Exhibit 10.9

FIRST AMENDMENT TO EXCLUSIVE LICENSE AGREEMENT (ACT IP)
This First Amendment to Exclusive License Agreement (ACT IP) (“First Amendment”)
is made and entered into as of this 1ST day of August, 2005 (the “Amendment
Effective Date”), by and between Advanced Cell, Inc. (formerly known as Advanced
Cell Technology, Inc.), a Delaware corporation with offices located at 381
Plantation Street, Worcester, Massachusetts 01605 (“LICENSOR”), and Lifeline
Cell Technology, LLC (formerly known as PacGen Cellco, LLC), a California
limited liability company with offices located at 157 Surfview Drive, Pacific
Palisades, CA 90272 (“LICENSEE”) (LICENSOR and LICENSEE sometimes hereinafter
referred to individually as a “Party” and collectively as the “Parties”).
WHEREAS, the Parties previously entered into an Exclusive License Agreement (ACT
IP), dated May 14, 2004 (the “License Agreement”), which grants LICENSEE defined
rights to use certain intellectual property controlled by LICENSOR; and
WHEREAS, the Parties also entered into that certain Agreement to Amend
ACT/Cellco License Agreements dated September 7, 2004 (the “Agreement to
Amend”), which contemplates that the Parties will amend the License Agreement in
certain respects; and
WHEREAS, the Parties have agreed to amend the License Agreement as provided
herein;
NOW, THEREFORE, in consideration of the premises and terms of this First
Amendment, and in consideration of the payment to LICENSOR by LICENSEE of
$84,375, the receipt of which is hereby acknowledged by LICENSOR, the Parties
agree to amend the License Agreement as follows:
1. Section 1.2 is deleted in its entirety and replaced with the following:

  1.2   “FIELD” shall mean (1) the research, development, manufacture and
selling to third parties of human and non-human animal cells for commercial
research use, including small molecule and other drug testing and basic research
and (2) the manufacture and selling of human cells for therapeutic and
diagnostic use in the treatment of human (a) diabetes, (b) liver diseases and
(c) retinal diseases and retinal degenerative diseases; but FIELD shall exclude
applications involving the use of cells in the treatment of tumors where the
primary use of the cells is the destruction or reduction of tumors and does not
involve regeneration of tissue or organ function.

2. Section 1.3 is deleted in its entirety and replaced with the following:

  1.3   “KNOW-HOW” means all compositions of matter, techniques and data and
other know-how and technical inventions (whether or not patentable),
improvements and developments, practices, methods, concepts, trade secrets,
documents, computer data, computer code, apparatus, clinical and regulatory
strategies, test data, analytical and quality control data, formulation,
manufacturing, patent data or descriptions, development information, drawings,
specifications, designs, plans, proposals and technical data and manuals and all
other proprietary

 

 

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      information that is owned or controlled by LICENSOR as of the Effective
Date that relates to cloning technology or to any of the subject matter
described in or claimed by the PATENT RIGHTS and is relevant to the FIELD. By
way of illustration, but not in limitation, KNOW-HOW shall include commercial
rights in the FIELD to any existing or potential research products, including
reagents, developed by LICENSOR in the course of its in-house research as more
fully described in Section 15.3 of this Agreement. An example of this is the
proprietary culture medium developed by LICENSOR in the course of the
development of LICENSOR’s proprietary ooplasmic transfer technology.

3. Section 1.9 is amended by deleting the text in Section 1.9 in its entirety
and replacing it with the following: “Intentionally omitted”.
4. Section 2.5 is deleted in its entirety and replaced with the following:
LICENSEE acknowledges and agrees that notwithstanding anything to the contrary
in this Agreement, LICENSOR may: (i) practice the LICENSED TECHNOLOGY and
develop and manufacture LICENSED PRODUCTS within the FIELD for research
purposes, provided that LICENSOR may not market or sell LICENSED PRODUCTS in the
FIELD to third parties in contravention of LICENSEE’S exclusive rights
hereunder; (ii) distribute or otherwise transfer cells or cell lines or other
reagents to collaborators for research purposes, and commercialize the results
of such research (other than media and other reagents produced for sale to the
commercial research market) outside the FIELD in connection with the research,
development, manufacture or sale of therapeutic products that are not in
contravention of LICENSEE’S exclusive rights hereunder; and (iii) distribute or
otherwise transfer cells or cell lines to collaborators for the purposes of
researching, developing and commercializing cell based therapeutics for purposes
other than those exclusively licensed to LICENSEE hereunder.
By way of illustration of subparagraph (ii) of Section 2.5 hereof, should
LICENSOR partner with a biopharmaceutical company in order to produce skin cells
for human therapeutic use, and in the process of basic research, preclinical, or
clinical development find it necessary or useful to transfer cell lines or other
reagents to that partner to facilitate the development of such dermatological
product, such transfer, provided that the transferred material is not sold or
marketed to such biopharmaceutical company for monetary compensation, shall be
considered outside of the FIELD.
LICENSOR may make LICENSED PRODUCTS available to its collaborators. In the event
LICENSOR requests that LICENSEE deliver to LICENSOR LICENSED PRODUCTS in the
FIELD for use in connection with the purposes described in the above paragraph,
LICENSEE shall make such LICENSED PRODUCTS available to LICENSOR on commercially
reasonable terms. LICENSOR may make

 

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LICENSED PRODUCTS in the FIELD, whether developed and manufactured by LICENSOR
or obtained from LICENSEE, available to its collaborators, provided that
LICENSOR enters into a license with any such collaborator that expressly
prohibits the collaborator from commercializing the LICENSED TECHNOLOGY in the
FIELD or using the LICENSED PRODUCTS in the FIELD for any purpose other than in
connection with the collaboration with LICENSOR for the purposes described
above. LICENSOR shall provide LICENSEE with a copy of any such license entered
into with a collaborator prior to delivering any LICENSED PRODUCTS in the FIELD;
provided, however, that LICENSOR may redact from such license agreements any
financial terms LICENSOR considers proprietary or confidential and not relevant
to LICENSEE’S exclusive rights hereunder, and provided further that any such
licenses provided to LICENSEE shall be considered and treated as Confidential
Information under Article 10 of this Agreement. Any license by LICENSOR to a
collaborator hereunder shall specifically provide that any intellectual property
developed under such collaboration shall be treated as if developed by LICENSOR
for purposes of determining if it is subject to any of the provisions of this
Agreement.
5. Section 2.6 is deleted in its entirety.
6. Section 4.3 is amended in part by deleting the text (including numbers) after
the words “and the following minimum amounts:” and replacing such text with the
following:

         
 
  (i)   At 12 months, $15,000
 
  (ii)   At 24 months, $37,500
 
  (iii)   At 36 months, $60,625
 
  (iv)   Annually thereafter, $75,000

7. Section 15.3 is amended by deleting the words “including any rights acquired
under Section 15.18 hereof,”.
8. Section 15.18 is amended by deleting the text in said Section in its entirety
and replacing it with the following:

  15.18   To support the grant of rights hereunder with respect to retinal
disease, LICENSOR shall provide the services of Robert Lanza, M.D., his
assistants and the use of such lab space and equipment as they may need that
LICENSOR can reasonable supply, understanding that Dr. Lanza, his assistants are
the full-time employees of LICENSOR and the equipment will be primarily used for
LICENSOR research. Such assistance will be for a period of the earlier of one
year from the date of this Amendment or until:

(a) the completion of preliminary animal studies to assess safety and efficacy
of applying cells for the treatment of retinitis pigmentosa and/or macular
degeneration (including any contracts or rights already established for initial
animal studies);

 

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(b) completion and submission of a scientific paper to a peer-reviewed journal
co-authored by LICENSOR and LICENSEE scientists presenting animal data and
analysis (subject to the pre-approval of both parties prior to publication);
(c) completion of consultations with the FDA to assess the suitability of animal
data gathered to initiate the paperwork for early stage human clinical trials;
(d) initiation of process of filing the paperwork for early stage human trials.
A committee composed of Michael West, Ph.D., Robert Lanza, M.D. and Irina
Klimanskaya, Ph.D., as the LICENSOR representatives, and Jeffrey Janus and two
additional representatives from LICENSEE that LICENSEE will promptly identify to
LICENSOR in writing (the “Committee”), will meet periodically during the
six-month period commencing on the Amendment Effective Date to discuss
completion of the above-identified tasks.
The LICENSEE Committee representatives may consult informally with the LICENSOR
Committee representatives, both in person and by telephone, regarding issues of
mutual interest identified by the Committee. The Committee shall meet during
such six-month period at the facilities of LICENSOR or LICENSEE as shall be
mutually determined; the time and place of such meetings, and the agenda for
such meetings, shall be determined by mutual agreement. It is contemplated by
the Parties that the Committee will meet three times during the six-month
period. Either party may replace its representatives at any time, upon written
notice and mutual agreement of the parties.
The foregoing notwithstanding, if LICENSOR is unable or unwilling to complete
the tasks outlined in this Section 15.18 above, LICENSEE shall have the right to
manage and carry the work forward so long as LICENSEE provides funding for the
project, in which case any intellectual property that is developed under
LICENSEE’s management and funding shall accrue to LICENSEE, and LICENSEE shall
be entitled to treat as prepayment of future licensing requirements under this
and other license agreements between LICENSOR and LICENSEE the actual costs
incurred by LICENSEE in completing subsections (a) through (d) above; provided,
however, that LICENSEE shall not be entitled to treat any such costs as
prepayment of future licensing requirements under this and other license
agreements between LICENSOR and LICENSEE if LICENSOR transfers to LICENSEE the
technological protocols, techniques and training necessary for LICENSEE to
replicate LICENSOR’S generation of retinal cells from stem cells. LICENSEE and
LICENSOR agree that the transfer to LICENSEE of the technological protocols,
techniques and training necessary for LICENSEE to replicate LICENSOR’S
generation of retinal cells from stem cells shall be complete when LICENSOR
provides LICENSEE with written copies of such protocols and techniques and two
weeks of additional lab training at the Worcester facility by two qualified
technicians within six months after the Amendment Effective Date.

 

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9. The Agreement is amended by replacing all references to the word “Product”
with the term “Licensed Product”.
10. This First Amendment shall be governed by and construed in accordance with
the laws of the State of Delaware, without regard to principles of conflicts of
law thereof, and shall be binding upon and inure to the benefit of the Parties
and their respective successors and assigns.
11. The Parties agree that the Agreement to Amend is terminated by mutual
agreement and that all of its provisions are superseded in their entirety by
this First Amendment. The License Agreement, as amended hereby, contains the
entire agreement of the Parties hereto and thereto with respect to the matters
discussed herein and therein. This First Amendment may not be modified except in
writing signed by the Parties.
12. Except to the extent specifically amended hereby, the terms and provisions
of the License Agreement are hereby ratified and affirmed in all respects and
continue in full force and effect.
IN WITNESS WHEREOF, this First Amendment has been executed by duly authorized
representatives of the Parties as of the Amendment Effective Date.
ADVANCED CELL, INC.
By: /S/ WILLIAM M. CALDWELL, IV
Printed Name: William M. Caldwell, IV
Title: Chief Executive Officer
LIFELINE CELL TECHNOLOGY, LLC
By: /S/ KENNETH ALDRICH
Printed Name: Kenneth Aldrich
Title: Managing Member

 

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