NON-EXCLUSIVE LICENSE AGREEMENT
EXHIBIT 10.24
Re: BLG# 03-037, “Large Scale Production of Helper-Dependent
Adenoviral Vectors”
and
BLG# 01-064, “Bacterial Recombination for Generation of
Helper-Dependent Adenoviral Vector”
This
Non-Exclusive License Agreement (hereinafter called “Agreement”), to be
effective as of the 25th day of
January, 2007 (hereinafter called “Agreement Date”), is by and between Baylor
College of Medicine (hereinafter called “BAYLOR”), a Texas nonprofit corporation
having its principal place of business at Xxx Xxxxxx Xxxxx, Xxxxxxx, Xxxxx
00000, and Medgenics, Inc., a corporation organized under the laws of Delaware
and having a principal place of business at Xxxxxxxx 00, Xxxxxxx 00000, Xxxxxx,
and its Affiliates (hereinafter, collectively referred to as
“MEDGENICS”).
WITNESSETH:
WHEREAS,
BAYLOR is the owner of the Subject Technology as defined below; and
WHEREAS,
BAYLOR is willing to grant a royalty bearing, worldwide, non-exclusive license
to the Subject Technology to MEDGENICS on the terms set forth herein;
and
WHEREAS,
MEDGENICS desires to obtain said non-exclusive license under the Subject
Technology.
WHEREAS
BAYLOR has created modifications of Subject Technology for MEDGENICS pursuant to
two (2) collaboration agreements dated January 25, 2006 and April 6, 2006 (the
“Collaboration Agreements”) copies attached in Appendix C.
NOW, THEREFORE, for and in
consideration of the premises and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties hereto
expressly agree as follows:
1.
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DEFINITIONS AS USED
HEREIN
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1.1
The term “Affiliates” shall mean any corporation, partnership, joint
venture or other entity of which the common stock or other equity ownership
thereof is twenty five percent (25%) or more owned by MEDGENICS.
1.2
The term
“Developers” shall mean Xxxxxx Xx, Xxxxxxx Xxx, Xxxxxx Xxxxxxx and
Xxxxxxxx Xxxxxxx employees of BAYLOR.
1.3
The term “Licensed Product(s)” shall mean any product, process or service
that incorporates, utilizes or is made with the use of the Subject
Technology.
l.4
The term “MEDGENICS Technology” shall mean technology, owned or controlled by
MEDGENICS, including, but not limited to, expression constructs provided to
BAYLOR by MEDGENICS under the Collaboration Agreements and other technology
generally relating to use of a living tissue sample as a production unit for
proteins or other therapeutics.
-1-
1.5
The term “Party” shall mean either MEDGENICS or BAYLOR, and “Parties” shall mean
MEDGENICS and BAYLOR.
1.6
The term “Subject Technology” shall mean: (i) Helper Dependent Adenovirus
pHDΔ28E4,
Helper Virus AdNG163 and Producer Cell Line 116, developed as of the Agreement
Date and supplied by BAYLOR together with any progeny, mutants or modifications
thereof created and supplied by BAYLOR under the Collaboration Agreements or
created by MEDGENICS; even if MEDGENICS’ expression
constructs are inserted into pHDΔ28E4 as combined under separate collaboration
agreements with Baylor or with third parties, the pHDΔ28E4 (but not the
expression constructs) remains Subject Technology, (ii) a protocol for
production of the Helper Dependent Adenovirus using the Producer Cell Line 116
and the Helper Virus AdNG163 as conducted at BAYLOR and as requested by
Medgenics.
MEDGENICS is hereby notified that the subject
Technology is considered a “Created Cre-Lox Material”, as defined in Appendix A,
and therefore the provisions of Appendix A shall apply.
2.
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GRANT OF
L1CENSE
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2.1
Subject to the limitations in 2.2 below, BAYLOR hereby grants to MEDGENICS
a non-exclusive, worldwide, sublicensable license under the Subject
Technology, to make, have made, use, market, sell, offer to sell, lease and
import Licensed Products.
2.2
Grant limitations include (i) the right to market, sell or offer to sell
the Subject Technology only in the
context of a use with MEDGENICS Technology, (ii) sublicense of the Subject
Technology only
in conjunction with a license or sublicense of MEDGENICS Technology which use
depends on Subject Technology, (iii) no other transfers except
as provided for in 2.4 below are allowed without BAYLOR’s permission which shall
in be BAYLOR’s sole discretion, (iii) the grant does not include right to file
patent applications on the Subject Technology or for the use of the Subject
Technology without BAYLOR’s prior written approval, which approval shall be in
BAYLOR’s sole discretion. Such right and license shall include, but not be
limited to, the right to generate modifications of the Subject Technology, for
example modifications of expression construct or placement of an expression
construct within the vector. Any modifications created within the context of the
Subject Technology supplied by Baylor are considered Subject Technology and
subject to this Agreement.
2.3
Government Reservation. Rights under this Agreement are subject to rights
required to be granted to the Government of the United States of America
pursuant to 35 USC Section 200-212, including a non-exclusive, nontransferable,
irrevocable, paid-up license to practice or have practiced for or on behalf of
the United States the subject inventions throughout the world.
2.4
In addition to the rights granted in Paragraph 2.1, MEDGENICS shall have
the right under the license granted in this Agreement to transfer the Subject
Technology to third party contract service providers (“Service Provider”) for
the sole purpose of propagating and producing Licensed Products and/or Subject
Technology for MEDGENICS. MEDGENICS warrants that it has, or will enter into
prior to transfer of Subject Technology, agreements with the Service Provider
binding the Service Provider to obligations of confidentiality and non-use
consistent with the provisions of this Agreement. Such agreement with Service
Provider shall also prohibit transfer of the Subject Technology to third
parties.
3.
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PAYMENTS
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3.1 As
partial consideration for the rights conveyed by BAYLOR under this Agreement,
MEDGENICS shall pay BAYLOR a one-time non refundable license fee of twenty five
thousand dollars ($25,000) upon receipt of invoice as described in Paragraph
3.9. For purposes of clarification. this is a one-time fee only and is intended
to cover the license of all Subject Technology, including the “Combined
MateriaIs” as
defined in and provided under the Collaboration Agreements, or the production of
equivalent combined materials with the same or different expression cassettes
under future collaboration agreements.
-2-
3.2
In addition to the foregoing license execution fee, MEDGENICS agrees to
pay to BAYLOR an annual non refundable maintenance fee of twenty thousand
dollars ($20,000), which shall be due and payable on the first anniversary and
on each subsequent anniversary of the Agreement Date and upon receipt of invoice
as described in Paragraph 3.9. For purposes of clarification, this annual
maintenance fee is intended to cover the license of all Subject Technology,
including the “Combined Materials” as defined in and provided under the
Collaboration Agreements, or the production of equivalent combined materials
with the same or different expression cassettes under future collaboration
agreements.
3.3
MEDGENICS shall also pay BAYLOR the following milestone payments set forth
below:
(i) a
one-time, seventy five thousand dollar ($75,000) payment upon FDA clearance or
non-US equivalent of clearance for therapeutic use.
(ii)
twenty five thousand dollars ($25,000) upon execution of any sublicenses that
MEDGENICS executes for the Subject Technology.
MEDGENICS
shall notify BAYLOR in writing within thirty (30) days upon the achievement of
such milestone, such notice to be accompanied by payment of the appropriate
milestone payment. Milestones are to be paid regardless of whether MEDGENICS or
MEDGENICS’ sublicensee attains such milestone. The FDA clearance milestone in
3.3 (i) shall be paid only once upon the first FDA or foreign equivalent
approved indication, it being understood and agreed that no further clearance
milestone payments shall be due by MEDGENICS in connection any future FDA or
foreign equivalent approvals.
3.4
MEDGENICS shall also provide to BAYLOR the following materials and
documentation, subject to the agreement of any third parties whose intellectual
property or other rights may be involved:
(i) one
quarter (1/4) of the Master Cell Bank for the Producer Cell Line 116 as
generated by MEDGENICS or a contractor thereof, and;
(ii) one
quarter (1/4) of the Master Virus Bank for the Helper Virus AdNG163 as generated
by MEDGENICS or a contractor thereof and
(iii)
copies of documentation on the processes used for creating the clinical grade
Licensed Products.
If
MEDGENICS no longer requires use of MEDGENICS’ portion of the Master Cell Bank
and/or Master Virus Bank created, any unused portion of these will be
provided to BAYLOR.
3.5
Should MEDGENICS fail to make any payment or obligation whatsoever due and
payable to BAYLOR hereunder, after due provision of notice by BAYLOR and failure
to cure by MEDGENICS pursuant to Section 8, BAYLOR may, at its sole option,
terminate this Agreement as provided in Section 8.
3.6
All payments due hereunder shall be deemed received when funds are credited
to BAYLOR’s bank account and shall be payable by check or wire transfer in
United States dollars. For sales of Licensed Products in currencies other than
the United States, MEDGENICS shall use exchange rates published in The Wall Street
Journal on the last business day of the calendar quarter that such
payment is due. No transfer, exchange, collection or other charges, including any wire transfer fees, shall be
deducted from such payments.
-3-
3.7
Late payments shall be subject to a charge of one and one-half percent
(1.5%) per month, the interest being compounded annually, or two hundred
fifty dollars ($250.00), whichever is greater. MEDGENICS shall calculate the
correct late payment charge, and shall add it to each such late payment. Said
late payment charge and the payment and acceptance thereof shall not negate or
waive the right of BAYLOR to seek any other remedy, legal or equitable, to which
it may be entitled because of the delinquency of any payment.
3.8
If payments are sent by check, they shall be sent to the address listed in
Paragraph 12.1. If payments are sent by wire transfer, they shall be sent using
the wiring instructions sent
by BAYLOR.
3.9
Any amounts payable to BAYLOR hereunder shall be made in full within thirty (30)
days after receipt by MEDGENICS of an invoice covering such payment. The Parties
understand and agree that one (1) invoice will be sent to MEDGENICS by BAYLOR
for each fee due. The invoice shall be in the form in Appendix B. Any additional
fees, such as taxes, wire or transfer fees, will not be included in the invoice,
but payment of such fees shall remain the responsibility of MEDGENICS and shall
not be deducted from the payment due BAYLOR. Subsequent invoices, if
requested by MEDGENICS, shall be subject to an administrative fee of five
hundred dollars ($500), in addition to the original payment due to BAYLOR plus
any interest charges incurred due to delays in payment, if applicable. The
calculation and payment of such interest payments shall not be invoiced and
shall be the sole responsibility of the MEDGENICS. Invoices shall be sent via
facsimile to the address listed in Paragraph 12.2. If MEDGENICS requires an
original invoice, such invoice shall be sent via overnight courier using
MEDGENICS’ courier Fedex (Name Courier) account number 242068602.
3.10. The
parties agree that the amounts and materials indicated in this Section 3
constitute the total consideration and payment due by MEDGENICS to BAYLOR for
all rights granted and materials provided under this Agreement. For clarity if
MEDGENICS requests further work of BAYLOR such as production of vectors or
generation of combined materials, such work shall be conducted under a
collaboration agreement and BAYLOR shall charge Medgenics for the cost of
such work. However, as long as no additional BAYLOR technology, other than the
Subject Technology, are required by MEDGENICS, no further license or payments are required
of
MEDGENICS.
4.
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REPORTING
|
4.1
No later than sixty (60) days after December 31 of each calendar year,
MEDGENICS shall provide to BAYLOR a written annual progress report describing
progress on research and development, regulatory approvals, during the most
recent twelve (12) month period ending December 31.
4.2
MEDGENICS shall
report to BAYLOR the date of first sale of Licensed Products within
thirty (30) days of occurrence.
4.3
In the event of acquisition, merger, change of corporate name, or change
of make-up, organization, or identity, MEDGENICS shall notify BAYLOR in writing
within thirty (30) days of such event.
-4-
5.
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TRANSFER OF SUBJECT
TECHNOLOGY
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5.1
Subject to its receipt of the license fee described in Paragraph 3.1
BAYLOR shall provide MEDGENICS with Subject Technology within thirty (30) days
following MEDGENIC’S written request as follows: 1 (one) 1ml vial of
Producer Cell Line 116 at approximately 3 X 106
cells/vial.; one vial at 10e10 vp of Helper Virus AdNG163; 10 micrograms of
Helper Dependent Adenovirus pHDΔ28E4 plasmid DNA
and a protocol for production of the Helper Dependent Adenovirus using the
Producer Cell Line 116 and the Helper Virus AdNG163 as conducted at
BAYLOR..
In
addition to the Subject Technology described above, BAYLOR will also provide
MEDGENICS with 10 micrograms each of the following Combined Materials as
generated under the Collaboration Agreernents:
CAG-EPO
and CMV-EPO
CAG-codon
optimized hINFalpha,
CMV-codon
optimized hINFalpha,
CAG-codon
optimized hEPO
CMV-codon
optimized hEPO
5.2 Such
Subject Technology shall be sent to MEDGENICS at MEDGENICS’ expense and only
upon receipt by BAYLOR of the necessary address and courier account information
specified by MEDGENICS in its written request per Section 5.1.
6.
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SUBLICENSES
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All
sublicenses granted by MEDGENICS of its rights hereunder shall be subject to the
terms of this Agreement. MEDGENICS shall be responsible for its sublicensees and
shall not grant any rights which are inconsistent with the rights granted to and
obligations of MEDGENICS hereunder. Any act or omission of a sublicensee which
would be a breach of this Agreement if performed by MEDGENICS shall be
deemed to be a breach by MEDGENICS of this Agreement. No such sublicense
agreement shall contain any provision which would cause it to extend beyond the
term of this Agreement. MEDGENICS shall give BAYLOR prompt notification of the
identity and address of each sublicensee with whom it concludes a sublicense
agreement and shall supply BAYLOR with a copy of each such
sublicense agreement.
7.
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TERM AND
EXPIRAT1ON
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Unless
sooner terminated as otherwise provided in Section 8, the license to employ
Subject Technology granted herein as part of Section 2 shall expire on the first
date following the tenth (10th)
anniversary of the first commercial sale of Licensed Products by MEDGENICS.
After such expiration, MEDGENICS shall have a perpetual, paid-in-full (i.e.,
royalty free) license to the Subject Technology.
8.
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TERMINATION
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8.1
In the event of default or failure by either party to perform any of the
terms, covenants or provisions of this Agreement, the other party shall have
thirty (30) days after the giving of written notice of such default by the
non-defaulting party to correct such default. If such default is not corrected
within the said thirty (30) day period, the non-defaulting party shall have the
right, at its option, to cancel and terminate this Agreement. The failure of
BAYLOR to exercise such right of termination, for non-payment of royalties/ fees
or otherwise, shall not be deemed to be a waiver of any right BAYLOR
might have, nor shall such failure preclude BAYLOR from exercising or enforcing
said right upon any subsequent failure by MEDGENICS.
-5-
8.2
BAYLOR shall have the right, at its option, to cancel and terminate this
Agreement in the event that MEDGENICS shall (i) become involved in insolvency,
dissolution, bankruptcy or receivership proceedings affecting the operation of
its business or (ii) make an assignment of all or substantially all of its
assets for the benefit of creditors, or in the event that (iii) a receiver or
trustee is appointed for MEDGENICS and MEDGENICS shall, after the expiration of
thirty (30) days following any of the events enumerated above, have been unable
to secure a dismissal, stay or other suspension of such
proceedings.
8.3
MEDGENICS shall have the right in its sole discretion to terminate this
Agreement upon sixty (60) days’ written notice to BAYLOR.
8.4
1n the event of termination of this Agreement, all rights to the Subject
Technology shall revert to BAYLOR, it being understood and agreed that any
Medgenics Technology shall not revert to BAYLOR. At the date of any termination
of this Agreement, MEDGENICS shall immediately cease using any of the Subject
Technology and MEDGENICS shall immediately destroy the Subject Technology and
send to BAYLOR a written affirmation of such destruction signed by an officer of
MEDGENICS; provided, however, that MEDGENICS may sell any Licensed Products
actually in the possession of MEDGENICS on the date of termination, provided
that MEDGENICS otherwise complies with the terms of this Agreement.
8.5
MEDGENICS shall provide, in all sublicenses granted by it under this
Agreement, that MEDGENICS’ interest in such sublicenses shall, at BAYLOR’s
option, terminate or be assigned to BAYLOR upon termination of this Agreement
under Section 8.
8.6
In the event this Agreement is terminated pursuant to this Section 8, or expires
as provided for in Section 7, BAYLOR is under no obligation to refund any
payments made by MEDGENICS to BAYLOR prior to the effective date of such
termination or expiration.
8.7
No termination of this Agreement shall constitute a termination or a
waiver of any rights of either Party against the other Party accruing at or
prior to the time of such termination. The obligations of Sections 11, 13 and 14
shall survive termination of this Agreement.
9.
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ASSIGNABILITY
|
Without
the prior written approval of BAYLOR, which will not be unreasonably withheld,
neither this Agreement nor the rights granted hereunder shall be transferred or
assigned in whole or in part by MEDGENICS to any person or entity whether
voluntarily or involuntarily, by operation of law or otherwise. BAYLOR’s consent
to assignment is dependent in part on; MEDGENICS providing to BAYLOR prompt
notice of such action and documentation that the successor entity or Affiliate,
as the case may be, acknowledges its consent and agreement to the terms of this
Agreement in writing before such assignment; and so long as such action is not
entered into solely to satisfy creditors of MEDGENICS. This Agreement shall be
binding upon and shall inure to the benefit of the respective successors, legal
representatives and assignees of BAYLOR and MEDGENICS.
10.
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GOVERNMENT
COMPLAINCE
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10.1
MEDGENICS shall at all times during the term of this Agreement and for so
long as it shall use the Subject Technology or sell Licensed Products, comply
and cause its sublicensees to comply with all laws that may control the import,
export, manufacture, use, sale, marketing, distribution and other commercial
exploitation of the Subject Technology or Licensed Products or any other activity undertaken
pursuant to this Agreement.
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11.
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ARBITRATION
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11.1
Amicable
Resolution. The Parties shall
attempt to settle any controversy between them amicably. To this end, a senior
executive from each Party shall consult and negotiate to reach a solution. The
Parties agree that the period of amicable resolution shall toll any otherwise
applicable statute of limitations. However, nothing in this clause shall
preclude any Party from commencing mediation if said negotiations do not result
in a signed written settlement agreement within thirty (30) days after written
notice that these amicable resolution negotiations have commenced.
11.2.
Mediation. If a controversy arises out of or relates to
this agreement, or the breach thereof, and if the controversy cannot be settled
through amicable resolution, the Parties agree to try in good faith to settle
the controversy by mediation before resorting to final and binding
arbitration. The Party seeking mediation shall propose five mediators, each of
whom shall be a lawyer licensed to practice by the state of Texas, having
practiced actively in the field of commercial law for at least fifteen (15)
years, to the other Party who shall select the mediator from the list. The
Parties shall split the cost of the mediator equally. The Parties agree that the
period of mediation shall toll any otherwise applicable statute of limitations.
However,
nothing in this clause shall preclude any Party from commencing arbitration if
said negotiations do not result in a signed written settlement agreement within
sixty (60) days after written notice that amicable resolution negotiations have
commenced.
11.3
Arbitration. Any dispute, controversy, or claim arising out
of or relating to this Agreement, or the breach, termination or invalidity
thereof, including claims for tortious interference or other tortious or
statutory claims arising before, during or after termination, providing only
that such claim touches upon matters covered by this Agreement shall be finally
settled by arbitration administered by the American Arbitration Association
pursuant to the Commercial Arbitration Rules in force at the time of the
commencement of the arbitration, except as modified by the specific provisions
of this Agreement. It is the specific intent of the Parties that this
arbitration provision is intended to be the broadest form allowed by
law.
11.4
Parties to
Arbitration. This agreement to
arbitrate is intended to be binding upon the signatories hereto, their
principals, successors, assigns, subsidiaries and affiliates. This agreement to
arbitrate is also intended to include any disputes, controversy or claims
against any Party’s employees, agents, representatives, or outside legal counsel
arising out of or relating to matters covered by this Agreement or any agreement
in which this Agreement is incorporated.
11.5
Consolidation
Permitted. The Parties expressly
agree that any court with jurisdiction may order the consolidation of any
arbitrable controversy under this Agreement with any related arbitrable
controversy not arising under this Agreement, as the court may deem necessary in
the interests of justice or effeciency or on such other grounds as the court may
deem appropriate.
11.6
Entry of
Judgement. The Parties agree that a
final judgment on the
arbitration award may be entered by any court having jurisdiction
thereof.
11.7
Appointing
Arbitrators. The American
Arbitration Association shall appoint the arbitrator(s) from its Large, Complex
Claims Panel. If such appointment cannot be made from the Large, Complex Claims
Panel, then from its Commercial Panel. The Parties hereby agree to and acquiesce
in any appointment of an arbitrator or arbitrators that may be made by such
appointing authority.
-7-
11.8.
Qualifications of the
Arbitrator(s). The arbitrator(s)
must be a lawyer, having practiced actively in the field of commercial law for
at least fifteen (15) years.
11.9.
Governing
Substantive Law. The arbitrator(s)
shall determine the rights and obligations of the Parties according to the
substantive laws of the State of Texas (excluding conflicts of law principles)
as though acting as a court of the State of Texas.
11.10
Governing
Arbitration Law. The law applicable
to the validity of the arbitration clause, the conduct of the arbitration,
including any resort to a court for provisional remedies, the enforcement of any
award and any other question of arbitration law or procedure shall be the
Federal Arbitration Act.
11.11
Governing
Convention. The Parties elect to have the New York Convention on the
Recognition and Enforcement of Foreign Arbitral Awards of June 10, 1958 (instead
of the Inter-American New York Convention on International Commercial
Arbitration of August 15, 1990) govern any and all disputes that may be the
subject of arbitration pursuant to this Agreement.
11.12
Preliminary Issues of
Law. The arbitrator(s) shall hear
and determine any preliminary issue of law asserted by a Party to be dispositive
of any claim, in whole or part, in the manner of a court hearing a motion to
dismiss for failure to state a claim or for summary judgment, pursuant to such
terms and procedures as the arbitrator(s) deems appropriate.
11.13
Confidentiality. The Parties and the arbitrator(s) shall treat
all aspects of the arbitration proceedings, including without limitation
discovery, testimony and other evidence, briefs and the award, as strictly
confidential. Further, except as may be required by law, neither Party nor the
arbitrator(s) may disclose the existence, content, or results of any arbitration
hereunder without the prior written consent of both Parties.
11.14
Place of
Arbitration. The seat of arbitration
shall be Houston, Texas, USA.
11.15
Language. The arbitration shall be conducted in the
English language. All submissions shall be made in English or with an English
translation. Witnesses may provide testimony in a language other than English,
provided that a simultaneous English translation is provided. Each Party shall
bear its own translation costs.
11.16.
Punitive Damages
Prohibited. The Parties hereby waive any claim to any damages in the
nature of punitive, exemplary, or statutory damages in excess of compensatory
damages, or any form of damages in excess of compensatory damages, and the
arbitrator(s) is/are specially divested of any power to award any damages in the
nature of punitive, exemplary, or statutory damages in excess of compensatory
damages, or any form of damages in excess of compensatory damages.
11.17
Costs. The Party prevailing on substantially all of its
claims shall be entitled to recover its costs, including attorneys’ fees, for
the arbitration proceedings, as well as for any ancillary proceeding, including
a proceeding to compel or enjoin arbitration, to request interim measures or to
confirm or set aside an award.
11.18 Survive. The
provisions of this Section 11 shall survive expiration or termination of this
Agreement.
-8-
12.
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ADDRESSES
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12.1 All
payments shall be made payable to “Baylor College of Medicine” and shall be sent
to the address below, and shall reference the applicable BLG numbers listed on the
front page of the Agreement.
BAYLOR
Tax ID #: 00-0000000
Director,
Baylor Licensing Group
Baylor
College of Medicine
Xxx
Xxxxxx Xxxxx, XXX000-000X
Xxxxxxx,
XX 00000
Telephone
No.
|
000-000-0000
|
Facsimile No.
|
000-000-0000
|
E-mail
|
xxx@xxx.xxx.xxx
|
12.2 For
questions about payments, BAYLOR can contact MEDGENICS at the address
below:
Title
Ms.
Name
Xxxxxxx Xxxxxx
Xxxxxxx
00 Xxxxxxxx Xx. POB 6314 Karmiel 00000 XXXXXX
Telephone
No.
|
x000-0-000-0000
|
Facsimile
No.
|
x000-0-000-0000
|
E-Mail
|
Xxxxxxx@xxxxxxxxx.xxx
|
12.3 All
notices, reports or other communication pursuant to this Agreement shall be sent
to such Party via (i) United States Postal Service postage prepaid, (ii)
overnight courier, or (iii) facsimile transmission, addressed to it at its
address set forth below or as it shall designate by written notice given to the
other Party. Notice shall be sufficiently made, or given and received (a) on the
date of mailing or (b) when a facsimile printer reflects
transmission.
In the
case of BAYLOR:
Xxxxxxx
Xxxxxx
Associate
General Counsel
Baylor
College of Medicine
Xxx
Xxxxxx Xxxxx, XXX000-000X
Xxxxxxx,
XX 00000
Telephone
No.
|
000-000-0000
|
Facsimile
No.
|
000-000-0000
|
E-Mail
|
xxx@xxx.xxx.xxx
|
In the
case of MEDGENICS:
Title
Dr.
Name
Xxxxxx X. Xxxxxxxx
Xxxxxxx
00 Xxxxxxxx Xx. POB 6314 Karmiel 00000 XXXXXX
Telephone
No.
|
x000-0-000-0000
|
Facsimile
No.
|
x000-0-000-0000
|
E-Mail
|
xxxx@xxxxxxxxx.xxx
|
-9-
With a
copy to:
Xxxxx
Xxxxx Zedek Xxxxxx, LLP
0000
Xxxxxxxx, 00xx Xxxxx
Xxx Xxxx,
XX 00000
Tel:
000-000-0000
Fax:
000-000-0000
email:
XxxxX@xxxxxx.xxx
Attention:
Xxxx Xxxxx
12.4
Each such report, notice or other communication shall include the
applicable BLG numbers
listed on the front page of the Agreement.
13.
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INDEMNITY, INSURANCE
& WARRANTIES
|
13.1
|
INDEMNITY.
|
(i)
EACH PARTY SHALL NOTIFY THE OTHER OF ANY CLAIM, LAWSUIT OR OTHER PROCEEDING
RELATED TO THE SUBJECT TECHNOLOGY. MEDGENICS AGREES THAT IT WILL DEFEND,
INDEMNIFY AND HOLD HARMLESS BAYLOR, ITS FACULTY MEMBERS, SCIENTISTS,
RESEARCHERS, EMPLOYEES, STUDENTS, OFFICERS, TRUSTEES AND AGENTS AND EACH OF THEM
(THE “INDEMNIFIED PARTIES”), FROM AND AGAINST ANY AND ALL CLAIMS, CAUSES OF
ACTION, LAWSUITS OR OTHER PROCEEDINGS (THE “BAYLOR CLAIMS”) FILED OR OTHERWISE
INSTITUTED AGAINST ANY OF THE INDEMNIFIED PARTIES RELATED DIRECTLY OR INDIRECTLY
TO OR ARISING OUT OF THE DESIGN, PROCESS, MANUFACTURE OR USE BY MEDGENICS OF THE
SUBJECT TECHNOLOGY, LICENSED PRODUCTS OR ANY OTHER EMBODIMENT OF THE SUBJECT
TECHNOLOGY, OR ANY PERSON OR ENTITY (OTHER THAN BAYLOR OR AN ENTITY ACCESSING
THE SUBJECT TECHNOLOGY THROUGH BAYLOR THAT IS NOT UNDER CONTRACT WITH MEDGENICS
(FOR EXAMPLE, SERVICE PROVIDERS)) ACCESSING THE SUBJECT TECHNOLOGY THROUGH
MEDGENICS EVEN THOUGH SUCH BAYLOR CLAIMS AND THE COSTS (INCLUDING, BUT NOT
LIMITED TO, THE PAYMENT OF ALL REASONABLE ATTORNEYS’ FEES AND COSTS OF
LITIGATION OR OTHER DEFENSE) RELATED THERETO RESULT IN WHOLE OR IN PART FROM THE
NEGLIGENCE OF ANY OF THE INDEMNIFIED PARTIES OR ARE BASED UPON DOCTRINES OF
STRICT LIABILITY OR PRODUCT LIABILITY; PROVIDED, HOWEVER, THAT SUCH INDEMNITY
SHALL NOT APPLY TO ANY BAYLOR CLAIMS ARISING FROM THE GROSS NEGLIGENCE OR
INTENTIONAL MISCONDUCT OF ANY INDEMNIFIED PARTY. MEDGENICS WILL ALSO ASSUME
RESPONSIBILITY FOR ALL COSTS AND EXPENSES RELATED TO SUCH BAYLOR CLAIMS FOR
WHICH IT IS OBLIGATED TO INDEMNIFY THE INDEMNIFIED PARTIES PURSUANT TO THIS
PARAGRAPH 13.1, INCLUDING, BUT NOT LIMITED TO, THE PAYMENT OF ALL REASONABLE
ATTORNEYS’ FEES AND COSTS OF LITIGATION OR OTHER DEFENSE.
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(ii) MEDGENICS FURTHER AGREES NOT TO SETTLE ANY
CLAIM AGAINST AN INDEMNIFIED PARTY WITHOUT THE
INDEMNIFIED PARTY’S WRITTEN CONSENT
WHICH CONSENT SHALL NOT BE UNREASONABLY WITHHELD. MEDGENICS FURTHER AGREES TO
KEEP THE INDEMNIFIED PARTIES FULLY APPRISED OF THE BAYLOR CLAIMS.
13.2
Insurance.
(i)
MEDGENICS shall for so long as MEDGENICS manufactures, uses or sells any
Licensed Product(s) in animals or in a Phase I Clinical Trial (or non-United
States equivalent) or in a Phase II clinical trail (or non-United States equivalent) conducted solely in the
State of Israel, maintain in full
force and effect policies of (a) worker’s compensation insurance within
statutory limits prescribed by the applicable
State or
country where
Medgenics has its facilities, (b) employers’ liability insurance with
limits of not less than three million dollars ($3,000,000) per occurrence, (c)
general liability insurance (with Broad Form General Liability endorsement) with
limits of not less than five million dollars ($5,000,000) per occurrence with an
annual aggregate of ten million dollars ($10,000,000) and (d) products liability
insurance, with limits of not less than five million dollars ($5,000,000) per
occurrence with an annual aggregate of ten million dollars
($10,000000).
(ii) MEDGENICS
shall for so long as MEDGENICS manufactures, uses or sells any Licensed
Product(s) in any Phase II (or non-United States equivalent) Clinical
Trials outside the State of Israel, any Phase III Clinical Trials (or non-United
States equivalent) or commercially, maintain in full force and effect policies
of (a) worker’s compensation insurance within statutory limits prescribed by the applicable
State or country where Medgenics has its facilities, (b) employers’ liability insurance with limits
of not less than three million dollars ($3,000,000) per occurrence, (c) general
liability insurance (with Broad Form General Liability endorsement) with limits
of not less than twenty million dollars ($20,000,000) per occurrence with an
annual aggregate of forty million dollars ($40,000,000) and (d) products
liability insurance, with limits of not less than twenty million dollars
($20,000,000) per occurrence with an annual aggregate of forty million dollars
($40,000000).
(iii)
Such coverage(s) shall be purchased from a carrier or carriers having an
A. M. Best rating of at least A- (A minus) and shall name BAYLOR as an
additional insured. MEDGENICS shall provide to BAYLOR copies of certificates of
insurance within thirty (30) days after execution of this Agreement. Upon
request by BAYLOR, MEDGENICS shall provide to BAYLOR copies of said policies of
insurance. It is the intention of the Parties hereto that MEDGENICS shall,
throughout the term of this Agreement, continuously and without interruption,
maintain in force the required insurance coverages set forth in this Paragraph
13.2. Failure of MEDGENICS to comply with this requirement shall constitute a
default of MEDGENICS allowing BAYLOR, at its option, to immediately terminate
this Agreement.
(iv)
BAYLOR reserves the right to request additional policies of insurance where
appropriate and reasonable in light of MEDGENICS’ business operations and
availability of coverage.
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13.3
DISCLAIMER OF WARRANTY. BAYLOR MAKES NO WARRANTIES OR REPRESENTATIONS, EXPRESS OR IMPLIED,
INCLUDING, BUT NOT
LIMITED TO, WARRANTIES OF FITNESS OR MERCHANTABILITY, REGARDING OR WITH RESPECT TO THE
SUBJECT TECHNOLOGY OR LICENSED PRODUCTS AND BAYLOR MAKES NO WARRANTIES OR REPRESENTIONS,
EXPRESS OR IMPLIED, OF THE PATENTABILITY OF THE SUBJECT TECHNOLOGY OR LICENSED PRODUCTS OR OF THE
ENFORCEABILITY OF ANY PATENTS ISSUING
THEREUPON, IF ANY, OR THAT THE SUBJECT TECHNOLOGY, OR LICENSED PRODUCTS ARE OR SHALL BE FREE FROM INFRINGEMENT OF
ANY PATENT OR OTHER RIGHTS OF THIRD PARTIES. NOTHING IN THIS
AGREEMENT SHALL BE CONSTRUED AS CONFERRING
BY IMPLICATION, ESTOPPEL OR OTHERWISE ANY LICENSE OR RIGHTS UNDER ANY PATENTS OF BAYLOR, REGARDLESS OF WHETHER SUCH PATENTS ARE DOMINANT OR SUBORDINATE TO THE PATENT RIGHTS. BAYLOR SHALL NOT BE LIABLE FOR ANY LOSSES INCURRED AS THE RESULT OF AN
ACTION FOR INFRINGEMENT BROUGHT AGAINST
MEDGENICS AS THE RESULT OF MEDGENICS’ EXERCISE OF ANY RIGHT GRANTED UNDER THIS
AGREEMENT. THE DECISION TO DEFEND OR NOT DEFEND SHALL BE IN MEDGENICS’ SOLE
DISCRETION.
14.
|
ADDITIONAL
PROVISIONS
|
14.1
Use of BAYLOR
Name. MEDGENICS agrees that it shall
not use in any way the name of “Baylor College of Medicine” or any logotypes or
symbols associated with BAYLOR or the names of any of the scientists or other
researchers at BAYLOR without the prior written consent of BAYLOR.
14.2
Confidentiality. Each party agrees to maintain any written,
confidential information associated with Subject Technology and marked as
“Confidential” in confidence, and to use the same only in accordance with this
Agreement. Such obligation of confidentiality shall not apply to information
which the receiving party can demonstrate: (i) was at the time of disclosure in
the public domain; (ii) has come into the public domain after disclosure through
no fault of MEDGENICS; (iii) was known to MEDGENICS prior to disclosure thereof
by BAYLOR; (iv) was lawfully disclosed to MEDGENICS by a third party which was
not under an obligation of confidence to BAYLOR with respect thereto; (v) which
MEDGENICS can reasonably demonstrate was independently developed by MEDGENICS
without use of the Subject Technology; or (vi) which MEDGENICS shall be
compelled to disclose by law or legal process.
14.3
BAYLOR’s
Disclaimers. Neither BAYLOR, nor any of its faculty members, scientists,
researchers, employees, students, officers, trustees or agents assume any
responsibility for the manufacture, product specifications, sale or use of the
Subject Technology or Licensed Products which are manufactured by or sold by
MEDGENICS.
14.4
Independent
Contractors. The Parties hereby
acknowledge and agree that each is an independent contractor and that neither
Party shall be considered to be the agent, representative, master or servant of
the other Party for any purpose whatsoever, and that neither Party has any
authority to enter into a contract, to assume any obligation or to give
warranties or representations on behalf of the other Party. Nothing in this
relationship shall be construed to create a relationship of joint venture,
partnership, fiduciary or other similar relationship between the
Parties.
14.5
Non-Waiver. The Parties covenant and agree that if a Party
fails or neglects for any reason to take advantage of any of the terms provided
for the termination of this Agreement or if a Party, having the right to declare
this Agreement terminated shall fail to do so, any such failure or neglect by
such Party shall not be a waiver or be deemed or be construed to be a waiver of
any cause for the termination of this Agreement subsequently arising, or as a
waiver of any of the terms, covenants or conditions of this Agreement or of the
performance thereof. None of the terms, covenants and conditions of this
Agreement may be waived by a Party except by its written
consent.
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14.6
Reformation. The Parties hereby agree that neither Party
intends to violate any public policy, statutory or common law, rule, regulation,
treaty or decision of any government agency or executive body thereof of any
country or community or association of countries, and that if any word,
sentence, paragraph or clause or combination thereof of this Agreement is found,
by a court or executive body with judicial powers having jurisdiction over this
Agreement or any of the Parties hereto, in a final, unappealable order to be in
violation of any such provision in any country or community or association of
countries, such words, sentences, paragraphs or clauses or combination shall be
inoperative in such country or community or association of countries, and the
remainder of this Agreement shall remain binding upon the Parties
hereto.
14.7
Force
Majeure. No liability hereunder shall result to a Party
by reason of delay in performance caused by force majeure, that is circumstances
beyond the reasonable control of the Party, including, without limitation, acts
of God, fire, flood, war, terrorism, civil unrest, labor unrest, or shortage of
or inability to obtain material or equipment.
14.8
Entire
Agreement. The terms and conditions
herein constitute the entire agreement between the Parties and shall supersede
all previous agreements, either oral or Written, between the Parties hereto with
respect to the subject matter hereof. No agreement of understanding bearing on
this Agreement shall be binding upon either Party hereto unless it shall be in
writing and signed by the duly authorized officer or representative of each of
the Parties and shall expresly refer to this Agreement.
IN
WITNESS WHEREOF, the Parties hereto have executed and delivered this Agreement
in multiple originals by their duly authorized officers and representatives on
the respective dates shown below, but effective as of the Agreement
Date.
BAYLOR
COLLEGE OF MEDICINE
|
||||
Name:
|
/s/Xxxxxx X. Xxxxxxxx |
Name:
|
/s/Xxxxx X. Xxxxx | |
Xxxxx
X. Xxxxx
|
||||
Title:
|
CEO
|
Title:
|
Senior
Vice President &
|
|
General
Counsel
|
||||
Date:
|
Jan. 14, 2007
|
Date:
|
Jan.
25,
2007
|
10/9/06
MEDGENICS BLG #
03-037, 01-064
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Appendix
A
1- The
Subject Technology transferred under this Agreement was created with Cre-Lox
Technology and therefore is considered a “Created Cre-Lox
Material”.
2-
Cre-Lox Technology is subject of United States Patent No. 4,959,317, to which
BAYLOR has a non-commercial research license from Xxxxxxx-Xxxxx Squibb
Company (“BMS”).
3- Use of
the Created Cre-Lox Material, and any progeny or derivatives containing cre DNA
and/or lox DNA derived directly or indirectly therefrom, requires a license
from BMS and a fee (in addition to any fee paid to BAYLOR under this
Agreement) will be payable to BMS by MEDGENICS in consideration for
transfer of the Created Cre-Lox Material to MEDGENICS (except as may be
otherwise permitted under a separate written agreement between MEDGENICS and
BMS).
4- No
license is granted either express or implied to MEDGENICS by BAYLOR to United
States Patent No. 4,959,317 under this Agreement.
5- For
inquiries regarding license rights under U.S. Patent Number 4,959,317,
contact:
Manager,
External Science, Technology & Licensing
Xxxxxxx-Xxxxx
Squibb Company
Xxxxx 000
xxx Xxxxxxxx Xxxx Xxxx
Xxxxxxxxx,
XX 00000-0000
6- As
required by BMS, BAYLOR will be providing to BMS the name of MEDGENICS and the
identification of the Subject Technology to be transferred to MEDGENICS under
this Agreement.
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XXXXXXXX
X
INVOICE
DATE
RECIPIENT
ADDRESS
RE:
XXXXXXXXXX Fee
BLG #XX-XXX TITLE
Please
let this letter serve as an INVOICE for the license
execution fee of $XXXXXX for the above-referenced technology, as stated in the
license Agreement dated _________, between _________________ and Baylor
College of Medicine.
Please
make the check payable to Baylor College of Medicine and
send it directly to me for processing at our address listed above.
I
appreciate your attention to this matter.
Best
regards,
Xxxxxx
Xxxxxxxxxx
Administrative
Coordinator III
/nv
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APPENDIX
C
COLLABORATION
AGREEMENTS
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