EXECUTION COPY

CONFIDENTIAL

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 Channel Collaboration Agreement

 

This Exclusive Channel Collaboration Agreement (the “Agreement”) is made and
entered into effective as of August 6, 2012 (the “Effective Date”) by and
between Intrexon Corporation, a Virginia corporation with offices at 20358
Seneca Meadows Parkway, Germantown, MD 20876 (“Intrexon”), and Synthetic
Biologics, Inc., a Nevada corporation having its principal place of business at
617 Detroit Street, Suite 100, Ann Arbor, MI 48104 (“Synthetic”). Intrexon and
Synthetic may be referred to herein individually as a “Party”, and collectively
as the “Parties.”

 

Recitals

 

Whereas, Intrexon has expertise in and owns or controls proprietary technology
relating to the identification, design and production of human antibodies and
DNA vectors; and

 

Whereas, Synthetic now desires to become Intrexon’s exclusive channel
collaborator with respect to such technology for the purpose of developing the
Anti-Infectives Program (as defined herein), and Intrexon is willing to appoint
Synthetic as a channel collaborator in the Field (as defined herein, and subject
to amendments to the definition as permitted herein) under the terms and
conditions of this Agreement.

 

Now Therefore, in consideration of the foregoing and the covenants and promises
contained herein, the Parties agree as follows:

 

ARTICLE 1

Definitions

 

As used in this Agreement, the following capitalized terms shall have the
following meanings:

 

1.1                   “Affiliate” means, with respect to a particular Party, any
other person or entity that directly or indirectly controls, is controlled by,
or is in common control with such Party. As used in this Section 1.1, the term
“controls” (with correlative meanings for the terms “controlled by” and “under
common control with”) means the ownership, directly or indirectly, of more than
fifty percent (50%) of the voting securities or other ownership interest of an
entity, or the possession, directly or indirectly, of the power to direct the
management or policies of an entity, whether through the ownership of voting
securities, by contract, or otherwise. Notwithstanding the foregoing, any
person, corporation, partnership, or other entity that would be an Affiliate of
a Party solely because it and such Party are under common control by Third
Security or Randal J. Kirk shall not be deemed to be an Affiliate of such Party
solely by reason of such common control, with the caveat that, notwithstanding
the foregoing, any entity other than Synthetic affiliated with Third Security or
Randal J. Kirk shall be deemed to be an Affiliate of Intrexon solely for
purposes of Article 9.

 

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CONFIDENTIAL

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                   “Applicable Laws” has the meaning set forth in Section
8.2(d)(xii).

 

1.3                    “Anti-Infectives Program” has the meaning set forth in
Section 2.1(a).

 

1.4                   “Authorizations” has the meaning set forth in Section
8.2(d)(xii).

 

1.5                   “CC” has the meaning set forth in Section 2.2(b).

 

1.6                   “Channel-Related Program IP” has the meaning set forth in
Section 6.1(c).

 

1.7                   “Claims” has the meaning set forth in Section 9.1.

 

1.8                   “CMCC” has the meaning set forth in Section 2.2(b).

 

1.9                   “Committees” has the meaning set forth in Section 2.2(a).

 

1.10               “Commercialize” or “Commercialization” means any activities
directed to marketing, promoting, distributing, importing for sale, offering to
sell and/or selling Synthetic Products.

 

1.11               “Commercial Sale” means for a given product and country the
sale for value of that product by a Party (or, as the case may be, by an
Affiliate or permitted sublicensee of a Party), to a Third Party after
regulatory approval (and any pricing or reimbursement approvals, if necessary)
has been obtained for such product in such country.

 

1.12               “Complementary In-Licensed Third Party IP” has the meaning
set forth in Section 3.9(a).

 

1.13               “Confidential Information” means each Party’s confidential
Information, inventions, non-public know-how or non-public data disclosed
pursuant to this Agreement or any other confidentiality agreement between the
Parties and shall include, without limitation, manufacturing, technical,
marketing, financial, personnel and other business information and plans,
whether in oral, written, graphic or electronic form.

 

1.14               “Control” means, with respect to Information, a Patent or
other intellectual property right, that a Party owns or has a license from a
Third Party to such right and has the ability to grant a license or sublicense
as provided for in this Agreement under such right without violating the terms
of any agreement or other arrangement with any Third Party.

 

1.15               “CRC” has the meaning set forth in Section 2.2(b).

 

1.16               “Diligent Efforts” means, with respect to a Party’s
obligation under this Agreement, the level of efforts and resources reasonably
required to diligently develop, manufacture, and/or Commercialize (as
applicable) each Synthetic Product in a sustained manner, consistent with the
efforts and resources a similarly situated company working in the Field would
typically devote to a product of similar market potential, profit potential,
strategic value and/or proprietary protection, based on market conditions then
prevailing. With respect to a particular task or obligation, Diligent Efforts
requires that the applicable Party promptly assign responsibility for such task
and consistently make and implement decisions and allocate resources designed to
advance progress with respect to such task or obligation.

 

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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.

 

 

1.17               “Equity Agreements” has the meaning set forth in Section 5.1.

 

1.18               “Excess Product Liability Costs” has the meaning set forth in
Section 9.3.

 

1.19               “Executive Officer” means : (i) the Chief Executive Officer
of the applicable Party, or (ii) another senior executive officer of such Party
who has been duly appointed by the Chief Executive Officer to act as the
representative of the Party to resolve, as the case may be, (a) a Committee
dispute, provided that such appointed officer is not a member of the applicable
Committee and occupies a position senior to the positions occupied by the
applicable Party’s members of the applicable Committee, or (b) a dispute
described in Section 11.1.

 

1.20               “FDA” has the meaning set forth in Section 8.2(d)(xiii).

 

1.21               “Field Infringement” has the meaning set forth in Section
6.3(b)

 

1.22               “Field” means the exogenous production and use of human
recombinant monoclonal antibodies, and mixes thereof, for the treatment of the
following eight (8) target toxins and/or diseases in humans (irespective of
whether such requires regulatory approval) : [*****]. The Field as defined in
the previous sentence is subject to amendment according to the mechanisms
described in Sections 2.1(b), 2.1(c) and 2.1(d) of this Agreement. Unless
context or usage for a particular reference herein to Field dictates otherwise,
each particular reference to Field in this Agreement should be interpreted as
meaning the definition of the Field that is in effect at the particular point in
time that is relevant to that particular reference.

 

1.23               “Fully Loaded Cost” means the direct cost of the applicable
good, product or service plus indirect charges and overheads reasonably
allocable to the provision of such good, product or service in accordance with
US GAAP. Subject to the approval of a project and its associated budget by the
JSC and the terms of Sections 4.6 and 4.7 (as appropriate), Intrexon will bill
for its internal direct costs incurred through the use of annualized standard
full-time equivalents; such rate shall be based upon the actual fully loaded
costs of those personnel directly involved in the provision of such good,
product or service. Intrexon may, from time to time, adjust such full-time
equivalent rate based on changes to its actual fully loaded costs and will
review the accuracy of its full-time equivalent rate at least quarterly.
Intrexon shall provide Synthetic with reasonable documentation indicating the
basis for any direct and indirect charges, any allocable overhead, and any such
adjustment in full-time equivalent rate.

 

1.24               “In-Licensed Program IP” has the meaning set forth in Section
3.9(a).

 

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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.

 

 

1.25               “Information” means information, results and data of any type
whatsoever, in any tangible or intangible form whatsoever, including without
limitation, databases, inventions, practices, methods, techniques,
specifications, formulations, formulae, knowledge, know-how, skill, experience,
test data including pharmacological, biological, chemical, biochemical,
toxicological and clinical test data, analytical and quality control data,
stability data, studies and procedures, and patent and other legal information
or descriptions.

 

1.26               “Infringement” has the meaning set forth in Section 6.3(a).

 

1.27               “Intrexon Channel Technology” means Intrexon’s current and
future technology directed towards the design, identification, and/or production
of recombinant monoclonal antibodies, including without limitation the
technology embodied in the Intrexon Materials and the Intrexon IP, and
specifically including without limitation the following of Intrexon’s platform
areas and capabilities: (1) UltraVector®, (2) mAbLogixTM (3) DNA and RNA MOD
engineering, (4) protein engineering, (5) transcription control chemistry, (6)
genome engineering, (7) LEAPTM, and (8) cell system engineering.

 

1.28               “Intrexon Indemnitees” has the meaning set forth in Section
9.2.

 

1.29               “Intrexon IP” means the Intrexon Patents and Intrexon
Know-How.

 

1.30               “Intrexon Know-How” means all Information (other than
Intrexon Patents) that (a) is Controlled by Intrexon as of the Effective Date or
during the Term and (b) is reasonably required or useful for Synthetic to
conduct the Anti-Infectives Program. For the avoidance of doubt, the Intrexon
Know-How shall include any Information (other than Intrexon Patents) in the
Channel-Related Program IP.

 

1.31               “Intrexon Materials” means the genetic code and associated
amino acids and gene constructs used alone or in combination and such other
proprietary reagents including but not limited to plasmid vectors, virus stocks,
cells and cell lines, antibodies, and ligand-related chemistry, in each case
that are reasonably required or provided to Synthetic to conduct the
Anti-Infectives Program.

 

1.32               “Intrexon Patents” means all Patents that (a) are Controlled
by Intrexon as of the Effective Date or during the Term; and (b) are reasonably
required or useful for Synthetic to conduct the Anti-Infectives Program. For the
avoidance of doubt, the Intrexon Patents shall include any Patent in the
Channel-Related Program IP.

 

1.33               “Intrexon Trademarks” means those trademarks related to the
Intrexon Channel Technology that are established from time to time by Intrexon
for use across its channel partnerships or collaborations.

 

1.34               “Inventions” has the meaning set forth in Section 6.1(b).

 

1.35               “IPC” has the meaning set forth in Section 2.2(b).

 

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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.

 

 

1.36               “JSC” has the meaning set forth in Section 2.2(b).

 

1.37               “Losses” has the meaning set forth in Section 9.1.

 

1.38               “Net Sales” means, with respect to any Synthetic Product, the
net sales of such Synthetic Product by Synthetic or an Affiliate of Synthetic
(including without limitation net sales of Synthetic Product to a non-Affiliate
sublicensee but not including net sales by such non-Affiliate sublicensee), as
determined in accordance with US GAAP as the gross amount invoiced on account of
sales of Synthetic Product less the usual and customary discounts as determined
in accordance with US GAAP. In the case of any sale for value, such as barter or
counter-trade other than in an arm’s length transaction exclusively for cash,
Net Sales shall be deemed to be the net sales at which substantially similar
quantities of the product are sold for cash in an arm’s length transaction in
the relevant country. If Synthetic Product is sold to any third party together
with other products or services, the price of such product, solely for purposes
of the calculation of Net Sales, shall be deemed to be no less than the price at
which such product would be sold in a similar transaction to a third party not
also purchasing the other products or services.

 

1.39               “Patents” means (a) all patents and patent applications
(including provisional applications), (b) any substitutions, divisions,
continuations, continuations-in-part, reissues, renewals, registrations,
requests for continued examination, confirmations, re-examinations, extensions,
supplementary protection certificates and the like of the foregoing, and (c) any
foreign or international equivalents of any of the foregoing.

 

1.40               “Primary Program Targets” has the meaning as set forth in
Section 2.1(b).

 

1.41               “Product-Specific Program Patent” means any issued Intrexon
Patent where all the claims are directed to Inventions that relate solely and
specifically to Synthetic Products. In the event of a disagreement between the
Parties as to whether a particular Intrexon Patent is or is not a
Product-Specific Program Patent, the Parties shall seek to resolve the issue
through discussions at the IPC, provided that if the Parties are unable to
resolve the disagreement, the issue shall be submitted to arbitration pursuant
to Section 11.2. Any Intrexon Patent that is subject to such a dispute shall be
deemed not to be a Product-Specific Program Patent unless and until (a) Intrexon
agrees in writing that such Patent is a Product-Specific Program Patent or (b)
an arbitrator or arbitration panel determines, pursuant to Article 11, that such
Intrexon Patent is a Product-Specific Program Patent.

 

1.42               “Proposed Terms” has the meaning set forth in Section 11.2.

 

1.43               “Prosecuting Party” has the meaning set forth in Section
6.2(c).

 

1.44               “Recovery” has the meaning set forth in Section 6.3(f).

 

1.45               “Retained Product” has the meaning set forth in Section
10.4(a).

 

1.46               “Reverted Product” has the meaning set forth in Section
10.4(c).

 

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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.

 

 

1.47               “SEC” means the United States Securities and Exchange
Commission.

 

1.48               “Sublicensing Revenue” means any cash consideration, or the
cash equivalent value of non-cash consideration, regardless of whether in the
form of upfront payments, milestones, or royalties, actually received by
Synthetic or its Affiliate from a Third Party in consideration for a grant of a
sublicense under the Intrexon IP or any rights to develop or commercialize
Synthetic Products, but excluding: (a) any amounts paid as bona fide
reimbursement for research and development costs to the extent incurred
following such grant; (b) bona fide loans or any payments in consideration for a
grant of equity of Synthetic to the extent that such consideration is equal to
or less than fair market value (i.e. any amounts in excess of fair market value
shall be Sublicensing Revenue); and (d) amounts received from sublicensees in
respect of any Synthetic Product sales that are included in Net Sales.

 

1.49               “Superior Therapy” means a therapy in the Field that, based
on the data then available, (a) demonstrably appears to offer either superior
efficacy or safety or significantly lower cost of therapy, as compared with both
(i) those therapies that are marketed (either by Synthetic or others) at such
time for the indication and (ii) those therapies that are being actively
developed by Synthetic for such indication; (b) demonstrably appears to
represent a substantial improvement over such existing therapies; and (c) has
intellectual property protection and a regulatory approval pathway that, in each
case, would not present a significant barrier to commercial development.

 

1.50               “Supplemental In-Licensed Third Party IP” has the meaning set
forth in Section 3.8(a).

 

1.51               “Support Memorandum” has the meaning set forth in Section
11.2.

 

1.52               “Synthetic Indemnitees” has the meaning set forth in Section
9.1.

 

1.53               “Synthetic Product” means any product in the Field that is
created, produced, developed, or identified in whole or in part, directly or
indirectly, by or on behalf of Synthetic during the Term through use or practice
of Intrexon Channel Technology, Intrexon IP, or the Intrexon Materials.

 

1.54               “Synthetic Program Patent” has the meaning set forth in
Section 6.2(b).

 

1.55               “Synthetic Termination IP” means all Patents or other
intellectual property that Synthetic or any of its Affiliates Controls as of the
Effective Date or during the Term that cover, or is otherwise necessary or
useful for, the development, manufacture or commercialization of a Reverted
Product or necessary or useful for Intrexon to operate in the Field.

 

1.56               “Term” has the meaning set forth in Section 10.1.

 

1.57               “Territory” means the entire world.

 

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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.

 

 

1.58               “Third Party” means any individual or entity other than the
Parties or their respective Affiliates.

 

1.59               “Third Security” means Third Security, LLC.

 

1.60               “US GAAP” means generally accepted accounting principles in
the United States.

 

ARTICLE 2

Scope of Channel Collaboration; Management

 

2.1                   Scope.

 

(a)               Generally. The general purpose of the channel collaboration
described in this Agreement will be to use the Intrexon Channel Technology to
research, develop and commercialize products for use in the Field (collectively,
the “Anti-Infectives Program”). As provided below, the JSC shall establish,
monitor, and govern projects for the Anti-Infectives Program. Either Party may
propose potential projects in the Field for review and consideration by the JSC.

 

(b)               Initial Project for Immediate Commencement. The Parties as of
the Effective Date have identified three specific targets in the Field as being
desirable projects for immediate development under the Anti-Infectives Program
(the “Primary Program Targets”), and the JSC will be directed upon its creation
to produce, and thereafter initiate performance of, an initial research project
for the production of Synthetic Products for each of the Primary Program
Targets. The Primary Program Targets are : [*****]. Synthetic will review data
derived from these research projects for the Primary Program Targets via the JSC
and will use such to consider the scientific and commercial viability of the
Primary Program Targets. The JSC, consistent with its authority herein and
subject to Synthetic’s agreement to reimburse Intrexon for expenses relating
thereto in accord with Section 4.7 below, may also authorize additional research
projects for any of the five (5) other targets in the Field that are not Primary
Program Targets. Such additional research projects may be authorized by the JSC
prior to Synthetic making its election in accord with Section 2.1(c) below.
Further, at any time prior to the two-year anniversary of the Effective Date and
prior to the election by Synthetic under Section 2.1(c), Synthetic at its sole
discretion may suspend the initial research project for one or more of the
Primary Program Targets, and swap for such, on a one-for-one basis, any of the
five (5) other targets in the Field that are not Primary Program Targets. In the
event that Synthetic swaps out a Primary Program Target as set forth in the
previous sentence, or in the event that Synthetic otherwise suspends or
terminates the initial research project for a Primary Program Target prior to
making its election under Section 2.1(c), the definition of Field under Section
1.21 above will be automatically amended such that the suspended, terminated, or
swapped-out Primary Program Target will be removed automatically, immediately
and irrevocably from the Field, and thereby all obligations and rights

 

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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.

 

 

of the Parties as set forth herein which are defined at least in part by or in
conjunction with the Field will likewise be immediately amended as such from
that time forward. In the event that Synthetic swaps out a Primary Program
Target as set forth in the previous sentence, the Primary Program Targets will
be automatically amended such that any swapped-out Primary Program Target is
removed and replaced with the other target in the Field chosen to be swapped-in
by Synthetic, and thereby all obligations and rights of the Parties as set forth
herein which are defined at least in part by or in conjunction with the Primary
Program Targets will likewise be immediately amended as such from that time
forward. Any Synthetic Products corresponding to these suspended, terminated, or
swapped-out Primary Program Targets will be treated as Reverted Products in
accord with Section 10.4. 

 

(c)                Field Election. On or before the two-year anniversary of the
Effective Date, Synthetic must notify Intrexon in writing of Synthetic’s final
and binding election, which election identifies up to three (3) target toxins or
diseases in the Field (as the Field is defined at the point in time of the
notification, taking into account any amendments to its definition caused by
operation of Section 2.1(b)). Such election must reference this Section 2.1(c),
will be effective immediately upon receipt by Intrexon, and will cause the
definition of Field under this agreement to be amended immediately and
permanently such that the Field from that time forward shall include only those
three (3) elected toxins or diseases (and not any of the toxins or diseases not
elected). All rights and obligations of the Parties under this Agreement within
and without the Field will be permanently altered accordingly from the date of
receipt of that election forward for the remaining Term. For any of the target
toxins or diseases in the Field that are not elected by Synthetic under this
Section 2.1(c), Synthetic (i) shall immediately cease, and shall cause its
Affiliates and, if applicable, (sub)licensees to immediately cease, all
development and Commercialization of Synthetic Products pertaining thereto;
(ii), shall not use or practice, nor shall it cause or permit any of its
Affiliates or, if applicable, (sub)licensees to use or practice, directly or
indirectly, any Intrexon IP with respect to such; and (iii) shall return to
Intrexon, or destroy all copies thereto at Intrexon’s option, all data and
materials relating to such not-elected indications. Any Synthetic Products
corresponding to these not-elected indications will be treated as Reverted
Products in accord with Section 10.4.

 

(d)               Effect of No Election. In the event that Synthetic does not
communicate an election to Intrexon under Section 2.1(c) on or before the
two-year anniversary of the Effective Date, the definition of Field will be
amended automatically, immediately and permanently such that on the day after
the two-year anniversary of the Effective Date the Field shall include only the
Primary Program Targets and not any of the other target toxins or diseases that
are not Primary Program Targets. All rights and obligations of the Parties under
this Agreement which are defined at least in part by or in conjunction with the
Field will thereby be permanently altered accordingly for the remaining Term
from that time forward.

 

(e)                Option to Expand Field Election. Synthetic, at its sole
option, may expand its election rights under Section 2.1(c) to enable it to
elect up to five (5) additional indications from the list of items (a) through
(h) in Section 1.21 if : (i) prior to or concurrent with making an election
under Section 2.1(c) Synthetic notifies Intrexon in writing of its intent to
expand its election rights in accord with this Section 2.1(e), and (ii)
Synthetic remits a payment, in cash or equity at Synthetic’s sole discretion, to
Intrexon

 

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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.

 

 

of two million dollars ($2M) for each target in excess of three (3) that it
desires to elect under Section 2.1(c). Any payment under this section made by
Synthetic in equity must be made in compliance with the terms of the Equity
Agreements. Any expansion of Synthetic’s election rights under Section 2.1(c)
hereunder shall not be effective until the appropriate payment required under
this Section 2.1(e) is received by Intrexon, and cannot be used to enable
Synthetic to elect any targets that were already permanently removed from the
Field under Section 2.1(b). Upon successful execution of the option to expand
under this Section 2.1(e), all rights and obligations of the Parties under this
Agreement within and without the Field will be permanently altered accordingly
from the date of receipt of that option forward for the remaining Term.

 

2.2                   Committees.

 

(a)               Generally. The Parties desire to establish several committees
(collectively, “Committees”) to oversee the Anti-Infectives Program and to
facilitate communications between the Parties with respect thereto. Each of such
Committees shall have the responsibilities and authority allocated to it in this
Article 2. Each of the Committees shall have the obligation to exercise its
authority consistent with the respective purpose for such Committee as stated
herein and any such decisions shall be made in good faith.

 

(b)               Formation and Purpose. Promptly following the Effective Date,
the Parties shall confer and then create the Committees listed in the chart
below, each of which shall have the purpose indicated in the chart. To the
extent that after conferring both Parties agree that a given Committee need not
be created until a later date, the Parties may agree to defer the creation of
the Committee until one Party informs the other Party of its then desire to
create the so-deferred Committee, at which point the Parties will thereafter
promptly create the so-deferred Committee and schedule a meeting of such
Committee within one (1) month.

 

Committee Purpose Joint Steering Committee (“JSC”)

Establish projects for the Anti-Infectives Program and establish the priorities,
as well as approve budgets for such projects. Approve all subcommittee projects
and plans. The JSC shall establish budgets not less than on a quarterly basis.

 

 

Chemistry, Manufacturing and Controls Committee (“CMCC”) Establish project plans
and review and approve activities and budgets for chemistry, manufacturing, and
controls under the Anti-Infectives Program.

 

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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.

 

 

Committee Purpose

Clinical/Regulatory Committee (“CRC”) Review and approve all research and
development plans, clinical projects and publications, and regulatory filings
and correspondence under the Anti-Infectives Program; review and approve
itemized budgets with respect to the foregoing. Commercialization Committee
(“CC”) Establish project plans and review and approve activities and budgets for
commercialization activities under the Anti-Infectives Program. Intellectual
Property Committee (“IPC”) Evaluate intellectual property issues in connection
with the Anti-Infectives Program; review and approve itemized budgets with
respect to the foregoing.

 

2.3                   General Committee Membership and Procedure.

 

(a)               Membership. For each Committee, each Party shall designate an
equal number of representatives (not to exceed four (4) for each Party) with
appropriate expertise to serve as members of such Committee. For the JSC the
representatives must all be employees of such Party or an Affiliate of such
Party, and for Committees other than the JSC the representatives must all be
employees of such Party or an Affiliate of such Party with the caveat that each
Party may designate for each such other Committee up to one (1) representative
who is not an employee if : (i) such non-employee representative agrees in
writing to be bound to the terms of this Agreement for the treatment and
ownership of Confidential Information and Inventions of the Parties, and (ii)
the other Party consents to the designation of such non-employee representative,
which consent shall not be unreasonably withheld. Each representative as
qualified above may serve on more than one Committee as appropriate in view of
the individual’s expertise. Each Party may replace its Committee representatives
at any time upon written notice to the other Party. Each Committee shall have a
chairperson; the chairperson of each committee shall serve for a two-year term
and the right to designate which representative to the Committee will act as
chairperson shall alternate between the Parties, with Synthetic selecting the
chairperson first for the JSC, CRC and CC, and Intrexon selecting the
chairperson first for the CMCC and IPC. The chairperson of each Committee shall
be responsible for calling meetings, preparing and circulating an agenda in
advance of each meeting of such Committee, and preparing and issuing minutes of
each meeting within fifteen (15) days thereafter.

 

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CONFIDENTIAL

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)               Meetings. Each Committee shall hold meetings at such times as
it elects to do so, but in no event shall such meetings be held less frequently
than once every six (6) months, with the caveat that both Parties may agree to
suspend activities of a given Committee other than the JSC until such time as
one Party informs the other Party of its then desire to reactivate the
so-suspended Committee, at which point the Parties will thereafter schedule and
hold the next meeting for the reactivated Committee within one (1) month.
Meetings of any Committee may be held in person or by means of telecommunication
(telephone, video, or web conferences). To the extent that a Committee holds any
meetings in person, the Parties will alternate in designating the location for
such in-person meetings, with Synthetic selecting the first meeting location for
each Committee. A reasonable number of additional representatives of a Party may
attend meetings of a Committee in a non-voting capacity. Each Party shall be
responsible for all of its own expenses of participating in any Committee
excepting that an Intrexon employee or agent serving on a Committee shall not
prevent Intrexon from recouping the Fully Loaded Costs otherwise derived from
the labor of that employee or agent in the course of providing manufacturing or
support services as set forth in Sections 4.6 and 4.7 below.

 

(c)                Meeting Agendas. Each Party will disclose to the other
proposed agenda items along with appropriate information at least three (3)
business days in advance of each meeting of the applicable Committee; provided,
that a Party may provide its agenda items to the other Party within a lesser
period of time in advance of the meeting, or may propose that there not be a
specific agenda for a particular meeting, so long as such other Party consents
to such later addition of such agenda items or the absence of a specific agenda
for such Committee meeting..

 

(d)               Limitations of Committee Powers. Each Committee shall have
only such powers as are specifically delegated to it hereunder or from time to
time as agreed to in writing by the mutual consent of the Parties and shall not
be a substitute for the rights of the Parties. Without limiting the generality
of the foregoing, no Committee shall have any power to amend this Agreement. Any
amendment to the terms and conditions of this Agreement shall be implemented
pursuant to Section 12.7 below.

 

2.4                   Committee Decision-Making. If a Committee is unable to
reach unanimous consent on a particular matter within thirty (30) days of its
initial consideration of such matter, then either Party may provide written
notice of such dispute to the Executive Officer of the other Party. The
Executive Officers of each of the Parties will meet at least once in person or
by means of telecommunication (telephone, video, or web conferences) to discuss
the dispute and use their good faith efforts to resolve the dispute within
thirty (30) days after submission of such dispute to the Executive Officers. If
any such dispute is not resolved by the Executive Officers within thirty (30)
days after submission of such dispute to such officers, then the Executive
Officer of the Party specified in the applicable subsection below shall have the
authority to finally resolve such dispute acting in good faith.

 

(a)               Casting Vote at JSC. If a dispute at the JSC is not resolved
pursuant to Section 2.4 above, then the Executive Officer of Synthetic shall
have the authority to finally resolve such dispute.

 

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CONFIDENTIAL

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)               Casting Vote at CMCC. If a dispute at the CMCC is not resolved
pursuant to Section 2.4 above, then (i) in the case of any disputes relating to
the Intrexon Materials or controls regarding the dissemination of Intrexon IP or
Intrexon Materials, the Executive Officer of Intrexon shall have the authority
to finally resolve such dispute; and (ii) in the case of any other disputes,
including the manufacture of a Synthetic Product active pharmaceutical
ingredient, the Executive Officer of Synthetic shall have the authority to
finally resolve such dispute.

 

(c)                Casting Vote at CRC. If a dispute at the CRC is not resolved
pursuant to Section 2.4 above, then the Executive Officer of Synthetic shall
have the authority to finally resolve such dispute.

 

(d)               Casting Vote at CC. If a dispute at the CC is not resolved
pursuant to Section 2.4 above, then the Executive Officer of Synthetic shall
have the authority to finally resolve such dispute.

 

(e)                Casting Vote at IPC. If a dispute at the IPC is not resolved
pursuant to Section 2.4 above, then the Executive Officer of Intrexon shall have
the authority to finally resolve such dispute, provided that such authority
shall be shared by the Parties with respect to Product-Specific Program Patents
(i.e., neither Party shall have the casting vote on such matters, and any such
disputes shall be resolved pursuant to Article 11).

 

(f)                Other Committees. If any additional Committee other than
those set forth in Section 2.2(b) is formed, then the Parties shall, at the time
of such formation, agree on which Party shall have the authority to finally
resolve a dispute that is not resolved pursuant to Section 2.4 above.

 

(g)               Restrictions. Neither Party shall exercise its right to
finally resolve a dispute at a Committee in accordance with this Section 2.4 in
a manner that (i) excuses such Party from any of its obligations specifically
enumerated under this Agreement; (ii) expands the obligations of the other Party
under this Agreement; (iii) negates any consent rights or other rights
specifically allocated to the other Party under this Agreement; (iv) purports to
resolve any dispute involving the breach or alleged breach of this Agreement;
(v) resolves a matter if the provisions of this Agreement specify that mutual
agreement is required for such matter; or (vi) would require the other Party to
perform any act that is inconsistent with applicable law.

 

ARTICLE 3

License Grants

 

3.1                   Licenses to Synthetic.

 

(a)               Subject to the terms and conditions of this Agreement,
Intrexon hereby grants to Synthetic a license under the Intrexon IP to research,
develop, use, import, export, make, have made, sell, and offer for sale
Synthetic Products in the Field in the Territory. Such license shall be
exclusive (even as to Intrexon) with respect to any clinical development,
selling, offering for sale or other Commercialization of Synthetic Products in
the Field, and shall be otherwise non-exclusive.

 

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CONFIDENTIAL

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)               Subject to the terms and conditions of this Agreement,
Intrexon hereby grants to Synthetic a non-exclusive, royalty-free license to use
and display the Intrexon Trademarks, solely in connection with the
Commercialization of Synthetic Products, in the promotional materials,
packaging, and labeling for Synthetic Products, as provided under and in
accordance with Section 4.9.

 

(c)                For purposes of clarity, the licenses from Intrexon to
Synthetic under Sections 3.1(a) and 3.1(b) will automatically change in
conjunction with any amendments to the definition of Field in accord with
Sections 2.1(c) through 2.1(e).

 

3.2                   Sublicensing. Except as provided below, Synthetic shall
not sublicense the rights granted under Section 3.1 to any Third Party, or
transfer the Intrexon Materials to any Third Party, or otherwise grant any Third
Party the right to research, develop, use, or Commercialize Synthetic Products
or use or display the Intrexon Trademarks, in each case except with Intrexon’s
written consent, which written consent may be withheld in Intrexon’s sole
discretion. Notwithstanding the foregoing, Synthetic shall have a limited right
to sublicense under the circumstances described in Sections 3.2(a) and 3.2(b).

 

(a)               Synthetic may transfer, to the extent reasonably necessary,
Intrexon Materials that are or express active pharmaceutical ingredients to a
Third Party contractor performing contract manufacturing, fill, and/or finish
responsibilities for Synthetic Products, and may in connection therewith grant
limited sublicenses necessary to enable such Third Party to perform such
activities. If Synthetic transfers any Intrexon Materials under this Section
3.2(a), Synthetic will remain obligated to ensure that the rights of Intrexon in
and to the Intrexon Materials and Intrexon IP and under the provisions of
Articles 6 and 7 of this Agreement are not violated by any such Third Party
contractor.

 

(b)               Synthetic may, with Intrexon’s written consent, which consent
cannot be unreasonably withheld, sublicense the rights granted under Section 3.1
to an Affiliate, or transfer the Intrexon Materials to an Affiliate, or grant an
Affiliate the right to research, develop, use, or Commercialize Synthetic
Products or use or display the Intrexon Trademarks. In the event that Intrexon
consents to any such grant or transfer to an Affiliate, Synthetic shall remain
responsible for, and be guarantor of, the performance by any such Affiliate and
shall cause such Affiliate to comply with the provisions of this Agreement in
connection with such performance (as though such Affiliate were Synthetic),
including any payment obligations owed to Intrexon hereunder.

 

3.3                   Limitation on Sublicensees. None of the enforcement rights
under the Intrexon Patents that are granted to Synthetic pursuant to Section 6.3
shall be transferred to, or exercised by, a sublicensee except with Intrexon’s
prior written consent, which may be withheld in Intrexon’s sole discretion.

 

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CONFIDENTIAL

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.

 

 

3.4                   No Non-Permitted Use. Synthetic hereby covenants that it
shall not, nor shall it permit any Affiliate or, if applicable, (sub)licensee,
to use or practice, directly or indirectly, any Intrexon IP, Intrexon Channel
Technology, or Intrexon Materials for any purposes other than those expressly
permitted by this Agreement.

 

3.5                   Exclusivity. Intrexon and Synthetic mutually agree that,
under the channel collaboration established by this Agreement, it is intended
that the Parties will be exclusive to each other in the Field. To this end,
neither Intrexon nor its Affiliates shall make the Intrexon Channel Technology
or Intrexon Materials available to any Third Party for the purpose of developing
or Commercializing products in the Field (except as set forth in Section 3.2),
and neither Intrexon nor any Affiliate shall pursue (either by itself or with a
Third Party or Affiliate) the research, development or Commercialization of any
product for purpose of sale in the Field, outside of the Anti-Infectives
Program. Further, other than Synthetic’s activities within the Anti-Infectives
Program, neither Synthetic nor its Affiliates shall pursue (either by itself or
with a Third Party or Affiliate) the research, development or Commercialization
of any product for purpose of sale in the Field.

 

3.6                   Off Label Use. For purpose of clarity, (a) following the
Commercial Sale of a Synthetic Product, the use by direct or indirect purchasers
or other users of Synthetic Products outside the Field (i.e. “off label use”)
shall not constitute a breach by Synthetic of the terms of Section 3.3, 3.4 or
3.5, provided that neither Synthetic nor its Affiliate (nor any Third Party
under contract with either of them) marketed or promoted Synthetic Products for
such off-label use; and (b) following the Commercial Sale of a product by
Intrexon, an Intrexon Affiliate, or a Third Party sublicensee, collaborator, or
partner of Intrexon, the use by direct or indirect purchasers or other users of
such products in the Field (i.e. “off label use”) shall not constitute a breach
by Intrexon of the terms of Section 3.5, provided that neither Intrexon nor its
Affiliate (nor any Third Party under contract with either of them) marketed or
promoted such products for such off-label use.

 

3.7                   No Prohibition on Intrexon. Except as explicitly set forth
in Sections 3.1 and 3.5, nothing in this Agreement shall prevent Intrexon from
practicing or using the Intrexon Materials, Intrexon Channel Technology, and
Intrexon IP for any purpose, and to grant to Third Parties the right to do the
same. Without limiting the generality of the foregoing, Synthetic acknowledges
that Intrexon has all rights, in Intrexon’s sole discretion, to make the
Intrexon Materials, Intrexon Channel Technology (including any active
pharmaceutical ingredient used in a Synthetic Product), and Intrexon IP
available to Third Party channel partners or collaborators for use in fields
outside the Field.

 

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CONFIDENTIAL

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.

 

 

3.8                   Rights to Clinical and Regulatory Data. Synthetic shall
own and control all clinical data and regulatory filings relating to
Commercialization of Synthetic Products during the Term. Synthetic shall provide
at Intrexon’s request full copies of all clinical and non-clinical data and
reports, regulatory filings, and communications from regulatory authorities that
relate specifically and solely to Synthetic Products. To the extent that there
exist any clinical and non-clinical data and reports, regulatory filings, and
communications from regulatory authorities owned by Synthetic that relate both
to Synthetic Products and other products produced by Synthetic outside the
Field, Synthetic shall provide to Intrexon upon Intrexon’s request copies of the
portions of such data, reports, filings, and communications that relate to
Synthetic Products. Subject to its ongoing obligations of exclusivity under
Section 3.5 and regarding off label use under 3.6, Intrexon shall be permitted,
directly or in conjunction with or through partners or other channel
collaborators, to reference this data, reports, filings, and communications
relating to Synthetic Products in regulatory filings made to obtain regulatory
approval for products indicated for use in fields outside the Field. Intrexon
shall have the right to use any such information in developing and
Commercializing products outside the Field and to license any Third Parties to
do so. Notwithstanding the provisions of this Section 3.8, Intrexon shall not,
outside of the Anti-Infectives Program, utilize knowingly any Synthetic clinical
and non-clinical data or reports in support of obtaining regulatory approval for
a product for use in the Field.

 

3.9                   Third Party Licenses.

 

(a)               [*****]shall obtain, [*****], any licenses from Third Parties
that are required in order to practice the Intrexon Channel Technology in the
Field where the licensed intellectual property is reasonably necessary for
Intrexon to identify and characterize human antibodies (but specifically
excluding intellectual property directed to any processes or methods for
expressing monoclonal antibodies from cloned cells or methods of treating humans
with antibodies for purposes of therapy) (“Supplemental In-Licensed Third Party
IP”). Other than with respect to Supplemental In-Licensed Third Party IP,
[*****] shall be solely responsible for obtaining, [*****], any licenses from
Third Parties that [*****] determines, in its sole discretion, are required in
order to lawfully make, use, sell, offer for sale, or import Synthetic Products
(“Complementary In-Licensed Third Party IP”). Supplemental In-Licensed Third
Party IP and Complementary In-Licensed Third Party IP are collectively referred
to as “In-Licensed Program IP”.

 

(b)               In the event that either Party desires to license from a Third
Party any Supplemental In-Licensed Third Party IP or Complementary In-Licensed
Third Party IP, such Party shall so notify the other Party, and the IPC shall
discuss such In-Licensed Program IP and its applicability to the Synthetic
Products and to the Field. As provided above in Section 3.9(a), [*****] shall
have the sole right and responsibility to pursue a license under Supplemental
In-Licensed Third Party IP, and [*****] hereby covenants that it shall not
itself directly license such Supplemental In-Licensed Third Party IP at any
time, provided that [*****] may (but shall not be obligated to) obtain such a
license directly if the Third Party owner or licensee of such Supplemental
In-Licensed Third Party IP brings an infringement action against [*****] or its
Affiliates and, after written notice to [*****] of such action, [*****] fails to
obtain a license to such Supplemental In-Licensed Third Party IP using Diligent
Efforts within ninety (90) days after such notice. Following the IPC’s
discussion of any Complementary In-Licensed Third Party IP, subject to Section
3.8(c), [*****] shall have the right to pursue a license under Complementary
In-Licensed Third Party IP, [*****]. For the avoidance of doubt, [*****] may at
any time obtain a license under Complementary In-Licensed Third Party IP outside
the Field, [*****], provided that if [*****] decides to seek to obtain such a
license, it shall use reasonable efforts to coordinate its licensing activities
in this regard with [*****].

 

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CONFIDENTIAL

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)                [*****] shall provide the proposed terms of any license under
Complementary In-Licensed Third Party IP and the final version of the definitive
license agreement for any Complementary In-Licensed Third Party IP to the IPC
for review and discussion prior to signing, and shall consider [*****] comments
thereto in good faith. To the extent that [*****] obtains a license under
Supplemental In-Licensed Third Party IP, [*****] shall provide the final version
of the definitive license agreement for such Supplemental In-Licensed Third
Party IP to the IPC. If [*****] acquires rights under any In-Licensed Program IP
outside the Field, it will do so on a non-exclusive basis unless it obtains the
prior written consent of [*****] for such license outside the Field to be
exclusive. For purposes of clarity, the foregoing requirement shall not restrict
[*****]ability with respect to licensing intellectual property owned by a Third
Party that is not required in order for [*****]to lawfully make, use, sell,
offer for sale, or import Synthetic Products. Any Party that is pursuing a
license to any In-Licensed Program IP with respect to the Field under this
Section 3.9 shall keep the other Party reasonably informed of the status of any
negotiations relating thereto. For purposes of clarity, (i) any costs incurred
by [*****]in obtaining and maintaining licenses to Supplemental In-Licensed
Third Party IP shall be borne solely by [*****], and (ii) any costs incurred by
[*****]in obtaining and maintaining licenses to Complementary In-Licensed Third
Party IP (and, to the limited extent provided in subsection (b), Supplemental
In-Licensed Third Party IP) shall be borne solely by [*****].

 

(d)               For any Third Party license under which Synthetic or its
Affiliates obtain a license under Patents claiming inventions or know-how
specific to or used or incorporated into the development, manufacture, and/or
Commercialization of Synthetic Products, Synthetic shall use commercially
reasonable efforts to ensure that Synthetic will have the ability, pursuant to
Section 10.4(h), to assign such agreement to Intrexon or grant a sublicense to
Intrexon thereunder (having the scope set forth in Section 10.4(h)).

 

(e)                The licenses granted to Synthetic under Section 3.1 may
include sublicenses under Intrexon IP that has been licensed to Intrexon by one
or more Third Parties. Any such sublicenses are subject to the terms and
conditions set forth in the applicable upstream license agreement, subject to
the cost allocation set forth in Section 3.9(c), provided that Intrexon shall
either provide unredacted copies of such upstream license agreements to
Synthetic or shall disclose in writing to Synthetic all of such terms and
conditions that are applicable to Synthetic. Synthetic shall not be responsible
for complying with any provisions of such upstream license agreements unless,
and to the extent that, such provisions have been disclosed to Synthetic as
provided in the preceding sentence.

 

(f)                If either Party receives notice from a Third Party concerning
activities of a Party taken in conjunction with performance of obligations under
this Agreement, which notice alleges infringement by a Party of, or offers
license under, Patents or other intellectual property rights owned or controlled
by that Third Party, the receiving Party shall inform the other party thereof
within five (5) business days.

 

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CONFIDENTIAL

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.

 

 

3.10               Licenses to Intrexon. Subject to the terms and conditions of
this Agreement, Synthetic hereby grants to Intrexon a non-exclusive, worldwide,
fully-paid, royalty-free license, under any applicable Patents or other
intellectual property Controlled by Synthetic or its Affiliates, solely to the
extent necessary for Intrexon to conduct those responsibilities assigned to it
under this Agreement, which license shall be sublicensable solely to Intrexon’s
Affiliates or to any of Intrexon’s permitted subcontractors.

 

3.11               Restrictions Relating to Intrexon Materials. Synthetic and
its permitted sublicensees shall use the Intrexon Materials solely for purposes
of the Anti-Infectives Program and not for any other purpose without the prior
written consent of Intrexon. With respect to the Intrexon Materials comprising
Intrexon’s vector assembly technology, Synthetic shall not, and shall ensure
that Synthetic personnel and permitted sublicensees do not, except as otherwise
permitted in this Agreement (a) distribute, sell, lend or otherwise transfer
such Intrexon Materials to any Third Party; (b) co-mingle such Intrexon
Materials with any other proprietary biological or chemical materials without
Intrexon’s written consent; or (c) analyze such Intrexon Materials or in any way
attempt to reverse engineer or sequence such Intrexon Materials.

 

ARTICLE 4

Other Rights and Obligations

 

4.1                   Development and Commercialization. Subject to Sections 4.6
and 4.7, Synthetic shall be solely responsible for the performance of the
Anti-Infectives Program and the development and Commercialization of Synthetic
Products in the Field. Synthetic shall be responsible for all costs incurred in
connection with the Anti-Infectives Program except that Intrexon shall be
responsible for the following: (a) costs of basic research with respect to the
Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements)
but, for clarity, excluding research described in Section 4.7 or research
requested by the JSC for the development of a Synthetic Product (which research
costs shall be reimbursed by Synthetic); (b) [*****]; and (c) costs of filing,
prosecution and maintenance of Intrexon Patents. The costs encompassed within
subsection (a) above shall include the scale-up of Intrexon Materials and
related active pharmaceutical ingredients for clinical trials and
commercialization of Synthetic Products undertaken pursuant to Section 4.6,
which shall be at Intrexon’s cost whether it elects to conduct such efforts
internally or through Third Party contractors retained by either Intrexon or
Synthetic (with Intrexon’s consent).

 

4.2                   Transfer of Technology and Information. The JSC shall
develop a plan and protocol for each project and timing for the transfer of
relevant data and materials between the Parties.

 

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CONFIDENTIAL

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                   Information and Reporting. Synthetic will keep Intrexon
informed about Synthetic’s efforts to develop and commercialize Synthetic
Products, including reasonable and accurate summaries of Synthetic’s (and its
Affiliates’ and, if applicable, (sub)licensees’) global development plans (as
updated), including preclinical, clinical and regulatory plans, global marketing
plans (as updated), progress towards meeting the goals and milestones in such
plans and explanations of any material deviations, and significant developments
in the development and/or commercialization of the Synthetic Products, including
initiation or completion of a clinical trial, submission of a United States or
international regulatory filing, receipt of a response to such United States or
international regulatory filing, clinical safety event, receipt of Regulatory
Approval, or commercial launch. As set forth in Section 3.8 above, Synthetic
shall also provide to Intrexon copies of all final preclinical protocols and
reports, final clinical protocols and reports, and regulatory correspondence and
filings generated by Synthetic as soon as practical after they become available.
Intrexon will keep Synthetic informed about Intrexon’s efforts (a) to establish
manufacturing capabilities and facilities for Synthetic Products (and Intrexon
Materials relevant thereto) and otherwise perform its manufacturing
responsibilities under Section 4.6 and (b) to undertake discovery-stage research
for the Anti-Infectives Program with respect to the Intrexon Channel Technology
and Intrexon Materials. Unless otherwise provided herein, such disclosures by
Synthetic and Intrexon will be made in the course of JSC meetings at least once
every six (6) months while Synthetic Products are being developed or
commercialized anywhere in the world, and shall be reflected in the minutes of
such meetings.

 

4.4                   Regulatory Matters. At all times after the Effective Date,
Synthetic shall own and maintain, at its own cost, all regulatory filings and
regulatory approvals for Synthetic Products that Synthetic is developing or
Commercializing pursuant to this Agreement. As such, Synthetic shall be
responsible for reporting all adverse events related to such Synthetic Products
to the appropriate regulatory authorities in the relevant countries, in
accordance with the applicable laws and regulations of such countries. To the
extent that Intrexon will itself develop, or in collaboration with other third
parties develop, Intrexon Materials outside of the Field, Intrexon may request
that Synthetic and Intrexon establish and execute a separate safety data
exchange agreement, which agreement will address and govern the timely exchange
of safety information generated by Synthetic, Intrexon, and relevant third
parties with respect to specific Intrexon Materials. The decision to list or not
list Patents in any regulatory filing for a Synthetic Product (for example, as
required by 21 C.F.R. § 314.53(b)), add or delete a Patent from a regulatory
filing, or to otherwise identify a Patent to a third party in compliance with
laws or regulations relating to regulatory approvals (for example, in compliance
with 42 U.S.C. § 262(a)(1)(A)(k) et seq.) shall be determined by Intrexon, after
consultation with Synthetic, except with respect to Product Specific Program
Patents, which will be mutually determined by the Parties.

 

4.5                   Diligence.

 

(a)               Synthetic shall use, and shall require its sublicensees to
use, Diligent Efforts to develop and commercialize Synthetic Products.

 

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CONFIDENTIAL

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)               Without limiting the generality of the foregoing, Intrexon
may, from time to time, notify Synthetic that it believes it has identified a
Superior Therapy, and in such case Intrexon shall provide to Synthetic its
then-available information about such therapy and reasonable written support for
its conclusion that the therapy constitutes a Superior Therapy. Synthetic shall
have the following obligations with respect to such proposed Superior Therapy:
(i) within sixty (60) days after such notification, Synthetic shall prepare and
deliver to the JSC for review and approval a development plan detailing how
Synthetic will pursue the Superior Therapy (including a proposed budget); (ii)
Synthetic shall revise the development plan as directed by the JSC; and (iii)
following approval of the development plan by the JSC, Synthetic shall use
Diligent Efforts to pursue the development of the Superior Therapy under the
Anti-Infectives Program in accordance with such development plan. If Synthetic
fails to comply with the foregoing obligations, or if Synthetic unreasonably
exercises its casting vote at the JSC to either (x) prevent the approval of a
development plan for a Superior Therapy; (y) delay such approval more than sixty
(60) days after delivery of the development plan to the JSC; or (z) approve a
development plan that is insufficient in view of the nature and magnitude of the
opportunity presented by the Superior Therapy, then Intrexon shall have the
termination right set forth in Section 10.2(c) (subject to the limitation set
forth therein). For clarity, any dispute arising under this 4.5, including any
dispute as to whether a proposed project constitutes a Superior Therapy (as with
any other dispute under this Agreement) shall be subject to dispute resolution
in accordance with Article 11.

 

(c)                The activities of Synthetic’s Affiliates and any permitted
sublicensees shall be attributed to Synthetic for the purposes of evaluating
Synthetic’s fulfillment of the obligations set forth in this Section 4.5.

 

4.6                   Manufacturing.

 

(a)               As part of the Therapeutic Program, Intrexon shall be tasked
with the development of one or more cell lines and may be asked by the JSC or
CMCC to research and develop processes, and may thereafter validate such
processes, for manufacturing one or more Synthetic Products hereunder. In
connection with such research and development, a Third Party selected by
Synthetic and approved by the JSC, which approval cannot be unreasonably
withheld, may manufacture and supply pre-clinical quantities of each Synthetic
Product. Intrexon shall provide, subject to reasonable controls concerning
protecting all provided Intrexon Materials, to Synthetic or the selected Third
Party such quantities of cells or other Intrexon Materials reasonable necessary
for the pre-commercial development activities hereunder, at Synthetic expense,
said expense approved in advance by written confirmation of the JSC.

 

(b)               Intrexon shall have the option to present a proposal for
consideration to the JSC to be the manufacturer of the Synthetic Product, or
component thereof, either in bulk form or as finished product, for Synthetic for
clinical and/or commercialization use. Synthetic will determine whether
Intrexon, or Synthetic’s or Intrexon’s proposed Third Party, is a manufacturer
of a Synthetic Product. Synthetic shall make their determination as to the
manufacturer of each Synthetic Product based on the commercially reasonable
consideration of their standards and criteria, as applied in a manner consistent
with that applied to the manufacture of other Synthetic products and in good
faith. Upon Intrexon’s request, Synthetic shall provide Intrexon with a
reasonable explanation and summary of the criteria that Synthetic used in
deciding upon the manufacturer(s). In the event Intrexon is chosen by Synthetic
to manufacture Synthetic Product under this Agreement, such supply shall be
carried out under the terms negotiated by the Parties in good faith and set
forth in separate supply and quality agreements.

 

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CONFIDENTIAL

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)                In the event that Intrexon is not selected as the
manufacturer for clinical and/or commercial quantities of a Synthetic Product,
Synthetic will assume all responsibility and related expense for manufacturing
and supply of clinical and/or commercial quantities of such Synthetic Product in
accordance with a validation process. Intrexon shall work with Synthetic to
coordinate the transfer to Synthetic, or Synthetic-designated contract
manufacturer(s), any process developed to date, along with any additional
Confidential Information or materials Controlled by Intrexon that is necessary
for the manufacturing of such bulk drug substance and/or finished product for
the sole purpose of manufacturing such bulk drug substance and/or finished
product on behalf of Synthetic for use in connection with Synthetic’s exercise
of its rights in the Field. The reasonable costs and expenses incurred by
Intrexon in carrying out such transfer shall be borne by Synthetic and shall be
negotiated in good faith by the Parties at the time Synthetic exercises its
rights under this Agreement. Synthetic, in consultation with Intrexon, will
oversee process validation of such Synthetic Products at the Synthetic selected
manufacturing site(s). The process, along with any additional manufacturing
Information transferred hereunder to Synthetic or its contract manufacturer
shall be deemed Confidential Information of Intrexon, and shall not be further
transferred to any Third Party or Synthetic Affiliate without the prior written
consent of Intrexon. Any such changes to the process provided by Intrexon to
Synthetic are owned by Intrexon, with Synthetic having a non-exclusive license
right (such non-exclusive right hereby granted to Synthetic by Intrexon) for
purposes of exercising rights in the Field, pursuant to this Section 4.6.

 

4.7                   Support Services. As set forth in Section 2.1(b),
immediately following the Effective Date, Intrexon will begin providing support
services to Synthetic by which Intrexon will conduct research and development of
Synthetic Products on behalf of Synthetic for the Primary Program Targets. The
JSC will meet promptly following the Effective Date and establish a plan for
this research and development, and Synthetic will compensate Intrexon for such
support services with cash payments equal to Intrexon’s Fully Loaded Cost in
connection with such services. Additionally, from time to time, on an ongoing
basis, Synthetic shall request, or Intrexon may propose, that Intrexon perform
certain additional support services with respect to the Anti-Infectives Program.
To the extent that the Parties mutually agree that Intrexon should perform such
additional services, the Parties shall negotiate in good faith the terms under
which services would be performed, it being understood that Intrexon would be
compensated for such services by cash payments equal to Intrexon’s Fully Loaded
Cost in connection with such services. The JSC from time to time may reasonably
determine that specific experiments under the Anti-Infectives Program require
special therapeutic or technical expertise and thus should be conducted by Third
Parties having such capabilities. Upon agreement by the Parties, the billing for
any such work conducted by Third Party under the previous sentence may be billed
directly to Synthetic or passed through to Synthetic.

 

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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.

 

 

4.8                   Compliance with Law. Each Party shall comply, and shall
ensure that its Affiliates, (sub)licensees and Third Party contractors comply,
with all applicable laws, regulations, and guidelines applicable to the
Anti-Infectives Program, including without limitation those relating to the
transport, storage, and handling of Intrexon Materials and Synthetic Products.

 

4.9                   Trademarks and Patent Marking. To the extent permitted by
applicable law and regulations, Synthetic shall, and shall ensure that the
packaging, promotional materials, and labeling for Synthetic Products shall
carry, in a conspicuous location, the applicable Intrexon Trademark(s), subject
to Synthetic’s reasonable approval of the size, position, and location thereof.
Consistent with the U.S. patent laws, Synthetic shall ensure that Synthetic
Products, or its packaging or accompanying literature as appropriate, bear
applicable and appropriate patent markings for Intrexon Patent numbers.
Synthetic shall provide Intrexon with copies of any materials containing the
Intrexon Trademarks or patent markings prior to using or disseminating such
materials, in order to obtain Intrexon’s approval thereof. Synthetic’s use of
the Intrexon Trademarks and patent markings shall be subject to prior review and
approval of the IPC. Synthetic acknowledges Intrexon’s sole ownership of the
Intrexon Trademarks and agrees not to take any action inconsistent with such
ownership. Synthetic covenants that it shall not use any trademark confusingly
similar to any Intrexon Trademarks in connection with any products (including
any Synthetic Product). From time to time during the Term, Intrexon shall have
the right to obtain from Synthetic samples of Synthetic Product sold by
Synthetic or its Affiliates or sublicensees, or other items which reflect public
uses of the Intrexon Trademarks or patent markings, for the purpose of
inspecting the quality of such Synthetic Products, the use of the Intrexon
Trademarks, or the accuracy of the patent markings. In the event that Intrexon
inspects under this Section 4.9, Intrexon shall notify the result of such
inspection to Synthetic in writing thereafter. Synthetic shall comply with
reasonable policies provided by Intrexon from time-to-time to maintain the
goodwill and value of the Intrexon Trademarks.

 

4.10               Reporting Compliance. During the Term, in the event that
Intrexon notifies Synthetic that Intrexon has reasonably concluded, after
consultation with its outside advisors, that Intrexon will have to consolidate
Synthetic’s financial statements with its own, for so long as Intrexon
reasonably believes that such consolidation is necessary, Synthetic shall use
its best efforts to comply with the following additional obligations:

 

(a)               Synthetic shall maintain at its principal place of business
or, upon notice to Intrexon, at such other place as Synthetic shall determine:

 

(i)                 a copy of Synthetic’s certificate of incorporation or
organizational document and all amendments thereto, together with executed
copies of any powers of attorney pursuant to which any amendment has been
executed;

 

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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)               a copy of this Agreement;

 

(iii)             a copy of Synthetic’s federal, state, and local income tax
returns and reports, if any; and

 

(iv)             minutes of meetings of Synthetic’s board of directors and
shareholders or actions by written consent in lieu thereof, redacted as
necessary by Synthetic to exclude any sensitive or confidential information that
Intrexon, by operation of law or contractual stipulation, is not permitted to
receive.

 

(b)               Synthetic shall use the accrual method of accounting in
preparation of its annual reports and for tax purposes and shall keep its books
and records accordingly, consistent with US GAAP.

 

(c)                Intrexon at its own expense and upon reasonable notice, may
examine any information it may reasonably request (including, to the extent
Synthetic has the right to provide such, the work papers of Synthetic’s internal
and independent auditors) and make copies of and abstracts from the financial
and operating records and books of account of Synthetic, and discuss the
affairs, finances and accounts of Synthetic with Synthetic and independent
auditors of Synthetic, all at such reasonable times and as often as Intrexon or
any agents or representatives of Intrexon may reasonably request. The rights
granted pursuant to this Section 4.10(c) are expressly subject to compliance by
Intrexon with the safety, security and confidentiality procedures and guidelines
of Synthetic, as such procedures and guidelines may be established from time to
time.

 

(d)               As soon as available but no later than ninety (90) days after
the end of each fiscal year, Synthetic shall cause to be prepared and Intrexon
to be furnished with an audited balance sheet as of the last day of such fiscal
year and an audited income statement, a statement of stockholders’ equity and
statement of cash flows for Synthetic for such fiscal year and notes associated
with each, in each case prepared in accordance with US GAAP, together with a
report of Synthetic’s independent auditor that such statements have been
prepared in accordance with US GAAP and present fairly, in all material
respects, the financial position, results of operations and cash flows of
Synthetic.

 

(e)                As soon as available but no later than forty five (45) days
after the end of each calendar quarter, Synthetic shall furnish the following to
Intrexon an unaudited balance sheet as of the last day of such period, and an
unaudited income statement, a statement of cash flows and a statement of
stockholders’ equity for Synthetic for such period, in each case prepared in
accordance with US GAAP.

 

(f)                As requested by Intrexon on no more than a quarterly basis, a
certificate, executed by the Executive Officer of Synthetic, certifying the
following:

 

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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.

 

 

(i)                 Synthetic maintains accurate books and records reflecting
its assets and liabilities and maintains proper and adequate internal accounting
controls that provide assurance that (1) transactions are executed with
management’s authorization; (2) transactions are recorded as necessary to permit
preparation of the consolidated financial statements of Synthetic and to
maintain accountability for Synthetic’s consolidated assets; (3) access to the
assets of Synthetic is permitted only in accordance with management’s
authorization; (4) the reporting of assets of Synthetic is compared with
existing assets at regular intervals; and (5) accounts, notes and other
receivables and inventory are recorded accurately, and proper and adequate
procedures are implemented to effect the collection of accounts, notes and other
receivables on a current and timely basis.

 

(ii)               Synthetic maintains disclosure controls and procedures to the
extent such would be required of a publicly registered company under the
Securities Exchange Act of 1934, as amended, and the rules and regulations
promulgated thereunder; any such controls and procedures are effective to ensure
that all material information concerning Synthetic is made known on a timely
basis to those individuals responsible for the preparation of any filings that
may be required to be made by Intrexon with the SEC and other public disclosure
documents.

 

(g)               Synthetic shall promptly prepare and furnish to Intrexon any
information, whether written or oral, requested by Intrexon that is reasonably
necessary for purposes of Intrexon’s ongoing compliance with applicable law.

 

4.11               Modification of Deadlines. The parties agree that the
delivery deadlines in Section 4.10 will be modified to the extent necessary to
ensure that such deliverables are provided by Synthetic no less than thirty (30)
days prior (inclusive of any cure period set forth in Section 10.2(a)) to the
date necessary for Intrexon to meet any disclosure obligation under rules or
regulations to which Intrexon may be or become subject from time to time.
Intrexon will provide Synthetic with notice as promptly as practicable regarding
any changes in Intrexon’s disclosure obligations that would require a change in
delivery deadlines or cure periods under this Section 4.11.

 

ARTICLE 5

Compensation

 

5.1                   Technology Access Fee. In partial consideration for
Synthetic’s appointment as an exclusive channel collaborator in the Field and
the other rights granted to Synthetic hereunder, within ten days after receipt
of approval from the NYSE Amex for the listing of the equity referred to below
(including any extension should the NYSE Amex require shareholder approval of
such issuance) but in no event later than one hundred twenty (120) days after
the Effective Date, Synthetic shall issue to Intrexon certain equity interests
in Synthetic, in accordance with the terms and conditions of that certain Equity
Purchase Agreement and Registration Rights Agreement, each of even date herewith
(collectively, the “Equity Agreements”). Provided that all closing conditions
for the Technology Access Fee Shares (as defined in the Equity Agreements) that
are within the reasonable control of Intrexon have been satisfied or waived, the
issuance of the Technology Access Fee Shares (as set forth in the Equity
Agreements) is a condition subsequent to the effectiveness of this Agreement.

 

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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.

 

 

5.2                   Milestones.

 

(a)               Synthetic Equity-Based Milestones. Upon the attainment of
certain milestone events by each different Synthetic Product, Synthetic has
agreed to issue to Intrexon certain equity interests of Synthetic, or at
Synthetic’s election make a cash payment to Intrexon at the fair market value of
the equity interests, as set forth in the Equity Agreements. The specific
milestone events and respective amounts due to Intrexon upon achievement of the
milestone events are set forth in the Equity Agreements.

 

5.3                   Equity Agreements Control. All issuances of equity
interests to Intrexon, or cash payments to Intrexon in lieu of equity, shall be
in accordance with the terms and conditions of the Equity Agreements, which
Equity Agreements shall control to the extent they may conflict with Sections
5.1 through 5.2 of this Agreement.

 

5.4                   Revenue Sharing.

 

(a)               No later than thirty (30) days after each calendar quarter in
which there are positive Net Sales arising from the sale of any Synthetic
Product in the Field in the Territory, Synthetic shall pay to Intrexon on a
Synthetic Product-by-Synthetic Product basis a [xxxx] royalty on the first
[xxxx] of annual Net Sales, and a [xxxx] royalty on the portion of annual Net
Sales exceeding [xxxx.] Commencing with the Effective Date, in the event that
are negative Net Sales for a particular Synthetic Product in any calendar
quarter, neither Synthetic nor Intrexon shall owe any payments hereunder with
respect to such Synthetic Product. Any negative Net Sales that results from
Excess Product Liability Costs may be carried forward to future quarters and
offset against positive Net Sales in such future quarters for the same Synthetic
Product. Except as set forth in the preceding sentence, Synthetic shall not be
permitted to carry forward any negative Net Sales to subsequent quarters.

 

(b)               No later than thirty (30) days after each calendar quarter in
which Synthetic or any Synthetic Affiliate receives Sublicensing Revenue,
Synthetic shall pay to Intrexon fifty percent (50%) of such Sublicensing
Revenue.

 

5.5                   Method of Payment. Except for payments payable as and made
in the form of equity interests, payments due to Intrexon under this Agreement
shall be paid in United States dollars by wire transfer to a bank in the United
States designated in writing by Intrexon. All references to “dollars” or “$”
herein shall refer to United States dollars.

 

5.6                   Payment Reports and Records Retention. Within thirty (30)
days after the end of each calendar quarter during which Net Sales have been
generated, during which Sublicensing Revenue has been received, or during which
a negative Net Sales has occurred, Synthetic shall deliver to Intrexon a written
report that shall contain at a minimum for the applicable calendar quarter:

 

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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.

 

 

(a)               gross sales of each Synthetic Product (on a country-by-country
basis);

 

(b)               itemized calculation of Net Sales, showing all applicable
deductions;

 

(c)                itemized calculation of Sublicensing Revenue;

 

(d)               the amount of any negative Net Sales for the applicable
calendar quarter, and any negative Net Sales amount carried forward from a prior
quarter and applied during the present quarter (as per Section 5.4(a));

 

(e)                the amount of the payment (if any) due pursuant to Section
5.4(a) and/or 5.4(b);

 

(f)                the amount of taxes, if any, withheld to comply with any
applicable law; and

 

(g)               the exchange rates used in any of the foregoing calculations.

 

For three (3) years after each sale of Synthetic Product or after incurring any
component item incorporated into a calculation of Net Sales, Synthetic shall
keep (and shall ensure that its Affiliates and, if applicable, (sub)licensees
shall keep) complete and accurate records of such sales or component item in
sufficient detail to confirm the accuracy of the payment calculations hereunder.

 

5.7                   Audits.

 

(a)               Upon the written request of Intrexon, Synthetic shall permit
an independent certified public accounting firm of internationally recognized
standing selected by Intrexon, and reasonably acceptable to Synthetic, to have
access to and to review, during normal business hours and upon no less than
thirty (30) days prior written notice, the applicable records of Synthetic and
its Affiliates to verify the accuracy and timeliness of the reports and payments
made by Synthetic under this Agreement. Such review may cover the records for
sales made in any calendar year ending not more than three (3) years prior to
the date of such request. The accounting firm shall disclose to both Parties
whether the royalty reports and/or know-how reports conform to the provisions of
this Agreement and/or US GAAP, as applicable, and the specific details
concerning any discrepancies. Such audit may not be conducted more than once in
any calendar year.

 

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CONFIDENTIAL

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)               If such accounting firm concludes that additional amounts were
owed during such period, Synthetic shall pay additional amounts, with interest
from the date originally due as set forth in Section 5.9, within thirty (30)
days of receipt of the accounting firm’s written report. If the amount of the
underpayment is greater than ten percent (10%) of the total amount actually owed
for the period audited, then Synthetic shall in addition reimburse Intrexon for
all costs related to such audit; otherwise, Intrexon shall pay all costs of the
audit. In the event of overpayment, any amount of such overpayment shall be
fully creditable against amounts payable for the immediately succeeding calendar
quarter(s); provided, however, that such credit cannot be applied to reduce the
amounts payable by Synthetic to Intrexon for any particular calendar quarter by
more than [*****] of the amount otherwise due to Intrexon.

 

(c)                Intrexon shall (i) treat all information that it receives
under this Section 5.7 in accordance with the confidentiality provisions of
Article 7 and (ii) cause its accounting firm to enter into an acceptable
confidentiality agreement with Synthetic obligating such firm to retain all such
financial information in confidence pursuant to such confidentiality agreement,
in each case except to the extent necessary for Intrexon to enforce its rights
under this Agreement.

 

5.8                   Taxes. The Parties will cooperate in good faith to obtain
the benefit of any relevant tax treaties to minimize as far as reasonably
possible any taxes which may be levied on any amounts payable hereunder.
Synthetic shall deduct or withhold from any payments any taxes that it is
required by applicable law to deduct or withhold. Notwithstanding the foregoing,
if Intrexon is entitled under any applicable tax treaty to a reduction of the
rate of, or the elimination of, applicable withholding tax, it may deliver to
Synthetic or the appropriate governmental authority (with the assistance of
Synthetic to the extent that this is reasonably required and is expressly
requested in writing) the prescribed forms necessary to reduce the applicable
rate of withholding or to relieve Synthetic of its obligation to withhold tax,
and Synthetic shall apply the reduced rate of withholding tax, or dispense with
withholding tax, as the case may be, provided that Synthetic has received
evidence of Intrexon’s delivery of all applicable forms (and, if necessary, its
receipt of appropriate governmental authorization) at least fifteen (15) days
prior to the time that the payment is due. If, in accordance with the foregoing,
Synthetic withholds any amount, it shall make timely payment to the proper
taxing authority of the withheld amount, and send to Intrexon proof of such
payment within forty-five (45) days following that latter payment.

 

5.9                   Late Payments. Any amount owed by Synthetic to Intrexon
under this Agreement that is not paid within the applicable time period set
forth herein shall accrue interest at the lower of (a) two percent (2%) per
month, compounded, or (b) the highest rate permitted under applicable law.

 

ARTICLE 6

Intellectual Property

 

6.1                   Ownership.

 

(a)               Subject to the license granted under Section 3.1, all rights
in the Intrexon IP shall remain with Intrexon.

 

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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)               Synthetic and/or Intrexon may solely or jointly conceive,
reduce to practice or develop discoveries, inventions, processes, techniques,
and other technology, whether or not patentable, in the course of performing the
Anti-Infectives Program (collectively “Inventions”). Each Party shall promptly
provide the other Party with a detailed written description of any such
Inventions that relate to the Field. Inventorship shall be determined in
accordance with United States patent laws.

 

(c)                Intrexon shall solely own all right, title and interest in
all Inventions related to Intrexon Channel Technology, together with all Patent
rights and other intellectual property rights therein (the “Channel-Related
Program IP”). Synthetic hereby assigns all of its right, title and interest in
and to the Channel-Related Program IP to Intrexon. Synthetic agrees to execute
such documents and perform such other acts as Intrexon may reasonably request to
obtain, perfect and enforce its rights to the Channel-Related Program IP and the
assignment thereof.

 

(d)               Notwithstanding anything to the contrary in this Agreement,
any discovery, invention, process, technique, or other technology, whether or
not patentable, that is conceived, reduced to practice or developed by Synthetic
solely or jointly through the use of the Intrexon Channel Technology, Intrexon
IP, or Intrexon Materials in breach of the terms and conditions of this
Agreement, together with all patent rights and other intellectual property
rights therein, shall be solely owned by Intrexon and shall be included in the
Channel-Related Program IP.

 

(e)                All information regarding Channel-Related Program IP shall be
Confidential Information of Intrexon. Synthetic shall be under appropriate
written agreements with each of its employees, contractors, or agents working on
the Anti-Infectives Program, pursuant to which such person shall grant all
rights in the Inventions to Synthetic (so that Synthetic may convey certain of
such rights to Intrexon, as provided herein) and agree to protect all
Confidential Information relating to the Anti-Infectives Program.

 

6.2                   Patent Prosecution.

 

(a)               Intrexon shall have the sole right, but not the obligation, to
(a) conduct and control the filing, prosecution and maintenance of the Intrexon
Patents, and (b) conduct and control the filing, prosecution, and maintenance of
any applications for patent term extension and/or supplementary protection
certificates that may be available as a result of the regulatory approval of any
Synthetic Product. At the reasonable request of Intrexon, Synthetic shall
cooperate with Intrexon in connection with such filing, prosecution, and
maintenance, at Intrexon’s expense. Under no circumstances shall Synthetic (a)
file, attempt to file, or assist anyone else in filing, or attempting to file,
any Patent application, either in the United States or elsewhere, that claims or
uses or purports to claim or use or relies for support upon an Invention owned
by Intrexon, (b) use, attempt to use, or assist anyone else in using or
attempting to use, the Intrexon Know-How, Intrexon Materials, or any
Confidential Information of Intrexon to support the filing of a Patent
application, either in the United States or elsewhere, that contains claims
directed to the Intrexon IP, Intrexon Materials, or the Intrexon Channel
Technology, or (c) without prior approval of the IPC, file, attempt to file, or
assist anyone else in filing, or attempting to file, any application for patent
term extension or supplementary protection certificate, either in the United
States or elsewhere, that relies upon the regulatory approval of a Synthetic
Product.

 

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CONFIDENTIAL

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)               Synthetic shall have the sole right, but not the obligation,
to conduct and control the filing, prosecution and maintenance of any Patents
claiming Inventions that are owned by Synthetic or its Affiliates and not
assigned to Intrexon under Section 6.1(c) (“Synthetic Program Patents”). At the
reasonable request of Synthetic, Intrexon shall cooperate with Synthetic in
connection with such filing, prosecution, and maintenance, at Synthetic’s
expense.

 

(c)                The Prosecuting Party shall be entitled to use patent counsel
selected by it and reasonably acceptable to the non-Prosecuting Party (including
in-house patent counsel as well as outside patent counsel) for the prosecution
of the Intrexon Patents and Synthetic Program Patents, as applicable. The
Prosecuting Party shall:

 

(i)                 regularly provide the other Party in advance with reasonable
information relating to the Prosecuting Party’s prosecution of Patents
hereunder, including by providing copies of substantive communications, notices
and actions submitted to or received from the relevant patent authorities and
copies of drafts of filings and correspondence that the Prosecuting Party
proposes to submit to such patent authorities (it being understood that, to the
extent that any such information is readily accessible to the public, the
Prosecuting Party may, in lieu of directly providing copies of such information
to such other Party, provide such other Party with sufficient information that
will permit such other Party to access such information itself directly);

 

(ii)               consider in good faith and consult with the non-Prosecuting
Party regarding its timely comments with respect to the same; provided, however,
that if, within fifteen (15) days after providing any documents to the
non-Prosecuting Party for comment, the Prosecuting Party does not receive any
written communication from the non-Prosecuting Party indicating that it has or
may have comments on such document, the Prosecuting Party shall be entitled to
assume that the non-Prosecuting Party has no comments thereon;

 

(iii)             consult with the non-Prosecuting Party before taking any
action that would reasonably be expected to have a material adverse impact on
the scope of claims within the Intrexon Patents and Synthetic Program Patents,
as applicable.

 

As used above “Prosecuting Party” means Intrexon in the case of Intrexon Patents
and Synthetic in the case of Synthetic Program Patents.

 

6.3                   Infringement of Patents by Third Parties.

 

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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.

 

 

(a)               Except as expressly provided in the remainder of this Section
6.3, Intrexon shall have the sole right to take appropriate action against any
person or entity directly or indirectly infringing any Intrexon Patent (or
asserting that an Intrexon Patent is invalid or unenforceable) (collectively,
“Infringement”), either by settlement or lawsuit or other appropriate action.

 

(b)               Notwithstanding the foregoing, Synthetic shall have the first
right, but not the obligation, to take appropriate action to enforce
Product-Specific Program Patents against any Infringement that involves a
commercially material amount of allegedly infringing activities in the Field
(“Field Infringement”), either by settlement or lawsuit or other appropriate
action. If Synthetic fails to take the appropriate steps to enforce
Product-Specific Program Patents against any Field Infringement within one
hundred eighty (180) days of the date one Party has provided notice to the other
Party pursuant to Section 6.3(g) of such Field Infringement, then Intrexon shall
have the right (but not the obligation), at its own expense, to enforce
Product-Specific Program Patents against such Field Infringement, either by
settlement or lawsuit or other appropriate action.

 

(c)                With respect to any Field Infringement that cannot reasonably
be abated through the enforcement of Product-Specific Program Patents pursuant
to Section 6.3(b) but can reasonably be abated through the enforcement of
Intrexon Patent(s) (other than the Product-Specific Program Patents), Intrexon
shall be obligated to choose one of the following courses of action: (i) enforce
one or more of the applicable Intrexon Patent(s) in a commercially reasonable
manner against such Field Infringement, or (ii) [*****]. Intrexon and Synthetic
shall bear the costs and expenses of such enforcement equally. The determination
of which Intrexon Patent(s) to assert shall be made by Intrexon in its sole
discretion; provided, however, that Intrexon shall consult in good faith with
Synthetic on such determination. For the avoidance of doubt, Intrexon has no
obligations under this Agreement to enforce any Intrexon Patents against, or
otherwise abate, any Infringement that is not a Field Infringement.

 

(d)               In the event a Party pursues an action under this Section 6.3,
the other Party shall reasonably cooperate with the enforcing Party with respect
to the investigation and prosecution of any alleged, threatened, or actual
Infringement, at the enforcing Party’s expense (except with respect to an action
under Section 6.3(c), where all costs and expenses will be shared equally in
accordance with terms thereof).

 

(e)                Synthetic shall not settle or otherwise compromise any action
under this Section 6.3 in a way that diminishes the rights or interests of
Intrexon outside the Field or adversely affects any Intrexon Patent without
Intrexon’s prior written consent, which consent shall not be unreasonably
withheld. Intrexon shall not settle or otherwise compromise any action under
this Section 6.3 in a way that diminishes the rights or interests of Synthetic
in the Field or adversely affects any Intrexon Patent with respect to the Field
without Synthetic’s prior written consent, which consent shall not be
unreasonably withheld.

 

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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)                Except as otherwise agreed to by the Parties in writing, any
settlements, damages or other monetary awards recovered pursuant to a suit,
proceeding, or action brought pursuant to Section 6.3 will be allocated first to
the costs and expenses of the Party controlling such action, and second, to the
costs and expenses (if any) of the other Party (to the extent not otherwise
reimbursed), and any remaining amounts (the “Recovery”) will be shared by the
Parties as follows: In any action initiated by Intrexon pursuant to Section
6.3(a) that does not involve Field Infringement, or in any action initiated by
Intrexon pursuant to Section 6.3(b), Intrexon shall retain one hundred percent
(100%) of any Recovery. In any action initiated by Synthetic pursuant to Section
6.3(b), Synthetic shall retain one hundred percent (100%) of any Recovery, but
such Recovery shall be shared with Intrexon as Sublicensing Revenue. In any
action initiated by Intrexon or Synthetic pursuant to Section 6.3(c), the
Parties shall share the Recovery equally, and such Recovery shall not be deemed
to constitute Sublicensing Revenue.

 

(g)               Synthetic shall promptly notify Intrexon in writing of any
suspected, alleged, threatened, or actual Infringement of which it becomes
aware, and Intrexon shall promptly notify Synthetic in writing of any suspected,
alleged, threatened, or actual Field Infringement of which it becomes aware.

 

ARTICLE 7

Confidentiality

 

7.1                   Confidentiality. Except to the extent expressly authorized
by this Agreement or otherwise agreed in writing by the Parties, each Party
agrees that it shall keep confidential and shall not publish or otherwise
disclose and shall not use for any purpose other than as provided for in this
Agreement any Confidential Information disclosed to it by the other Party
pursuant to this Agreement, except to the extent that the receiving Party can
demonstrate by competent evidence that specific Confidential Information:

 

(a)               was already known to the receiving Party, other than under an
obligation of confidentiality, at the time of disclosure by the other Party;

 

(b)               was generally available to the public or otherwise part of the
public domain at the time of its disclosure to the receiving Party;

 

(c)                became generally available to the public or otherwise part of
the public domain after its disclosure and other than through any act or
omission of the receiving Party in breach of this Agreement;

 

(d)               was disclosed to the receiving Party, other than under an
obligation of confidentiality to a Third Party, by a Third Party who had no
obligation to the disclosing Party not to disclose such information to others;
or

 

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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)                was independently discovered or developed by the receiving
Party without the use of Confidential Information belonging to the disclosing
Party, as documented by the receiving Party’s written records.

 

The foregoing non-use and non-disclosure obligation shall continue (i)
indefinitely, for all Confidential Information that qualifies as a trade secret
under applicable law; or (ii) for the Term of this Agreement and for seven (7)
years thereafter, in all other cases.

 

7.2                   Authorized Disclosure. Notwithstanding the limitations in
this Article 7, either Party may disclose the Confidential Information belonging
to the other Party to the extent such disclosure is reasonably necessary in the
following instances:

 

(a)               complying with applicable laws or regulations or valid court
orders, provided that the Party making such disclosure provides the other Party
with reasonable prior written notice of such disclosure and makes a reasonable
effort to obtain, or to assist the other Party in obtaining, a protective order
preventing or limiting the disclosure and/or requiring that the terms and
conditions of this Agreement be used only for the purposes for which the law or
regulation required, or for which the order was issued;

 

(b)               to regulatory authorities in order to seek or obtain approval
to conduct clinical trials, or to gain regulatory approval, of Synthetic
Products or any products being developed by Intrexon or its other licensees
and/or channel partners or collaborators, provided that the Party making such
disclosure (i) provides the other Party with reasonable opportunity to review
any such disclosure in advance and to suggest redactions or other means of
limiting the disclosure of such other Party’s Confidential Information and (ii)
does not unreasonably reject any such suggestions;

 

(c)                disclosure to investors and potential investors, acquirers,
or merger candidates who agree to maintain the confidentiality of such
information, provided that such disclosure is used solely for the purpose of
evaluating such investment, acquisition, or merger (as the case may be);

 

(d)               disclosure on a need-to-know basis to Affiliates, licensees,
sublicensees, employees, consultants or agents (such as CROs and clinical
investigators) who agree to be bound by obligations of confidentiality and
non-use at least equivalent in scope to those set forth in this Article 7; and

 

(e)                disclosure of the terms of this Agreement by Intrexon to
collaborators and other channel partners or collaborators who agree to be bound
by obligations of confidentiality and non-use at least equivalent in scope to
those set forth in this Article 7.

 

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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.

 

 

7.3                   Publicity; Publications. The Parties agree that the public
announcement of the execution of this Agreement shall be substantially in the
form of a press release mutually agreed to by the Parties. Each Party will
provide the other Party with the opportunity to review and comment, prior to
submission or presentation, on external reports, publications and presentations
(e.g., press releases, reports to government agencies, abstracts, posters,
manuscripts and oral presentations) that refer to the Anti-Infectives Program or
programs that are approved by the JSC. For such reports, publications, and
presentations, the disclosing Party will provide the other Party at least
fifteen (15) days for review of the proposed submission or presentation. For
reports and manuscripts, the disclosing Party will provide the other Party at
least thirty (30) days for review of the report or manuscript. The presenting
Party will act in good faith to incorporate the comments of the other Party and
shall, in any event, redact any Confidential Information of the other Party and
cooperate with the other Party to postpone such submissions or presentations if
necessary to provide the other Party with sufficient time to prepare and file
any related Patent applications before the submission or presentation occurs, as
appropriate.

 

7.4                   Terms of the Agreement. Each Party shall treat the terms
of this Agreement as the Confidential Information of other Party, subject to the
exceptions set forth in Section 7.2. Notwithstanding the foregoing, each Party
acknowledges that the other Party may be obligated to file a copy of this
Agreement with the SEC, either as of the Effective Date or at some point during
the Term. Each Party shall be entitled to make such a required filing, provided
that it requests confidential treatment of certain commercial terms and
sensitive technical terms hereof to the extent such confidential treatment is
reasonably available to it. In the event of any such filing, the filing Party
shall provide the other Party with a copy of the Agreement marked to show
provisions for which the filing Party intends to seek confidential treatment and
shall reasonably consider and incorporate the other Party’s comments thereon to
the extent consistent with the legal requirements governing redaction of
information from material agreements that must be publicly filed. The other
Party shall promptly provide any such comments.

 

7.5                   Proprietary Information and Operational Audits.

 

(a)               For the purpose of confirming compliance with the
Field-limited licenses granted in Article 3, the diligence obligations of
Article 4, and the confidentiality obligations under Article 7, Synthetic
acknowledges that Intrexon’s authorized representative(s), during regular
business hours may (i) examine and inspect Synthetic’s facilities and (ii)
inspect all data and work products relating to this Agreement, subject to
restrictions imposed by applicable laws. Any examination or inspection hereunder
shall require five (5) business days written notice from Intrexon to Synthetic.
Synthetic will make itself and the pertinent employees and/or agents available,
on a reasonable basis, to Intrexon for the aforementioned compliance review.

 

(b)               For the purpose of confirming compliance with the diligence
obligations of Section 4.6, and the confidentiality obligations under Article 7,
Intrexon acknowledges that Synthetic authorized representative(s), during
regular business hours may (i) examine and inspect Intrexon’s facilities and
(ii) inspect all data and work products relating to this Agreement. Any
examination or inspection hereunder shall require five (5) business days written
notice from Synthetic to Intrexon. Intrexon will make itself and the pertinent
employees and/or agents available, on a reasonable basis, to Synthetic for the
aforementioned compliance review.

 

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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)                In view of the Intrexon Confidential Information, Intrexon
Know-How, and Intrexon Materials transferred to Synthetic hereunder, Intrexon
from time-to-time, but no more than quarterly, may request that Synthetic
confirm the status of the Intrexon Materials at Synthetic (i.e. how much used,
how much shipped, to whom and any unused amounts destroyed (by whom, when) as
well as any amounts returned to Intrexon or destroyed). Within ten (10) business
days of Synthetic’s receipt of any such written request, Synthetic shall provide
the written report to Intrexon.

 

7.6                   Intrexon Commitment. Intrexon shall use reasonable efforts
to obtain an agreement with its other licensees and channel partners or
collaborators to enable Synthetic to disclose confidential information of such
licensees and channel partners or collaborators to regulatory authorities in
order to seek or obtain approval to conduct clinical trials, or to gain
regulatory approval of, Synthetic Products, in a manner consistent with the
provisions of Section 7.2(b).

 

ARTICLE 8

Representations And Warranties

 

8.1                   Representations and Warranties of Synthetic. Synthetic
hereby represents and warrants to Intrexon that, as of the Effective Date:

 

(a)               Corporate Power. Synthetic is duly organized and validly
existing under the laws of Nevada and has full corporate power and authority to
enter into this Agreement and to carry out the provisions hereof.

 

(b)               Due Authorization. Synthetic is duly authorized to execute and
deliver this Agreement and to perform its obligations hereunder, and the person
executing this Agreement on Synthetic’s behalf has been duly authorized to do so
by all requisite corporate action.

 

(c)                Binding Agreement. This Agreement is a legal and valid
obligation binding upon Synthetic and enforceable in accordance with its terms,
except as such enforcement may be limited by applicable bankruptcy, insolvency,
reorganization, arrangement, moratorium or other similar laws affecting
creditors’ rights, and subject to general equity principles and to limitations
on availability of equitable relief, including specific performance. The
execution, delivery and performance of this Agreement by Synthetic does not
conflict with any agreement, instrument or understanding, oral or written, to
which it is a party or by which it may be bound. Synthetic is aware of no
action, suit or inquiry or investigation instituted by any governmental agency
which questions or threatens the validity of this Agreement.

 

8.2                   Representations and Warranties of Intrexon. Intrexon
hereby represents and warrants to Synthetic that, as of the Effective Date:

 

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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.

 

 

(a)               Corporate Power. Intrexon is duly organized and validly
existing under the laws of Virginia and has full corporate power and authority
to enter into this Agreement and to carry out the provisions hereof.

 

(b)               Due Authorization. Intrexon is duly authorized to execute and
deliver this Agreement and to perform its obligations hereunder, and the person
executing this Agreement on Intrexon’s behalf has been duly authorized to do so
by all requisite corporate action.

 

(c)                Binding Agreement. This Agreement is a legal and valid
obligation binding upon Intrexon and enforceable in accordance with its terms,
except as such enforcement may be limited by applicable bankruptcy, insolvency,
reorganization, arrangement, moratorium or other similar laws affecting
creditors’ rights, and subject to general equity principles and to limitations
on availability of equitable relief, including specific performance. The
execution, delivery and performance of this Agreement by Intrexon does not
conflict with any agreement, instrument or understanding, oral or written, to
which it is a party or by which it may be bound. Intrexon is aware of no action,
suit or inquiry or investigation instituted by any governmental agency which
questions or threatens the validity of this Agreement.

 

(d)               Additional Intellectual Property Representations.

 

(i)                 Intrexon possesses sufficient rights to enable Intrexon to
grant all rights and licenses it purports to grant to Synthetic with respect to
the Intrexon Patents under this Agreement;

 

(ii)               The Intrexon Patents existing as of the Effective Date
constitute all of the Patents Controlled by Intrexon as of such date that are
necessary for the development, manufacture and Commercialization of Synthetic
Products;

 

(iii)             Intrexon has not granted, and during the Term Intrexon will
not grant, any right or license, to any Third Party under the Intrexon IP that
conflicts with the rights or licenses granted or to be granted to Synthetic
hereunder;

 

(iv)             There is no pending litigation, and Intrexon has not received
any written notice of any claims or litigation, seeking to invalidate or
otherwise challenge the Intrexon Patents or Intrexon’s rights therein;

 

(v)               None of the Intrexon Patents is subject to any pending
re-examination, opposition, interference or litigation proceedings;

 

(vi)             All of the Intrexon Patents have been filed and prosecuted in
accordance with all applicable laws and have been maintained, with all
applicable fees with respect thereto (to the extent such fees have come due)
having been paid;

 

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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)           Intrexon has entered into agreements with each of its current
and former officers, employees and consultants involved in research and
development work, including development of the Intrexon’s products and
technology providing Intrexon, to the extent permitted by law, with title and
ownership to patents, patent applications, trade secrets and inventions
conceived, developed, reduced to practice by such person, solely or jointly with
other of such persons, during the period of employment by Intrexon (except where
the failure to have entered into such an agreement would not have a material
adverse effect on the rights granted to Synthetic herein), and Intrexon is not
aware that any of its employees or consultants is in material violation thereof;

 

(viii)         To Intrexon’s knowledge, there is no infringement,
misappropriation or violation by third parties of any Intrexon Channel
Technology or Intrexon IP in the Field;

 

(ix)             There is no pending or, to Intrexon’s knowledge, threatened
action, suit, proceeding or claim by others against Intrexon that Intrexon
infringes, misappropriates or otherwise violates any intellectual property or
other proprietary rights of others in connection with the use of the Intrexon
Channel Technology or Intrexon IP, and Intrexon has not received any written
notice of such claim;

 

(x)               To Intrexon’s knowledge, no employee of Intrexon is the
subject of any claim or proceeding involving a violation of any term of any
employment contract, patent disclosure agreement, invention assignment
agreement, non-competition agreement, non-solicitation agreement, non-disclosure
agreement or any restrictive covenant to or with a former employer (A) where the
basis of such violation relates to such employee’s employment with Intrexon or
actions undertaken by the employee while employed with Intrexon and (B) where
such violation is relevant to the use of the Intrexon Channel Technology in the
Field;

 

(xi)             None of the Intrexon Patents owned by Intrexon or its
Affiliates, and, to Intrexon’s knowledge, the Intrexon Patents licensed to
Intrexon or its Affiliates, have been adjudged invalid or unenforceable by a
court of competent jurisdiction or applicable government agency, in whole or in
part, and there is no pending or, to Intrexon’s knowledge, threatened action,
suit, proceeding or claim by others challenging the validity or scope of any
such Intrexon Patents; and

 

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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.

 

 

(xii)           Except as otherwise disclosed in writing to Synthetic, Intrexon:
(A) is in material compliance with all statutes, rules or regulations applicable
to the ownership, testing, development, manufacture, packaging, processing, use,
distribution, marketing, labeling, promotion, sale, offer for sale, storage,
import, export or disposal of any product that is under development,
manufactured or distributed by Intrexon in the Field (“Applicable Laws”); (B)
has not received any FDA Form 483, notice of adverse finding, warning letter,
untitled letter or other correspondence or notice from the United States Food
and Drug Administration (the “FDA”) or any other federal, state, local or
foreign governmental or regulatory authority alleging or asserting material
noncompliance with any Applicable Laws or any licenses, certificates, approvals,
clearances, authorizations, permits and supplements or amendments thereto
required by any such Applicable Laws (“Authorizations”), which would,
individually or in the aggregate, result in a material adverse effect; (C)
possesses all material Authorizations necessary for the operation of its
business as described in the Field and such Authorizations are valid and in full
force and effect and Intrexon is not in material violation of any term of any
such Authorizations; and (D) since January 1, 2011, (1) has not received notice
of any claim, action, suit, proceeding, hearing, enforcement, investigation,
arbitration or other action from the FDA or any other federal, state, local or
foreign governmental or regulatory authority or third party alleging that any
product operation or activity is in material violation of any Applicable Laws or
Authorizations and has no knowledge that the FDA or any other federal, state,
local or foreign governmental or regulatory authority or third party is
considering any such claim, litigation, arbitration, action, suit investigation
or proceeding; (2) has not received notice that the FDA or any other federal,
state, local or foreign governmental or regulatory authority has taken, is
taking or intends to take action to limit, suspend, modify or revoke any
material Authorizations and has no knowledge that the FDA or any other federal,
state, local or foreign governmental or regulatory authority is considering such
action; (3) has filed, obtained, maintained or submitted all material reports,
documents, forms, notices, applications, records, claims, submissions and
supplements or amendments as required by any Applicable Laws or Authorizations
and that all such reports, documents, forms, notices, applications, records,
claims, submissions and supplements or amendments were materially complete and
correct on the date filed (or were corrected or supplemented by a subsequent
submission); and (4) has not, either voluntarily or involuntarily, initiated,
conducted, or issued or caused to be initiated, conducted or issued, any recall,
market withdrawal or replacement, safety alert, post sale warning, “dear doctor”
letter, or other notice or action relating to the alleged lack of safety or
efficacy of any product or any alleged product defect or violation and, to
Intrexon’s knowledge, no third party has initiated, conducted or intends to
initiate any such notice or action.

 

except, in each of (ix) through (xii), for any instances which would not,
individually or in the aggregate, result in a material adverse effect on the
rights granted to Synthetic hereunder or Intrexon’s ability to perform its
obligations hereunder.

 

8.3                   Warranty Disclaimer. EXCEPT FOR THE EXPRESS WARRANTIES
PROVIDED IN THIS ARTICLE 8 OR IN THE EQUITY AGREEMENTS, EACH PARTY HEREBY
DISCLAIMS ANY AND ALL OTHER WARRANTIES, EITHER EXPRESS OR IMPLIED, INCLUDING
WITHOUT LIMITATION ANY WARRANTIES OF TITLE, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, OR NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF
THIRD PARTIES.

 

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CONFIDENTIAL

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.

 

 

ARTICLE 9

Indemnification

 

9.1                   Indemnification by Intrexon. Intrexon agrees to indemnify,
hold harmless, and defend Synthetic and its Affiliates and their respective
directors, officers, employees, and agents (collectively, the “Synthetic
Indemnitees”) from and against any and all liabilities, damages, costs,
expenses, or losses (including reasonable legal expenses and attorneys’ fees)
(collectively, “Losses”) resulting from any claims, suits, actions, demands, or
other proceedings brought by a Third Party (collectively, “Claims”) to the
extent arising from (a) the gross negligence or willful misconduct of Intrexon
or any of its Affiliates, or their respective employees or agents, (b) the use,
handling, storage or transport of Intrexon Materials by or on behalf of Intrexon
or its Affiliates, licensees (other than Synthetic) or sublicensees; or (c)
breach by Intrexon of any representation, warranty or covenant in this
Agreement. Notwithstanding the foregoing, Intrexon shall not have any obligation
to indemnify the Synthetic Indemnitees to the extent that a Claim arises from
(i) the gross negligence or willful misconduct of Synthetic or any of its
Affiliates, licensees, or sublicensees, or their respective employees or agents;
or (ii) a breach by Synthetic of a representation, warranty, or covenant of this
Agreement.

 

9.2                   Indemnification by Synthetic. Synthetic agrees to
indemnify, hold harmless, and defend Intrexon, its Affiliates and Third
Security, and their respective directors, officers, employees, and agents (and
any Third Parties which have licensed to Intrexon intellectual property rights
within Intrexon IP on or prior to the Effective Date, to the extent required by
the relevant upstream license agreement) (collectively, the “Intrexon
Indemnitees”) from and against any Losses resulting from Claims, to the extent
arising from any of the following: (a) the gross negligence or willful
misconduct of Synthetic or any of its Affiliates or their respective employees
or agents; (b) the use, handling, storage, or transport of Intrexon Materials by
or on behalf of Synthetic or its Affiliates, licensees, or sublicensees; (c)
breach by Synthetic of any material representation, warranty or covenant in this
Agreement; or (d) the design, development, manufacture, regulatory approval,
handling, storage, transport, distribution, sale or other disposition of any
Synthetic Product by or on behalf of Synthetic or its Affiliates, licensees, or
sublicensees. Notwithstanding the foregoing, Synthetic shall not have any
obligation to indemnify the Intrexon Indemnitees to the extent that a Claim
arises from (i) the gross negligence or willful misconduct of Intrexon or any of
its Affiliates, or their respective employees or agents; or (ii) a breach by
Intrexon of a representation, warranty, or covenant of this Agreement.

 

9.3                   Product Liability Claims. Notwithstanding the provisions
of Section 9.2, any Losses arising out of any Third Party claim, suit, action,
proceeding, liability or obligation involving any actual or alleged death or
bodily injury arising out of or resulting from the development, manufacture or
Commercialization of any Synthetic Products for use or sale in the Field, to the
extent that such Losses exceed the amount (if any) covered by the applicable
Party’s product liability insurance (“Excess Product Liability Costs”), shall be
paid by [*****], except to the extent such Losses arise out of any Third-Party
Claim based on the gross negligence or willful misconduct of a Party, its
Affiliates, or its Affiliates’ Sublicensees, or any of the respective officers,
directors, employees and agents of each of the foregoing entities, in the
performance of obligations or exercise of rights under this Agreement.

 

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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.

 

 

9.4                   Control of Defense. As a condition precedent to any
indemnification obligations hereunder, any entity entitled to indemnification
under this Article 9 shall give written notice to the indemnifying Party of any
Claims that may be subject to indemnification, promptly after learning of such
Claim. If such Claim falls within the scope of the indemnification obligations
of this Article 9, then the indemnifying Party shall assume the defense of such
Claim with counsel reasonably satisfactory to the indemnified Party. The
indemnified Party shall cooperate with the indemnifying Party in such defense.
The indemnified Party may, at its option and expense, be represented by counsel
of its choice in any action or proceeding with respect to such Claim. The
indemnifying Party shall not be liable for any litigation costs or expenses
incurred by the indemnified Party without the indemnifying Party’s written
consent, such consent not to be unreasonably withheld. The indemnifying Party
shall not settle any such Claim if such settlement (a) does not fully and
unconditionally release the indemnified Party from all liability relating
thereto or (b) adversely impacts the exercise of the rights granted to the
indemnified Party under this Agreement, unless the indemnified Party otherwise
agrees in writing.

 

9.5                   Insurance. Immediately prior to, and during marketing,
Synthetic shall maintain in effect and good standing a product liability
insurance policy issued by a reputable insurance company in amounts considered
standard for the industry. Immediately prior to, and during the conduct of any
clinical trials, Synthetic shall maintain in effect and good standing a clinical
trials liability insurance policy issued by a reputable insurance company in
amounts considered standard for the industry. At Intrexon’s reasonable request,
Synthetic shall provide Intrexon with all details regarding such policies,
including without limitation copies of the applicable liability insurance
contracts. Synthetic shall use reasonable efforts to include Intrexon as an
additional insured on any such policies.

 

ARTICLE 10

Term; Termination

 

10.1               Term. The term of this Agreement shall commence upon the
Effective Date and shall continue until terminated pursuant to Section 10.2 or
10.3 (the “Term”).

 

10.2               Termination for Material Breach; Termination Under Section
4.5(b)

 

(a)               Either Party shall have the right to terminate this Agreement
upon written notice to the other Party if the other Party commits any material
breach of this Agreement that such breaching Party fails to cure within sixty
(60) days following written notice from the nonbreaching Party specifying such
breach; provided, however, that if Synthetic commits any breach of the
provisions of Section 4.10 of this Agreement, Intrexon shall have the right to
terminate this Agreement if Synthetic fails after notice from Intrexon to cure
such breach within thirty (30) days following written notice thereof.

 

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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)               Intrexon shall have the right to terminate this Agreement, at
its sole discretion, if any necessary shareholder, member, exchange, and/or
board of director approvals of Synthetic have not been obtained, and the
Technology Access Fee Shares (as defined in the Equity Agreements) have not been
issued, within the time frames set forth in Section 5.1.

 

(c)                Intrexon shall have the right to terminate this Agreement
under the circumstances set forth in Section 4.5(b) upon written notice to
Synthetic, such termination to become effective sixty (60) days following such
written notice unless Synthetic remedies the circumstances giving rise to such
termination within such sixty (60) day period.

 

(d)               Intrexon shall have the right to terminate this Agreement
should Synthetic execute any purported assignment of this Agreement contrary to
the prohibitions in Section 12.8, such termination occurring upon Intrexon
providing written notice to Synthetic and becoming effective immediately upon
such written notice.

 

10.3               Termination by Synthetic. Synthetic shall have the right to
voluntarily terminate this Agreement in its entirety upon ninety (90) days
written notice to Intrexon at any time, provided that such notice may not be
given during the eighteen (18) month period commencing on the Effective Date.

 

10.4               Effect of Termination. In the event of termination of this
Agreement pursuant to Section 10.2 or Section 10.3, the following shall apply:

 

(a)               Retained Products. Synthetic shall be permitted to continue
the clinical development and Commercialization in the Field of any Synthetic
Product that, at the time of termination, satisfies at least one of the
following criteria (a “Retained Product”):

 

(i)                 the particular Synthetic Product is being sold by Synthetic
triggering profit sharing payments therefor under Section 5.4(a) of this
Agreement,

 

(ii)               the particular Synthetic Product has received regulatory
approval,

 

(iii)             the particular Synthetic Product is a subject of an
application for regulatory approval in the Field that is pending before the
applicable regulatory authority,

 

(iv)             the particular Synthetic Product is the subject of at least an
ongoing Phase 2 or Phase 3 clinical trial in the Field (in the case of a
termination by Intrexon due to a Synthetic uncured breach pursuant to Section
10.2(a) or a termination by Synthetic pursuant to Section 10.3).

 

Such right to continue development and commercialization shall be subject to
Synthetic’s full compliance with the payment provisions in Article 5, a
continuing obligation for Synthetic to use in accord with Sections 4.5(a) and
4.5(c) Diligent Efforts to develop and commercialize any Retained Products, and
all other provisions of this Agreement that survive termination.

 

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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)               Termination of Licenses. Except as necessary for Synthetic to
continue to obtain regulatory approval for, clinically develop, use, manufacture
and Commercialize the Retained Products in the Field as permitted by Section
10.4(a), all rights and licenses granted by Intrexon to Synthetic under this
Agreement shall terminate and shall revert to Intrexon without further action by
either Intrexon or Synthetic. Synthetic’s license with respect to Retained
Products shall be exclusive or non-exclusive, as the case may be, on the same
terms as set forth in Section 3.1.

 

(c)                Reverted Products. All Synthetic Products other than the
Retained Products shall be referred to herein as the “Reverted Products.”
Synthetic shall immediately cease, and shall cause its Affiliates and, if
applicable, (sub)licensees to immediately cease, all development and
Commercialization of the Reverted Products, and Synthetic shall not use or
practice, nor shall it cause or permit any of its Affiliates or, if applicable,
(sub)licensees to use or practice, directly or indirectly, any Intrexon IP with
respect to the Reverted Products. Synthetic shall immediately discontinue making
any representation regarding its status as a licensee or channel collaborator of
Intrexon with respect to the Reverted Products.

 

(d)               Intrexon Materials. Synthetic shall promptly return, or at
Intrexon’s request, destroy, any Intrexon Materials in Synthetic’s possession or
control at the time of termination other than any Intrexon Materials necessary
for the continued development, regulatory approval, use, manufacture and
Commercialization of the Retained Products in the Field.

 

(e)                Licenses to Intrexon. Synthetic is automatically deemed to
grant to Intrexon a worldwide, fully paid, royalty-free, exclusive (even as to
Synthetic and its Affiliates), irrevocable, license (with full rights to
sublicense) under the Synthetic Termination IP, to make, have made, import, use,
offer for sale and sell Reverted Products and to use the Intrexon Channel
Technology, the Intrexon Materials, and/or the Intrexon IP in the Field, subject
to any exclusive rights held by Synthetic in Reverted Products pursuant to
Section 10.4(c). The Parties shall also take such actions and execute such other
instruments and documents as may be reasonably necessary to document such
license to Intrexon.

 

(f)                Regulatory Filings. Synthetic shall promptly assign to
Intrexon, and will provide full copies of, all regulatory approvals and
regulatory filings that relate specifically and solely to Reverted Products.
Synthetic shall also take such actions and execute such other instruments,
assignments and documents as may be necessary to effect the transfer of rights
thereunder to Intrexon. To the extent that there exist any regulatory approvals
and regulatory filings that relate both to Reverted Products and other products,
Synthetic shall provide copies of the portions of such regulatory filings that
relate to Reverted Products and shall reasonably cooperate to assist Intrexon in
obtaining the benefits of such regulatory approvals with respect to the Reverted
Products.

 

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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.

 

 

(g)               Data Disclosure. Synthetic shall provide to Intrexon copies of
the relevant portions of all material reports and data, including clinical and
non-clinical data and reports, obtained or generated by or on behalf of
Synthetic or its Affiliates to the extent that they relate to Reverted Products,
within sixty (60) days of such termination unless otherwise agreed, and Intrexon
shall have the right to use any such Information in developing and
commercializing Reverted Products and to license any Third Parties to do so.

 

(h)               Third-Party Licenses. At Intrexon’s request, Synthetic shall
promptly provide to Intrexon copies of all Third-Party agreements under which
Synthetic or its Affiliates obtained a license under Patents claiming inventions
or know-how specific to or used or incorporated into the development,
manufacture and/or commercialization of the Reverted Products. At Intrexon’s
request such that Intrexon may Commercialize the Reverted Products, Synthetic
shall promptly work with Intrexon to either (A) assign to Intrexon the Third
Party agreement(s), or (B) grant a sublicense (with an appropriate scope) to
Intrexon under the Third Party agreement(s). Thereafter Intrexon shall be fully
responsible for all obligations due for its actions under the sublicensed or
assigned Third Party agreements. Notwithstanding the above, if Intrexon does not
wish to assume any financial or other obligations associated with a particular
Third Party agreement identified to Intrexon under this Section 10.4(h), then
Intrexon shall so notify Synthetic and Synthetic shall not make such assignment
or grant such sublicense (or cause it to be made or granted).

 

(i)                 Remaining Materials. At the request of Intrexon, Synthetic
shall transfer to Intrexon all quantities of Reverted Product (including active
pharmaceutical ingredient or work-in-process) in the possession of Synthetic or
its Affiliates. Synthetic shall transfer to Intrexon all such quantities of
Reverted Products without charge, except that Intrexon shall pay the reasonable
costs of shipping.

 

(j)                 Third Party Vendors. At Intrexon’s request, Synthetic shall
promptly provide to Intrexon copies of all agreements between Synthetic or its
Affiliates and Third Party suppliers, vendors, or distributors that relate to
the supply, sale, or distribution of Reverted Products in the Territory. At
Intrexon’s request, Synthetic shall promptly: (A) with respect to such Third
Party agreements relating solely to the applicable Reverted Products and
permitting assignment, immediately assign (or cause to be assigned), such
agreements to Intrexon, and (B) with respect to all other such Third Party
agreements, Synthetic shall reasonably cooperate to assist Intrexon in obtaining
the benefits of such agreements. Synthetic shall be liable for any costs
associated with assigning a Third Party agreement to Intrexon or otherwise
obtaining the benefits of such agreement for Intrexon, to the extent such costs
are directly related to Synthetic’s breach. For the avoidance of doubt, Intrexon
shall have no obligation to assume any of Synthetic’s obligations under any
Third Party agreement.

 

(k)               Commercialization. Intrexon shall have the right to develop
and commercialize the Reverted Products itself or with one or more Third
Parties, and shall have the right, without obligation to Synthetic, to take any
such actions in connection with such activities as Intrexon (or its designee),
at its discretion, deems appropriate.

 

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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.

 

 

(l)                 Confidential Information. Each Party shall promptly return,
or at the other Party’s request destroy, any Confidential Information of the
other Party in such Party’s possession or control at the time of termination;
provided, however, that each Party shall be permitted to retain (i) a single
copy of each item of Confidential Information of the other Party in its
confidential legal files for the sole purpose of monitoring and enforcing its
compliance with Article 7, (ii) Confidential Information of the other Party that
is maintained as archive copies on the recipient Party’s disaster recovery
and/or information technology backup systems, or (iii) Confidential Information
of the other Party necessary to exercise such Party’s rights in Retained
Products (in the case of Synthetic) or Reverted Products (in the case of
Intrexon). The recipient of Confidential Information shall continue to be bound
by the terms and conditions of this Agreement with respect to any such
Confidential Information retained in accordance with this Section 10.4(l).

 

10.5               Surviving Obligations. Termination or expiration of this
Agreement shall not affect any rights of either Party arising out of any event
or occurrence prior to termination, including, without limitation, any
obligation of Synthetic to pay any amount which became due and payable under the
terms and conditions of this Agreement prior to expiration or such termination.
The following portions of this Agreement shall survive termination or expiration
of this Agreement: Sections 3.1 (as applicable with respect to 10.4(b), 5.5,
5.7, 6.1, 6.2 (with subsection (c) surviving only to the extent relating to
Intrexon Patents that are relevant to Retained Products that, to Intrexon’s
knowledge, are being developed or commercialized at such time, if any), 7.1,
7.2, 7.4, 7.5, 10.4, and 10.5; Articles 9, 11, and 12; and any relevant
definitions in Article 1. Further, Article 7 and Sections 4.5(a), 4.5(c), 5.2
through 5.8, and 9.5 will survive termination of this Agreement to the extent
there are applicable Retained Products.

 

ARTICLE 11

Dispute Resolution

 

11.1               Disputes. It is the objective of the Parties to establish
procedures to facilitate the resolution of disputes arising under this Agreement
in an expedient manner by mutual cooperation and without resort to litigation.
In the event of any disputes, controversies or differences which may arise
between the Parties out of or in relation to or in connection with this
Agreement (other than disputes arising from a Committee), including, without
limitation, any alleged failure to perform, or breach, of this Agreement, or any
issue relating to the interpretation or application of this Agreement, then upon
the request of either Party by written notice, the Parties agree to meet and
discuss in good faith a possible resolution thereof, which good faith efforts
shall include at least one in-person meeting between the Executive Officers of
each Party. If the matter is not resolved within thirty (30) days following the
written request for discussions, either Party may then invoke the provisions of
Section 11.2. For the avoidance of doubt, any disputes, controversies or
differences arising from a Committee pursuant to Article 2 shall be resolved
solely in accordance with Section 2.4.

 

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1934, as amended.  A complete copy of this document has been filed separately
with the Securities and Exchange Commission.

 

 

11.2               Arbitration. Any dispute, controversy, difference or claim
which may arise between the Parties and not from a Committee, out of or in
relation to or in connection with this Agreement (including, without limitation,
arising out of or relating to the validity, construction, interpretation,
enforceability, breach, performance, application or termination of this
Agreement) that is not resolved pursuant to Section 11.1 shall, subject to
Section 11.10, be settled by binding “baseball arbitration” as follows. Either
Party, following the end of the thirty (30) day period referenced in Section
11.1, may refer such issue to arbitration by submitting a written notice of such
request to the other Party, with the arbitration to be held in the state where
the other Party’s principal office is located (or some other place as may be
mutually agreed by the Parties). Promptly following receipt of such notice, the
Parties shall meet and discuss in good faith and seek to agree on an arbitrator
to resolve the issue, which arbitrator shall be neutral and independent of both
Parties and all of their respective Affiliates, shall have significant
experience and expertise in licensing and partnering agreements in the
pharmaceutical and biotechnology industries, and shall have some experience in
mediating or arbitrating issues relating to such agreements. If the Parties
cannot agree on a single arbitrator within fifteen (15) days of request by a
Party for arbitration, then each Party shall select an arbitrator meeting the
foregoing criteria and the two (2) arbitrators so selected shall select within
ten (10) days of their appointment a third arbitrator meeting the foregoing
criteria. Within fifteen (15) days after an arbitrator(s) is selected (in the
case of the three-person panel, when the third arbitrator is selected), each
Party will deliver to both the arbitrator(s) and the other Party a detailed
written proposal setting forth its proposed terms for the resolution for the
matter at issue (the “Proposed Terms” of the Party) and a memorandum (the
“Support Memorandum”) in support thereof. The Parties will also provide the
arbitrator(s) a copy of this Agreement, as it may be amended at such time.
Within fifteen (15) days after receipt of the other Party’s Proposed Terms and
Support Memorandum, each Party may submit to the arbitrator(s) (with a copy to
the other Party) a response to the other Party’s Support Memorandum. Neither
Party may have any other communications (either written or oral) with the
arbitrator(s) other than for the sole purpose of engaging the arbitrator or as
expressly permitted in this Section 11.2; provided that, the arbitrator(s) may
convene a hearing if the arbitrator(s) so chooses to ask questions of the
Parties and hear oral argument and discussion regarding each Party’s Proposed
Terms. Within sixty (60) days after the arbitrator’s appointment, the
arbitrator(s) will select one of the two Proposed Terms (without modification)
provided by the Parties that he or she believes is most consistent with the
intention underlying and agreed principles set forth in this Agreement. The
decision of the arbitrator(s) shall be final, binding, and unappealable. For
clarity, the arbitrator(s) must select as the only method to resolve the matter
at issue one of the two sets of Proposed Terms, and may not combine elements of
both Proposed Terms or award any other relief or take any other action.

 

11.3               Governing Law. This Agreement shall be governed by and
construed under the substantive laws of the State of New York, excluding any
conflicts or choice of law rule or principle that might otherwise refer
construction or interpretation of this Agreement to the substantive law of
another jurisdiction.

 

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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.

 

 

11.4               Award. Any award to be paid by one Party to the other Party
as determined by the arbitrator(s) as set forth above under Section 11.2 shall
be promptly paid in United States dollars free of any tax, deduction or offset;
and any costs, fees or taxes incident to enforcing the award shall, to the
maximum extent permitted by law, be charged against the losing Party. Each Party
agrees to abide by the award rendered in any arbitration conducted pursuant to
this Article 11, and agrees that, subject to the United States Federal
Arbitration Act, 9 U.S.C. §§ 1-16, judgment may be entered upon the final award
in any United States District Court located in New York and that other courts
may award full faith and credit to such judgment in order to enforce such award.
The award shall include interest from the date of any damages incurred for
breach of the Agreement, and from the date of the award until paid in full, at a
rate fixed by the arbitrator(s). With respect to money damages, nothing
contained herein shall be construed to permit the arbitrator(s) or any court or
any other forum to award consequential, incidental, special, punitive or
exemplary damages. By entering into this agreement to arbitrate, the Parties
expressly waive any claim for consequential, incidental, special, punitive or
exemplary damages. The only damages recoverable under this Agreement are direct
compensatory damages.

 

11.5               Costs. Each Party shall bear its own legal fees. The
arbitrator(s) shall assess his or her costs, fees and expenses against the Party
losing the arbitration.

 

11.6               Injunctive Relief. Nothing in this Article 11 will preclude
either Party from seeking equitable relief or interim or provisional relief from
a court of competent jurisdiction, including a temporary restraining order,
preliminary injunction or other interim equitable relief, concerning a dispute
either prior to or during any arbitration if necessary to protect the interests
of such Party or to preserve the status quo pending the arbitration proceeding.
Specifically, the Parties agree that a material breach by either Party of its
obligations in Section 3.5 or Article 7 of this Agreement may cause irreparable
harm to the other Party, for which damages may not be an adequate remedy.
Therefore, in addition to its rights and remedies otherwise available at law,
including, without limitation, the recovery of damages for breach of this
Agreement, upon an adequate showing of material breach of such Section 3.5 or
Article 7, and without further proof of irreparable harm other than this
acknowledgement, such non-breaching Party shall be entitled to seek (a)
immediate equitable relief, specifically including, but not limited to, both
interim and permanent restraining orders and injunctions, without bond, and (b)
such other and further equitable relief as the court may deem proper under the
circumstances. For the avoidance of doubt, nothing in this Section 11.6 shall
otherwise limit a breaching Party’s opportunity to cure a material breach as
permitted in accordance with Section 10.2.

 

11.7               Confidentiality. The arbitration proceeding shall be
confidential and the arbitrator(s) shall issue appropriate protective orders to
safeguard each Party’s Confidential Information. Except as required by law, no
Party shall make (or instruct the arbitrator(s) to make) any public announcement
with respect to the proceedings or decision of the arbitrator(s) without prior
written consent of the other Party. The existence of any dispute submitted to
arbitration, and the award, shall be kept in confidence by the Parties and the
arbitrator(s), except as required in connection with the enforcement of such
award or as otherwise required by applicable law.

 

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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.

 

 

11.8               Survivability. Any duty to arbitrate under this Agreement
shall remain in effect and be enforceable after termination of this Agreement
for any reason.

 

11.9               Jurisdiction. For the purposes of this Article 11, the
Parties acknowledge their diversity and agree to accept the jurisdiction of any
United States District Court located in New York for the purposes of enforcing
or appealing any awards entered pursuant to this Article 11 and for enforcing
the agreements reflected in this Article 11 and agree not to commence any
action, suit or proceeding related thereto except in such courts.

 

11.10           Patent Disputes. Notwithstanding any other provisions of this
Article 11, and subject to the provisions of Section 6.2, any dispute,
controversy or claim relating to the scope, validity, enforceability or
infringement of any Intrexon Patents shall be submitted to a court of competent
jurisdiction in the country in which such Patent was filed or granted.

 

ARTICLE 12

General Provisions

 

12.1               Use of Name. No right, express or implied, is granted by this
Agreement to either Party to use in any manner the name of the other or any
other trade name or trademark of the other in connection with the performance of
this Agreement, except that (a) either Party may use the name of the other Party
as required by regulations and in press releases accompanying quarterly and
annual earnings reports approved by the issuer’s Board of Directors, and (b)
Synthetic may use the Intrexon Trademarks in accord with licenses and
restrictions set forth herein.

 

12.2               LIMITATION OF LIABILITY. NEITHER PARTY SHALL BE LIABLE TO THE
OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING,
NOTHING IN THIS PARAGRAPH IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION
RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER ARTICLE 9, OR DAMAGES AVAILABLE FOR
BREACHES OF THE OBLIGATIONS SET FORTH IN ARTICLE 7.

 

12.3               Independent Parties. The Parties are not employees or legal
representatives of the other Party for any purpose. Neither Party shall have the
authority to enter into any contracts in the name of or on behalf of the other
Party. This Agreement shall not constitute, create, or in any way be interpreted
as a joint venture, partnership, or business organization of any kind.

 

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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.

 

 

12.4               Notice. All notices, including notices of address change,
required or permitted to be given under this Agreement shall be in writing and
deemed to have been given when delivered if personally delivered or sent by
facsimile (provided that the party providing such notice promptly confirms
receipt of such transmission with the other party by telephone), on the business
day after dispatch if sent by a nationally-recognized overnight courier and on
the third business day following the date of mailing if sent by certified mail,
postage prepaid, return receipt requested. All such communications shall be sent
to the address or facsimile number set forth below (or any updated addresses or
facsimile number communicated to the other Party in writing):

 

If to Intrexon:

 

 

 

 

 

with a copy to:

Intrexon Corporation

20358 Seneca Meadows Parkway

Germantown, MD 20876

Attention: President, Protein Production Division

Fax: (301) 556-9901

 

Intrexon Corporation

20358 Seneca Meadows Parkway

Germantown, MD 20876

Attention: Legal Department

Fax: (301) 556-9902

 

 

If to Synthetic:

 

 

 

 

 

with a copy to:

 

Synthetic Biologics, Inc.

617 Detroit Street, Suite 100

Ann Arbor, MI 48104

Attention: Chief Executive Officer

Fax: (734) 332-7878

 

Gracin & Marlow, LLP

405 Lexington Avenue

New York, NY 10174

Attn: Leslie Marlow, Esq.

Fax: (212) 208-4657

 

12.5               Severability. In the event any provision of this Agreement is
held to be invalid or unenforceable, the valid or enforceable portion thereof
and the remaining provisions of this Agreement will remain in full force and
effect.

 

12.6               Waiver. Any waiver (express or implied) by either Party of
any breach of this Agreement shall not constitute a waiver of any other or
subsequent breach.

 

12.7               Entire Agreement; Amendment. This Agreement, including any
exhibits attached hereto, constitute the entire, final, complete and exclusive
agreement between the Parties and supersede all previous agreements or
representations, written or oral, with respect to the subject matter of this
Agreement (including any prior confidentiality agreement between the Parties).
All information of Intrexon or Synthetic to be kept confidential by the other
Party under any prior confidentiality agreement, as of the Effective Date, shall
be maintained as Confidential Information by such other Party under the
obligations set forth in Article 7 of this Agreement. This Agreement may not be
modified or amended except in a writing signed by a duly authorized
representative of each Party.

 

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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.

 

 

12.8               Non-assignability; Binding on Successors. Any attempted
assignment of the rights or delegation of the obligations under this Agreement
shall be void without the prior written consent of the non-assigning or
non-delegating Party; provided, however, that either Party may assign its rights
or delegate its obligations under this Agreement without such consent (a) to an
Affiliate of such Party or (b) to its successor in interest in connection with
any merger, acquisition, consolidation, corporate reorganization, or similar
transaction, or sale of all or substantially all of its assets, provided that
such assignee agrees in writing to assume and be bound by the assignor’s
obligations under this Agreement. This Agreement shall be binding upon, and
inure to the benefit of, the successors, executors, heirs, representatives,
administrators and permitted assigns of the Parties. Notwithstanding the
foregoing, in the event that either Party assigns this Agreement to its
successor in interest by way of merger, acquisition, consolidation, corporate
reorganization, or similar transaction, or sale of all or substantially all of
its assets (whether this Agreement is actually assigned or is assumed by such
successor in interest or its affiliate by operation of law (e.g., in the context
of a reverse triangular merger)), the intellectual property rights of such
successor in interest or any of its Affiliates other than those licensed in this
Agreement shall be automatically excluded from the rights licensed to the other
Party under this Agreement.

 

12.9               Force Majeure. Neither Party shall be liable to the other for
its failure to perform any of its obligations under this Agreement, except for
payment obligations, during any period in which such performance is delayed
because rendered impracticable or impossible due to circumstances beyond its
reasonable control, including without limitation earthquakes, governmental
regulation, fire, flood, labor difficulties, civil disorder, acts of terrorism
and acts of God, provided that the Party experiencing the delay promptly
notifies the other Party of the delay.

 

12.10           No Other Licenses. Neither Party grants to the other Party any
rights or licenses in or to any intellectual property, whether by implication,
estoppel, or otherwise, except to the extent expressly provided for under this
Agreement.

 

12.11           Non-Solicitation. During the Term and for a period of one (1)
year following the end of the Term, neither Synthetic nor Intrexon may directly
or indirectly solicit in order to offer to employ, engage in any discussion
regarding employment with, or hire any employee of the other Party or an
individual who was employed by the other party with one (1) year prior to such
solicitation, discussion, or hire, without the prior approval of such other
Party. General employment solicitations or advertisements shall not be
considered direct or indirect solicitations, and are not prohibited under this
Agreement.

 

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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.

 

 

12.12           Legal Compliance. The Parties shall review in good faith and
cooperate in taking such actions to ensure compliance of this Agreement with all
applicable laws.

 

12.13           Counterparts. This Agreement may be executed in any number of
counterparts (including by facsimile, PDF, or other means of electronic
communication), each of which taken together will constitute one and the same
instrument, and any of the Parties hereto may execute this Agreement by signing
any such counterpart.

 

[Remainder of page intentionally left blank.]

 

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1934, as amended.  A complete copy of this document has been filed separately
with the Securities and Exchange Commission.

 

 

In Witness Whereof, the Parties hereto have duly executed this Exclusive Channel
Collaboration Agreement.

 

 

 

Intrexon Corporation

 

By:/s/ Saiid Zarrabian

 

Name: Saiid Zarrabian

 

Title: President of Protein Production Division and Senior Vice President

Synthetic Biologics, Inc.

 

By:/s/Jeffrey Riley

 

Name: Jeffrey Riley

 

Title: Chief Executive Officer, President, and Director

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

SIGNATURE PAGE FOR EXCLUSIVE CHANNEL COLLABORATION AGREEMENT

 

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