Confidential Treatment Requested. Confidential portions of this document have been redacted and filed separately with the Commission. ***** Confidential material redacted and filed separately with the Commission. RESEARCH AND LICENSE AGREEMENT
Confidential
Treatment Requested. Confidential portions of this document have been redacted
and filed separately with the Commission.
*****
Confidential material redacted and filed separately with the
Commission.
RESEARCH
AND LICENSE AGREEMENT (the “Agreement”) made and entered into as of April 18,
2000 the “Effective Date”), by and between DRK
BLUTSPENDEDIENDST BADEN-WURTTENBERG, INSTITUT ULM (the
“Licensor”), having an address at Xxxxxxxx
00 00, X-00000 Xxx, Xxxxxxx, and XTL
BIOPHARMACEUTICALS, LTD.
(the
“Company”), having an address at Xxxxxx Xxxxxxxx, X.X. Xxx 000, Xxxxxxx, 00000,
Xxxxxx.
RECITALS
A. *****
has
conducted research and made new inventions with respect to technology relating
to antibodies to HCV;
B. The
Company is willing to partially finance the performance of further research
at
the laboratories, and under the supervision, of ***** relating to antibodies
to
HCV;
C. The
Company is also willing to provide ***** antigens for HCV and access to its
animal models to screen antibodies to HCV; and
D. Subject
to and in accordance with the terms and conditions of this Agreement, the
Company wishes to acquire, and Licensor is willing to grant the Company,
the
exclusive license set forth in this Agreement.
1
*****
Confidential material redacted and filed separately with the
Commission.
NOW,
THEREFORE, in consideration of the mutual promises and agreements contained
herein, the parties hereto agree as follows:
1. Definitions
“Affiliate”
means
any corporation or other entity that directly, or indirectly through one
or more
intermediaries, controls, is controlled by, or is under common control with
the
designated party but only for so long as such relationship exists.
For the purposes of this section, “Control”
shall
mean ownership of at least 50% (or such lesser percent as may be the maximum
that may be owned by foreign interests pursuant to the laws of the country
of
incorporation) of the shares of stock entitled to vote for directors in the
case
of a corporation and at least 50% (or such lesser percent as may be the maximum
that may be owned by foreign interests pursuant to the laws of the country
of
domicile) of the interests in profits in the case of a business entity other
than a corporation.
“Antibodies”
mean
those cell lines secreting antibodies to HCV listed on Exhibit
A
hereto
and other cell lines secreting antibodies to HCV developed by Licensor as
a
result of the Research.
“Effective
Date”
means
the date set forth at the beginning of this Agreement.
“Existing
Technology”
means
all Patent Rights and Know-How of Licensor in the Field existing as of the
Effective Date, including without limitation, the Patent Rights and Know-How
listed on Exhibit
B
hereto.
“Field”
means
HCV therapeutics and diagnostics.
“Know-How”
means
all unpatented or nonpatentable chemical and biological materials (including
cell lines, antibodies and other biological materials), inventions, ideas,
data,
formulations, processes, techniques, specifications, and other trade secrets
or
know-how.
“License”
means
the exclusive license granted to the Company by Licensor pursuant to Section
6.1.
2
*****
Confidential material redacted and filed separately with the
Commission.
“Licensed
Product”
shall
mean any product that incorporates one or more Antibodies or a part of the
Licensed Technology for use in the Field.
“Licensed
Technology”
means
the Existing Technology and the Research Technology.
“Net
Sales”
shall
mean the total amount actually received by the Company or its Sublicensees
from
the sale of the Licensed Product, in all cases after deduction of (i) sales
or service taxes (including value added taxes) and other government charges
to
the extent applicable to such transaction and not collected separately from
the
counterparty to the transaction; (ii) credits or allowances, if any,
actually granted on account of price adjustments or customary discounts,
recalls, rejections or return of Licensed Product previously sold; and
(iii) freight and insurance charges which are separately invoiced.
Net
Sales will be calculated using generally accepted accounting
principles.
“Patent
Rights”
means
(i) all patents and patent applications useful in the Field conceived
and
reduced to practice by Licensor during the Research Period and the patents
and
patent applications listed in Exhibit
B
hereto;
(ii) all patents and patent applications relating to the Antibodies
and
(iii) any divisionals, continuations, continuations-in-part, reissues,
reexaminations, extensions or other governmental actions which extend any
of the
subject matter of the patent applications or patents in (i) or (ii) above,
and any substitutions, confirmations, registrations or revalidations of any
of
the foregoing, in each case, which is owned or controlled, in whole or part,
by
license, assignment or otherwise by Licensor during the term of this
Agreement.
“Research”
means
the research to be undertaken at the laboratories, and under the supervision
of
*****, as specified in the work plan attached hereto to Exhibit
C.
“Research
Period”
means
the period commencing on the Effective Date and, unless extended by written
agreement of the parties or sooner terminated as provided herein, terminating
on
the first anniversary of the Effective Date.
3
*****
Confidential material redacted and filed
separately with the Commission.
“Research
Technology”
means
Patent Rights and Know-How created, discovered or developed by Licensor during
the Research Period or as a result of the Research during the three-month
period
following the Research Period.
“Sublicensee”
shall
mean a third party to whom the Company has granted a license or sublicense
to
make, have made, import, use, offer for sale or sell a Licensed
Product.
2. Performance
of Research
2.1. In
consideration of the aggregate sum of ***** to be paid by the Company to
Licensor *****, Licensor shall perform, or cause to be performed, the Research
during the Research Period.
2.2. In
further consideration of this Agreement, XTL agrees to pay consulting fees
in
the aggregate sum of *****, to be paid by the Company to *****.
2.3. During
the Research Period, Licensor shall not collaborate with any third party
in the
Field; provided, however, that the Licensor shall have the right to collaborate
with academic partners for research purposes only.
2.4. In
further consideration of the sums to be paid to Licensor ***** under Section
2.1
and Section 2.2, respectively, and the royalties payable to Licensor under
Section 6 below, Licensor shall provide the Company with Antibodies
pursuant to a Materials Transfer Agreement in the form attached hereto as
Exhibit
D.
2.5. During
the Research Period, Licensor shall provide XTL employees access to the
laboratories where the Research is being conducted and shall instruct them
on
how to practice the Licensed Technology.
2.6. The
Company shall provide Licensor antigens for HCV and access to its animal
models
to screen antibodies for HCV and shall also provide any necessary Know-How
related thereto. Any such XTL Know-How shall be treated by Licensor as
confidential information subject to the obligations of Section 8.1
below.
4
*****
Confidential material redacted and filed separately with the
Commission.
3. Reporting
Licensor
will submit to the Company a detailed written report on the progress of the
Research ***** during the Research Period, within 30 days of the end of each
***** period, and a written report summarizing the results of the Research
within 60 days of the end of the Research Period. Further, prompt written
reports will be
submitted by Licensor to the Company on each significant development in the
Research during the Research Period and for the three-month period
thereafter.
4. Title
Subject
to the License granted to the Company hereunder, it is hereby agreed that
all
right, title and interest in and to the Licensed Technology shall vest in
Licensor, exclusively. All right, title and interest in and to the Company’s
animal models shall be retained by the Company, exclusively, and no license
or
other right to such technology is granted or implied hereby.
5. Patents
and Patent Applications
5.1. The
parties shall consult with one another regarding the filing of patent
applications in respect of any portion of the Licensed Technology including,
but
without limitation, the content and the timing of the filing of such
applications. The Company shall have primary responsibility for the preparation,
filing, prosecution and maintenance of such patent applications through counsel
of its choice. In the event the Company decides not to pursue such preparation,
filing, prosecution or maintenance, it shall so inform Licensor in writing,
and
Licensor shall assume responsibility for such preparation, filing, prosecution
and maintenance through counsel of its choice reasonably satisfactory to
the
Company. The Company shall bear all costs and fees related to the preparation,
filing, prosecution and maintenance of the Patent Rights.
5.2. The
Company shall have the right to take such action as shall be necessary to
protect or to xxx for infringement of any Patent Rights. At its option, the
Company may bring suit against an infringer and join Licensor as a party
plaintiff in any such suit. At the request of the Company, Licensor shall
also
take such action as the Company shall deem necessary to protect any Patent
Rights. All costs (including legal costs and other sums awarded to the
counter-party in such action) involved in any action taken at the Company’s
request, or by the Company, shall be borne by the Company exclusively. Any
recovery in any such action shall be retained by the Company
***** and by Licensor *****, after the deduction of all legal costs and
expenses.
5
*****
Confidential material redacted and filed separately with the
Commission.
6. License
6.1. Subject
to the terms and conditions hereinafter set forth, Licensor hereby grants
the
Company an exclusive worldwide license, with the right to sublicense, under
the Licensed Technology to develop, make, have made, use, import, offer for
sale
or sell the Licensed Product.
6.2. The
License shall remain in force (if not previously terminated according to
the
provisions of this Agreement) until the later of the date of expiry of the
last
to expire of the Patent Rights or the twentieth anniversary of the Effective
Date.
7. Royalties
7.1. In
consideration of the License, the Company shall pay Licensor a royalty of
*****
of all Net Sales. In the event the Company shall have to pay a royalty to
a
third party to commercialize the Licensed Product, the Company may reduce
royalty payments on Net Sales to Licensor by ***** royalty paid by the Company
to such third party; provided that the Company’s royalty paid to Licensor on Net
Sales shall not be less than *****.
7.2. In
consideration of the License, the Company shall also pay Licensor ***** of
any
milestone payments received by the Company from its Sublicensees. In the
event
the Company shall have to pay a license fee or royalty to a third party to
commercialize the Licensed Product, the Company may credit against the amounts
otherwise due Licensor on milestones, ***** made to such third party; provided
that the percentage of milestone payments paid to Licensor shall not be less
than *****.
6
*****
Confidential material redacted and filed separately with the
Commission.
7.3. Amounts
payable to Licensor under this Section 7 shall be paid to Licensor
on a
quarterly basis and no later than ***** after the end of each calendar quarter,
commencing with the first calendar quarter in which any Net Sales or milestone
payments are received; provided, however, payments on Net Sales by Sublicensees
shall be paid to Licensor no later than ***** after the end of the calendar
quarter when such payments are received by the Company. The Company shall
take
all reasonable actions as shall be necessary to protect the interests of
Licensor to receive royalties hereunder, including the submission of reports
and
the maintenance of detailed accounts substantiating the calculations of
royalties being paid to Licensor. Licensor is authorized to appoint an
independent certified public accountant reasonably acceptable to the Company
to
audit such accounts during normal business hours and upon reasonable advance
notice, solely for the purpose of verifying the accuracy of the payment
calculations made. Such inspection shall be at Licensor’s sole expense unless it
reveals an underpayment of at least ***** of the amount due, in which case
the
reasonable costs of such inspection shall be promptly reimbursed by the Company
together with prompt payment for any unpaid amounts that are discovered.
The
Company shall pay to Licensor interest on amounts payable to Licensor from
the
date such payments were due at the base rate of the German Federal Bank plus
***** per annum.
8. Confidentiality
8.1. The
Company and Licensor each shall use reasonable care to avoid disclosure of
the
Licensed Technology to any third party, and each party shall be liable to
the
other for unauthorized disclosure or failure to exercise such reasonable
care.
Neither party shall have any obligation with respect to the Licensed Technology
to the extent that it (a) is in the public domain at the Effective
Date or
becomes part of the public domain thereafter other than through a violation
of
this undertaking of confidentiality, (b) was known to such party at the time
of
disclosure, or (c) was subsequently disclosed to such party by a third
party not in breach of any confidentiality obligations.
7
*****
Confidential material redacted and filed
separately with the Commission.
8.2. In
addition to and without derogating from the foregoing, the Company undertakes
not to use the names of Licensor ***** in any advertising, sales literature,
promotional material or other publications, but excluding private placement
memoranda and public offering registration statements, without the prior
written
approval of Licensor (such approval not to be unreasonably withheld or delayed).
Once an approval has been granted by Licensor to a certain form of words
for use
in a particular context, then the same form of words can be used again by
the
Company in the same context, without further approval from
Licensor.
8.3. For
the
removal of doubt, nothing in Sections 8.1 and 8.2 above contained
shall be
deemed to prevent the Company from mentioning the names of Licensor *****,
or to
prevent the Company from disclosing any information, where such mention or
disclosure is to competent authorities for the purposes of obtaining approval
or
permission for the exercise of the License or is in the fulfillment of any
legal
duty owed to any competent authority.
8.4. The
obligations of Licensor under Section 8.1 above to the contrary
notwithstanding, it is hereby expressly agreed that ***** shall have the
right
to (and, with ***** consent, his students shall have the right to) publish
articles relating to the Licensed Technology in scientific publications,
provided that at least ***** before the intended date of such publication,
the
text thereof shall be submitted to the Company in order to enable it to file,
or
request the filing of, a patent application relating to the subject-matter
of
the article before the publication takes place. Licensor shall, and shall
use
its reasonable efforts to cause ***** to use its or his, as the case may
be,
reasonable efforts to include the name of the Company in any such article
or
publication.
8
*****
Confidential material redacted and filed separately with the
Commission.
9. No
Assignment
Except
as
expressly provided herein, the Company may not assign all or any of its rights
or obligations under this Agreement without the prior written consent of
Licensor, which shall not be unreasonably withheld or delayed, except that
the
Company may, without such consent, assign this Agreement and its rights and
obligations under this Agreement, in whole or in part, to its Affiliates,
to any
purchaser or other transferee of all or substantially all of its assets in
the
line of business to which this Agreement pertains, or to any successor
corporation resulting from any merger or consolidation of the Company with
or
into another entity.
10. Term
and Termination
10.1. Unless
previously terminated or extended in accordance with the provisions hereof,
the
respective obligations of the parties hereto under Sections 2 and
3 above
shall terminate at the expiration of the Research Period. The Company may
extend
the Research Period by one additional year by the giving of written notice
of
extension to Licensor at ***** days prior to the expiration of the initial
Research Period. Upon the giving of such notice, the parties shall negotiate,
in
good faith, the funding obligations of the Company during, and with respect
to,
such extended period. The provisions of this Section 10.1 will not
affect
the rights of the parties with respect to the License or the Licensed
Technology, which will be governed by Section 10.2 below.
10.2. Unless
this Agreement is previously terminated in accordance with this Section 10.2,
the License shall continue in full force and effect as set forth in Section
6.2. Either Licensor or the Company may terminate this Agreement and the
License
hereunder by serving a written notice to that effect on the other, upon or
after
the winding up or insolvency of the other, or upon or after the commitment
of a
material breach hereof by the other (which breach cannot be cured or, if
curable, has not
been
cured by the party in breach within 60 days after receipt of a written notice
to
the other party in respect of such breach); and in such event this Agreement
and
the License hereunder shall be terminated forthwith upon receipt of notice
as
aforesaid.
9
*****
Confidential material redacted and filed separately with the
Commission.
10.3. Upon
termination of this Agreement and the License thereunder pursuant to
Section 10.2, all rights to the Licensed Technology vested in the
Company
shall revert to Licensor, and the Company shall not thereafter be entitled
to
make any use of the Licensed Technology. The termination of this Agreement
for
any reason shall not relieve the parties of any obligations to make payments
thereunder which shall have accrued prior to such termination.
11. Representations
11.1. The
Company hereby represents to Licensor as follows:
(a) The
Company is a corporation duly organized, validly existing and in good standing
under the laws of the State of Israel. The Company has been granted all
requisite power and authority to carry on its business and to own and operate
its properties and assets. The execution, delivery and performance of this
Agreement have been duly authorized by the Board of Directors of the
Company;
(b) There
is
no pending or, to the Company’s knowledge, threatened litigation involving the
Company which would have any material adverse effect on this Agreement or
on the
Company’s ability to perform its obligations hereunder; and
(c) There
is
no indenture, contract, or agreement to which the Company is a party or by
which
the Company is bound which prohibits or would prohibit the execution and
delivery by the Company of this Agreement or the performance or observance
by
the Company of any material term or condition of this Agreement.
10
*****
Confidential material redacted and filed separately with the
Commission.
11.2. Licensor
represents to the Company as follows:
(a) The
execution and delivery of this Agreement have been duly authorized by all
requisite action on the part of Licensor and Licensor has all right, power
and
authority necessary to grant the License and perform its other obligations
hereunder.
(b) There
is
no pending or, to Licensor’s knowledge, threatened litigation involving Licensor
which would have any material adverse effect on this Agreement or Licensor’s
ability to perform its obligations hereunder;
(c) To
the
best of Licensor’s knowledge, Licensor holds exclusive worldwide rights in and
to the Existing Technology and, as of the Effective Date,
there are no restrictions on its rights to license the Existing Technology
to
the Company. Licensor has not received notice of, and has no knowledge of
any
basis for, any claim that the Existing Technology infringes on any patent
or
other intellectual property right or trade secret of any third party;
and
(d) Licensor
has not previously granted, and will not grant, during the term of this
Agreement, any right, license or interest in or to the Licensed Technology
in
the Field or with respect to the Licensed Product.
12. Governing
Law and Forum
This
Agreement shall be governed by the laws of England and Wales. The parties
agree
to submit to the jurisdiction of the courts of London, England.
13. Entire
Agreement
This
Agreement, together with the Exhibits constitutes the entire agreement between
the parties pertaining to the subject matter hereof. The parties expressly
intend that this Agreement shall supersede that certain Research and License
Agreement between the parties dated ***** and that the terms of this Agreement
shall apply to the Antibodies listed on Exhibit
A.
Any
addition or amendment of this Agreement shall not be effective unless in
writing
signed by the authorized signatories of both parties.
11
*****
Confidential material redacted and filed separately with the
Commission.
13. Notices
All
notices shall be in writing mailed via certified mail, return receipt requested,
or overnight express mail, courier providing evidence of delivery, addressed
as
follows, or to such other address as may be designated by written notice
so
given from time to time:
If
to Licensor
|
DRK
Blutspendediendst Baden-Wurttenberg, Institut Ulm
|
Xxxxxxxxxxxxxxxx
00
|
|
00000
Xxx
Xxxxxxx
|
|
Attention:
*****
|
|
If
to the Company:
|
XTL
Pharmaceuticals Ltd.
|
Xxxxxx
Xxxxxxxx
|
|
X.X.
Xxx 000
|
|
Xxxxxxx
00000, Xxxxxx
|
|
Attention:
Chief Executive Officer
|
|
Notices
shall be deemed given as of the date received.
12
*****
Confidential material redacted and filed
separately with the Commission.
IN
WITNESS WHEREOF the parties hereto have set their signatures as of the 18th
day
of April, 2000.
DRK
BLUTSPENDEDIENDST BADEN-WURTTENBERG, INSTITUT ULM
|
XTL
BIOPHARMACEUTICALS, LTD.
|
By:
_________________________________
|
By:
_________________________________
|
Title:
_________________________________
|
Title:
_________________________________
|
13
*****
Confidential material redacted and filed separately with the
Commission.
Exhibit
A
*****
***** *****
***** *****
***** *****
***** *****
***** *****
Note
that
confidential
treatment has been requested and one (1) page of material from this Exhibit
A
has been omitted and filed separately with the Commission.
14
*****
Confidential material redacted and filed separately with the
Commission.
Exhibit
B
Existing
Technology
*****
*****:
*****
*****
*****
*****
*****
*****
*****
*****
*****
*****
Note
that
confidential
treatment has been requested and one (1) page of material from this Exhibit
B
has been omitted and filed separately with the Commission.
15
*****
Confidential material redacted and filed separately with the
Commission.
Exhibit
C
Work
Plan
-
|
*****
|
-
|
*****
|
-
|
*****
|
-
|
*****
|
-
|
*****
|
-
|
*****
|
-
|
*****
|
Note
that
confidential
treatment has been requested and one (1) page of material from this Exhibit
C
has been omitted and filed separately with the Commission.
16
*****
Confidential material redacted and filed separately with the
Commission.
Exhibit
D
MATERIALS
TRANSFER AGREEMENT
*****.
1. *****.
2. *****.
3. *****.
4. *****.
5. *****.
6. *****.
7. *****.
8. *****.
9. *****.
10. *****.
11. *****.
12. *****.
13. *****:
*****
|
*****
|
*****
|
|
*****
|
|
*****
|
|
*****
|
*****
|
*****
|
|
*****
|
|
*****
|
|
*****
|
|
17
*****
Confidential material redacted and filed separately with the
Commission.
*****.
*****.
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
Note
that
confidential
treatment has been requested and two pages of material from this Exhibit
D have
been omitted and filed separately with the Commission.
18
*****
Confidential material redacted and filed separately with the
Commission.
Exhibit
1
*****
1. *****
*****
*****
*****
*****
*****
*****
*****
2. *****
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
*****
|
3. *****
*****
*****.
Note
that
confidential
treatment has been requested and one (1) page of material from this Exhibit
1
has been omitted and filed separately with the Commission.
19