from specific
countries, states, regions or localities relative to the marketing, sales and
distribution of the Products. Further, Xxxxxx will be obligated to meet all
applicable regulations relative to its role as exclusive seller and distributor
of the Products. 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, while Xxxxxx shall be responsible for conducting marketing studies.
Initiation of marketing studies will be coordinated between Xxxxxx Regions and
UroGen for continuity. Xxxxxx may provide certain regulatory support to UroGen,
but only as specifically provided in the Services Agreement.
(b) In the event UroGen believes, in UroGen's reasonable judgement,
that the cost of obtaining regulatory approval in any jurisdiction would not be
economically prudent, UroGen may refuse to obtain regulatory approval in such
jurisdiction and shall provide written
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notice of such an election to Xxxxxx. Upon receipt of notice from UroGen that it
has elected not to pursue regulatory approval in a jurisdiction, Xxxxxx may
elect to assume regulatory responsibility for that jurisdiction (to the extent
such an assumption is permissible in that jurisdiction) within sixty (60) days
of receipt of such notice from UroGen. Upon assumption of regulatory
responsibility for a jurisdiction, Xxxxxx will become solely responsible for
regulatory compliance for that jurisdiction, except for any obligations UroGen
must retain in its role as manufacturer of the Products. Upon Xxxxxx'x
assumption of regulatory responsibility for a jurisdiction, UroGen will continue
to supply Xxxxxx with Products for sale in such jurisdiction, but the price
Xxxxxx shall pay UroGen for such Products shall be the UroGen Price Floor.
UroGen shall cooperate with and assist Xxxxxx in Xxxxxx'x regulatory efforts,
including providing Xxxxxx access to any and all information and documentation
necessary in order for Xxxxxx to assume regulatory responsibility, and any costs
UroGen may incur in such cooperation or assistance shall be borne by Xxxxxx at
UroGen's Fully Loaded Cost. After assuming regulatory responsibility for a
jurisdiction, Xxxxxx may elect at any time to withdraw from regulatory
responsibility for such jurisdiction. In the event Xxxxxx elects to assume
regulatory responsibility for a jurisdiction and such an assumption by Xxxxxx is
not permitted in that jurisdiction, UroGen shall obtain regulatory approval in
that jurisdiction upon Xxxxxx'x request, at Xxxxxx'x expense and at UroGen's
Fully Loaded Cost. The price Xxxxxx will pay to UroGen for Products sold in that
jurisdiction will be the UroGen Price Floor and Xxxxxx may elect at any time to
have UroGen withdraw from regulatory responsibility for that jurisdiction.
6.2 Regulatory Actions: UroGen shall be responsible for all
regulatory actions and incur all costs of such actions, Xxxxxx will cooperate
with and assist UroGen, at UroGen's expense, with any regulatory action, and
Xxxxxx will maintain and provide UroGen with a current customer list as needed
solely for regulatory actions. If a regulatory action is determined to be due
to Xxxxxx'x negligence in distributing Products, Xxxxxx shall incur all costs of
such action, to the extent such costs are due to Xxxxxx'x negligence. In the
event of a Regulatory Action with respect to Products which requires Xxxxxx to
return Products it has purchased from UroGen, Xxxxxx may elect to invoice UroGen
for the full amount paid by Xxxxxx for such Products which UroGen shall pay
within thirty (30) days of receipt. UroGen shall bear the cost of all return
shipments of and field notifications which are reasonably required with respect
to such Products, as well as any associated import/export licenses, fees,
customs duties or taxes on such returned Products. As used in this paragraph,
"regulatory actions" mean: mandatory notifications, repairs, replacements and
refunds; safety alerts; "cease distribution and notification" and mandatory
recall actions; voluntary recalls, market withdrawals or stock recoveries; and
device removals and corrections, as defined or understood under law or FDA
policy, or related or analogous actions.
6.3 Product Complaints: Xxxxxx shall complete product complaint
forms provided by UroGen to Xxxxxx and forward any product complaint information
to UroGen's post-quality assurance group. UroGen and Xxxxxx will work together
to manage product complaints in an effective and responsive manner. Should
Xxxxxx or its customers receive significant amounts of defective Products,
UroGen will issue to Xxxxxx, or to a customer if directed to do so by Xxxxxx, a
refund for such Products, including the cost of return shipment for such
Products as
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well as any associated import/export licenses, fees, customs duties and taxes,
or, at Xxxxxx'x option, replacement Products, and the cost of shipping such
replacement Products as well as any associated import/export licenses, fees,
customs duties and taxes shall be at UroGen's expense.
7. MARKETING OF PRODUCT.
7.1 Obligation to Market:
(a) Upon receipt of Regulatory Approval for a Product, Xxxxxx agrees
to follow its marketing plan on an annual basis, as such plan may be revised or
changed by Xxxxxx from time to time. Xxxxxx will use commercially reasonable
diligence in its marketing and sales efforts. Xxxxxx'x sales and marketing
efforts, which will comply with the regulatory requirements of the applicable
regulatory jurisdiction, may include the development of promotional materials,
certain customer letters, sales calls, presentations and other documentation in
support of marketing and sales personnel representation of the Products. Xxxxxx
shall coordinate the production of promotional materials with UroGen so that the
parties' marketing efforts are complementary and so that UroGen may comply with
such regulatory requirements as may apply to such materials and will provide
UroGen with marketing comments on promotional materials prepared by UroGen.
Xxxxxx'x efforts may also include, at its sole discretion, the funding of
marketing studies relating to the Products. Xxxxxx will coordinate the
initiation and completion of such marketing studies with UroGen.
(b) If, after the first anniversary of Regulatory Approval, UroGen
reasonably believes that Xxxxxx is not using commercially reasonable diligence
in its marketing and sales efforts in a given Xxxxxx Region (as such Xxxxxx
Regions may be set forth in Xxxxxx'x marketing plans) during a given calendar
quarter, UroGen may provide Xxxxxx with written notice of such dissatisfaction
within sixty (60) days of the end of such calendar quarter. Upon Xxxxxx'x
receipt of such notice, the parties shall mutually agree to a remedial marketing
and sales plan for such Xxxxxx Region, the structure and implementation of which
shall be coordinated with any concurrent marketing or production plans then in
effect or being implemented under Sections 4.3 and 4.4 hereof which apply to
such Xxxxxx Region. If UroGen still reasonably believes that Xxxxxx is not
using commercially reasonable diligence in its marketing and sales efforts in
that Xxxxxx Region for the next consecutive calendar quarter, UroGen may provide
Xxxxxx with written notice of such continuing dissatisfaction within sixty (60)
days of the end of such calendar quarter. Upon Xxxxxx'x receipt of such notice,
the issue of whether Xxxxxx is utilizing commercially reasonable diligence in
its marketing and sales efforts in that Xxxxxx Region shall be submitted to
arbitration in accordance with the terms of Section 24 hereof. In the event it
is finally determined in arbitration that Xxxxxx failed to use commercially
reasonable diligence in its marketing and sales efforts for that Xxxxxx Region,
UroGen's sole remedy shall be the right to co-market the Product or Products
which UroGen complained Xxxxxx did not adequately market in that Xxxxxx Region
and UroGen will be entitled to receive its maximum Purchase Price Percentage on
sales of such co-marketed Products in that Xxxxxx Region.
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7.2 Technical Materials & Medical Inquiries: UroGen will be
responsible for developing, publishing and revising, as appropriate, all
technical and educational materials (for example, technical articles, abstracts,
publications) relating to the Products; provided, however, that the cost of
-------- -------
developing and complying with regulatory requirements for such materials shall
be borne by UroGen and shall not be included in UroGen's Fully Loaded Cost.
Xxxxxx will pay UroGen's Fully Loaded Cost for printing any such promotional or
educational materials. These technical and educational materials will otherwise
be provided to Xxxxxx and Xxxxxx'x customers free of charge. UroGen shall
retain a medical affairs staff to handle the medical inquiries from Xxxxxx.
Xxxxxx may, from time to time, request UroGen to prepare certain additional
technical or educational materials and UroGen shall meet such requests as are
reasonable.
7.3 UroGen's Right to Market, Sell and Distribute: Subject to
Section 3 above, UroGen shall be solely responsible for its own marketing,
selling and distribution efforts for products utilizing the Mini-Ad Vector
Technology outside the Field of Distribution. UroGen shall apprise Xxxxxx on a
periodic basis of its activities in this regard so that the parties' marketing
and selling efforts are complementary.
7.4 Customer Feedback: As either party develops, surveys or
otherwise receives feedback from customers, operators and others relative to the
Products, it will share the results and data obtained with the other party
hereto. The parties may choose to jointly seek customer feedback or use similar
data to agree upon changes or improvements to the Products, to the use and
administration of the Products, the training of users, or the technical
presentation of the Products.
7.5 Use of Trademarks and Labeling: UroGen hereby grants to Xxxxxx
and Xxxxxx hereby accepts a license to use the trademarks, trade names, service
marks and corporate logos of UroGen on a non-exclusive, royalty-free, worldwide
basis solely in connection with the marketing, sales and distribution of the
Products. No other use of the trademarks, trade names or corporate logos is
permitted. Nothing herein shall give Xxxxxx any right, title or interest in or
to UroGen's trademarks or trade names. Xxxxxx shall not at any time assert any
claim to any goodwill, reputation or ownership of UroGen's trademarks, trade
names or corporate logo. All uses of UroGen's trademarks or trade names shall
inure to the benefit of UroGen. The parties agree that the Products as well as
promotional materials will be labeled and primarily referred to as products of
UroGen and will bear UroGen's name. UroGen shall provide all labeling, product
inserts and packaging for the Products, provided that Xxxxxx has reviewed and
approved in writing each use or display on such labels, inserts or packaging of
any trademark, trade name, service xxxx or logo used or owned by Xxxxxx.
Xxxxxx'x name and logo may be used in any labeling, product inserts and
packaging for the Products by UroGen, if and when required by regulatory
guidelines, to indicate Xxxxxx'x exclusive appointment as the marketer, seller
and distributor of the Product.
8. FOREIGN CURRENCY CONVERSION. Where calculations of Xxxxxx'x Fully
Loaded Cost or UroGen's Fully Loaded Cost relate to currency other than United
States dollars, all such calculations shall be made pursuant to GAAP.
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9. WITHHOLDING TAXES. Where required to do so by applicable law, Xxxxxx
shall withhold taxes required to be paid to a taxing authority on account of any
payments to UroGen hereunder, and Xxxxxx 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.
Xxxxxx shall cooperate with UroGen in obtaining exemption from withholding taxes
wherever available under applicable law.
10. INTEREST ON OVERDUE PAYMENTS. Interest shall accrue and be payable on
all overdue payments owing by a party under this Agreement from the date due at
the rate of [ * ] percent ([ * ]%) per month (or the highest rate allowed by
law, if lower), compounded annually, until fully paid (including full payment of
such interest).
11. WARRANTIES.
11.1 Warranty: UroGen shall warrant or shall obtain such warranty
from its suppliers and contract manufacturers that all Products sold to Xxxxxx
hereunder are, as of the date of shipment or delivery, not adulterated or
misbranded within the meaning of the United States Food, Drug and Cosmetic Act,
or amendments thereto, and any similar federal, state or local laws or
regulations, and are not articles which may not, under the provisions of the
Act, be introduced into interstate commerce. This warranty shall be continuing
and shall be binding on UroGen, its suppliers and contract manufacturers and
UroGen's permitted successors and assigns and shall inure to the benefit of
Xxxxxx and its permitted successors and assigns. Xxxxxx shall represent to its
customers that any product which it distributes on behalf of a manufacturer
other than Xxxxxx is warranted by the manufacturer and not Xxxxxx.
11.2 Xxxxxx Indemnity: Subject to Section 14 below, Xxxxxx agrees to
indemnify UroGen and hold it harmless from any liability, loss, expense, cost,
claim or judgment arising out of any claim for property damage, personal injury
or death which is caused by Xxxxxx'x failure to meet its obligations as provided
herein. At Xxxxxx'x expense, UroGen shall cooperate fully with Xxxxxx in
defending or otherwise resolving any such claim. Xxxxxx shall have full control
of any litigation brought against UroGen with respect to any claim that is
indemnifiable by Xxxxxx hereunder; but UroGen may at its expense, also be
represented by its own counsel in any such litigation. Xxxxxx shall not enter
into any settlement that materially affects UroGen's rights or interests under
this Agreement, the Development Agreement or otherwise without UroGen's prior
written consent, which consent shall not be unreasonably withheld.
11.3 UroGen Indemnity: Subject to Section 14 below and subject to
Xxxxxx'x obligation to indemnify UroGen under Section 11.2 hereof, UroGen hereby
indemnifies and agrees to defend and hold Xxxxxx harmless from and against all
claims, liabilities, losses, expenses (including attorneys' fees), including any
property damage, personal injury or death, arising out of or in connection with
the design, manufacture, sale or use of the Products, unless such claims,
liabilities, losses or expenses arise from the negligence or wilful misconduct
of Xxxxxx. In the event UroGen controls any litigation brought against Xxxxxx
with respect to a
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claim which is indemnifiable by UroGen hereunder, UroGen shall not enter into
any settlement that materially affects Xxxxxx'x rights or interests under this
Agreement, the Development Agreement or otherwise without Xxxxxx'x prior written
consent, which consent shall not be unreasonably withheld.
11.4 Insurance: UroGen shall obtain and keep in force during the Term
of this Agreement, general comprehensive liability insurance covering each
occurrence of bodily injury and property damage combined single limit with
special endorsements (i) immediately after achieving the First Equity Milestone,
in an amount not less than $[ * ] and (ii) immediately after obtaining
Regulatory Approval, in an amount not less than the greater of (x) $[ * ]or (y)
[ * ]% of the annual net sales of Products under the terms of this Agreement,
providing coverage for:
(i) Products and completed operations liability;
(ii) blanket contractual liability; and
(iii) blanket broad form supplier liability.
The insurance policy shall be endorsed to name Xxxxxx as an additional insured
and to provide for written notification to Xxxxxx by the insurer not less than
thirty (30) days prior to cancellation, expiration or modification of the
insurance policy. A certificate of insurance evidencing compliance with this
Section and referencing this Agreement shall be furnished to Xxxxxx immediately
prior to achieving the First Equity Milestone and again immediately prior to
obtaining Regulatory Approval for any Product.
12. INDEMNIFICATION FOR INFRINGEMENT. Subject to Section 14 below, UroGen
shall defend, indemnify and hold Xxxxxx harmless with respect to all claims,
liabilities, losses or expenses (including attorneys' fees) of Xxxxxx arising
out of or in connection with the infringement of patents, trademarks (except
trademarks used on the Products at the request of Xxxxxx) or copyrights arising
out of the use or sale of the Products supplied to Xxxxxx under this Agreement.
Xxxxxx shall communicate to UroGen all charges of alleged infringement, within a
reasonable time after their receipt. Xxxxxx will cooperate with UroGen in
defending or otherwise resolving each charge of infringement. UroGen agrees to
bear all costs and expenses of litigation, including attorneys fees in
connection with such alleged infringement, and UroGen will reimburse Xxxxxx for
each disbursement made by Xxxxxx in satisfaction of a final judgement issued in
such litigation, but Xxxxxx may, at its own expense, be also represented by its
own counsel in any such litigation. In the event that sale of any Product is
enjoined, UroGen shall repurchase Xxxxxx'x inventory of such Product at Xxxxxx'x
Fully Loaded Cost therefor. However, the foregoing indemnification obligation
shall not apply to (i) claims for infringement of any rights relating to the
Factor VIII gene rights which have been supplied to UroGen by Xxxxxx or (ii)
claims for infringement in any jurisdiction in which Xxxxxx has assumed
responsibility for regulatory compliance in accordance with Section 6.1 hereof.
In the event Xxxxxx elects to defend such infringement claim, UroGen will
cooperate with Xxxxxx, at Xxxxxx'x expense, in such defense. Neither party shall
settle any suit for infringement the settlement of which would materially affect
the other's rights or interests under this Agreement, the Development
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Agreement or otherwise without the other party's prior written consent, which
consent shall not be unreasonably withheld.
13. 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.
14. 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.
15. 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 to the extent UroGen has elected not to pursue regulatory approval in
such jurisdiction in accordance with Section 6.1 (in which case Xxxxxx shall be
permitted to do so, pursuant to Section 6.1).
16. 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 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 Xxxxxx,
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.
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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 16. 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.
17. 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 24
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.
18. 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 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.
19. 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.
20. 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.
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21. ASSIGNMENT. UroGen may not assign its rights or obligations under
this Agreement without the prior written consent of Xxxxxx, unless such
assignment occurs in connection with a Change of Control (as such term is
defined in the Development Agreement) of UroGen and the assignee assumes all of
the duties and obligations of UroGen hereunder. Xxxxxx may assign its rights
and obligations hereunder to any Affiliate of Xxxxxx 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 21. Subject to the foregoing, this Agreement shall inure to the benefit
of and be binding on the parties' permitted successors and assigns.
22. 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.
23. 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.
24. DISPUTE RESOLUTION.
24.1 Provisional Remedies: The procedures specified in this Section
24 shall be the sole and exclusive procedures for the resolution of disputes
between the parties arising out of or relating to this Agreement; provided,
--------
however, that a party, without prejudice to these procedures, may seek a
-------
preliminary injunction or other provisional relief 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 24.
24.2 Negotiations Between Executives: The parties will attempt in
good faith to resolve 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 this Section
24) promptly by negotiations between one designated executive from each of
UroGen and Xxxxxx who will attempt in good faith to resolve any dispute or
undecided matter referred to them.
24.3 Arbitration: In the event that any dispute arising out of or
relating to this Agreement or its breach, termination or validity has not been
resolved after good faith negotiation pursuant to the procedures of Section
24.2, such dispute shall upon written notice by either party to the other, 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:
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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
Xxxxxx 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 Xxxxxx, in Xxxx County,
Illinois, or (b) if notice demanding arbitration is delivered by Xxxxxx 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.
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 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 no authority to award special, punitive or exemplary damages, or other
money damages that are not measured by the prevailing party's actual damages.
24.4 Performance During Dispute: 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.
24.5 Costs of Arbitration: The party which is found to have been more
at fault in a dispute arbitrated under this Section 24 shall be responsible for
paying the costs and
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expenses, including reasonable attorney's fees, which the other party has
incurred in such arbitration.
25. 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;
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;
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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.
26. 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 per facility unless the next preceding audit disclosed a failure to
conform to the terms of any such 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.
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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 /s/ Xxxx X. Xxxxxxx
--------------------- ---------------------------
Name: Xxxxxx X. Xxxxxxx Name: Xxxx X. Xxxxxxx
Title: President, Venture Management Title: President and CEO
