DEVELOPMENT AND LICENSE AGREEMENT between
Exhibit
10.1
Confidential
treatment has been requested for portions of this exhibit. The copy filed
herewith omits the information subject to the confidentiality request. Omissions
are designated as [***]. A complete version of this exhibit has been filed
separately with the Securities and Exchange Commission.
between
M
& P Patent AG, c/o Fundationsanstalt, Xxxxxxxxxxx 0, 0000 Xxxxx,
Xxxxxxxxxxxxx
(the
"Licensor")
and
Urigen
Pharmaceuticals, Inc., 000 Xxxxxx Xxxx, Xxxxx 000, Xxxxxxxxxx, XX
00000, XXX
(the
"Licensee")
(each
a
"Party" and collectively the
"Parties")
concerning
rights
pertaining to Licensor's product NASOBOL®
1
INDEX
1.
|
DEFINITIONS
|
2
|
2.
|
LICENSE
|
2
|
3.
|
DEVELOPMENT
|
2
|
4.
|
COMMERCIALIZATION
|
2
|
5.
|
PAYMENTS
AND ROYALTIES
|
2
|
6.
|
REPORTS
AND RECORDS
|
2
|
7.
|
PATENT
AND TRADEMARK REGISTRATION AND MAINTENANCE
|
2
|
8.
|
INFRINGEMENT,
VALIDITY CHALLENGES AND THIRD PARTY RIGHTS
|
2
|
9.
|
INDEMNIFICATION
|
2
|
10.
|
WARRANTIES,
LIABILITY AND DISCLAIMER
|
2
|
11.
|
TERM
AND TERMINATION
|
2
|
12.
|
MISCELLANEOUS
|
2
|
13.
|
GOVERNING
LAW AND DISPUTE RESOLUTION
|
2
|
2
PREAMBLE
Licensor
is established as a company limited by shares in accordance with the laws of
Liechtenstein.
Licensor
holds patents, trade marks and other intellectual property rights pertaining
to
an intranasal testosterone product (including the device for its administration)
in development for the treatment of male hypogonadism.
Licensee
is a stock corporation established in accordance with the laws of Delaware
and
listed on the OTCBB under the stock symbol URGP. Licensee has an authorized
capital stock of two hundred million (200,000,000) shares of which one hundred
ninety million (190,000,000) shares of a nominal value of zero point zero zero
one United States Dollars (USD 0.001) each are common shares and ten
million (10,000,000) shares of a nominal value of zero point zero zero one
United States Dollars (USD 0.001) each are preferred shares. As of the date
hereof, Licensee has sixty eight million two hundred eighty-nine thousand five
hundred thirty-five (68,289,535) common shares and two hundred ten (210)
preferred shares series B issued and outstanding.
Licensee
specializes in the design and implementation of medicinal products for patients
with urological ailments.
Licensee
desires to obtain from Licensor, and Licensor is willing to grant Licensee,
the
right to develop the Product in cooperation with Licensor and to commercialize
it on an exclusive basis.
Therefore,
the Parties have come to the following agreement:
1.
|
DEFINITIONS
|
Terms
used in this Agreement, unless otherwise specified, shall have the following
meanings:
|
Affiliate
|
Any
corporation or other legal entity controlling, controlled by or under
common control with the respective legal entity, whereby the term
"control" shall mean direct or indirect ownership of at least fifty
percent (50%) of the voting securities having the right to elect
directors.
|
|
Agreement
|
This
agreement together with the
Annexes.
|
|
Annex
|
Any
annex to this Agreement.
|
|
Claims
|
The
Claims according to
Section 9.1.
|
3
|
Commercial
Sale
|
Any
Transfer of the Product by Licensee, an Affiliate or Distributor
to a
Third Party following regulatory approval of said Product in the
country
where such Transfer took place.
|
Commercially Reasonable
Efforts
|
Those
efforts employed by the Parties, equivalent to that level of attention
and
care that they devote to their other businesses and products of similar
commercial potential and at a similar stage of progress of
development.
|
|
Confidential
Information
|
With
respect to a Party, all information (and all tangible and intangible
embodiments thereof), which is owned or controlled by such Party,
is
disclosed by such Party to the other Party pursuant to this Agreement
and
which a reasonable party would consider as confidential. Notwithstanding
the foregoing, Confidential Information of a Party shall not include
information which, and only to the extent, the receiving Party can
establish by written documentation (i) has been generally known prior
to
disclosure of such information by the disclosing Party to the receiving
Party, (ii) has become generally known, without the fault of the
receiving
Party, subsequent to disclosure of such information by the disclosing
Party to the receiving Party, (iii) has been received by the receiving
Party at any time from a source, other than the disclosing Party,
rightfully having possession of and the right to disclose such information
free of confidentiality obligations, (iv) has been otherwise known
by the
receiving Party free of confidentiality obligations prior to disclosure
of
such information by the disclosing Party to the receiving Party,
(v) is
independently developed without reference to the Confidential Information
of the disclosing Party or (vi) is required to be disclosed by the
receiving Party by applicable law or court
order.
|
|
Development
Plan
|
The
Development Plan attached hereto as
Annex 1.
|
4
|
Distributor(s)
|
Any
Third Party who buys Products from Licensee or its Affiliates for
Transfer, including Exclusive and Non-Exclusive
Distributor(s).
|
|
Effective
Date
|
The
date when both Parties have signed this
Agreement.
|
|
Exclusive
Distributor(s)
|
Any
Distributor who has been granted any exclusivity (e.g. sole-exclusive,
semi-exclusive or co-exclusive) to sell the Product with respect
to one or
several countries in the License
Territory.
|
|
FDA
|
The
United States Food and Drug
Administration.
|
|
FDA
Approval
|
The
formal and final approval of the NDA by
FDA.
|
|
Gross
Sales
|
Gross
amount invoiced by:
|
(i)
|
Licensee
or its Affiliates for Transfer of Product(s), including Transfer
to
Non-Exclusive Distributors, but excluding Transfer to Exclusive
Distributors; and
|
(ii)
|
the
Exclusive Distributors or their Affiliates for Transfer of
Product(s).
|
In
the
case of a transfer of the Product between Licensee or an Exclusive Distributor,
respectively, and any of its Affiliate(s), Gross Sales shall be based on the
further Transfer of such Product by such transferee.
|
Holopack
|
HOLOPACK
Verpackungstechnik GmbH, Xxxxxxxxxxxxxx 00, X-00000
Xxxxxxxxx-Xxxxxxxxxxxxxx.
|
|
Improvements
|
Any
and all developments, inventions or discoveries of the Product in
the
License Field made by Licensor or its Affiliates, at any time during
the
term of this Agreement and shall include, but not be limited to,
developments intended to enhance the safety and/or efficacy of the
Product.
|
5
|
IND
|
The
investigational new drug application, as defined in the United States
Federal Food, Drug and Cosmetic Act, filed by Licensor for the Product
with the FDA (ref. no. 70,512), and any amendments or supplement
thereto.
|
|
Initial
Milestone Payment
|
The
Initial Milestone Payment according to
Section 5.1(ii).
|
Joint
Development Steering Committee
|
The
Joint Development Steering Committee according to
Section 3.5.
|
|
Joint
Marketing Committee
|
The
Joint Marketing Committee according to
Section 4.3.
|
|
Joint
Patent
|
A
Joint Patent according to
Section 7.6.
|
|
Know-How
|
Preclinical
data which are in Licensor's possession or control and required for
Licensee to conduct the clinical trials and other development activities
as provided by the Development
Plan.
|
|
Licensee
Indemnitee
|
A
Licensee Indemnitee according to Section
9.2.
|
|
License
Field
|
Nasal
delivery of testosterone to males (excluding
females).
|
|
License
Territory
|
World-wide.
|
|
Licensor
Indemnitee
|
A
Licensor Indemnitee according to Section
9.1.
|
|
Marketing
Authorization(s)
|
With
respect to a country within the License Territory, the regulatory
and
other authorizations required to market and sell the Product in such
country.
|
|
NDA
|
A
new drug application, as defined in the United States Federal Food,
Drug
and Cosmetic Act, which covers the Product for the treatment of
hypogonadism.
|
|
Net
Sales
|
Gross
Sales of the Product less applicable Sales Returns and Allowances.
Net
Sales and its components shall be determined in accordance with US
GAAP,
consistently applied.
|
6
|
Non-Exclusive
Distributor(s)
|
Any
Distributor who is not an Exclusive
Distributor.
|
|
Party
|
Each
party to this Agreement.
|
|
Patent
Right(s)
|
Any
right in or deriving from the patents and patent applications or
the
equivalent of such patents or applications including but not limited
to
any division, continuation, continuation-in-part (CIP), including
any
foreign patent application or letters patent or the equivalent thereof,
issuing thereon or reissue, re-examination or extension thereof,
which
claim the priority of or claim substantially the same subject matter
as
disclosed in the patents and patent applications listed in Annex
2.
|
|
Product(s)
|
Licensor's
intranasal testosterone product, referred to as NASOBOL®
and
identified by Licensor's product ref. no. 291007, composed of (i)
Licensor's proprietary device 3319F-B03B60 specified in Annex 3
filled with (ii) Licensor's proprietary testosterone-preparation
ref. no.
291007 specified in Annex 4, and any Improvements thereto. For the
sake of clarity, the term "Product" always means the combination
product
of Licensor's device and Licensor's testosterone preparation and
not each
of these components separately.
|
|
Reporting
Period
|
Each
three (3) month period ending March 31, June 30,
September 30 and December 31 in each calendar
year.
|
|
Reports
|
The
Reports according to
Section 6.3.
|
|
Revenue-Independent
Fees
|
Any
payments from a Distributor to Licensee which are (i) attributable
to the
Product or any right granted in connection with the Product and (ii)
not
identified as Gross Sales; provided that such payments have actually
been
received by Licensee.
|
7
|
Royalties
|
The
Royalties according to
Section 5.2.
|
|
Royalty
Ceiling
|
The
Royalty Ceiling according to
Section 5.4.
|
|
Royalty
Period
|
With
respect to (i) the first Royalty Period, the period beginning on the
date of the first Marketing Authorization and ending at the end of
the
Reporting Period in effect twelve (12) months thereafter and
(ii) each subsequent Royalty Period, the twelve (12) month period
beginning on the day following the end of the first Royalty Period
and
each succeeding twelve (12) month period
thereafter.
|
|
Sales
Returns and Allowances
|
Sum
of (a) and (b), where (a) is a provision, determined by Licensee
or an
Exclusive Distributor, respectively, under US GAAP for Transfer of
the
Product in the License Territory for (i) trade, cash and quantity
discounts on the Product (other than price discounts granted at the
time
of invoicing and which are already included in the determination
of Gross
Sales), (ii) credits or allowances given or made for rejection or
return
of previously sold Products or for rebates or retroactive price reductions
(including rebates and chargebacks based upon statutory or governmental
regulations), (iii) taxes, duties or other governmental charges levied
on
or measured by the billing amount for the Product, as adjusted for
rebates
and refunds (excluding income and franchise taxes), (iv) charges
for
freight and insurance directly related to the distribution of the
Product,
to the extent included in Gross Sales, and (v) credits for allowances
given or made for wastage replacement, promotional samples, indigent
patient and any other sales programs for the Product to the extent
the
sale of the Product was included in Gross Sales and the credit is
applied
against such Gross Sales and (b) is a periodic adjustment of the
provision
determined in (a) to reflect amounts actually incurred by Licensee
or an
Exclusive Distributor, respectively, in the License Territory for
items
(i), (ii), (iii), (iv) and (v) in clause (a) in a calendar
year.
|
8
|
Section
|
Any
section of this Agreement.
|
|
Sublicensee(s)
|
Holopack
and/or any other contract manufacturer determined in accordance with
the
terms and conditions of this Agreement which is granted a sublicense
by
Licensee to manufacture the Product for Licensee in accordance with
the
terms and conditions of this
Agreement.
|
|
Third
Party
|
Any
entity other than Licensor, Licensee, or their
Affiliates.
|
|
Trademark(s)
|
Licensor's
trademark NASOBOL®
or any other
trademark that is both (a) determined by the Joint Marketing Committee
and
(b) registered and owned by
Licensor.
|
|
Transfer
|
Any
sale, for value in the form of cash or otherwise, of the Product
to a
Third Party.
|
|
USA
|
Xxx
Xxxxxx Xxxxxx xx Xxxxxxx.
|
|
XX
XXXX
|
Xxxxxx
Xxxxxx Generally Accepted Accounting Principles, consistently
applied.
|
|
Valid
Claim
|
A
claim of an unexpired, issued patent included in the Patent Rights
that
has not been held to be invalid by a final judgment of a court of
competent jurisdiction or decision of a governmental agency from
which no
appeal can be taken.
|
2.
|
LICENSE
|
2.1
|
Grant
of License
|
(i)
|
Subject
to the terms and conditions set forth by this Agreement, Licensor
hereby
grants to Licensee in the License Field in the License Territory
an
exclusive and royalty-bearing license to any and all of the Patent
Rights,
Know-How and Trademarks to:
|
(a)
|
develop
the Product in accordance with the Development
Plan;
|
9
(b)
|
manufacture
and have manufactured the Product by Sublicensee(s);
and
|
(c)
|
commercialize
and sell the Product.
|
(ii)
|
Unless
stated otherwise by this Agreement, the exclusivity granted by Licensor
to
Licensee in Section 2.1(i) shall be effective also with regard to
Licensor and its Affiliates.
|
(iii)
|
The
license grant pursuant to Section 2.1(i) shall include the grant of
said license to any Affiliate of Licensee, provided that such Affiliate
shall assume the same obligations as those of Licensee and be subject
to
the same terms and conditions hereunder and further provided that
Licensee, jointly with said Affiliate, shall be responsible to Licensor
for the proper performance by said Affiliate of any and all terms
and
conditions and obligations set forth by this
Agreement.
|
(iv)
|
The
license grant pursuant to Section 2.1(i) shall include Licensee's
right to sell the Products to Distributors; provided, however, that
so
long as the Royalty Ceiling is not achieved in accordance with
Section 5.4 or 11.5 (a) any Exclusive Distributors are
determined by the Joint Marketing Committee and (b) the agreement
between Licensee and the respective Distributor is (aa) made in
writing, (bb) is concluded at arms-length conditions,
(cc) requires the Distributor to sell the Product under the
Trademark(s), (dd) requires the Distributor to deliver to Licensee
commercial sales reports with respect to the Product at the end of
each
Reporting Period, (ee) is consistent with the terms of this Agreement
and (ff) incorporates terms and conditions sufficient to enable
Licensee to comply with this Agreement. Licensee may not delegate
to any
Distributor its responsibility to file and maintain the applications
for
Marketing Authorizations pursuant to the terms and conditions of
this
Agreement unless (a) the Joint Marketing Committee approves such
delegation and (b) Licensee procures by written agreement that such
delegee holds any Marketing Authorization only on a trust basis,
i.e., in
the name and on behalf of Licensee. Licensee shall, promptly upon
execution thereof, submit to Licensor a copy of any agreement entered
into
with any Distributor. Upon termination of this Agreement for any
reason,
any agreements with any Distributor shall be addressed in accordance
with
Section 11.7.
|
(v)
|
So
long as the Royalty Ceiling is not achieved in accordance with
Section 5.4 or 11.5, the license grant pursuant to
Section 2.1(i) shall exclude Licensee's right to make any
modifications or alterations of the Product without the prior approval
of
the Joint Development Steering
Committee.
|
(vi)
|
Subject
to this Section 2 and so long as the Royalty Ceiling is not achieved
in accordance with Section 5.4 or 11.5, the license grant pursuant to
Section 2.1(i) shall exclude Licensee's right to grant sublicenses of
the rights under
Section 2.1(i).
|
2.2
|
Sublicenses.
The Parties agree that the Product shall be manufactured by Holopack
and/or any other Sublicense(s) determined by the Joint Marketing
Committee. Licensee shall use Commercially Reasonable Efforts to
enter
into respective agreement(s) with such Sublicensee(s) and Licensor
shall
use Commercially Reasonable Efforts to support Licensee in entering
into
such agreement(s).
|
10
3.
|
DEVELOPMENT
|
3.1
|
Development
Plan. The Product shall be developed in accordance with the
Development Plan attached hereto as Annex
1.
|
3.2
|
Licensor's
Responsibilities. Licensor shall have the following
responsibilities in connection with the development of the
Product:
|
(i)
|
make
Commercially Reasonable Efforts to assist and support Licensee in
conducting the development work under the Development
Plan;
|
(ii)
|
make
accessible to Licensee within thirty (30) days after payment of the
Initial Milestone Payment the Know-How in a form reasonably usable
by
Licensee;
|
(iii)
|
authorize
Licensee, including without limitation by providing the required
declarations and powers of attorney, as the case may be, to use the
IND to
conduct the development work under the Development Plan;
and
|
(iv)
|
transfer
the IND to Licensee upon receipt of the Initial Payment and (a) Urigen
issues a purchase order for the validation study, phase II PK study
and
the safety study listed in Annex 1 or (b) pays the costs incurred
by the
Licensor in with accordance Section
3.6(ii)..
|
3.3
|
Licensee's
Responsibilities. Licensee shall have the following
responsibilities in connection with the development of the
Product:
|
(i)
|
make
Commercially Reasonable Efforts to perform the development work provided
by the Development Plan, including, without limitation, to conduct
all
clinical trials required for the filing of the
NDA;
|
(ii)
|
make
Commercially Reasonable Efforts to get any and all information and
data
relating to the Product which are required to get Marketing Authorizations
others than the FDA Approval;
|
(iii)
|
keep
Licensor informed about the activities under the Development Plan
and make
Licensee accessible any and all results derived from the work under
the
Development Plan;
|
(iv)
|
copy
Licensor on all correspondence with regulatory authorities and invite
the
Licensor members of the Joint Development Steering Committee to attend
the
meetings with such regulatory authorities;
and
|
(v)
|
subject
to the approval of the Joint Development Steering Committee pursuant
to
Section 3.5(iii)(f), refrain from using (a) the Product, (b) the
Know-How and (c) any Product-related data generated under this Agreement
for any activity other than the activities foreseen by the Development
Plan.
|
11
3.4
|
Development
Work Prior to Initial Milestone Payment. Notwithstanding anything
to the contrary in this Section 3, Licensor shall have final decision
authority on and be responsible for any development work in relation
to
the Product conducted in accordance with the Development Plan and
performed prior to the payment of the Initial Milestone Payment.
With
respect to costs incurred by Licensor in connection with such development
work, Section 3.6(ii) applies.
|
3.5
|
Joint
Development Steering Committee. Licensor and Licensee shall
establish a joint committee to coordinate and oversee the execution
of the
Development Plan.
|
(i)
|
Members.
The Joint Development Steering Committee shall consist of four (4)
members, two (2) members from each Party. Licensee shall designate
one (1)
of its members as chairperson of the Joint Development Steering
Committee.
|
(ii)
|
Responsibilities
of the Chairperson. The chairperson of the Joint Development
Steering Committee shall:
|
(a)
|
call
meetings of the Joint Development Steering
Committee;
|
(b)
|
establish
the agenda for each meeting of the Joint Development Steering Committee;
and
|
(c)
|
inform
the members on progress made on the development of the Product upon
request of any member and at each meeting of the Joint Development
Steering Committee.
|
(iii)
|
Responsibilities.
The Joint Development Steering Committee
shall:
|
(a)
|
review
and oversee the development of the Product as provided by the Development
Plan;
|
(b)
|
plan,
schedule, review and evaluate the clinical trials as provided by
the
Development Plan;
|
(c)
|
decide
on any amendment or alteration of the Development
Plan;
|
(d)
|
approve
any extension of the period for the filing of the
NDA;
|
(e)
|
decide
on any modifications or alterations of the
Product;
|
(f)
|
approve
uses of the Product, the Know-How and the Product-related data generated
in connection with the development of the Product in accordance with
the
Development Plan for any activity other than the activities foreseen
by
the Development Plan; and
|
(g)
|
decide
on any other subject matter within the scope of the Development
Plan.
|
12
(iv)
|
Meetings.
The Joint Development Steering Committee shall meet on an as needed
basis
on such dates and at such times as the Parties shall agree; provided,
however, that Licensor shall have the right to request up to two
such
meetings in every calendar year. The meetings shall alternate between
the
offices of the Parties unless the Parties otherwise
agree.
|
(v)
|
Decisions.
All decisions of the Joint Development Steering Committee on matters
pursuant to Section 3.5(iii) shall be made unanimously by the members
(or their designees) present at any meeting. Such decisions shall
require
at least one (1) member of each Party being present at such meeting.
However, with respect to development matters in dispute between the
Parties which are (a) not referred to in Section 3.5(iii) and
(b) outside the scope of the Development Plan, Licensee shall have
final decision authority after due consultation with
Licensor.
|
(vi)
|
Expenses.
Licensee shall be responsible for all travel (business class or
equivalent) and related costs and expenses for all members, designees
and
invitees to attend meetings of, and otherwise participate on, the
Joint
Development Steering Committee.
|
3.6
|
Costs
|
(i)
|
Costs.
Licensee shall fund the work to be performed pursuant to the Development
Plan as provided thereby and bear all costs in connection with the
execution of the Development Plan.
|
(ii)
|
Costs
Incurred Prior to Initial Milestone Payment. Costs incurred by
Licensor in connection with the execution of the Development Plan
prior to
the payment of the Initial Milestone Payment shall be reimbursed
by
Licensee at the time of the payment of the Initial Milestone Payment
together [***]
to
compensate for Licensor's risk.
|
4.
|
COMMERCIALIZATION
|
4.1
|
Licensor's
Responsibilities
|
(i)
|
Upon
payment of the Initial Milestone Payment, subject to strict
confidentiality pursuant to the terms set forth herein, Licensee
may use
all equipment listed in Annex 5 hereto free of charge at the
premises of Holopack. For the avoidance of doubt, Licensee is responsible
to procure the equipment required for scaling-up the manufacture
of the
Product. Licensee's aforementioned right may not impede the development
and/or production by Licensor of products other than the
Product.
|
______________
|
[***]CERTAIN
INFORMATION ON
THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND
EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
WITH
RESPECT TO SUCH OMITTED
PORTIONS.
|
13
(ii)
|
Licensor
has no obligation to fulfill production contracts for
Licensee.
|
4.2
|
Licensee's
Responsibilities. Licensee shall have the following
responsibilities in connection with the commercialization of the
Product:
|
(i)
|
file
the NDA [***];
however, in the event the FDA requires, instead of the PK study provided
by the Development Plan, a clinical end point study (i.e., a study
including primary parameters on efficacy), such period is automatically
extended [***] and,
thereafter, such period may only be extended by the Joint Development
Steering Committee pursuant to Section 3.5(iii)(d), whereby it is
understood that the grant of such extension is subject to the Joint
Development Steering Committee's unanimous
decision;
|
(ii)
|
file
and maintain with the European Medicines Agency (EMEA) within
[***]
after the filing date of the NDA the application for European Marketing
Authorization;
|
(iii)
|
file
and maintain within [***]
after the filing date of the NDA all applications for Marketing
Authorizations in such other countries where Licensee wishes to exercise
the license rights granted under this
Agreement;
|
(iv)
|
manufacture
and, as the case may be, have manufactured the Product in accordance
with
the terms and conditions of this
Agreement;
|
(v)
|
sell
the Product under one or several
Trademark(s);
|
(vi)
|
make
Commercially Reasonable Efforts to perform the required marketing
activities (such as quarterly plans of action, continuing medical
education programs, direct-to consumer advertising and public relations
campaigns in relation to the Product);
and
|
(vii)
|
subject
to the approval of the Joint Marketing Committee pursuant to
Section 4.3(iii)(e), refrain from using (a) the Product, (b) the
Know-How, (c) any Product-related data generated in connection with
the
development of the Product in accordance with the Development Plan
and (d)
any Product-related data generated in connection with the
commercialization of the Product for any other activity than the
commercialization of the Product in accordance with the terms and
conditions of this Agreement.
|
________________________
14
4.3
|
Joint
Marketing Committee. Licensor and Licensee shall establish a
joint committee to approve, coordinate and oversee the commercialization
of the Product (the "Joint Marketing
Committee").
|
(i)
|
Members.
The Joint Marketing Committee shall consist of four (4) members,
two (2)
members from each Party. Licensee shall designate one (1) of its
members
as the chairperson of the Joint Marketing
Committee.
|
(ii)
|
Responsibilities
of the Chairperson. The chairperson of the Joint Marketing
Committee shall:
|
(a)
|
call
meetings of the Joint Marketing
Committee;
|
(b)
|
establish
the agenda for each meeting of the Joint Marketing Committee;
and
|
(c)
|
inform
the members on progress made on the commercialization of the Product
upon
request of any member and at each meeting of the Joint Marketing
Committee.
|
(iii)
|
Responsibilities.
The Joint Marketing Committee
shall:
|
(a)
|
determine
the Trademark(s) under which the Product shall be
sold;
|
(b)
|
determine
the Exclusive Distributor(s) pursuant to Section
2.1(iv);
|
(c)
|
approve
the delegation of Licensee's responsibility to file and maintain
an
application for Marketing Authorization to a Distributor pursuant
to
Section 2.1(iv);
|
(d)
|
determine
the Sublicensee(s) pursuant to Section 2.2;
and
|
(e)
|
approve
uses of the Product, the Know-How, the Product-related data generated
in
connection with the development of the Product in accordance with
the
Development Plan and the Product-related data generated in connection
with
the commercialization of the Product for any activity other than
the
commercialization of the Product in accordance with the terms and
conditions of this Agreement.
|
(iv)
|
Meetings.
The Joint Marketing Committee shall meet on an as needed basis on
such
dates and at such times as the Parties shall agree; provided, however,
that Licensor shall have the right to request up to two such meetings
in
every calendar year. The meetings shall alternate between the offices
of
the Parties unless the Parties otherwise
agree.
|
(v)
|
Decisions.
All decisions of the Joint Marketing Committee, including without
limitation on matters pursuant to Section 4.3(iii), shall be made
unanimously by the members (or their designees) present at any meeting.
Such decisions shall require at least one (1) member of each Party
being
present at such meeting. However, with respect to marketing matters
not
addressed in Section 4.3(iii) which are in dispute between the
Parties, Licensee shall have final decision authority after due
consultation with Licensor.
|
15
(vi)
|
Expenses.
Licensee shall be responsible for all travel (business class or
equivalent) and related costs and expenses for all members, designees
and
invitees to attend meetings of, and otherwise participate on, the
Joint
Marketing Committee.
|
4.4
|
Marketing
Authorizations. Subject to Section 11.6(iii), all Marketing
Authorizations (and applications therefore and rights thereto) for
the
Product shall be applied for in the name of, and shall be owned
exclusively, by Licensee.
|
4.5
|
Costs.
Licensee shall bear all costs in connection with the commercialization
of
the Product.
|
5.
|
PAYMENTS
AND ROYALTIES
|
5.1
|
Milestone
Payments. Licensee shall pay Licensor the following
non-refundable milestone payments to be paid or transferred, respectively,
only once irrespective of the number of times a milestone has been
achieved:
|
(i)
|
[***]of
restricted common shares of Licensee upon the execution of this Agreement,
to be transferred within ten (10) working days after the Effective
Date
and to be freely disposable by Licensor in accordance with the Securities
Act of 1933 and Securities and Exchange Commission rules and
regulations;
|
(ii)
|
[***];
|
(iii)
|
[***];
and
|
(iv)
|
[***].
|
5.2
|
Royalty.
Licensee shall pay Licensor within sixty (60) days after the end
of each
Royalty Period the following royalties on the Net Sales of all Products
which are manufactured or Transferred in any country in the License
Territory during the respective Royalty Period based on cumulated
Net
Sales in such Royalty Period (the
"Royalties"):
|
_________________
|
[***]CERTAIN
INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE
SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN
REQUESTED WITH RESPECT TO SUCH OMITTED
PORTIONS.
|
16
(i)
|
zero
percent (0%) on the cumulated Net Sales from zero United States Dollars
(USD 0) to thirty million United States Dollars
(USD 30,000,000);
|
(ii)
|
five
percent (5%) on the cumulated Net Sales from thirty million one United
States Dollars (USD 30,000,001) to sixty million United States
Dollars (USD 60,000,000);
|
(iii)
|
twelve
percent (12%) on the cumulated Net Sales from sixty million one United
States Dollars (USD 60,000,001) to one hundred million United States
Dollars (USD 100,000,000);
|
(iv)
|
sixteen
percent (16%) on the cumulated Net Sales from one hundred million
one
United States Dollars (USD 100,000,001) to two hundred million United
States Dollars
(USD 200,000,000);
|
(v)
|
twenty
percent (20%) on the cumulated Net Sales from two hundred million
one
United States Dollars (USD 200,000,001) to three hundred million
United States Dollars (USD 300,000,000);
and
|
(vi)
|
twenty-five
percent (25%) on the cumulated Net Sales above three hundred million
United States Dollars
(USD 300,000,00).
|
5.3
|
Participation
in Revenue-Independent Fees. In addition to the payments pursuant
to Section 5.2, Licensee shall pay Licensor within thirty (30) days
after the end of each Reporting Period twenty-five percent (25%)
of all
Revenue-Independent Fees in the respective Reporting
Period.
|
5.4
|
Royalty
Ceiling. Licensee's obligation to pay Royalties shall cease if
the cumulative Royalties, excluding (i) the milestone payments pursuant
to
Section 5.1 and (ii) the participation in Revenue-Independent Fees
pursuant to Section 5.3 have reached one hundred fifty million United
States Dollars (USD 150,000,000; the "Royalty
Ceiling"). Upon achievement of the Royalty Ceiling, the exclusive
licenses granted to Licensee under Section 2 shall be automatically
and without further notice deemed fully paid-up, freely assignable
and
sublicensable and shall irrevocably be granted until the date on
which all
Valid Claims included in the Patent Rights have expired in all countries
of the License Territory.
|
5.5
|
Form
of Payment. All payments due to Licensor under this Agreement
shall be payable in United States Dollars and shall be transferred
by wire
to:
|
Bank: | Centrum Bank, FL 9490 Vaduz | |||
Account: | 072 1100 A 000 U | |||
IBAN: | LI 610880-8072-1100-A-000-U | |||
Address of holder: | M et P Patent AG, FL 9490 Vaduz |
5.6
|
Overdue
Payments. The payments due under this Agreement shall, if
overdue, bear interest beginning on the first day following the Royalty
Period to which such payment was incurred and until payment thereof
at a
per annum rate equal to five percent (5%). Any such overdue payments
when
made shall be accompanied by all interest so
accrued.
|
17
5.7
|
Taxes
and Withholding. Licensor shall pay any and all taxes levied on
account of all payments it receives under this Agreement. If laws
or
regulations require that taxes be withheld, Licensee will (i) deduct
those
taxes from the remittable payment (ii) timely pay the taxes to the
proper
taxing authority and (iii) send proof of payment to Licensor within
thirty
(30) days of receipt of confirmation of payment from the relevant
taxing authority. Licensee agrees to make all lawful and reasonable
efforts to minimize such taxes to Licensor. If Licensee is so required
then Licensor and Licensee shall co-operate in all respects and take
all
reasonable steps to lawfully avoid payment of any such withholding
taxes.
Licensor shall provide Licensee prior to any payments under this
Agreement, with all necessary forms or documentation required to
claim the
exemption from such withholding
taxes.
|
5.8
|
Foreign
Exchange. The currency for all accounting to be made under this
Agreement shall be United States Dollars. Except as the Parties otherwise
mutually agree, the Reports shall be translated into United States
Dollars
using the currency exchange rates quoted by Bloomberg, a service
of
Bloomberg L.P., or in the event Bloomberg is not available, then
The Wall
Street Journal, on the last business day of the applicable calendar
month
or calendar quarter, as applicable. Payments shall be made in United
States Dollars, using the currency exchange rates quoted by Bloomberg,
a
service of Bloomberg L.P., or in the event Bloomberg is not available,
then The Wall Street Journal for the average monthly rate of
exchange.
|
6.
|
REPORTS
AND RECORDS
|
6.1
|
Progress
Reports. At the end of each Reporting Period, Licensee shall
report in writing to Licensor on progress made on research and
development, status of applications for regulatory approvals,
manufacturing and sublicensing.
|
6.2
|
Milestone
Achievement Notification. Licensee shall report to Licensor the
dates on which it achieves the milestones set forth in Sections 5.1(iii)
and 5.1(iv) within ten (10) days of each such
occurrence.
|
6.3
|
Commercial
Sales and Revenue-Independent Fees Reports. Licensee shall
deliver reports to Licensor within ten (10) days after the end of
each
Reporting Period (the "Reports"). Each report shall
contain:
|
(i)
|
Net
Sales for the applicable Reporting Period in each
territory;
|
(ii)
|
amount
of all Revenue-Independent Fees for the applicable Reporting
Period;
|
(iii)
|
total
Royalties payable on Net Sales in United States Dollars;
and
|
(iv)
|
total
participation of Licensor in the Revenue-Independent Fees in United
States
Dollars.
|
18
If
no
amounts are due to Licensor for any Reporting Period, the report shall so
state.
6.4
|
Records
Retention; Audit
|
(i)
|
Records.
Commencing as of the date of the first Commercial Sale, Licensee
shall
keep at Licensee's headquarters for at least three (3) years from
the end
of the Royalty Period to which they pertain complete and accurate
records
of sales of the Product by Licensee, its Affiliates and the Exclusive
Distributor(s), in sufficient detail to allow the accuracy of the
Royalties to be confirmed.
|
(ii)
|
Audit.
Subject to the other terms of this Section 6.4(ii), at the request of
Licensor, upon at least ten (10) business days' prior written notice,
and
at its sole expense (except as otherwise provided herein), Licensee
shall
permit an independent certified public accountant reasonably selected
by
Licensor and reasonably acceptable to Licensee to inspect the relevant
records required to be maintained by Licensee under Section 6.4(i) at
the headquarter of the Licensee during regular business hours. At
Licensor's request, the accountant shall be entitled to audit the
then-preceding three (3) years of Licensee's records for purposes
of
verifying Licensee's calculations of the Royalties, provided that
no year
shall be audited more than once. At Licensee's request, the accountant
shall enter into a confidentiality agreement with both Parties limiting
the disclosure and use of such information by such accountant to
authorized representatives of the Parties and the purposes of this
Section 6.4. Results of any such audit and at a Party's request the
working papers for such audit shall be made available to both Parties
and
such results shall be binding on both Parties. If any such audit
reveals a
deficiency in the calculation of Royalties resulting from any underpayment
by Licensee, Licensee shall promptly pay Licensor the amount remaining
to
be paid (plus interest thereon at the rate provided in Section 5.6),
and if such underpayment is by five percent (5%) or more, Licensee
shall
pay the costs and expenses of the audit. If such audit reveals
overpayments by Licensee in any year, such amounts shall promptly
be
refunded by Licensor to Licensee (plus interest thereon at the rate
provided in Section 5.6).
|
7.
|
PATENT
AND TRADEMARK REGISTRATION AND MAINTENANCE; OWNERSHIP AND
INVENTIONS
|
7.1
|
Responsibility.
Licensor shall have the sole responsibility to register and maintain
the
registrations of the Patent Rights and
Trademarks.
|
7.2
|
Information.
Licensor shall keep Licensee reasonably informed of all filings and
payments in connection with the registrations and maintenance of
the
Patent Rights and Trademarks.
|
7.3
|
Costs.
Licensor shall bear all costs in connection with the registration
and
maintenance of the Patent Rights and
Trademarks.
|
7.4
|
Ownership.
Each Party shall remain the sole owner or licensee, as applicable,
of all
technology, discoveries, patent applications, patents, trade secrets
and
inventions owned or controlled by such Party on the Effective Date
and
shall have no rights in or to technology, discoveries, patent
applications, patents, know-how and inventions owned by the other
Party
except as specifically provided by this
Agreement.
|
19
7.5
|
Product-Related
Inventions. The entire right and title in all technology relating
to the Product and arising out of work performed by the Parties in
the
course of conducting activities pursuant to this Agreement conceived
by
employees or others acting on behalf of Licensor, Licensee or their
Affiliates shall be owned solely by Licensor, subject to Licensee's
exclusive rights hereunder. Licensee hereby assigns to Licensor without
further compensation all of Licensee's right with respect to such
Product-related inventions. To ensure Licensor's ownership of such
Product-related inventions, Licensee shall promptly disclose each
such
Product-related invention to Licensor and, without disclosing the
same to
others, communicate to Licensor all available information relating
to such
Product-related inventions.
|
7.6
|
Other
Inventions. Subject to Section 7.5, the entire right and
title in all technology out of work performed by the Parties in the
course
of conducting activities pursuant to this Agreement (i) conceived
by
employees or others acting solely on behalf of Licensor or its Affiliates
shall be owned solely by Licensor, subject to Licensee's exclusive
rights
hereunder (ii) conceived by employees or others acting solely on
behalf of
Licensee or its Affiliates shall be owned solely by Licensee, and
(iii)
conceived by employees or others acting jointly on behalf of Licensor
and
Licensee, or their respective Affiliates, shall be owned solely by
Licensor, subject to Licensee's exclusive rights hereunder. The Joint
Development Steering Committee will determine the Party responsible
for
prosecuting patent applications relating to jointly owned technology.
The
preparation, filing and prosecution of patent application(s) relating
to
any jointly owned technology, and the maintenance and prosecution
of any
patent(s) resulting there from (a "Joint Patent"), shall
be performed by counsel mutually acceptable to the Parties and costs
for
such preparation, filing, prosecution and maintenance shall be borne
equally by the Parties. In the event either Party becomes aware of
any
actual or threatened infringement in the License Territory of any
claim of
a Joint Patent, that Party shall promptly notify the other and shall
promptly discuss how to proceed in connection with such actual or
threatened infringement. In the event that only one Party wishes
to
participate in such proceeding, it shall have the right to proceed
alone,
at its expense, and may retain any recovery; provided, at the request
and
expense of the participating Party, the other Party agrees to cooperate
and join in any proceedings in the event that a Third Party asserts
that
the co-owner of such Joint Patent is necessary or indispensable to
such
proceedings. Subject to Licensee's exclusive rights hereunder, each
Party
shall have the right to practice any jointly owned technology as
provided
under applicable law, and with respect thereto, neither Party shall
have a
duty to account for revenues or profits earned in respect of the
uses and
exploitation of such inventions jointly owned by such Party to the
other
joint owner(s).
|
20
8.
|
INFRINGEMENT,
VALIDITY CHALLENGES AND THIRD PARTY
RIGHTS
|
8.1
|
Infringement
|
(i)
|
Notice
of Infringement. Each Party shall promptly report in writing to
the other Party during the term of this Agreement any known or suspected
infringement of any Patent Right or Trademark in the License Field
and
License Territory of which such Party becomes aware, and shall provide
the
other Party with all available evidence supporting such infringement
or
suspected infringement.
|
(ii)
|
Infringement
Action by Licensor. Licensor shall have the sole right (but not
the obligation), at its own costs and expense, to bring an infringement
action or file any other appropriate action or claim directly related
to
infringement of a Patent Right or Trademark against any Third Party.
If
Licensor elects not to bring a suit against an alleged infringer,
it shall
inform Licensee and Licensee shall be entitled by Licensor to bring
such
infringement action by way of authority at Licensee's costs and expense.
Licensor shall have the right to participate in and be represented
in any
suit under this Section 8.1(ii) by its own counsel at its own costs
and expense.
|
(iii)
|
Mutual
Information. The Parties shall keep each other reasonably
informed of all material developments in connection with any proceedings
under this Section 8.1.
|
8.2
|
Validity
Challenges
|
(i)
|
Defense
by Licensor. Licensor shall, at its own costs and expense, use
its reasonable efforts to defend the Patent Rights and Trademarks
against
validity challenges of Third
Parties.
|
(ii)
|
Defense
by Licensee. In the event Licensor decides not to defend the
Patent Rights or Trademarks as provided in Section 8.2(i), it shall
inform Licensee thereof and Licensee shall be entitled by Licensor
to
conduct such litigation by way of authority at Licensee's costs and
expense. Licensor shall have the right to participate in and be
represented in any proceedings under this Section 8.2(ii) by its own
counsel at its own costs and
expense.
|
(iii)
|
Mutual
Information. The Parties shall keep each other reasonably
informed of all material developments in connection with any proceedings
under this Section 8.2.
|
8.3
|
Third
Party Rights
|
(i)
|
Notice
of Infringement Allegation. If Licensee is alleged by a Third
Party to infringe patent rights or trademarks of such Third Party
based on
the exploitation of the Patent Rights or Trademarks, Licensee shall
promptly inform in writing Licensor about such
allegation.
|
21
(ii)
|
Defense
by Licensee. Licensee shall make Commercially Reasonable Efforts
to defend against any assertions pursuant to Section 8.3(i) at its
own costs and expense. Licensee shall keep Licensor reasonably informed
of
all material developments in connection with any suit under this
Section 8.3(ii). Licensor shall have the right to participate in and
be represented in any suit under this Section 8.3(ii) by its own
counsel at its own costs and
expense.
|
8.4
|
Conduct
of Action; Costs. If required under applicable law in order for
either Party to initiate or maintain a suit under this Section 8, the
non-initiating Party shall join as a party to the suit, at the initiating
Party's expense. The non-initiating Party shall offer reasonable
assistance to the initiating Party in connection therewith at no
charge to
the non-initiating Party except for reimbursement of reasonable
out-of-pocket expenses incurred in rendering such
assistance.
|
8.5
|
Recovery.
Any award paid by a Third Party as the result of such proceedings
(whether
by way of settlement or otherwise) shall first be applied to reimbursement
of the unreimbursed legal fees and expenses incurred by either Party
and
then the remainder shall be divided between the Parties as
follows:
|
(i)
|
if
the amount is based on lost profits, (a) Licensee shall receive an
amount
equal to the damages the court determines Licensee has suffered as
a
result of the infringement less the amount of any Royalties and other
payments that would have been due to Licensor on Net Sales lost by
Licensee and any other lost opportunities as a result of the infringement
and (b) Licensor shall receive an amount equal to the Royalties and
other
payments it would have received if such Net Sales had been made and
such
other opportunities captured by Licensee;
and
|
(ii)
|
awards
other than those based on lost profits shall inure to the benefit
of the
initiating Party.
|
8.6
|
Losses.
The non-initiating Party shall not be liable for any losses incurred
as
the result of an action for infringement brought against the initiating
Party as a result of the initiating Party's exercise of any right
granted
under this Agreement.
|
9.
|
INDEMNIFICATION
|
9.1
|
Indemnification
by Licensee. Subject to Licensee’s indemnification rights under
Section 9.2, Licensee shall indemnify, defend and hold harmless
Licensor and its Affiliates and their respective trustees, directors,
officers, medical and professional staff, employees and agents and
their
respective successors, heirs and assigns (each an
"LicensorIndemnitee") from and against
any liability, damage, loss or expense (including reasonable attorney's
fees and expenses of litigation) incurred by or imposed upon the
Licensor
Indemnitees or any one of them in connection with any claims, suits,
actions, demands, proceedings, causes of action or judgments arising
out
of (i) any theory of product liability (including, but not limited
to,
actions in the form of tort, warranty or strict liability; collectively
the "Claims") concerning any Product developed, designed,
tested preclinically or clinically, made, used or sold pursuant to
any
right or license granted under this Agreement or (ii) any breach
of
Licensee’s representations, warranties, covenants or other obligations
hereunder or failure to comply with applicable law, except to the
extent
that the Claim results from gross negligent act or willful misconduct
by
an Licensor Indemnitee.
|
22
9.2
|
Indemnification
by Licensor. Subject to Licensor's indemnification rights under
Section 9.1, Licensor shall indemnify, defend and hold harmless
Licensee and its Affiliates and their respective directors, officers,
employees and agents and their respective successors, heirs and assigns
(each a "Licensee Indemnitee") from and against any
liability, damage, loss or expense (including reasonable attorney's
fees
and expenses of litigation) incurred by or imposed upon the Licensee
Indemnitees or any one of them in connection with any Claims arising
out
of any breach of Licensor's representations and warranties pursuant
to
Sections 10.1, 10.3 and 10.4, except to the extent that the Claim
results from gross negligent act or willful misconduct by a Licensee
Indemnitee.
|
9.3
|
Procedure.
As applicable, each indemnifying Party agrees, at its own expense,
to
provide attorneys reasonably acceptable to the indemnified Party
to defend
against any Claim brought or filed against any Licensor or Licensee
Indemnitee (as the case may be) with respect to the subject of indemnity
contained herein, whether or not such Claims are rightfully brought.
With
respect to any Claim for indemnification under this Section 9, the
Licensor or Licensee Indemnitees (as the case may be)
shall:
|
(i)
|
promptly
notify the indemnifying Party in writing of any Claim in respect
of which
the Licensor or Licensee Indemnitees (as the case may be) intend
to seek
such indemnification hereunder;
|
(ii)
|
provide
the indemnifying Party sole control of the defense or settlement
thereof;
and
|
(iii)
|
provide
the indemnifying Party, at the indemnifying Party's request and expense,
with reasonable assistance and full information with respect
thereto.
|
10.
|
WARRANTIES,
LIABILITY AND DISCLAIMER
|
10.1
|
General.
As of the Effective Date, each Party represents to the other Party
that:
|
(i)
|
such
Party is duly organized and validly existing under the laws of the
state
of its incorporation and has full corporate power and authority to
enter
into this Agreement and to carry out the provisions
hereof;
|
(ii)
|
such
Party is duly authorized to execute and deliver this Agreement and
to
perform its obligations hereunder;
|
(iii)
|
this
Agreement is a legal and valid obligation binding upon it and is
enforceable in accordance with its terms. To the best knowledge of
such
Party, the execution, delivery and performance of this Agreement
by such
Party does not conflict with any agreement, instrument or understanding,
oral or written, to which it is a party or by which it may be bound,
nor
violate any law or regulation of any court, governmental body or
administrative or other agency having authority over it;
and
|
23
(iv)
|
there
are no actions, suits or proceedings pending or, to its knowledge,
threatened against it or its Affiliates that affect its ability to
carry
out its obligations under this
Agreement.
|
10.2
|
Restricted
Shares in Licensee. Licensee represents to Licensor that the
shares to be transferred to Licensor by Licensee pursuant to
Section 5.1(i) are subject to the U.S. Federal Securities Act of
1933. Licensor understands that such shares are characterized as
"restricted securities" under U.S. federal securities laws inasmuch
as
they are being acquired from the Licensor in a transaction not involving
a
public offering and that under such laws and applicable regulations
such
securities may be resold without registration under the U.S. Federal
Securities Act of 1933only in certain limited circumstances. Licensor
agrees to resell such shares only in accordance with the provisions
of
Regulation S, pursuant to registration under the U.S. Federal Securities
Act of 1933, or pursuant to an available exemption from registration,
and
agrees not to engage in hedging transactions with regard to such
securities unless in compliance with the U.S. Federal Securities
Act of
1933. Licensor understands that the shares have not been registered
under
the Securities Act and will not sell, offer to sell, assign, pledge,
hypothecate or otherwise transfer any of the Shares unless (i) pursuant
to
an effective registration statement under the U.S. Federal Securities
Act
of 1933, as amended, (ii) such holder provides Licensee with an opinion
of
counsel, in form and substance reasonably acceptable to Licensee,
to the
effect that a sale, assignment or transfer of the Shares may be made
without registration under the U.S. Federal Securities Act of 1933
and the
transferee agrees to be bound by the terms and conditions of this
Agreement, (iii) such holder provides Licensee with reasonable assurances
(in the form of seller and broker representation letters) that the
Shares
can be sold pursuant to Rule 144 promulgated under the U.S. Federal
Securities Act of 1933, (iv) pursuant to Rule 144(k) promulgated
under the U.S. Federal Securities Act of 1933 following the applicable
holding period, or (v) in accordance with the provisions of
Regulation S. Licensor further understands that, except as provided
below,
certificates evidencing the shares may bear the following or any
similar
legend: "The
securities represented hereby may not be transferred unless (i) such
securities have been registered for sale pursuant to the U.S. Federal
Securities Act of 1933, as amended, (ii) such securities may be sold
pursuant to Rule 144(k), (iii) such securities may be sold pursuant
to
Regulation S, or (iv) the Company has received an opinion of counsel
reasonably satisfactory to it that such transfer may lawfully be
made
without registration under the U.S. Federal Securities Act of 1933
or
qualification under applicable state securities laws. Hedging transactions
involving the securities represented hereby may not be conducted
unless in
compliance with the U.S. Federal Securities Act of
1933."
|
10.3
|
Licensor's
Patent Rights, Trademarks and IND. As of the Effective Date,
Licensor represents to Licensee that to the best of Licensor's
knowledge:
|
24
(i)
|
Licensor
is the sole owner of all right, title and interest in and to the
Patent
Rights and the Trademarks and that, within the License Field, no
such
rights are licensed from a Third
Party;
|
(ii)
|
Licensor,
within the License Field, has not at any time disposed of any Patent
Rights or Trademarks whether by selling, assignment, license grant
or
otherwise and that it has the right to grant the exclusive licenses
granted to Licensor in this Agreement. Licensor further has not granted
any license under the Patent Rights or the Trademarks to any Third
Party
that would conflict with the licenses granted to Licensee hereunder
and is
under no obligation to grant any such
license;
|
(iii)
|
no
patent or patent application included in the Patent Rights is the
subject
of any pending reexamination, reissue, interference, opposition,
cancellation or other protest proceedings or legal disputes. No Trademark
is the subject of any opposition or cancellation proceedings or other
protest proceedings or legal
disputes;
|
(iv)
|
Licensor
is the sole owner of the IND, free and clear of all liens, claims
and
encumbrances;
|
(v)
|
no
outstanding notice, citation, summons or order has been issued, no
outstanding complaint has been filed, no outstanding penalty has
been
assessed and no investigation or review is pending or threatened
by any
government authority or other person with respect to any alleged
violation
by Licensor related to the Product;
and
|
(vi)
|
Licensor
has paid all user fees and all other fees and payments due as of
the
Effective Date necessary in connection with the filing of the
IND.
|
10.4
|
No
Third-Party Infringement. Licensor represents and warrants that
to its knowledge there are no restrictions or limitations on the
Licensor's Patent Rights and Trademarks and that there has been,
by the
Effective Date, no conflict with, or infringement or threatened or
likely
infringement directed to Licensor of any of the Licensor's Patent
Rights,
Know-How or Trademarks. Licensor makes no representation or warranty
that
the manufacture, use, importation or sale of the Product by Licensee
or
its Affiliates, Distributors or Sublicensees or their customers will
not
constitute an infringement of the intellectual property rights of
others.
Licensor makes no representations, extends no warranties of any kind,
either express of implied, including but not limited to the implied
warranties of merchantability or fitness for a particular purpose,
and
assumes no responsibility whatever with respect to design, development,
manufacture, use, sale, importation or other disposition of the Product
by
Licensee, its Affiliates, Distributors or Sublicensees to their respective
customers.
|
10.5
|
Liability
Limitation. Notwithstanding anything herein to the contrary, in
no event shall either Party be liable to the other Party for lost
profits
or indirect, incidental, special, consequential or punitive damages
resulting from this Agreement. For the avoidance of doubt, Licensor
does
not assume any liability under this Agreement as to the fitness of
the
Product for a particular use or the marketability of the
Product.
|
25
11.
|
TERM
AND TERMINATION
|
11.1
|
Term.
This Agreement shall enter into force on the Effective Date and shall
remain in effect, on a country by country basis, until the date on
which
all Valid Claims included in the Patent Rights of such country have
expired, unless this Agreement is terminated earlier in accordance
with
this Section 11.
|
11.2
|
Ordinary
Termination. Licensee may terminate this Agreement by giving nine
(9) months' advance notice to
Licensor.
|
11.3
|
Termination
with Immediate Effect. This Agreement may be terminated with
immediate effect:
|
(i)
|
by
Licensor if Licensee fails to perform the Initial Milestone Payment
when
due;
|
(ii)
|
by
Licensor if Licensee fails to file the NDA pursuant to
Section 4.2(i);
|
(iii)
|
by
Licensor, if the Net Sales of all Products do not reach or
[***]in
the second Royalty Period; provided, however, that Licensor refunds
to
Licensee the clinical development costs of the Product up to
[***]
which Licensee can show by written evidence (a) have been incurred
by
Licensee and (b) are directly attributable to the development of
the
Product; in the event the FDA requires a clinical end point study
as
provided in Section 4.2(i), such [***];
|
(iv)
|
by
Licensor if the Net Sales of all Products do not reach or exceed
[***]in
the fourth Royalty Period; provided, however, that Licensor refunds
to
Licensee the clinical development costs of the Product up to a maximum
of
[***]
which Licensee can show by written evidence (a) have been incurred
by
Licensee and (b) are directly attributable to the development of
the
Product; in the event the FDA requires a clinical end point study
as
provided in Section 4.2(i), such maximum shall be [***];
|
(v)
|
by
Licensor if Licensee develops, manufactures or commercializes a product
which Licensor reasonably considers to substitute the Product in
any
country of the License Territory where a Valid Claim
exists;
|
26
(vi)
|
by
Licensor if Licensee directly or indirectly challenges the validity
of any
Patent Right or Trademark;
|
(vii)
|
subject
to Licensor's right to immediate termination according to
Sections 11.3(i) and 11.3(ii), by the non-defaulting Party if the
other Party defaults in the performance of any of its material obligations
under this Agreement to an extent that renders continuation of this
Agreement unacceptable for the non-defaulting Party and if such default
has not been cured within ninety (90) days after notification of
the
defaulting Party; "material obligation" shall include, without limitation,
Licensee's obligations pursuant to Sections 4.2(ii), 5.1(iii) and
5.1(iv); and
|
(viii)
|
by
Licensor in the event of bankruptcy, receivership, insolvency or
assignment for the benefit of creditors of
Licensee.
|
11.4
|
Partial
Termination. This Agreement automatically terminates in those
countries of the License Territory where Licensee has not filed Marketing
Authorizations within [***]
after the filing date of the NDA pursuant to Section 4.2(iii). In
respect
of the countries concerned by such partial termination, the provisions
set
forth in Section 11.6 shall apply
correspondingly.
|
11.5
|
Change
of Licensee's Ownership. If Licensee is acquired by a share or
asset deal by a Third Party before the Royalty Ceiling has been reached,
Licensee has the option to (i) pay, at the same time Licensee's
acquisition is executed, to Licensor the difference between the Royalty
Ceiling and the cumulative Royalties effectively paid up to that
time,
whereupon no further Royalties shall be due, or (ii) terminate this
Agreement with immediate effect after the execution of Licensee's
acquisition without any duty of Licensor to compensate for Licensee's
clinical development costs of the
Product.
|
11.6
|
Effects
of Termination. Upon termination of this
Agreement in accordance with Section 11.2, 11.3, 11.4 or
11.5(ii):
|
(i)
|
Licensee
shall immediately cease all (a) use of the rights and licenses granted
under this Agreement and (b) Transfer of the
Product;
|
(ii)
|
each
Party shall immediately return the Confidential Information of the
other
Party;
|
(iii)
|
all
Marketing Authorizations including, without limitation, any related
application documents held by Licensee shall immediately be transferred
to
Licensor, whereby such transfer shall be arranged for by Licensee
in due
time in order that such transfer can be effected by the date the
termination becomes effective;
|
____________________
|
[***]CERTAIN
INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE
SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN
REQUESTED WITH RESPECT TO SUCH OMITTED
PORTIONS.
|
27
(iv)
|
ownership
of all trademarks and other intellectual property attributable to
the
Product and held by Licensee shall immediately be transferred to
Licensor;
|
(v)
|
all
Royalties and other payments accrued or due to Licensor as of the
termination date shall become immediately payable;
and
|
(vi)
|
Licensor
has the option to acquire Licensee's remaining inventory of the Product
at
Licensee's cost price. If Licensor does not exercise such option
within
fourteen (14) days after termination of this Agreement, Licensee
is
granted a period of six (6) months from the date of termination of
this
Agreement during which it may sell its remaining inventory of the
Product;
provided, however, that it (a) sells such inventory in a manner
substantially similar to the manner in which it was selling the Product
prior to the termination of this Agreement and (b) pays to Licensor
any
Royalties accruing on sales of such Product in accordance with Section
5
hereof.
|
11.7
|
Effects
of Termination on Sublicenses and Distributors. Any sublicenses
granted by Licensee under this Agreement as well as any agreements
with
any Distributors shall provide for termination or assignment to Licensor
of Licensee's interest therein at the option of Licensor upon termination
of this Agreement.
|
11.8
|
Survival.
Expiration or termination of this Agreement for any reason shall
neither
release either Party from any liability which at such time has already
accrued or which thereafter accrues from a breach or default prior
to such
expiration or termination, nor affect in any way the survival of
any other
right, duty or obligation of either Party which is expressly stated
elsewhere in this Agreement to survive such termination.
Sections 7.5, 7.6, 9, 11.6, 11.7, 12.7 and 13 shall survive
expiration or termination of this
Agreement.
|
12.
|
MISCELLANEOUS
|
12.1
|
Notices.
All notices or other communications between the Parties in connection
with
this Agreement shall be made in writing and sent by registered mail
or a
recognized courier service to the addresses listed on the first page
of
this Agreement or such other address as the addressee shall have
specified
in a notice actually received by the
addressor.
|
28
12.2
|
Costs,
Expenses and Taxes. Except as otherwise provided in this
Agreement, all costs, expenses and taxes incurred in connection with
this
Agreement and the transactions contemplated hereby shall be paid
by the
Party incurring such costs, expenses and
taxes.
|
12.3
|
Entire
Agreement. This Agreement constitutes the entire agreement
between the Parties with respect to the subject matter of this Agreement
and supersedes all other prior written and oral agreements of the
Parties
relating thereto.
|
12.4
|
Amendment;
Waiver. No provision of this Agreement may be modified, amended
or waived except by an instrument in writing signed by the Parties.
No
failure of a Party to exercise a contractual right or to insist on
strict
compliance with this Agreement, and no practice at variance with
the terms
of this Agreement shall constitute a waiver of the right to demand
strict
compliance and shall not impair the rights with respect to any subsequent
breach of this Agreement.
|
12.5
|
Severability.
If any provision of this Agreement is found invalid or unenforceable,
the
remainder of this Agreement remains in full force and effect. The
invalid
or unenforceable provision shall be replaced by such valid and enforceable
provision attaining as nearly as possible the same economic
effect.
|
12.6
|
Assignment.
So long as the Royalty Ceiling is not achieved in accordance with
Section 5.4 or 11.5, Licensee may not transfer or assign its rights
and obligations under this Agreement without the prior written consent
of
Licensor. Licensor shall not be restricted to assign or transfer
the
Patent Rights, the Trademarks, this Agreement or any of its rights
and
obligations under this Agreement. The rights and obligations of the
Parties under this Agreement shall be binding upon and inure to the
benefit of the successors and permitted assigns of the Parties. Any
assignment not in accordance with this Agreement shall be
void.
|
12.7
|
Confidentiality.
The Parties shall keep the Confidential Information and the contents
of
this Agreement strictly confidential. All public announcements or
press
releases issued in connection with the transactions contemplated
by this
Agreement shall only be published after the Parties have agreed on
the
contents of such public announcements or press
releases.
|
12.8
|
Execution.
This Agreement may be executed in two or more counterparts, all of
which
when taken together shall be considered one and the same
instrument.
|
12.9
|
Force
Majeure. Neither Party shall be held liable or responsible to the
other Party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term
of
this Agreement when such failure or delay is caused by or results
from
causes beyond the control of the affected Party, such as fire, floods,
embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other
labor
disturbances or acts of God.
|
12.10
|
Independent
Contractors. It is expressly agreed that Licensor and Licensee
shall be independent contractors and that the relationship between
the two
Parties shall not constitute a partnership or agency of any kind.
Neither
Licensor nor Licensee shall have the authority to make any statements,
representations or commitments of any kind, or to take any action,
which
shall be binding on the other Party, without the prior written consent
of
the other Party.
|
29
13.
|
GOVERNING
LAW AND DISPUTE RESOLUTION
|
13.1
|
Governing
Law. This Agreement shall be governed by, and construed in
accordance with, the laws of Switzerland, without giving effect to
any
conflict of law provisions thereof.
|
13.2
|
Dispute
Resolution. Any dispute arising out of or in relation to this
Agreement shall be finally settled under the Rules of Arbitration
of the
International Chamber of Commerce. The place of arbitration shall
be in
Paris, France, and the arbitration proceedings shall be held in English.
The arbitration tribunal shall consist of three (3) arbitrators.
Each
Party shall nominate in the request for arbitration and the answer
thereto
one (1) arbitrator and the two (2) arbitrators so named will then
jointly
appoint the third arbitrator as the chairman of the arbitration tribunal.
If a Party fails to nominate its arbitrator or if the Parties cannot
agree
on the person to be named as chairman within sixty (60) days, the
International Chamber of Commerce in Paris, France, shall make the
necessary appointment of arbitrator or
chairman.
|
[signature
page follows]
30
Place / date | Place / date | ||
November 20, 2007 | November 20, 2007 | ||
M & P Patent AG | Urigen Pharmaceuticals, Inc. | ||
/s/ Xxx Xxxxxxx | /s/ Xxxxx Xxxx | ||
Chairman and CEO | COO | ||
31
Annexes
Annex
1 Development
Plan
Annex
2 Patent
Rights
Annex
3 Specification
of the device 3319F-B03B60
Annex
4 Specification
of the testosterone-preparation ref. no. 291007
Annex
5 Licensor's
equipment
K:\mandate\118184\license
agreement\071115 license agreement urigen.doc
32
Annex
1 - Development Plan
[***]
Annex
2 - Patent Rights
|
[***]CERTAIN
INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE
SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS
BEEN
REQUESTED WITH RESPECT TO SUCH OMITTED
PORTIONS.
|
33
[***]Annex
3 -
Specification of the device 3319F-B03B60
[***]
Annex
4 - Specification of the testosterone-preparation ref. no.
291007
[***]
Annex
5 - Licensor's equipment
Amount
|
Description
|
Specification
|
6
(six)
|
Tank
for transport and storage of bulk mixture
|
250
litre, stainless steel,
no.
GST 250
|
1
(one)
|
Tool
for BFS filling and packaging
|
3
x
10 moulds,
design
no. 3319F-B03B60
|