Portions herein identified by [*****]
have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
EXCLUSIVE LICENSE AGREEMENT
THIS
EXCLUSIVE LICENSE AGREEMENT (“Agreement”) is entered into as of this 5th day of December, 2013
(“Effective Date”) by and among CEDARS-SINAI MEDICAL CENTER,
a California nonprofit public benefit corporation (“CSMC”), with
offices at 8700 Beverly Boulevard, Los Angeles, California 90048-1865, SYNTHETIC BIOLOGICS, INC.,
a Nevada corporation, with offices at 155 Gibbs Street, Suite 412, Rockville, Maryland 20850 (“Synthetic”),
and SYNTHETIC BIOMICS, INC., a Nevada corporation with offices at 155 Gibbs Street, Suite 412, Rockville, Maryland 2085
which is a majority-owned subsidiary of Synthetic (the “Licensee”).
RECITALS
A. CSMC
owns and/or is entitled to grant license rights with respect to certain Patent Rights and Technical Information (as defined below)
invented or developed in connection with research performed at CSMC’s Gastrointestinal Motility Program and Laboratory
and CSMC’s Division of Endocrinology, Diabetes and Metabolism under the direction of Mark Pimentel, M.D., Henry Lin,
M.D., Christopher Chang, M.D., and Ruchi Mathur, M.D. (hereinafter collectively referred to as the “Inventors”).
B. CSMC
desires to have the Patent Rights and the Technical Information developed, used and commercialized in the Field of Use (as defined
below) by Licensee, and Licensee desires to obtain an exclusive, worldwide license to conduct research in the Field of Use, and
to develop, manufacture, use and sell Licensed Products and Licensed Technology Products (as defined below) in the Field of Use,
using the Patent Rights and Technical Information in accordance with the terms of this Agreement. Other than the rights expressly
granted by CSMC hereunder within the Field of Use, Licensee acknowledges that CSMC shall retain all other rights with respect
to the Patent Rights and the Technical Information.
C. CSMC
and Licensee intend that the execution, delivery and performance of this Agreement by each party, and the consummation of the
transactions contemplated hereunder, shall not at any time threaten CSMC’s tax-exempt status under Section 501(c)(3) of
the Internal Revenue Code and Section 23701d of the California Revenue and Taxation Code, or cause CSMC to be in default under
any of CSMC’s issued and outstanding tax-exempt bonds.
Now,
Therefore, in consideration of the mutual covenants and premises herein contained, and for other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:
1. Definitions
1.1 “Affiliate”
or “Affiliates” shall mean any corporation, person or entity, which controls, is controlled by, or is under
common control with, a party to this Agreement without regard to stock or other equity ownership. For purposes hereof, the terms
“control” and “controls” mean the possession, direct or indirect, of the power to direct or cause the
direction of the management and policies of a corporation, person or entity, whether through the ownership of voting securities,
by contract or otherwise.
Portions herein identified by [*****]
have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as
amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission.
1.2 “Confidential
Information” shall mean any confidential or proprietary information furnished by one party (the “Disclosing Party”)
to the other parties (the “Receiving Party”) in connection with this Agreement, including, without limitation, all
specifications, know-how, trade secrets, technical information, drawings, software, models, business information and patent applications
pertaining to the Patent Rights and Technical Information, and as further provided in Section 10 hereof.
1.3 “FDA”
shall mean the United States Food and Drug Administration, or any successor agency thereof.
1.4 “Field
of Use” shall mean all human or veterinary therapeutic, prophylactic, diagnostic or prognostic applications, excluding
the following:
1. the
therapeutic use of rifaximin;
2. the
therapeutic use of any of the following, as each is more fully described in U.S. Patent No. 6,558,708: (A) active lipids, (B)
serotonin, serotonin agonists, or serotonin re-uptake inhibitors, (C) peptide YY or peptide YY functional analogs, (D) calcitonin
gene-related peptide or functional analogs thereof, (E) adrenergic agonists, (F) opioid agonists, (G) combinations of any of (A),
(B), (C), (D), (E) and/or (F); and (H) antagonists of receptors for any of (B), (C), (D), (E) and/or (F));
3. the
diagnosis, prognosis, or the testing of, or the provision of information to clinicians or patients regarding, small intestinal
bacterial overgrowth (SIBO), and/or conditions or disorders related thereto in human subjects, using breath testing products or
breath testing services to detect SIBO or SIBO-related conditions (provided, however, that the right to include information
about diagnostic testing described in the Patent Rights as inclusion, exclusion or similar criteria for regulatory purposes, including
without limitation on prescribing labels shall not be excluded); and
4. the
diagnosis, prognosis, or the testing of, or the provision of information to clinicians or patients regarding, conditions, based
on the analysis of anti-vinculin antibodies and/or anti-CDT (cytolethal distending toxins) antibodies.
1.5 “Funding
Agencies” shall mean any public or private granting agencies which have provided funding to CSMC or to Dr. Pimentel
for the development of any of the Patent Rights or Technical Information prior to the Effective Date.
1.6 “Improvements”
shall mean all improvements or enhancements to the Patent Rights that, after the Effective Date, are conceived and reduced
to practice if patentable, or reduced to practice if not patentable, by or under the direction of any of the Inventors at CSMC.
For the avoidance of doubt, Improvements shall not include Sponsored Inventions (as defined in Section 2.4).
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
1.7 “Licensee
Developments” shall mean any and all processes, uses, designs, applications, methods and compositions-of-matter, indications,
improvements, enhancements and modifications in the Field of Use directly based upon or directly created using the Patent Rights
and/or Technical Information and which were discovered or developed by or on behalf of Licensee (exclusive of work performed by
CSMC or the Inventors) during the term of this Agreement.
1.8 “Licensed
Product” or “Licensed Products” shall mean all therapeutic and prophylactic products and all diagnostic
and/or prognostic products or services, in each case, the manufacture, use, offer for sale or sale of which would, but for the
licenses granted in this Agreement, directly or indirectly infringe a Valid Claim of a Patent Right in the jurisdiction in the
Territory where such product or service is manufactured, used, offered for sale or sold, and in each case, within the Field of
Use.
1.9 “Licensed
Technology” shall mean the clinical trial protocols, know-how, clinical trial results and data, developed and owned
by CSMC relating to the Licensed Products, and in each case, within the Field of Use.
1.10 “Licensed
Technology Product” shall mean a product or service made through the use of or incorporating Licensed Technology that
is not otherwise a Licensed Product.
1.11 “Net
Sales” shall mean the gross amount invoiced by Licensee or Permitted Sublicensees to third parties for all sales of
Licensed Products or Licensed Technology Products less (a) trade, cash or quantity discounts or rebates actually allowed or taken;
(b) credits for claims or allowances given or made for rejection of, or return of previously sold Licensed Products or Licensed
Technology Products or retroactive price reductions (including Medicare and similar types of rebates); (c) charges for prepaid
freight, insurance and other transportation costs directly related to the delivery of the Licensed Product or Licensed Technology
Product and invoiced by Licensee or Permitted Sublicensees; and (d) sales, transfer and other excise taxes or other governmental
charges actually paid in connection with sales of Licensed Products or Licensed Technology Products (but excluding what are commonly
known as franchise, income taxes and value-added taxes). Sales of Licensed Products or Licensed Technology Products by Licensee,
or a Permitted Sublicensee of Licensee, to any Permitted Sublicensee which is a reseller thereof shall be excluded, and only the
subsequent sale of such Licensed Products or Licensed Technology Products by Permitted Sublicensees of Licensee shall be deemed
Net Sales hereunder. If a Licensed Product or Licensed Technology Product is sold or provided as part of a system, package, or
combination product or service that involve one or more products or services not covered by the Patent Rights (each, a “Combination
Product”), Net Sales shall be calculated by multiplying the Net Sales of such Combination Product, by the fraction A/B,
where “A” is the price of the Licensed Product or Licensed Technology Product included in such Combination Product
when sold separately from any other products or services not covered by the Patent Rights and “B” is the price of
the Combination Product. In the event that no market price is available for the Licensed Product or Licensed Technology Products
included in such Combination Product when supplied or priced separately, CSMC and Licensee shall determine in good faith the fair
market value thereof.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
1.12 “Non-Royalty
Sublicense Revenues” shall mean, but is not limited to, upfront fees, license maintenance fees, and milestone payments,
or other payments, including the fair market value of any non-cash consideration, received by Licensee in consideration for any
rights granted to Patent Rights under a sublicense agreement, including but not limited to upfront and milestone payments, license
maintenance fees and the Fair Market Value of any non-cash consideration, excluding (a) sales-based royalties; and (b) reimbursements
for customary patent expenses with respect to Patent Rights. As used in this Section 1.12, “Fair Market Value”
means: (a) if the Permitted Sublicensee’s common stock is publicly traded on an exchange, the value of such equity using
a per share price equal to the average of the reported closing prices of such stock on such exchange for the twenty (20) trading
days prior to such purchase; or (b) if the Permitted Sublicensee’s common stock is not publicly traded, the value of such
equity determined by the Permitted Sublicensee’s Board of Directors in good faith based on the per share purchase price
of the Permitted Sublicensee’s most recent equity financing as of a date which is within thirty (30) days of the date as
of which the determination is to be made.
1.13 “Patent
Rights” shall mean the patents and/or patent applications existing on the Effective Date which are described on Schedule
A attached hereto, and any patent that issues thereon. The Patent Rights are all owned by CSMC. The Licensed Patent Rights
specifically exclude U.S. Patent Nos. 7,452,857, 7,605,240, 7,718,608, 7,935,799, 7,081,239, 7,244,412, 7,608,245, 7,615,207,
8,562,952, 6,558,708 and 5,977,175 and U.S. Patent Application Serial No. 11/411,733.
1.14 “Technical
Information” shall mean, as of the Effective Date, the following information in the Field of Use which is described
in the Patent Rights or otherwise provided to Licensee: know-how, trade secrets, unpublished patent applications, software, bioinformatics,
unpatented technology, technical information, statistical information and analyses, biological materials, chemical reagents, preclinical
and clinical information, in each case which has been conceived or reduced to practice prior to the Effective Date, in connection
with research performed at CSMC’s Gastrointestinal Motility Program and Laboratory and CSMC’s Division of Endocrinology,
Diabetes and Metabolism under the direction of one or any of the Inventors. The Technical Information shall further include information
in the Field of Use described in Schedule B hereto and which has been reduced to practice prior to the Effective Date in
the conduct of the aforementioned research programs at CSMC under the direction of one or any of the Inventors. Technical Information
is all owned by CSMC.
1.15 “Territory”
shall mean worldwide.
1.16 “Valid
Claim” shall mean a claim of an issued patent included within the Patent Rights, which claim has not: (a) lapsed, been
canceled, or become abandoned; (b) been declared invalid or unenforceable by a non-appealable decision or judgment of a court
or other appropriate body or authority of competent jurisdiction; or (c) been admitted to be invalid or unenforceable through
reissue, disclaimer or otherwise. The term Valid Claim shall also include the claims of a pending patent application within the
Patent Rights.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
2. License
2.1 Grant
of Exclusive Rights. Subject to the terms of this Agreement, CSMC hereby grants to Licensee, and Licensee hereby accepts
from CSMC, the exclusive license, with the right to grant sublicenses (subject to the terms of Section 2.3 hereof), under and
to the Patent Rights and Technical Information during the term of this Agreement (as provided in Section 6 hereof) to conduct
research in the Field of Use and to make, have made, use, develop, import, have imported, export, have exported, offer for sale,
or have offered for sale, sell and/or have sold Licensed Products and Licensed Technology Products in the Field of Use in the
Territory. The foregoing grant of exclusivity is made expressly subject to the following:
(a) All
applicable laws and regulations, including, without limitation, the requirements of federal law as pertain to the manufacture
of products within the United States;
(b) All
applicable rules of the Funding Agencies which have provided funding to CSMC or to any of its employees (including any of the
Inventors) for the development of the Patent Rights and Technical Information; and
(c) The
following non-exclusive rights to the Patent Rights and Technical Information, which are retained by CSMC within the Field of
Use:
(i) the
right to submit for publication the scientific findings from research conducted by or through CSMC or its investigators (including
the Inventors) related to the Patent Rights and the Technical Information; and
(ii) the
right (A) to use any tangible or intangible information contained in the Patent Rights or the Technical Information or any Improvements
(so long as CSMC shall treat such information as Confidential Information and maintain its confidentiality in accordance with
Section 10 hereof), for CSMC’s internal non-commercial scientific, research, internal teaching, non-profit clinical research
and other educationally-related and non-commercial (except for charges to its own patients) clinical purposes, where clinical
use does not involve a third party funding grant to commercialize such information, and (B) to obtain research funding for further
study and development thereof from governmental and other nonprofit organizations (including grant applications).
(d) Notwithstanding
any other provision hereof to the contrary, all rights to the Patent Rights, Technical Information and Improvements outside of
the Field of Use are retained by CSMC. Furthermore, this Agreement confers no license or rights by implication, estoppel, or otherwise
under any patent applications or patents of CSMC other than Patent Rights regardless of whether such patents are dominant or subordinate
to Patent Rights.
2.2 Guarantee
of Licensee’s Performance. Synthetic hereby unconditionally guarantees to CSMC the full and complete performance of
all of the terms, covenants and conditions of this Agreement as required to be performed by Licensee, including, but not limited
to, the payment of all amounts due hereunder. Synthetic’s guarantee obligations hereunder shall terminate on the later of
(a) the date on which Licensee ceases to be controlled or majority-owned by Synthetic, whether alone or together with one or more
of Synthetic’s Affiliates (other than Licensee); and (b) the date on which Licensee has paid CSMC the second milestone payment
required by Section 4.6(e)(ii). For purposes of this Section 2.2, the term “control” means the possession, direct
or indirect, of the power to direct or cause the direction of the management and policies of Licensee, whether through the ownership
of voting securities, by contract or otherwise.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
2.3 Sublicensing.
Licensee shall have the right to grant sublicenses or to assign (subject to Section 13.11) any or all of the rights granted
hereunder to (a) public companies listed on the NYSE, NYSE MKT, NYSE Arca or NASDAQ stock exchanges; (b) private companies having
at least $25 million in annual sales; or (c) entities which have been approved in writing by CSMC (such consent not to be unreasonably
withheld) (each, “Permitted Sublicensee”). Any such Permitted Sublicensee shall be subject in all respects to the
provisions contained in this Agreement and Licensee will remain primarily liable to CSMC for, and shall be responsible for monitoring
and enforcing, performance of all of Licensee’s obligations hereunder by any such Permitted Sublicensee. Without limiting
the generality of the foregoing, as an express condition of any such sublicense, any such Permitted Sublicensee shall be required
to agree in writing to be bound by commercially reasonable reporting and record keeping, indemnification and inspection provisions,
and the applicable provisions of this Agreement, including, without limitation, those pertaining to the use of CSMC’s name
and marks, indemnification of CSMC and the use of CSMC’s Confidential Information. Permitted Sublicensees may not further
sublicense without CSMC’s prior written consent, which consent shall not be unreasonably withheld. Licensee shall promptly
forward to CSMC a copy of any and all fully executed sublicense agreements, any subsequent amendments, and all copies of Permitted
Sublicensees’ profit sharing or royalty reports, in no event more than thirty (30) days following execution or receipt thereof,
as applicable. Licensee shall also keep CSMC reasonably informed with respect to the progress of any relations entered into with
any Permitted Sublicensees. If Licensee shall conduct one or more audits of its Permitted Sublicensees hereunder during the term
hereof, Licensee shall provide copies of all audit reports to CSMC on a timely basis. The covenants pertaining to the use of CSMC’s
name and marks, the indemnification of CSMC and the use of CSMC’s Confidential Information in any sublicense or assignment
shall run for the benefit of CSMC, who shall be expressly stated as being a third-party beneficiary thereof with respect to the
covenants set forth in this Agreement. Licensee understands and agrees that none of its permitted sublicenses hereunder shall
reduce in any manner any of its obligations set forth in this Agreement.
(a) Required
Sublicensing. If Licensee is unable or unwilling to serve or develop a potential market or market territory for which there
is a company willing to be a Permitted Sublicensee, Licensee will, at CSMC’s request, negotiate in good faith a sublicense
with any such Permitted Sublicensee.
(b) Royalty-Free
Sublicenses. If, and only if, Licensee pays all royalties due CSMC from a Permitted Sublicensee’s Net Sales, Licensee
may grant that Permitted Sublicensee a royalty-free or non-cash sublicense or cross-license.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
2.4 Sponsored
Research. Licensee shall sponsor at CSMC, under an Investigational New Drug application, at least one of the clinical trials
described in Schedule G attached hereto, for the purpose of testing an oral anti-methanogen for (a) constipation-predominant
irritable bowel syndrome and/or (b) obesity/hypercholesterolemia/pre-diabetes, as may be further enumerated pursuant to the protocols
and budgets to be mutually developed by the parties (each, a “Sponsored Clinical Trial”). In the event that Licensee
conducts the second clinical trial described in Schedule G, Licensee agrees to sponsor such clinical trial at CSMC. Any
inventions within the Field of Use that are (a) created, discovered or invented as a direct result of the Sponsored Clinical Trial(s)
and (b) the practice of which are generally described in a specification of the Patent Rights (each, a “Sponsored Invention”),
shall automatically be, and shall be deemed to be, without any further consideration and without any further action by the parties,
part of the rights licensed to Licensee under Section 2.1 hereof; provided, however, that to the extent that any such Sponsored
Invention is captured in a patent application, the parties shall amend Schedule A of this Agreement to include such patent
application.
2.5 Improvements.
Subject to the rights and applicable rules of the Funding Agencies, Licensee shall have, for a period of three (3) months
after receipt by Licensee of written notice from CSMC disclosing an Improvement, the exclusive first right to negotiate with CSMC
to obtain one or more licenses to the Improvement in the Field of Use upon such terms and conditions as shall be agreed by the
parties hereto, which terms and conditions shall include provisions for fair market value consideration for the grant of any such
licenses. If Licensee declines or fails to pursue a license to such Improvement in the Field of Use within the three (3) month
period described above, or if the parties engage in good faith negotiations and fail to conclude negotiations for a license to
such Improvement in the Field of Use within a six (6) month period from the date of such notice, then CSMC shall have the right
to commence discussions with any other party concerning such Improvement. Subject to the provisions of this Section 2.5, Licensee
acknowledges and agrees that CSMC expressly retains and reserves any and all right, title and interest in and to the Improvement,
whether or not in the Field of Use and, accordingly, no license to any Improvement is granted to Licensee under this Agreement.
2.6 Licensee
Developments. Licensee hereby grants, and shall require its Permitted Sublicensee(s) to grant to CSMC a nonexclusive, royalty-free,
irrevocable, paid-up license, with the right to grant sublicenses to non-profit research institutions and governmental agencies,
to practice and use Licensee Developments for non-commercial research purposes, which license shall include, without limitation,
the rights to: (a) publish the scientific findings from research conducted by or through CSMC or on its behalf; provided, however,
that Licensee is provided forty-five (45) days prior notice of any such publication and an opportunity to review such publication;
(b) use any tangible or intangible information contained in the Licensee Developments (so long as CSMC shall treat such information
as Confidential Information and maintain its confidentiality in accordance with Section 10 hereof), for CSMC’s internal
teaching and other educationally-related and non-commercial (except for charges to its own patients) clinical purposes, where
clinical use does not involve a third party funding grant to commercialize such information; and (c) obtain research funding from
governmental and other nonprofit organizations (including grant applications).
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
2.7 Milestones.
Licensee acknowledges that it is important to CSMC, and a requirement of the United States Government under Title 35, Section
203 of the United States Code, that Licensee pursue the development, commercialization and marketing of Licensed Products and
Licensed Technology Products and otherwise exercises commercially reasonable efforts to maximize the value of this Agreement to
CSMC. CSMC and Licensee have agreed on the Milestones set forth on Schedule F, with each such Milestone being deemed a
separate and independent condition. Within sixty (60) days after each anniversary of the Effective Date, Licensee shall prepare
and deliver to CSMC an annual written report (to be certified by an executive officer of Licensee) indicating its compliance with
the Milestones. If Licensee believes that it is or will be unable to achieve such Milestones despite its diligent efforts, Licensee
may request amendments or reasonable extensions to Schedule F in writing for CSMC’s consideration. Licensee agrees
to provide any additional information reasonably required by CSMC to evaluate Licensee’s performance under this Agreement.
If Licensee fails to meet any annual Milestone designated in Schedule F hereto, and has not obtained an extension or amendment
to such Milestone(s), CSMC may, at its option and as its sole remedy for Licensee’ breach of this Section 2.7, upon written
notice to Licensee, convert the exclusive license granted under Section 2.1 hereof to a non-exclusive license or to a co-exclusive
license, or terminate the license.
3. Representations
And Warranties
3.1 Rights
to Technology. Except for the rights, if any, of the Funding Agencies or the United States Government, CSMC represents and
warrants to Licensee that, to the best of its actual, current knowledge (without investigation outside of CSMC as to such representations
and warranties) (a) it has the right to grant the licenses in this Agreement; (b) it has not granted licenses to the Patent Rights
or Technical Information to any other party that would restrict the rights granted hereunder except as stated herein; and (c)
there are no claims, judgments or settlements to be paid by CSMC with respect the Patent Rights or Technical Information or pending
claims or litigation relating to the Patent Rights or Technical Information. Except for any potential or actual rights of Funding
Agencies or the United States Government, CSMC is not aware that any additional rights or licenses are necessary for Licensee
to exercise its licensed rights granted by CSMC under this Agreement.
3.2 Limited
Warranty; Certain Damages.
(a) Limited
Warranty. CSMC makes no representation or warranty other than those expressly specified in this Agreement. Licensee accepts
the Patent Rights and the Technical Information on an “AS-IS” basis. OTHER THAN AS SET FORTH IN THIS AGREEMENT, CSMC
MAKES NO OTHER WARRANTIES CONCERNING PATENT RIGHTS OR TECHNICAL INFORMATION COVERED BY THIS AGREEMENT, INCLUDING WITHOUT LIMITATION,
ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO PATENT RIGHTS, TECHNICAL INFORMATION
OR ANY PRODUCT. OTHER THAN AS SET FORTH IN THIS AGREEMENT CSMC MAKES NO WARRANTY OR REPRESENTATION AS TO THE VALIDITY OR SCOPE
OF PATENT RIGHTS, OR THAT ANY PRODUCT WILL BE FREE FROM AN INFRINGEMENT ON PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES, OR THAT NO THIRD PARTIES ARE IN ANY WAY INFRINGING PATENT RIGHTS COVERED BY THIS AGREEMENT. LICENSEE HEREBY AGREES THAT
LICENSEE WILL NOT GIVE, AND SHALL NOT PERMIT ANY AFFILIATES OR SUBLICENSEES OR AFFILIATES THEREOF TO GIVE, ANY SUCH WARRANTY OR
REPRESENTATION TO THIRD PARTIES ON BEHALF OF CSMC.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
(b) Certain
Damages. EXCEPT FOR THE BREACH OF THE CONFIDENTIALITY PROVISIONS IN SECTION 10 OR IN ACCORDANCE WITH THE OBLIGATION TO INDEMNIFY
SET FORTH IN SECTION 8, IN NO EVENT SHALL CSMC BE LIABLE FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING, WITHOUT
LIMITATION, DAMAGES FOR LOSS OF PROFITS OR EXPECTED SAVINGS OR OTHER ECONOMIC LOSSES, OR FOR INJURY TO PERSONS OR PROPERTY) ARISING
OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER, REGARDLESS OF WHETHER CSMC KNOWS OR SHOULD KNOW OF THE POSSIBILITY
OF SUCH DAMAGES. EXCEPT FOR THE BREACH OF THE CONFIDENTIALITY PROVISIONS IN SECTION 10 OR IN ACCORDANCE WITH THE OBLIGATION TO
INDEMNIFY SET FORTH IN SECTION 8, CSMC’S AGGREGATE LIABILITY FOR ALL DAMAGES OF ANY KIND RELATING TO THIS AGREEMENT OR ITS
SUBJECT MATTER SHALL NOT EXCEED THE AMOUNT PAID BY LICENSEE TO CSMC UNDER THIS AGREEMENT. THE FOREGOING EXCLUSIONS AND LIMITATIONS
SHALL APPLY TO ALL CLAIMS AND ACTIONS OF ANY KIND, WHETHER BASED ON CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO NEGLIGENCE),
OR ANY OTHER GROUNDS.
3.3 Rights
Retained by Funding Agencies. Licensee acknowledges that to the extent that the Patent Rights and Technical Information have
been developed in part under one or more funding agreements (“Funding Agreements”) with one or more Funding Agencies,
such Funding Agencies have certain statutory, non-exclusive rights relative thereto for use for government purposes as well as
regulatory or statutory “march-in rights” (collectively, “Statutory Rights”). Licensee also acknowledges
that to the extent that the Improvements may be developed in part under one or more Funding Agreements with one or more Funding
Agencies, such Funding Agencies may have certain Statutory Rights relative thereto. This Agreement is explicitly made subject
to such Statutory Rights and, to the extent of any conflict between any such Statutory Rights and this Agreement, such Statutory
Rights shall prevail.
4. Consideration
In consideration of
the execution and delivery by CSMC of this Agreement, Licensee agrees as follows:
4.1 Initial
License Fee. No later than thirty (30) days after the execution of this Agreement, Synthetic shall issue to CSMC $150,000
in shares of its common stock; provided that such share issuance shall be subject to Section 4.5 hereof and the execution of a
Stock Purchase Agreement in the form attached hereto as Schedule C (the “Synthetic Stock Purchase Agreement”).
Failure of Synthetic either to issue such shares to CSMC or pay the equivalent amount in cash to CSMC within thirty (30) days
of the execution of this Agreement shall render this Agreement null and void (ab initio).
4.2 Reimbursement
of Patent Expenses. No later than thirty (30) days after the execution of this Agreement, CSMC shall be reimbursed
for its prior patent expenses related to Patent Rights through the issuance by Synthetic to CSMC of $220,000 in shares of its
common stock; provided that such share issuance shall be subject to Section 4.5 hereof and the execution of the Synthetic Stock
Purchase Agreement. Failure of Licensee either to issue such shares to CSMC or pay the equivalent amount in cash to CSMC within
thirty (30) days of the execution of this Agreement shall render this Agreement null and void (ab initio).
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
4.3 Annual
Maintenance Fee. Commencing on the second annual anniversary of this Agreement, and each anniversary thereof, Licensee shall
pay CSMC an annual maintenance fee of $**** (“Maintenance Fee”). The Maintenance Fee shall be creditable against Royalties
otherwise payable hereunder during the applicable twelve (12) month period; provided, however, that Licensee may not carry
over to the following year any amount by which the Maintenance Fee paid exceeds the actual amount of Royalties payable hereunder
during the applicable twelve (12) month period.
4.4 Licensee
Equity Issuance. Prior to execution of this Agreement, Licensee shall have issued eleven and one-half percent (11.5%) of its
issued and outstanding shares of common stock on a fully diluted basis to CSMC, subject to execution of a Stock Purchase Agreement
in the form attached hereto as Schedule D (the “Licensee Stock Purchase Agreement”). Failure of Licensee to
issue such shares shall render this Agreement null and void (ab initio). Such shares issued hereunder shall be of the same
class and series as founders’ shares. A true and complete copy of Licensee’s capitalization table as of the Effective
Date of the Agreement is set forth in Schedule E hereto. CSMC shall have the anti-dilution protections, tag-along rights
and the right to exchange CSMC’s equity in Licensee for equity in Synthetic as set forth in the Licensee Stock Purchase
Agreement.
4.5 Exchange
Approval. The parties acknowledge that subject to Synthetic’s obligations under the Synthetic Stock Purchase Agreement(s),
any issuance of stock by Synthetic hereunder, including with respect to the license fees, patent expense reimbursements, and Milestone
payments referred to herein, may be subject to the prior approval of the NYSE MKT or any other exchange upon which the shares
of Synthetic are traded, and shareholder approval, if so required by such exchange or any other rule or regulation applicable
to the Licensee or Synthetic. Synthetic shall submit an application to the NYSE MKT for approval to issue the shares required
to be issued under Sections 4.1 and 4.2 within five (5) days of the execution of this Agreement. In the event that Synthetic elects
to pay either or both of the Phase I and Phase II Milestone payments described in Section 4.6(e)(ii) by issuing shares of Synthetic
stock to CSMC, Synthetic shall submit an application to the NYSE MKT for approval to issue such shares within thirty (30) days
of the occurrence of the applicable Milestone. In the event that Synthetic shall not have received shareholder approval or NYSE
MKT approval to issue any such shares hereunder
within fifteen (15) business days of the submission of any such application to the NYSE MKT, then Company shall instead make cash
payments in satisfaction of its obligations under Sections 4.1, 4.2 and/or 4.6(e)(ii), as applicable.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
4.6 Royalties
and Non-Royalty Revenue.
(a) Running
Royalties for Licensed Products and Licensed Technology Products. Licensee agrees to pay and shall pay to CSMC the following
running royalties: (a) **** percent (****%) of Net Sales of Licensed Products made, used, sold or otherwise distributed by Licensee
or any Permitted Sublicensee hereunder; and (b) **** percent (****%) of Net Sales of Licensed Technology Products made, used,
sold or otherwise distributed by Licensee or any Permitted Sublicensee hereunder (each, a “Royalty”). If Licensee
is required to make any payment to a third party to obtain a license for the manufacture, use, sale or import of a Licensed Product
or Licensed Technology Product or otherwise exploit the Licensed Patent Rights, Licensee shall be entitled to deduct up to ****
percent (****%) of such third party payments made in a particular calendar year against Royalties payable to CSMC for that year;
provided, however, that in no event shall the Royalties payable to CSMC hereunder for any one-year period be reduced by
operation of this section by more than **** percent (****%); and provided, further, that such third party payments shall
only be creditable against Royalties payable to CSMC for the calendar year in which the third party payment was actually made
by Licensee.
(b) Licensee
Challenge of Patent Rights. Should Licensee bring, directly or through a third party indirectly, an action challenging the
validity, scope or enforceability of any Patent Rights, Licensee will first provide CSMC with at least ninety (90) days’
prior written notice that it intends so to do before filing such a challenge. Following the giving of such notice, Licensee will
pay to CSMC the Royalties and Non-Royalty Sublicense Revenue due hereunder at the rate of two times the applicable rate during
the pendency of such action. Should the outcome of such action determine that any claim of a patent challenged by Licensee is
valid and/or infringed and/or enforceable, as applicable, Licensee will thereafter pay to CSMC the Royalties and Non-Royalty Sublicense
Revenue due hereunder at the rate of three times the applicable rate for all Licensed Products and Licensed Technology Products
sold that would infringe such claim and/or transactions that include a grant of rights to such claim. Such increased royalty reflects
the increased value of the Patent Rights upheld in such action. In the event that a challenge of Patent Rights brought by Licensee
is partially or entirely successful, Licensee will have no right to recoup any Royalties or other amounts paid before or during
the period of the challenge. Additionally, Licensee agrees to disburse any and all proceeds received from any sublicense of the
applicable Patent Rights throughout the duration of any such challenge to CSMC, and agrees to reimburse CSMC for all costs actually
incurred by CSMC in connection with the applicable legal proceedings. In the event that all or any portion of this Section 4.6(b)
is invalid, illegal or unenforceable, then the parties will use their best efforts to replace the invalid, illegal or unenforceable
provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, gives effect to the intent of this Section
4.6(b).
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
(c) Arm’s-Length
Transactions. On sales of Licensed Products and Licensed Technology Products which are made in other than an arms’-length
transaction, the value of the Net Sales attributed under this Section 4.6 to such a transaction shall be that which would have
been received in an arms’-length transaction, based on sales of like quality and quantity products on or about the time
of such transaction.
(d) Duration
of Royalty Obligations. The royalty obligations of Licensee as to each Licensed Product shall terminate on the later of, on
a country-by-country basis, (a) the expiration of the last to expire of a Valid Claim within the Patent Rights that covers such
Licensed Product, including any term extensions thereof, or (b) twelve years after the first commercial sale of such Licensed
Product. The royalty obligations of Licensee as to each Licensed Technology Product shall terminate twenty (20) years after the
first commercial sale of such Licensed Technology Product.
(e) Non-Royalty
Revenues.
(i) Non-Royalty
Sublicense Revenues. Any and all “Non-Royalty Sublicense Revenues” shall be reported and paid to CSMC by Licensee
as set forth below within sixty (60) days of receipt by Licensee. Licensee shall pay to CSMC a percentage of these Non-Royalty
Sublicense Revenues according to the following schedule:
| Effective Date
of Sublicense Agreement |
|
Percent of Non-Royalty
Sublicense
Revenues Payable to CSMC |
| Prior to initiation of Phase I clinical trial |
|
****% |
| Prior to initiation of Phase II clinical trial |
|
****% |
| Prior to initiation of Phase III clinical trial |
|
****% |
| After initiation of Phase III clinical trial |
|
****% |
Any non-cash consideration
received by Licensee from Permitted Sublicensees shall be valued at its Fair Market Value as of the date of receipt and such amount
shall be paid in cash to CSMC in accordance with the schedule above. In the event that the Patent Rights are sublicensed in combination
with one or more patented technologies that are not covered under this Agreement, Non-Royalty Sublicense Revenues for the purposes
of this Section 4.6(e) shall be calculated on a pro-rata basis in a manner to be mutually agreed by CSMC and Licensee (which agreement
may be a condition of approval under Section 2.3).
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
(ii) Product
Development Milestones. Licensee agrees to pay and shall pay to CSMC the following non-creditable, non-refundable product
development milestone payments within sixty (60) days of the first occurrence of a milestone (or its equivalent):
| Milestone Event |
|
Milestone Payment |
| |
|
|
| On a Licensed Product by Licensed Product and Licensed Technology Product by Licensed Technology
Product basis: |
|
|
| |
|
|
| Successful Phase I trial completion for first Licensed Product or first Licensed Technology
Product |
|
$**** (payable in cash or as $**** worth (at the time the payment is due) of stock of Synthetic
at Licensee’s option, subject to the terms of the Synthetic Stock Purchase Agreement) |
| |
|
|
| Successful Phase II trial completion for first Licensed Product or first Licensed Technology
Product and thereafter upon initiation of Phase III patient dosing for each additional indication of a Licensed Product and/or
Licensed Technology Product |
|
$**** (payable in cash or as $**** worth (at the time the payment is due) of stock of Synthetic
at Licensee’s option, subject to the terms of the Synthetic Stock Purchase Agreement |
| |
|
|
| Successful Phase III trial completion |
|
$**** |
| |
|
|
| FDA’s acceptance of the NDA |
|
$**** |
| |
|
|
| Regulatory Approval |
|
$**** |
| |
|
|
| First Commercial Sale |
|
$**** |
For the avoidance of
doubt, in the event that Licensee has paid CSMC the required milestone payments with respect to a Licensed Product or Licensed
Technology Product, new milestone payments (as set forth above) shall be due in the event that the Licensee proceeds with the
development of new indications of such Licensed Product or Licensed Technology Product and initiates Phase III patient dosing
for such new indications; provided, however, that no new milestone payments shall be due in the event that Licensee proceeds
with subsequent clinical trials testing different formulations or dosing requirements with respect to such Licensed Product or
Licensed Technology Product.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
(f) Payment
and Accounting.
(i) Reports.
Each payment of Royalties shall be accompanied by a report in the form attached as Schedule H hereto, which sets forth
in reasonable detail the number and each type of Licensed Product and Licensed Technology Product sold and the calculation of
Net Sales applicable thereto, and such additional details as may be reasonably requested by CSMC for the determination of Royalties
payable hereunder. Licensed Products and Licensed Technology Products shall be considered as being sold for the purpose of the
calculation of Royalties under this Agreement when payment has been received for the Licensed Products or Licensed Technology
Products. Each payment of Non-Royalty Sublicense Revenue shall be accompanied by a report in the form attached as Schedule
H hereto setting forth in reasonable detail the basis for the calculation of such amounts, and such additional details as
may be reasonably requested by CSMC for the determination of Non-Royalty Sublicense Revenue payable hereunder. Hard copies of
such reports shall be sent to CSMC’s address set forth in Section 13.1 of the Agreement, while an electronic copy shall
be sent by electronic mail to CSTechTransfer@cshs.org. Except as otherwise provided herein, all amounts due hereunder shall
be paid in United States dollars and shall be made without set off and free and clear of (and without any deduction or withholding
for) any taxes, duties, levies, imposts or similar fees or charges. Royalties shall be payable by Licensee quarterly, within sixty
(60) days after the end of each calendar quarter, based upon revenues received during the immediately preceding calendar quarter.
Licensee agrees to pay and shall pay to CSMC, or cause its Permitted Sublicensees to pay to CSMC, all Royalties resulting from
the activities of its Permitted Sublicensees, within sixty (60) days after the end of each calendar quarter in which Licensee
has received payment from the Permitted Sublicensees.
(ii) Notice
of Payment. Licensee shall provide prompt written notice to CSMC that it has paid any annual maintenance fee required by Section
4.3 or any product development milestone payment required by Section 4.6(e) by electronic mail to CSTechTransfer@cshs.org.
(iii) Wire
Transfer Instructions. All payments due hereunder shall be made by Licensee to CSMC in accordance with the following wire
transfer instructions:
****
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
(iv) Records
and Audits. Licensee shall create and maintain complete and accurate records and documentation concerning all sales of Licensed
Products and Licensed Technology Products by Licensee, its Affiliates and Permitted Sublicensees as well as transactions based
upon which Non-Royalty Sublicense Revenue is due, in sufficient detail to enable the Royalties and Non-Royalty Sublicense Revenue,
respectively, that is payable hereunder to be determined. Licensee shall retain such records and documentation for not less than
seven (7) years from the date of their creation. During the term of this Agreement and for a period of three (3) years thereafter,
CSMC and its representatives shall have the right to audit such records and documentation as shall pertain to the determination
and payment of Royalties and Non-Royalty Sublicense Revenue upon ten (10) days prior written notice to Licensee. Such examiners
shall have reasonable access during regular business hours to Licensee’s offices and the relevant records,
files and books of account, and shall have the right to examine any other records reasonably necessary to determine the accuracy
of the calculations of Royalties and Non-Royalty Sublicense Revenue provided by Licensee; provided, however, that such
examiners must execute a confidentiality agreement in form and substance satisfactory to Licensee. The costs of any such audit
shall be borne by CSMC, unless as a result of such inspection it is determined that the amounts payable by Licensee for any period
are in error by greater than five percent (5%), in which case the costs of such audit shall be borne by Licensee. CSMC shall report
the results of any such audit to Licensee within thirty (30) days of completion. Thereafter, Licensee shall promptly pay to CSMC
the amount of any underpayment discovered in such audit, or CSMC shall credit to Licensee against future Royalty payments the
amount of any overpayment discovered in such audit, as the case may be. In addition, Licensee shall pay interest on any underpayment
at the rate that is the lower of (i) two percent (2%) over the rate of interest announced by Bank of America in Los Angeles, California
(or any successor in interest thereto or any commercially equivalent financial institution if no such successor exists) to be
its “prime rate”, or (ii) the highest rate permitted by applicable law, from the date such amount was underpaid to
the date payment is actually received.
(v) Currency
Transfer Restrictions. If any restrictions on the transfer of currency exist in any country or other jurisdiction so as to
prevent Licensee from making payments to CSMC, Licensee shall take all commercially reasonable steps to obtain a waiver of such
restrictions or to otherwise enable Licensee to make such payments. If Licensee is unable to do so, Licensee shall make such payments
to CSMC in a bank account or other depository designated by CSMC in such country or jurisdiction, which payments shall be in the
local currency of such country or jurisdiction, unless payment in United States dollars is permitted. Any payment by Licensee
to CSMC in currencies other than United States dollars shall be calculated using the appropriate foreign exchange rate for such
currency quoted in the California edition of The Wall Street Journal for the close of business of the last banking day
of the calendar quarter in which such payment is being made.
(vi) Late
Charges. A service charge of two percent (2%) per month, not to exceed the maximum rate allowed by applicable law, shall
be payable by Licensee on any portion of Licensee’s outstanding Royalty or Non-Royalty Sublicense Revenue balance or any
other amount payable by Licensee hereunder that is not paid to CSMC within thirty (30) days past the due date
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
(vii) Taxes.
Licensee shall pay, or cause to be paid, any and all taxes required to be paid or withheld on any sales, licenses or other
transfers for value of Licensed Products, Licensed Technology Products or Patent Rights (other than taxes imposed on the income
or revenues of CSMC); provided, however, that under no circumstances shall the amounts of such taxes be deducted from the
total amount of payments otherwise due to CSMC hereunder. Upon CSMC’s request, Licensee shall secure and send to CSMC proof
of any such taxes withheld and paid by Licensee, its Affiliates or Permitted Sublicensees.
(viii) No
Escrow. Licensee shall pay all Royalties and Non-Royalty Sublicense Revenue directly to CSMC and shall not pay royalties into
any escrow or other similar account, including in the event of a validity or non-infringement challenge to the Patent Rights.
5. Patent
Rights
5.1 Prosecution.
CSMC will continue to have full responsibility for the application, maintenance, reexamination, reissue, opposition and prosecution
of any kind relating to the Patent Rights in the Territory (“Prosecution”) with due input from Licensee and using
counsel reasonably acceptable to Licensee; provided, however, that CSMC’s patent counsel shall bill Licensee directly
for all costs and expenses, including reasonable attorneys’ fees, filing fees and translation fees incurred in the prosecution
of the Patent Rights (“Prosecution Costs”).
5.2 Abandonment,
Disclaimers, etc. CSMC shall not abandon, disclaim, withdraw, seek reissue or allow to lapse any patent or patent application
within the Patent Rights as long as Licensee continues to timely and fully pay all Prosecution Costs as set forth in Section 5.1;
provided, however, that Licensee may elect to notify CSMC of its decision not to continue to pay the Prosecution Costs
to prosecute or maintain a patent or patent application included in the Patent Rights in various jurisdictions at least forty-five
(45) days before a final due date which would result in abandonment or bar of patentability of the patent or patent application
with respect to such jurisdiction. In such event, CSMC may, at its sole option, continue Prosecution of the patent application
or patent at its own cost and expense; provided, however, that in the event that CSMC intends to develop or commercialize
any product in such jurisdiction with any third party based upon such patent or patent application, Licensee shall have an exclusive
first right of negotiation for a period lasting sixty (60) days following notice from CSMC to Licensee of its intent to so develop
or commercialize with respect to such patent or patent application, and if Licensee either does not exercise such right or if
a license is not concluded with Licensee within the aforesaid sixty (60)-day period, then this right shall expire and CSMC shall
have no further obligation to Licensee with respect to such patent or patent application.
5.3 CREATE
Act. Licensee shall not invoke the Cooperative Research and Technology Enhancement Act of 2004, as set forth under Title 35,
Section 102(c) of the United States Code (the “CREATE Act”), with respect to the Patent Rights without first obtaining
the prior written consent of CSMC.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
6. Term
And Termination
6.1 Term.
Unless earlier terminated as provided in Section 6.2 hereof, the term of this Agreement shall commence on the Effective Date
and shall expire, on a country-by-country and Licensed Product-by-Licensed Product and/or Licensed Technology Product-by-Licensed
Technology Product basis, upon expiration of Licensee’s obligation to pay royalties for such Licensed Product or Licensed
Technology Product in such country.
6.2 Termination.
Except as provided by Section 6.3 hereof, and in addition to the termination provisions of Section 2.7, this Agreement shall
terminate upon the earliest to occur of the following:
(a) Automatically
if Licensee shall enter into a liquidating bankruptcy, be adjudged insolvent, liquidate, dissolve and/or if the business of Licensee
shall be placed in the hands of a receiver, assignee, or trustee, whether by voluntary act of Licensee or otherwise; provided,
however, that if any such action is involuntary, termination shall not take place unless the action is not reversed within
thirty (30) days. Further, Licensee shall give CSMC at least forty-five (45) days’ prior written notice before Licensee
initiates any bankruptcy proceeding, and CSMC shall have the right to terminate this Agreement immediately upon receipt of such
notice;
(b) Automatically
if the performance by either party to this Agreement of any term, covenant, condition or provision hereof: (i) shall jeopardize
(A) the licensure of CSMC; (B) CSMC’s participation in the Medicare, Medi-Cal or other reimbursement or payment programs;
(C) the full accreditation of CSMC by the Joint Commission of Accreditation of Healthcare Organizations or any other state or
nationally recognized accreditation organization; or (D) CSMC’s tax-exempt status; or (ii) is deemed illegal or unethical
by any recognized governmental agency or body. Upon the occurrence of any of the items set forth in this subparagraph (b), CSMC
shall provide written notice to Licensee setting forth the reason for such termination (which termination shall be effective immediately);
(c) Upon
thirty (30) days’ written notice from CSMC if, within such thirty (30) day period (i) Licensee shall fail to pay fully any
Royalty or Non-Royalty Sublicense Revenue payment required by Section 4.3 hereof, or (ii) Licensee shall fail to undertake commercially
reasonable efforts to exploit the Patent Rights in the Field of Use in the Territory, regardless of Licensee’s satisfaction
of the Milestones provided in Schedule F hereto;
(d) Upon
sixty (60) days’ written notice from CSMC if, within such sixty (60) day period, Licensee shall fail to cure fully any breach
or default of any material obligation under this Agreement as described in such written notice detailing the facts of such breach
with reasonable specificity; provided, however, that Licensee may avoid such termination if, before the end of such 60-day
period, such breach or default has been cured by Licensee to the reasonable satisfaction of CSMC;
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
(e) Upon
ninety (90) days’ written notice from Licensee if, within such ninety (90) day period, CSMC shall fail to cure fully any
breach or default of any material obligation under this Agreement as described in such written notice detailing the facts of such
breach with reasonable specificity; provided, however, that CSMC may avoid such termination if, before the end of such
90-day period, such breach or default has been cured by CSMC to the reasonable satisfaction of Licensee;
(f) Licensee
shall have the right to terminate this Agreement at any time without cause upon six (6) months written notice to CSMC; provided,
however, that in the event of such termination without cause by Licensee, Licensee shall pay to CSMC a termination fee calculated
in accordance with the following table no later than the effective date of termination:
| Time of Termination | |
Termination Fee | |
| Prior to IND Submission | |
$ | **** | |
| Prior to completion of Phase II clinical trial | |
$ | **** | |
| Prior to completion of Phase III clinical trial | |
$ | **** | |
| Following completion of Phase III clinical trial | |
$ | **** | |
(g) Upon
the mutual written agreement of the parties hereto (such termination to be effective as of the date mutually agreed upon in such
written agreement).
6.3 Obligations
Upon Termination. Upon any termination of this Agreement pursuant to Section 6.2 hereof, nothing herein shall be construed
to release any party from any liability for any obligation incurred through the effective date of termination (e.g., confidentiality,
reimbursement of patent expenses incurred prior to such date, etc.) or for any breach of this Agreement prior to the effective
date of such termination. Obligations which accrued prior to termination (including milestones which have been triggered) would
survive termination.
Licensee may, for
a period of one (1) year after the effective date of such termination, sell all tangible Licensed Products and Licensed Technology
Products customarily classified as “inventory” that it has on hand at the date of termination, subject to payment
by Licensee to CSMC of the applicable Royalty and Non-Royalty Sublicense Revenue; provided, however, that any such action
by Licensee does not subject CSMC to any of the occurrences set forth in Section 6.2(b) hereof.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
6.4 Effect
of Termination. In the event of any termination of this Agreement pursuant to Section 6.2 hereof, where such termination has
not been caused by any action or inaction on the part of any Permitted Sublicensee of Licensee or by any breach by such Permitted
Sublicensee of its obligations under its sublicense from Licensee, such termination of this Agreement shall be without prejudice
to the rights of each non-breaching Permitted Sublicensee of Licensee and each non-breaching Permitted Sublicensee shall be deemed
to be a licensee of CSMC thereunder, and CSMC shall be entitled to all rights, but shall not be subject to any obligations (other
than the grant of license and appurtenant obligations under this Agreement to the extent provided for in such sublicense) of Licensee
thereunder. This Section 6.4, however, shall not be applicable if this Agreement has been terminated under Section 6.2(b) under
circumstances where the application of this Section 6.4 would subject CSMC to any of the occurrences set forth in Section 6.2(b).
6.5 Right
to Institute Legal Actions. Notwithstanding the provisions of Section 6.2 hereof, CSMC, on the one hand, and Licensee,
on the other hand, may institute any other legal action or pursue any other remedy against the other party permitted by applicable
law if the other party does not substantially cure any breach or default of any material obligation as provided herein.
6.6 Reversion
of Rights. Notwithstanding anything to the contrary set forth herein (including, but not limited to, Section 5 hereof),
full responsibility for Prosecution of the Patent Rights shall, at the option of CSMC (exercisable in its sole and absolute discretion),
and at its sole expense from the date of reversion, revert to CSMC upon any termination of this Agreement.
6.7 Return
of Data. In the event of any termination or expiration of this Agreement, Licensee may consider providing CSMC with copies
of data, information and materials obtained or generated by or on behalf of Licensee in the course of conducting research and
developing Licensed Products and Licensed Technology Products using the Patent Rights and the Technical Information.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
7. Infringement
By Third Parties
7.1 Enforcement.
Subject to contradictory obligations CSMC may have to any other licensee thereof, Licensee shall have the first right and
the obligation to enforce, at its sole expense, any Patent Rights to the extent licensed hereunder against infringement by third
parties and shall notify CSMC in writing in advance of all such enforcement efforts. Upon Licensee’s undertaking to pay
all expenditures reasonably incurred by CSMC, CSMC shall reasonably cooperate in any such enforcement and, as necessary, join
as a party therein. Licensee shall reimburse CSMC for all expenses, including reasonable attorneys’ fees, incurred in connection
with any such enforcement. In the event that Licensee does not file suit against or commence and conclude settlement negotiations
with a substantial infringer of Patent Rights within ninety (90) days of receipt of a written demand from CSMC that Licensee bring
suit, then the parties will consult with one another in an effort to determine whether a reasonably prudent licensee would institute
litigation to enforce the patent in question in light of all relevant business and economic factors (including, but not limited
to, the projected cost of such litigation, the likelihood of success on the merits, the probable amount of any damage award, the
prospects for satisfaction of any judgment against the alleged infringer, the possibility of counterclaims against the parties
hereto, the impact of any possible adverse outcome on Licensee and the effect any publicity might have on the parties’ respective
reputations and goodwill). If, after such process, it is determined that a suit should be filed and Licensee does not file suit
or commence settlement negotiations forthwith against the infringer, then CSMC shall have the right, at its own expense, to enforce
any Patent Rights licensed hereunder on behalf of itself and Licensee. Any damages or other recovery from an infringement action
undertaken by Licensee shall first be used to reimburse the parties, on a pro rata pari passu basis, for the costs and
expenses incurred in such action, and shall thereafter be allocated between the parties as follows: (i) fifty percent (50%)
to CSMC and (ii) fifty percent (50%) to Licensee. If Licensee fails to prosecute any such action to completion, then any
damages or other recovery net of the parties’ costs and expenses incurred in such infringement action shall be the sole
property of CSMC. The foregoing notwithstanding, to the extent that any portion of damages awarded in a lawsuit brought by Licensee
are specifically allocated in a judgment as lost sales, the amount due to CSMC for such amount shall be based on treating such
amount as Net Sales.
7.2 Defense
of Patent Rights. In the event that any Patent Rights are the subject of a legal action seeking declaratory relief or of
any reexamination or opposition proceeding instituted by a third party, the parties agree to promptly consult with each other
concerning the defense of such actions or proceedings. If the parties agree that such defense should be undertaken, then Licensee
shall bear the expenses, including attorneys’ fees, associated with such defense and in any recoupment of expenses. If the
parties disagree, then the party desiring to defend the action or proceeding may proceed with such defense and will bear its own
expenses, and be entitled to all sums recovered.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
8. Indemnification
8.1 Indemnification
by Licensee. Subject to Section 8.2 hereof, Licensee shall hold harmless, defend and indemnify CSMC and each of its officers,
directors, employees (including the Inventors), agents and sponsors of the research (except Licensee) (each, an “Indemnified
Party”, and collectively, the “Indemnified Parties”) from and against any and all claims, damages, losses, liabilities,
costs and expenses (including reasonable attorneys’ fees and expenses and costs of investigation, whether or not suit is
filed) suffered or incurred by any of the Indemnified Parties in any action, suit, litigation, arbitration or dispute of any kind
(“Action”) arising or resulting from any negligence or willful acts or omissions on the part of Licensee, its Affiliates
or Permitted Sublicensees in connection with (a) their use the Patent Rights or Technical Information and/or (b) the exercise
of their rights hereunder or under any sublicense, including, but not limited to (i) the preclinical development and clinical
testing of Licensed Products or Licensed Technology Products, and (ii) the manufacture, sale, use, marketing, or other disposition
of Licensed Products or Licensed Technology Products developed, manufactured, sold, marketed, used or otherwise disposed of under
this Agreement. As part of its obligations hereunder, Licensee shall defend any Action brought against any of the Indemnified
Parties with counsel of its own choosing and reasonably acceptable to CSMC, and neither CSMC nor any other Indemnified Party shall
enter into any settlement of any such Action without first obtaining prior approval of Licensee. Licensee shall pay all costs,
including attorney’s fees, incurred in enforcing this indemnification provision. Should CSMC or any other Indemnified Party
not afford Licensee the right to defend any such Action, or should CSMC or any other Indemnified Party not obtain the approval
of Licensee to any such settlement, Licensee shall have no obligation to indemnify CSMC or any other Indemnified Party hereunder.
Should Licensee fail to provide a defense for the Indemnified Parties as required hereunder, then Licensee shall reimburse CSMC
for its out-of-pocket expenses (including reasonable attorneys’ fees and expenses and costs of investigation) which are
incurred as a result of any investigation, defense or settlement relating to the foregoing, which reimbursement shall be made
to CSMC upon receipt by Licensee of invoices reflecting in reasonable detail such expenses incurred by CSMC. Licensee shall obtain
and maintain insurance policies (including products liability and general liability policies at such time as is appropriate) which
are reasonable and necessary to cover its activities and to comply with the indemnification obligations set forth above. Such
insurance policies shall name CSMC as an additional insured party and shall provide a minimum of $3,000,000 in coverage per occurrence.
Upon initiation of any human clinical studies of Licensed Products or Licensed Technology Products, Licensee shall have first
increased its insurance coverage to a minimum of $10,000,000 in the aggregate. Licensee shall provide CSMC with prompt written
notice of any material change in coverage under such policies. If the parties determine that evidence of Licensee’s insurance
coverage is necessary and appropriate, within thirty (30) days of the Effective Date (subject to extension if reasonably required)
and annually thereafter, Licensee shall provide CSMC with a certificate of insurance issued by the appropriate insurance company
evidencing the insurance coverage required by this Section 8.1, together with copies of the endorsement which specifies CSMC
as an additional insured and the declarations page for each such insurance policy. The certificate of insurance, endorsements
and declarations pages (and any renewals or replacements thereof), if required, shall be sent to CSMC’s Technology Transfer
Office by electronic mail at CSTechTransfer@cshs.org and by prepaid, first class, certified mail, return receipt requested,
at the following address: 8797 Beverly Boulevard, Suite 206, Los Angeles, CA 90048.
8.2 Notice
of Claim. CSMC shall promptly notify Licensee in writing of any claim or Action or material threat thereof brought against
any Indemnified Party in respect of which indemnification may be sought and, to the extent allowed by law, shall reasonably cooperate
with Licensee in defending or settling any such claim or Action. No settlement of any claim, Action or threat thereof received
by CSMC and for which CSMC intends to seek indemnification (for itself or on behalf of any other Indemnified Party) shall be made
without the prior joint written approval of Licensee and CSMC.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
9. Use
Of Names
Licensee shall not,
unless as required by any law or governmental regulation, use the name of CSMC, and/or any of its trademarks, service marks, trade
names or fictitious business names without express prior written consent of the Vice President for Public Relations and Marketing
of CSMC. Further, prior to any reference by Licensee to the names or marks of CSMC in any manner, Licensee shall provide CSMC
with a writing reflecting the proposed reference so that CSMC can review the reference within a reasonable period of time prior
to the proposed use thereof by Licensee. This limitation includes, but is not limited to, use by Licensee in any regulatory filing,
advertising, offering circular, prospectus, sales presentation, news release or trade publication. Notwithstanding the foregoing,
certain specific language shall be mutually agreed upon by the parties for Licensee’s use in certain contexts and with respect
to certain topics, and once agreed upon, may be utilized by Licensee in connection with the approved contexts and topics without
further permission of CSMC. Subject to compliance by Licensee with the foregoing, which shall be deemed conditions precedent to
any use of CSMC’s name or marks by Licensee, Licensee shall ensure that the name of CSMC is used as scientifically or academically
appropriate in the “byline” of any article, abstract, manuscript or any other publication related to the subject matter
hereof.
10. Confidentiality
10.1 Non-Disclosure.
The parties hereto shall keep the terms of this Agreement and all business and scientific discussions relating to the business
of the parties strictly confidential. All patient information to which a party is given access by the other party shall be subject
to the provisions of the Confidentiality of Medical Information Act (Cal. Civ. Code §§56, et seq.) and the Health Insurance
Portability and Accountability Act of 1996, and all regulations promulgated thereunder. It may, from time to time, be necessary
for the parties, in connection with performance under this Agreement, to disclose Confidential Information (including know-how)
to each other. The Receiving Party (as defined in Section 1.2 hereof) shall keep in strictest confidence the Confidential Information
of the Disclosing Party (as defined in Section 1.2 hereof), using the standard of care it normally uses for information of like
character, and shall not disclose the Confidential Information to any third party or use it except as expressly authorized
by the prior written consent of the Disclosing Party or as otherwise permitted by this Agreement; provided, however, that
Licensee may disclose the Confidential Information received from CSMC to its Affiliates and Permitted Sublicensees as shall
be reasonably necessary to carry out the intent of this Agreement or any sublicense granted by Licensee as contemplated by this
Agreement if, but only if, such Affiliates and/or Permitted Sublicensees each execute a confidentiality agreement containing confidentiality
provisions no less restrictive than those confidentiality provisions contained in this Section 10. The Receiving Party’s
obligation hereunder shall not apply to Confidential Information that the Receiving Party can show by written documentation:
(a) Is
or later becomes part of the public domain through no fault or neglect of the Receiving Party;
(b) Is
received in good faith from a third party having no obligations of confidentiality to the Disclosing Party, provided,
however, that the Receiving Party complies with any restrictions imposed by the third party;
(c) Is
independently developed by the Receiving Party without use of the Disclosing Party’s Confidential Information as shown by
its books and records at the time of disclosure; or
(d) Is
required by law or regulation to be disclosed (including, without limitation, in connection with FDA filings, filings with another
government agency or as required under the California Public Records Act), provided, however, that the Receiving Party
uses reasonable efforts to restrict disclosure and to obtain confidential treatment.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
10.2 Limits
on Permitted Disclosures. Each party agrees that any disclosure or distribution of the other party’s Confidential Information
within its own organization shall be made only as is reasonably necessary to carry out the intent of this Agreement. The
parties further agree that all of their respective officers, employees, agents, representatives or approved sublicensees to whom
any Confidential Information is disclosed or distributed shall have agreed to maintain its confidentiality. In such event, the
Receiving Party shall identify with reasonable particularity, upon request by the Disclosing Party, each person within the Receiving
Party’s organization to whom the Receiving Party has disclosed or distributed Confidential Information.
10.3 Legally
Required Disclosures. If a subpoena or other legal process concerning Confidential Information is served upon any party hereto
pertaining to the subject matter hereof, the party served shall notify the other party immediately, the other party shall cooperate
with the party served, at the other party’s expense, in any effort to contest the validity of such subpoena or other legal
process. This Section 10.3 shall not be construed in any way to limit any party’s ability to satisfy any disclosure of its
relationship with the other party required by any governmental authority. Notwithstanding anything to the contrary set forth in
Section 10.1, the parties hereto acknowledge that Synthetic may be obligated to file a copy of this Agreement, any Schedules hereto,
and summaries of the terms hereof with the U.S. Securities and Exchange Commission as reasonably required to comply with applicable
laws or the rules of a nationally-recognized securities exchange. Synthetic shall be entitled to make such filings, provided that
it requests confidential treatment of the commercial terms and sensitive technical terms hereof and thereof to the extent such
confidential treatment is reasonably available. In the event of any such filing, Synthetic will provide CSMC with a copy of this
Agreement (including the Schedules hereto) and related filings marked to show provisions for which Synthetic intends to seek confidential
treatment and shall reasonably consider and incorporate CSMC’s comments thereon to the extent consistent with the legal
requirements and the rules of any nationally recognized securities exchange governing disclosure of material agreements and material
information to be publicly filed.
10.4 Patent
Rights as Confidential Information. The Patent Rights are understood by Licensee to be the Confidential Information of CSMC
to the extent “unpublished” as such term is construed under the United States Patent Laws. As such, Licensee’s
confidentiality obligations hereunder automatically extend to any and all Technical Information and to any and all patent applications
of CSMC relating to any Patent Rights, Technical Information and Improvements and to any and all communications with the United
States Patent Office, and any foreign patent office relating to any Patent Rights, Technical Information or Improvements.
10.5 Return
of Confidential Information. In the event of any termination of this Agreement, the Receiving Party, upon request, shall promptly
return all Confidential Information and any copies made thereof previously made available to the Receiving Party by the Disclosing
Party.
10.6 Remedies.
Both parties acknowledge and agree that it would be difficult to measure damages for breach by either party of the covenants
set forth in this Section 10, and that injury from any such breach would be incalculable, and that money damages would therefore
be an inadequate remedy for any such breach. Accordingly, either party shall be entitled, in addition to all other remedies available
hereunder or under law or equity, without the obligation of posting a bond, to injunctive or such other equitable relief as a
court may deem appropriate to restrain or remedy any breach of such covenants.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
11. Information
Exchange
In addition to the
Patent Rights and Technical Information, the parties shall cooperate to exchange such non-confidential information as may be appropriate
and necessary to facilitate Licensee’s development and commercialization of Licensed Products and Licensed Technology Products
incorporating any Patent Rights or Technical Information.
12. Patent
Marking
In the event any Licensed
Product or Licensed Technology Product is the subject of a patent under the Patent Rights, Licensee shall actually or virtually
mark all Licensed Products and Licensed Technology Products made, sold or otherwise disposed of by or on behalf of it or any of
its Permitted Sublicensees as set forth under Title 35, Section 287(a) of the United States Code and shall respond to any request
or disclosure under Title 35, Section 287(b)(4)(B) of the United States Code by only notifying CSMC of the request for disclosure.
13. Miscellaneous
13.1 Notices.
Any notice, request, instruction or other document required by this Agreement shall be in writing and shall be deemed to
have been given: (a) if mailed with the United States Postal Service by prepaid, first class, certified mail, return receipt requested,
at the time of receipt by the intended recipient; (b) if sent by Federal Express or other overnight carrier, signature of delivery
required, at the time of receipt by the intended recipient; or (c) if sent by facsimile transmission, when so sent and when receipt
has been acknowledged by appropriate telephone or facsimile receipt, addressed as follows:
In the case of CSMC
to:
Cedars-Sinai Medical Center
8700 Beverly Boulevard
Los Angeles, California 90048-1865
Attention: Senior Vice President for Academic Affairs
with a copy to Senior Vice President for Legal Affairs
& General Counsel
or in the case of Synthetic
Biologics, Inc. or Licensee to:
| | Synthetic Biologics, Inc. |
| | 155 Gibbs Street, Suite 412 |
| | Rockville, Maryland 20850 |
| | Attention: Jeffrey Riley, CEO |
| | email: jriley@syntheticbiologics.com |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| | 405 Lexington Avenue, 26th
Floor |
| | Attention: Leslie Marlow, Esq. |
| | email: lmarlow@gracinmarlow.com |
or to such other address or to such other
person(s) as may be given from time to time under the terms of this Section 13.1.
13.2 Compliance
with Laws. Each party shall comply with all applicable federal, state and local laws and regulations in connection with its
activities pursuant to this Agreement.
13.3 Governing
Law. For any dispute between the parties to this Agreement which arises from or relates to this Agreement, the Agreement
shall be construed and enforced in accordance with the laws of the United States of America and of the State of California, irrespective
of choice of laws provisions. The parties agree that Los Angeles County, California shall be the situs of any legal proceeding
arising out of or relating to this Agreement. Each party hereby waives any right it may have to assert the doctrine of forum
non conveniens or similar doctrine or to object to venue with respect to any proceeding brought in accordance with this Section,
and stipulates that the state and federal courts located in Los Angeles, California shall have in personam jurisdiction
and venue over each of them for the purpose of litigating any dispute, controversy, or proceeding arising out of or related to
this Agreement. Each party hereby authorizes and accepts service of process sufficient for personal jurisdiction in any action
against it as contemplated by this Section by registered or certified mail, return receipt requested, postage prepaid, to its
address for the giving of notices as set forth in this Agreement.
13.4 Waiver.
Failure of any party to enforce a right under this Agreement shall not act as a waiver of that right or the ability to assert
that right relative to the particular situation involved.
13.5 Enforceability.
If any provision of this Agreement shall be found by a court of competent jurisdiction to be void, invalid or unenforceable,
the same shall be reformed to comply with applicable law or stricken if not so conformable, so as not to affect the validity or
enforceability of the remainder of this Agreement.
13.6 Modification.
No change, modification, or addition or amendment to this Agreement, or waiver of any term or condition of this Agreement,
is valid or enforceable unless in writing and signed and dated by the authorized officers of the parties to this Agreement.
13.7 Entire
Agreement. This Agreement and the Schedules hereto (which are incorporated herein by this reference as if fully set
forth herein) constitute the entire agreement between the parties with respect to the subject matter hereof and thereof, and replace
and supersede as of the date hereof and thereof any and all prior agreements and understandings, whether oral or written, between
the parties with respect to the subject matter of such agreements.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
13.8 Construction.
This Agreement has been prepared, examined, negotiated and revised by each party and their respective attorneys, and no implication
shall be drawn and no provision shall be construed against any party to this Agreement by virtue of the purported identity of
the drafter of this Agreement or any portion thereof.
13.9 Counterparts.
This Agreement may be executed simultaneously in one or more counterparts, each of which shall constitute one and the same
instrument. This Agreement may be executed by facsimile or in .pdf format.
13.10 Attorneys’
Fees. In the event of any action at law or in equity between the parties hereto to enforce any of the provisions hereof,
the unsuccessful party to such litigation shall pay to the successful party all reasonable costs and expenses, including reasonable
attorneys’ fees, incurred therein by such successful party; and if such successful party shall recover a judgment in any
such action or proceeding, such reasonable costs, expenses and attorneys’ fees may be included in and as part of such judgment.
13.11 Assignment;
Successors.
(a) Licensee
may assign this Agreement to an Affiliate upon the prior written consent of CSMC. Subject to Section 13.11(b), Licensee
may assign this Agreement without the consent of CSMC as part of a sale, regardless of whether such a sale occurs through an asset
sale, stock sale, merger or other combination, or any other transfer of Licensee’s entire business, or that part of Licensee’s
business that exercises all rights granted under this Agreement. Any other attempt to assign this Agreement by Licensee is null
and void. In the event of a bankruptcy, assignment is permitted only to a party that can provide adequate assurance of future
performance, including diligent development and sales, of Licensed Products and Licensed Technology Products. Synthetic shall
have no right to assign this Agreement without the consent of CSMC other than as part of a sale of Synthetic, regardless of whether
such a sale occurs through an asset sale, stock sale, merger or other combination, or any other transfer of Synthetic’s
entire business; provided, however, that the successor entity shall have (a) a market capitalization greater than that
of Synthetic at the time of the sale and (b) the ability to assume Synthetic’s guarantee obligations under Section 2.2 hereof;
provided, further, that in the event that such sale occurs prior to the payment of the first and/or second milestone payment
required by Section 4.6(e)(ii), then notwithstanding anything to the contrary set forth herein, such milestone payments shall
be payable either in cash or stock of the successor entity in the amounts set forth in Section 4.6(e)(ii), at CSMC’s sole
discretion,.
(b) Prior
to any assignment, the following conditions must be met: (i) Licensee or Synthetic, as the case may be, must give CSMC thirty
(30) days prior written notice of the assignment, including the new assignee’s contact information, (ii) the new assignee
must agree in writing to CSMC to be bound by this Agreement, and (iii) CSMC must have received a $25,000.00 assignment fee.
(c) Subject
to the limitations on assignment herein, this Agreement shall be binding upon and inure to the benefit of any successors in interest
and assigns of CSMC, Licensee and Synthetic. CSMC shall have the right to assign its rights hereunder as part of any reorganization
or bond financing.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
13.12 Further
Assurances. At any time and from time to time after the Effective Date, each party shall do, execute, acknowledge
and deliver, and cause to be done, executed, acknowledged or delivered, all such further acts, transfers, conveyances, assignments
or assurances as may be reasonably required to consummate the transactions contemplated by this Agreement.
13.13 Survival.
The following sections shall survive any expiration or earlier termination of this Agreement: 4.6(e), 6.3, 8, 9, 10, 12 and
13.
[signature page follows]
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
IN
WITNESS WHEREOF, the parties have caused their duly authorized representatives to execute this Agreement as of the
date first above written.
| |
“LICENSEE”: |
| |
|
| |
SYNTHETIC BIOMICS, INC., a nevada corporation |
| |
|
|
| |
By: |
/s/ Steve Kanzer |
| |
Name: |
Steve Kanzer |
| |
Title: |
CEO & President |
| |
|
| |
Date: |
| |
|
| |
SYNTHETIC BIOLOGICS, INC., |
| |
a nevada corporation |
| |
|
|
| |
By: |
/s/ Jeff Riley |
| |
Name: |
Jeff Riley
|
| |
Title: |
CEO |
| |
|
| |
Date: |
| |
“CSMC”: |
| |
|
| |
Cedars-Sinai
Medical Center, a
california
nonprofit public benefit
corporation |
| |
|
|
| |
By: |
/s/ Shlomo Melmed, M.D. |
| |
|
Shlomo Melmed, M.D. |
| |
|
Senior Vice President for Academic Affairs and Dean of the Medical Faculty |
|
|
|
| |
|
|
| |
Date: |
|
| |
|
|
| |
By: |
/s/ Richard Katzman |
| |
|
Richard Katzman |
| |
|
Vice President, Academic Affairs |
| |
|
|
| |
Date: |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| ACKNOWLEDGED AND AGREED: |
|
| |
|
| “INVENTORS”: |
|
| |
|
| /s/ Mark Pimentel, M.D. |
|
| Mark Pimentel, M.D. |
|
| |
|
| /s/ Christopher Chang, M.D. |
|
| Christopher Chang, M.D. |
|
| |
|
| /s/ Ruchi Mathur, M.D. |
|
| Ruchi Mathur, M.D. |
|
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
Schedule A
Patent Rights
| Country |
Serial No |
Filing
Date |
Patent
No |
Title |
Status |
| AUSTRIA |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| BELGIUM |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| SWITZERLAND |
00952739.1 |
8/11/2000 |
1200828 |
METHODS
OF DIAGNOSING AND TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS |
GRANTED |
| SWITZERLAND |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| CYPRUS |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| GERMANY |
00952739.1 |
8/11/2000 |
60036871.8 |
METHODS
OF DIAGNOSING AND TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS |
GRANTED |
| GERMANY |
07075358.7 |
8/11/2000 |
60046160.2 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| DENMARK |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| EUROPEAN
PATENT OFFICE |
00952739.1 |
8/11/2000 |
1200828 |
METHODS
OF DIAGNOSING AND TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS |
GRANTED |
| EUROPEAN
PATENT OFFICE |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| EUROPEAN
PATENT OFFICE |
10177153.3 |
8/11/2000 |
|
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS |
FILED |
| EUROPEAN
PATENT OFFICE |
10183223.6 |
8/11/2000 |
|
METHODS
OF DIAGNOSING AND TREATING CROHN'S DISEASE |
FILED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| EUROPEAN
PATENT OFFICE |
10183213.7 |
8/11/2000 |
|
METHODS OF TREATING BLOATING,
ABDOMINAL PAIN AND DIARRHEA
|
FILED |
| **** |
**** |
**** |
**** |
**** |
**** |
| SPAIN |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| FINLAND |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| **** |
**** |
**** |
**** |
**** |
**** |
| FRANCE |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| UNITED
KINGDOM |
00952739.1 |
8/11/2000 |
1200828 |
METHODS
OF DIAGNOSING AND TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS |
GRANTED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| UNITED
KINGDOM |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| GREECE |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| IRELAND |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| ITALY |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| LUXEMBOURG |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| MONACO |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| NETHERLANDS |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| PORTUGAL |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| SWEDEN |
07075358.7 |
8/11/2000 |
1811303 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| UNITED
STATES |
09/374,142 |
8/11/1999 |
6,861,053 |
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| UNITED
STATES |
10/107,240 |
3/26/2002 |
6,805,852 |
METHODS
OF DIAGNOSING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| UNITED
STATES |
10/915,193 |
8/10/2004 |
7,056,686 |
METHOD
OF DIAGNOSING FIBROMYALGIA CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| UNITED
STATES |
11/838,631 |
8/14/2007 |
7,585,838 |
METHODS
OF TREATING FIBROMYALGIA CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| UNITED
STATES |
13/073,169 |
3/28/2011 |
8,197,805 |
METHODS
OF TREATING AUTOIMMUNE DISEASES CAUSED BY SMALL INTESTINAL BACTERIAL OVERGROWTH |
GRANTED |
| WIPO |
US2000/
22030 |
8/11/2000 |
|
METHODS
OF DIAGNOSING OR TREATING IRRITABLE BOWEL SYNDROME AND OTHER DISORDERS |
NAT'L
PHASE FILED |
| AUSTRALIA |
2002256254 |
4/16/2002 |
2002256254 |
METHODS
OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
GRANTED |
| AUSTRALIA |
2007201246 |
4/16/2002 |
2007201246 |
METHODS
OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
GRANTED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| CANADA |
2,444,548 |
4/16/2002 |
|
METHODS
OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
FILED |
| EUROPEAN
PATENT OFFICE |
02725704.7 |
4/16/2002 |
|
METHODS
OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
FILED |
| EUROPEAN
PATENT OFFICE |
10178066.6 |
4/16/2002 |
|
METHODS
OF DETECTING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) IN A HUMAN SUBJECT |
FILED |
| EUROPEAN
PATENT OFFICE |
10181342.6 |
4/16/2002 |
|
METHODS
OF TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
FILED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| JAPAN |
2002-582263 |
4/16/2002 |
4653936 |
METHODS OF DIAGNOSING AND TREATING
SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS
|
GRANTED |
| **** |
**** |
**** |
|
**** |
**** |
| UNITED
STATES |
09/837,797 |
4/17/2001 |
7,048,906 |
METHODS
OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
GRANTED |
| UNITED
STATES |
11/348,995 |
2/7/2006 |
7,736,622 |
METHODS
OF DIAGNOSING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
GRANTED |
|
|
| UNITED
STATES |
12/768,531 |
4/27/2010 |
8,110,177 |
METHODS
OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
GRANTED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| UNITED
STATES |
13/315,671 |
12/9/2011 |
8,388,935 |
METHODS
OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
GRANTED |
| UNITED
STATES |
13/755,515 |
1/31/2013 |
|
METHODS
OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
FILED |
| UNITED
STATES |
14/025,531 |
9/12/2013 |
|
METHODS
OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
FILED |
| WIPO |
US2002/
12034 |
4/16/2002 |
|
METHODS
OF DIAGNOSING AND TREATING SMALL INTESTINAL BACTERIAL OVERGROWTH (SIBO) AND SIBO-RELATED CONDITIONS |
NAT'L
PHASE FILED |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
| UNITED
STATES |
12/050,736 |
3/18/2008 |
|
DIAGNOSIS OF CONSTIPATION BY ANALYSIS
OF METHANE CONCENTRATION
|
FILED |
| UNITED
STATES |
**** |
**** |
|
****Unpublished |
FILED |
| UNITED
STATES |
**** |
**** |
|
****Unpublished |
FILED |
| UNITED
STATES |
|
|
|
ANTI-METHANOGEN
COMPOSITIONS AND USES THEREOF |
|
and all divisions, continuations, continuations-in-part,
reissues, reexaminations, supplementary protection certificates and extensions thereof, whether domestic or foreign, except as
excluded under the definition of Patent Rights.
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
Schedule B
Technical Information
| 1. | The following information or material in the Field of
Use which is embodied in the Patent Rights conceived or reduced to practice prior to the Effective Date in the conduct of research
performed at CSMC under the direction of the Inventors:Hwang L, Low K, Khoshini R, Melmed G, Sahakian A, Makhani M, Pokkunuri
V, Pimentel M. Evaluating breath methane as a diagnostic test for constipation predominant IBS. Dig Dis Sci2010;55:398-403. |
| 2. | Low K, Hwang L, Hua J, Zhu A, Morales W, Pimentel
M. A combination of rifaximin and neomcyin is most effective in treating IBS patients with methane on lactulose
breath test. J Clin Gastroenterol 2010 Sep;44(8):547-50. |
| 3. | Shah ED, Basseri RJ, Chong K, Pimentel M.
Abnormal breath testing in IBS: A meta-analysis. Dig Dis Sci 2010;55:2441-9. |
| 4. | Kunkel, D, Basseri RJ, Makhani MD, Chong K, Chang C, Pimentel
M. Methane on breath testing is associated with constipation: A systematic review and meta-analysis. Dig Dis Sci 2011;56:1612-18. |
| 5. | Basseri RJ, Basseri B, Pimentel M, Chong
K, Youdim A, Low K, Hwang L, Soffer E, Chang C, Mathur R. Intestinal methane production in obese humans is associated with higher
body mass index. In press, Gastroenterol Hepatol, 2012;8:22-28 |
| 6. | Kim G, Deepinder F, Morales W, Hwang L, Weitsman S, Chang
C, Gunsalus R, Pimentel M. Methanobrevibacter smithii is the predominant methanogen in patients with constipation-predominant
IBS and methane on breath. Dig Dis Sci 2012;57:3213-8. |
| 7. | Mathur R, Kim G, Morales W, Weitsman S, Barlow G, Chang
C, Pimentel M. Intestinal Methanobrevibacter smithii but not Total Bacteria is Related to Diet-Induced
Weight Gain in Rats. Obesity 2013;21:748-54. |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
Schedule C
Stock Issuance Agreement – Synthetic
Biologics, Inc.
See attached
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
Schedule D
Stock Issuance Agreement – Licensee
See attached
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
Schedule E
Capitalization Table – Licensee
| Synthetic Biomics, Inc. Capitalization Table (December 4, 2013) |
| | |
| | |
| |
| Common Stock, par value $0.0001 | |
| | |
| |
| 50,000,000 shares authorized, | |
| | |
| |
| 44,000,000 issued and outstanding | |
Number Shares | | |
Percent | |
| Synthetic Biologics, Inc. | |
| 35,200,000 | | |
| 80.0 | % |
| Cedars-Sinai Medical Center | |
| 5,060,000 | | |
| 11.5 | % |
| Mark Pimentel, M.D. | |
| 3,740,000 | | |
| 8.5 | % |
| Total | |
| 44,000,000 | | |
| 100 | % |
See attached
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
Schedule F
Milestones
| 1. | Licensee shall use commercially reasonable efforts, alone
or in conjunction with third parties, to commercialize and sell at least one Licensed Product in the Territory. |
| 2. | Licensee shall submit an Investigational New Drug application
to the FDA for a Licensed Product within two (2) years of the Effective Date. |
| 3. | Licensee shall have completed the first Phase I clinical
trial for a Licensed Product within three (3) years of the Effective Date. |
| 4. | Licensee shall have enrolled the first patient in the
first Phase II clinical trial for a Licensed Product within four (4) years of the Effective Date. |
| 5. | Licensee shall have completed the first Phase II clinical
trial for the first Licensed Product or the first Licensed Technology Product within six (6) years of the Effective Date. |
| 6. | Licensee shall have enrolled the first patient in the
first Phase III clinical trial for a Licensed Product within eight (8) years of the Effective Date. |
| 7. | Licensee shall have completed the first Phase III clinical
trial for the first Licensed Product or the first Licensed Technology Product within ten (10) years of the Effective Date. |
| 8. | The FDA shall have accepted Licensee’s New Drug
Application within fourteen (14) years of the Effective Date. |
| 9. | Licensee shall have obtained regulatory approval of the
first Licensed Product or the first Licensed Technology Product within fourteen (14) years of the Effective Date. |
| 10. | The first commercial sale of the first Licensed Product
or the first Licensed Technology Product shall have occurred within fifteen (15) years of the Effective Date. |
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
Schedule G
CLINICAL TRIALS TO BE SPONSORED BY LICENSEE
AND CONDUCTED AT CSMC
****
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
Schedule H
Royalty Reporting Form
Licensee name:
Reporting period:
Date of report:
Date of first commercial sale:
Royalty Report
Licensed
Product or
Licensed
Technology
Product
(list
products by
name) |
No.
units
sold |
Invoiced
price per
unit |
Gross
sales |
Allowable
deductions
(attached
itemized
detail) |
Country
of
sale/foreign
currency/
conversion
rate |
Net
sales |
| Product
name |
|
|
|
|
|
|
| Product
name |
|
|
|
|
|
|
| Product
name |
|
|
|
|
|
|
| Total |
|
|
|
|
|
|
| Total net
sales |
$ |
| Royalty
rate |
|
| Royalty
due |
$ |
Total royalty due: $___________________________
Non-Royalty Sublicense
Revenue Report
| Total Non-Royalty
Sublicense Revenue received |
$ |
| Date
received |
|
| Applicable
percentage payable to CSMC |
|
| Total
Non-Royalty Sublicense Revenue payable to CSMC |
$ |
Report prepared by:
Title:
Date:
| Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. |
Please send report to:
Cedars-Sinai Medical Center
8700 Beverly Boulevard
Los Angeles, California 90048-1865
Attention: Senior Vice President for Academic Affairs
with a copy to Senior Vice President for Legal Affairs &
General Counsel
Please send electronic copy to CSTechTransfer@cshs.org.
