Exhibit 10.18

4 August 2011

AGREEMENT ON CO-DEVELOPMENT AND

THE TERMS OF EXCLUSIVE LICENCE

between

(1) LIPOXEN PLC

(2) LIPOXEN TECHNOLOGIES LTD

- and-

(3) SYNBIO LLC

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THIS AGREEMENT is entered into on 4 August 2011

BETWEEN:

 

(1) Lipoxen PLC, a Company registered under the laws of England with Company
number 03213174 located at: the London Bioscience Innovation Centre, 2 Royal
College Street, London, NW1 0NH, United Kingdom, represented by Chief Executive
Officer Scott Maguire acting on the basis of the Articles of Association of
Lipoxen PLC;

 

(2) Lipoxen Technologies Ltd, a Company registered under the laws of England
with Company registration number 03401495 located at: London Bioscience
Innovation Centre, 2 Royal College Street, London, NW1 0NH, United Kingdom,
represented by Chief Executive Officer Scott Maguire, acting on the basis of the
Articles of Association of Lipoxen Technologies Limited;

(Lipoxen PLC and Lipoxen Technologies Ltd. shall be jointly referred to as
“Lipoxen”); and

 

(3) SynBio LLC, a limited liability company incorporated under the laws of the
Russian Federation, Main State Registration Number 1117746126321, located at:
building 2, 55/1, Leninsky Prospekt, Moscow, Russian Federation (“SynBio”)
represented by the General Director Kruglyakov Pyotr Vladimirovich, acting on
the basis of the Charter of SynBio.

(Lipoxen and SynBio shall be jointly referred to as the “Parties” and each
individually as a “Party”)

 

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RECITALS:

 

(1) Lipoxen is a drug and vaccine delivery company and is dedicated to
innovative methods for the optimal delivery of therapeutics in the treatment and
prevention of disease.

 

(2) Lipoxen’s proprietary PolyXen Technology (defined below) involves the use of
polysialic acid conjugation as a means to improve the pharmacokinetics and
pharmacodynamics of protein drugs.

 

(3) Lipoxen is planning to acquire rights in the Oncohist Technology (defined
below) which involves the use of human’s N-bis-met-histone H.1.3 for the
creation of drugs.

 

(4) SynBio is a limited liability company, incorporated with the purpose of
carrying out pre-clinical trials and clinical trials, registration, manufacture
and sale of pharmaceutical products in the SynBio Market (defined below).

 

(5) SynBio has or shall acquire worldwide rights to use and transfer to third
parties (including Lipoxen) the right to use cell lines for the production of
six molecules under development by SynBio, which includes: (i) EPO; (ii) GCSF;
(iii) insulin; (iv) interferon alpha; (v) human growth hormone; (vi) Histone.

 

(6) SynBio wishes to receive and Lipoxen is willing to grant to SynBio an
exclusive license in the SynBio Market to develop pharmaceutical products using
the Molecules and the PolyXen Technology.

 

(7) If Lipoxen is able to source PSA, EPO and/or Product A from SIIL and is
requested to do so by SynBio, Lipoxen will endeavor to supply these materials to
SynBio under this Agreement on an “as is” basis.

 

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(8) If requested to do so by Lipoxen, it is the intention of the Parties that
SynBio will supply the Molecules and/or the Products to Lipoxen.

 

(9) Lipoxen and SynBio have agreed to collaborate in the development of: (a)
certain products combining the PolyXen Technology and SynBio Molecules (defined
below); and (b) Histone using the Oncohist Technology, which, if successful,
will lead to clinical development of pharmaceutical and biotechnology products.

 

(10) Lipoxen wishes to receive and SynBio is willing to grant to Lipoxen an
exclusive license to use the SynBio Cell Lines (defined below) and pre-clinical
and clinical data generated by SynBio in relation to the Products, subject to
and in accordance with the terms of this agreement (“Agreement”).

THE PARTIES AGREE as follows:

 

1. DEFINITIONS

In this Agreement, the following words shall have the following meanings:

 

“Affiliate”    in relation to a Party, means any entity or person which
controls, is controlled by, or is under common control with that Party. For the
purposes of this definition, “control” shall mean direct or indirect beneficial
ownership of 50% (or, outside a Party’s home territory, such lesser percentage
as is the maximum, permitted level of foreign investment) or more of the share
capital, stock or other participating interest carrying the right to vote or to
distribution of profits of that entity or person, as the case may be;

 

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“Appointed CRO”    means any contract research organization appointed by either
of the Parties to carry out any pre-clinical and/or clinical trials in relation
to the Products; “Arising IPR”   

means any and all Intellectual Property Rights arising from or in relation to
the work carried out by or on behalf of SynBio (and/or its Affiliates) and/or
Lipoxen in relation to this Agreement, including any and all Intellectual
Property Rights relating to:

 

(a) the Results, including any and all data arising from the the Clinical
Trials; and

 

(b) the Products;

 

but shall exclude the CMO Arising IPR.

 

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“Clinical Dossier”    means in relation to each of the Products:    (a) the
results of and data arising from any pre-clinical and/or clinical trials
relating to the relevant Product conducted by or on behalf of SynBio; and    (b)
any technical or other information prepared for submission to and/or actually
submitted to regulatory authorities in relation to the relevant Product by or on
behalf of SynBio, including information relating to quality, safety and efficacy
of Products; “Clinical Trials”    means the clinical trials to be carried out by
or on behalf of the Parties in relation to the Products including the SynBio
Stage 2 Trials and the SynBio Stage 3 Trials in the SynBio Market and the
Lipoxen Trials in the Lipoxen Market; “CMO Arising IPR”    means any and all
Intellectual Property Rights arising from or in relation to work carried out on
behalf of Lipoxen by contract manufacturing organizations (other than SynBio) in
relation to the Molecules;

 

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“Commencement Date”    means the date upon which 110,800,000 of the shares of
Lipoxen PLC are allotted to SynBio pursuant to the Subscription Agreement;
“Confidential Information”    means any and all data, results, know-how,
show-how, software, algorithms, trade secrets, plans, forecasts, analyses,
evaluations, research, technical information, business information, financial
information, business plans, strategies, customer lists, marketing plans, or
other information whether oral, in writing, in electronic form or in any other
form, and any physical items, compounds, components or other materials disclosed
before, on or after the date of this Agreement by one Party (and/or its
Affiliates) to the other Party (and/or its Affiliates) including, but not
limited to the Lipoxen Know How and any SynBio know how. “Development Program”
   means the detailed program for the collaboration for each Product set out in
Schedule 1 of this Agreement as modified from time to time by the Scientific
Subcommittee in accordance with clause 8.13 and 8.14 and otherwise in accordance
with the terms of this Agreement;

 

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“Diligent and Reasonable Efforts”    means exerting such effort and employing
such resources as would normally be exerted or employed by a reasonable third
party for a product of similar market potential at a similar state of its
product life, taking into account the competitiveness of the relevant
marketplace, the proprietary and development positions of third parties, the
regulatory structure involved, and the profitability of the product, when
utilising sound and reasonable scientific, business and medical practice and
judgment in order to develop a product in a timely manner and maximise the
economic return to the parties form its commercialization; “EMEA”    means the
European Medicines Agency and/or any successor to it; “EPO”    means EPO as
specified in the European Pharmacopea under Erythropoietin concentrated solution
(01/2002:1316) and further described in Schedule 2;

 

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“EPO Cell Line”    means the EPO cell line used by SIIL to manufacture EPO;
“Excluded Field”   

[***]

“FDA”    means the US Food and Drug Administration and/or any successor to it;
“GCP”    means all applicable laws, regulations, codes and guidelines relating
to good clinical practice, including:- good clinical practice pursuant to
Directive 2001/20/EEC and Directive 2005/28/EEC and all applicable implementing
and/or amending legislation and guidelines; the regulations established by the
MHRA and/or the FDA, for example as embodied in the Code of Federal Regulations
and relevant guidelines published by the FDA, relating to the standard of
practice that is

 

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   acceptable to the FDA in the conduct of clinical studies; the version of the
Declaration of Helsinki in force; and the International Conference on
Harmonisation Guidelines for Good Clinical Practice in force; “GCSF”    means
GCSF as further described in Schedule 2; “GMP”    means those practices in the
manufacture of pharmaceutical products that are recognised as the current good
manufacturing practices by the MHRA and comparable Governmental Authorities
including, without limitation, in accordance with:- (i) European Community
Commission Directive

 

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   2003/94/EEC of 08 October 2003 and all applicable implementing and/or
amending legislation and guidelines; (ii) the EC Guide to Good Manufacturing
Practice for Medicinal Products and any amendments thereto or other guidelines
made under the above directives from time to time; and (iii) International
Conference on Harmonization (ICH) guidance documents, including without
limitation the ICH Guidance Q7 Good Manufacturing Practice Guide for Active
Pharmaceutical Ingredients; “Histone”    means histone as further described in
Schedule 2; “Human Growth Hormone”    means human growth hormone as further
described in Schedule 2; “Insulin”    means insulin as further described in
Schedule 2; “Intellectual    means all possible intellectual property as defined
in any

 

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“Property Rights”    jurisdiction including but not limited to rights to
inventions, patents, any extensions of the exclusivity granted in connection
with patents, petty patents, utility models, applications for any of the
foregoing (including, but not limited to, continuations, continuations-in-part
and divisional applications), the right to apply for any of the foregoing,
database rights, rights in data and know-how, trade secrets and confidential
information and all other forms of intellectual property rights having
equivalent or similar effect to any of the foregoing which may exist anywhere in
the world; “Interferon Alpha 2b”    means interferon alpha 2b as further
described in Schedule 2; “Joint Arising IPR”    means the Arising IPR that is
owned jointly by the Parties pursuant to clause 9.6 of this Agreement; “Know How
Transfer Time”    means the time of two scientists each working for ten (10)
working days; “Lipoxen Arising IPR”    means any and all Arising IPR which is
owned by Lipoxen pursuant to clause 9.1 of this Agreement;

 

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“Lipoxen Development Products”    means Product A, Product B and Product F;
“Lipoxen Know How”    means the Oncohist Know How, the PSA Manufacturing Know
How and the PolyXen Know How; “Lipoxen Market”    means any country in the world
which is not a SynBio Market; “Lipoxen Patents”    means the Oncohist Patents,
the PSA Manufacturing Patents and the PolyXen Patents; “Lipoxen Royalty Product”
  

means a Lipoxen Development Product which is sold or supplied by Lipoxen and/or
its Affiliates and:

 

(a)    which was manufactured using a SynBio Cell Line; and

 

(b)    in relation to which SynBio has provided to Lipoxen a Clinical Dossier
which has enabled Lipoxen to commence Phase 1 clinical trials in an EMEA and/or
FDA regulated country in the Lipoxen Market without carrying out any further
pre-clinical or clinical development of the relevant Lipoxen Development
Product;

 

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“Lipoxen Technology”    means the PolyXen Technology, the PolyXen Manufacturing
Technology and the Oncohist Technology; “Lipoxen Stage 2 Trials”    means the
Phase I clinical trials to be carried out by Lipoxen in the Lipoxen Market in
relation to the Lipoxen Development Products as set out in the Development
Program and as determined by the Scientific Subcommittee in accordance with
clause 5; “Lipoxen Stage 3 Trials”    means the Phase II clinical trials to be
carried out by Lipoxen in the Lipoxen Market in relation to the Lipoxen
Development Products in Stage 3 as set out in the Development Program and as
determined by the Scientific Subcommittee in accordance with clause 6; “Lipoxen
Trials”    means the Lipoxen Stage 2 Trials and the Lipoxen Stage 3 Trials;
“Molecules”    means EPO, GCSF, Insulin, Interferon Alpha, Human Growth Hormone
and Histone;

 

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“Oncohist Know How”    means any and all know how which is disclosed to SynBio
pursuant to this Agreement or was disclosed pursuant to the Oncohist Licence
Agreement that relates to the inventions disclosed in the Oncohist Patents;
“Oncohist Licence Agreement”    means the license agreement entered into between
Closed Joint Stock Company Cryonics and Symbiotec GmbH, Germany on 25 September
2008 under future development Closed Joint Stock Company Cryonics will transfer
the exclusive right for the use of the Oncohist Technology as a contribution to
the charter capital SynBio; “Oncholiist Patents”    means the patents and patent
applications set out in Schedule 3 of this Agreement, including any
continuations, continuations in part, extensions, reissues, divisions, and any
patents, supplementary protection certificates and similar rights that are based
on or derive priority from the foregoing;

 

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“Oncohist Technology”    means the multifaceted platform technology histone H1.3
that allows the development of anticancer drugs as described in detail in the
Oncohist Patents; “PolyXen Know How”    means the know how in the possession and
control of Lipoxen at the Commencement Date relating to the technology disclosed
in the PolyXen Patents in relation to which Lipoxen has a right to grant a
licence; “PolyXen Patents”    means the patents and patent applications set out
in Schedule 5 of this Agreement, including any continuations, continuations in
part, extensions, reissues, divisions, and any patents, supplementary protection
certificates and similar rights that are based on or derive priority from the
foregoing; “PolyXen Technology”    means the multifaceted platform technology
that employs PSA to prolong the active life and improve the pharmacokinetics of
therapeutic proteins and peptides, as well as conventional drugs, as described
in detail in the PolyXen Patents;

 

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“Products”

   means Product A, Product B, Product C, Product D, Product E and Product F;

“Product A”

   means pharmaceutical preparations for the treatment and/or prevention in
humans of anemia containing conjugates of EPO and PSA as their active
ingredient;

“Product B”

   means pharmaceutical preparations for use in human patients receiving
treatment for cancer containing conjugates of GCSF and PSA as their active
ingredient;

“Product C”

  

[***]

“Product D”

   means pharmaceutical preparations for the treatment and/or prevention in
humans of hepatitis C containing conjugates of Interferon Alpha 2b and PSA as
their active ingredient;

“Product E”

   means preparations for use in humans containing conjugates of Human Growth
Hormone and PSA as their active ingredient;

 

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“Product F”

   means pharmaceutical preparations for the treatment and/or prevention in
humans of cancer containing Histone as their active ingredient;

“PSA”

  

[***]

“PSA Cell Line”

   means the E.coli cell line used by Lipoxen to manufacture PSA;

“PSA Know How”

   means the know-how in the possession and control of Lipoxen at the
Commencement Date relating to the PSA Manufacturing Process in relation to which
Lipoxen has the right to grant a licence, which shall include the PSA Cell Line;

“PSA Manufacturing Process”

  

means each and every step in the process of manufacturing and purifying PSA from
an E.coli cell line including but not limited to;

 

(a) fermentation of E.coli strains producing PSA;

 

(b) purification of PSA from the product of the process described in paragraph
(a) above; and

 

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   (c) scale up of any of the processes described in (a) and (b) above;

“PSA Patents”

   means the patens and patent applications set out in Schedule 6 of this
Agreement, including any continuations, continuations in part, extensions,
reissues, divisions, and any patents, supplementary protection certificates and
similar rights that are based on or derive priority from the foregoing;

“PSA Technology”

   means the technology relating to the PSA Manufacturing Process which is
described in the PSA Patents;

“Quarter”

   means the quarterly periods ending 31 March, 30 June, 30 September and 31
December;

“Relationship Deed”

   means the agreement to regulate the relationship between SynBio and Lipoxen
PLC in the agreed form;

“Results”

   means the results of and data arising from the Development Program;

 

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“Scientific Subcommittee”

   means a committee formed and operating in accordance with clauses 8.10 – 8.19
of this Agreement;

“SIIL”

   means Serum Institute of India Limited, a company incorporated under Indian
law, having its principal place of business at S. No. 212/2, Off Soli Poonawalla
Road, Hadapsar, Pune – 411 028, Maharashtra, India;

“SIIL Agreement”

   means the Exclusive Know How and Manufacturing Agreement dated on or around
the Commencement Date between Lipoxen and SIIL;

“SynBio Arising IPR”

   means any and all Arising IPR which is owned by SynBio pursuant to clause 9.2
of this Agreement;

“SynBio Background IP”

   means any and all Intellectual Property Rights which, prior to or after the
Commencement Date, are owned by or controlled by SynBio or licensed to SynBio by
a third party other than Lipoxen and which have utility in the research,
development, manufacture, use, sale, supply and exploitation of Products and
which includes (to the extent it is not Lipoxen Arising IPR), but is not limited
to, any and all Intellectual Property Rights relating to:

 

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(a) the Molecules;

 

(b) the SynBio Cell Lines;

 

(c) the Products;

 

(d) the methods and/or processes used by SynBio to manufacture the Molecules;

 

(e) the methods and/or processes used by SynBio to manufacture the Products; and

 

(f) the Clinical Dossiers;

“SynBio Cell Lines”

   means any and all cell lines used by SynBio to manufacture and/or create any
of the Molecules;

“SynBio Market”

   means the Russian Federation and the commonwealth of independent states
comprising the following countries:- Armenia, Azerbaijan, Belarus, Kazakhstan,
Kyrgyzstan, Republic of Moldova, Tajikistan, Turkmenistan, Ukraine and
Uzbekistan;

“SynBio PolyXen Products”

   means the Products excluding Product F;

 

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“SynBio Royalty Products”

   means any and all products that are manufactured, sold and/or supplied by
SynBio or any of its Affiliates which incorporate or make use of any of the
PolyXen Technology, the Oncohist Technology, CMO Arising IPR and/or the Lipoxen
Arising IPR;

“SynBio Stage 2 Trials”

   means the clinical trials to be carried out in Stage 2 by SynBio in the
SynBio Market in relation to the Products as set out in Schedule 4;

“SynBio Stage 3 Trials”

   means the clinical trials to be carried out in Stage 3 by SynBio in the
SynBio Market in relation to the Products as set out in the Development Program
and as determined by the Scientific Subcommittee in accordance with clause 3;

“SynBio Trials”

   means the SynBio Stage 2 Trials and the SynBio Stage 3 Trials;

“Specifications”

   means the specifications for the Products to be determined by the Scientific
Subcommittee in accordance with clause 8.14.1 of this Agreement;

 

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“Stage 1”

   means the creation, formulation and pre-clinical testing of the Products by
SynBio as described in further detail in Stage 1 of the Development Program;

“Stage 2”

   means the phase I clinical trials to be conducted by SynBio in relation to
the Products and by Lipoxen in relation to the Lipoxen Development Products as
described in further detail in Stage 2 of the Development Program;

“Stage 3”

   means the phase II and phase III clinical trials to be conducted by SynBio in
relation to the Products and by Lipoxen in relation to the Lipoxen Development
Products as described in further detail in Stage 3 of the Development Program;

“Stage 1 Costs”

   means any and all costs and expenses incurred by Lipoxen and/or SynBio in
relation to Stage 1;

“Stage 2 Costs”

   means any and all costs and expenses incurred by Lipoxen and/or SynBio in
relation to Stage 2;

Stage 3 Costs”

   means any and all costs and expenses properly and reasonably incurred by
Lipoxen and/or SynBio in relation to Stage 3;

“Subscription Agreement”

   means the agreement between Lipoxen PLC and SynBio relating to the placement
of shares in Lipoxen PLC by private subscription;

 

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“Success Criteria”

   means the criteria to be determined by the Scientific Subcommittee for each
of the Products which the relevant Product must meet prior to entering Stage 2
and/or Stage 3, as described in clause 8.14.1 of this Agreement;

“Supply Products”

   means any products supplied by Lipoxen to SynBio pursuant to clause 7.1;

“Third Party IP Rights”

   means Third Party IP Rights as defined in clause 9.17;

“Timetable”

   means the timetable for the Development Program set out in Schedule 1 of this
Agreement;

“Valid Claim”

   means a claim of a patent or patent application that has not expired or been
held invalid or unenforceable by a decision of a patent office or court of
competent jurisdiction, which decision (a) it is not possible to appeal or, (b)
is not the subject of an appeal within the prescribed time limits.

 

2. COMMENCEMENT GENERALLY AND HISTONE/PRODUCT F

 

  2.1.

The Parties hereby agree that each Party’s rights and obligations in relation to
Product F (including those set out in

 

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  clause 2.3) shall be excluded entirely from the scope of this Agreement until
such time that Lipoxen notifies SynBio in writing that Lipoxen:- (i) has
acquired rights to the Oncohist Technology; and (ii) Lipoxen is free and able to
use the Oncohist Technology in accordance with the terms of this Agreement.

 

  2.2. On receipt of the notice referred to in clause 2.1 by SynBio, any rights
and obligations under this Agreement of the Parties in relation to Product F
shall automatically commence without any further action by either of the
Parties.

 

  2.3. To the extent that SynBio is not already licensed to do so pursuant to
the Oncohist Licence Agreement, conditional upon the events set out in clause
2.1 of this Agreement, Lipoxen grants to SynBio an exclusive licence during the
term of this Agreement in the SynBio Market under the Oncohist Patents and/or
the Oncohist Know How to research, develop, manufacture, have manufactured, use,
sell and supply Product F.

 

  2.4. The Parties agree that to the extent there is any conflict between the
scope of the Oncohist Licence Agreement and the terms of this Agreement, the
terms of this Agreement shall prevail.

 

  2.5. Without prejudice to the generality of clause 2.4, the Parties agree that
Lipoxen will have exclusive rights in the Lipoxen Market to research, develop,
manufacture, have manufactured, use, sell and supply Product F, and/or to
licence third parties to do so.

 

  2.6.

Lipoxen’s obligations under this Agreement and SynBio’s rights under clauses
11.1, 11.3 and 11.4 shall not commence in any circumstance until the date upon
which Lipoxen receives the funds from SynBio which are due to Lipoxen under the
Subscription

 

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  Agreement. The Parties agree that this Agreement shall automatically expire if
such funds are not received by Lipoxen on or before 31 December 2011.

 

3. STAGE 1: CANDIDATE OPTIMIZATION

 

  3.1. Lipoxen and SynBio shall collaborate to fulfill the objectives of Stage
1.

 

  3.2. Each Party shall use its reasonable endeavors to fulfill the obligations
allocated to it in Stage 1 in accordance with the Timetable.

 

  3.3. The Parties acknowledge that in Stage 1, Lipoxen’s obligations are
limited to a transfer of the PolyXen Know How (as specified in clauses 11.10 of
this Agreement) from Lipoxen to SynBio to enable SynBio to carry out its
obligations under Stage 1.

 

  3.4. SynBio shall transfer to Lipoxen within ten (10) business days upon
Lipoxen’s request any and all information, data and know how in the possession
and/or control of SynBio relating to the Molecules which is reasonably required
by Lipoxen to carry out its obligations under Stage 1 in accordance with the
Timetable according to the procedure set forth in clauses 10.7-10.9 of this
Agreement.

 

  3.5. Unless SynBio and Lipoxen agree otherwise, a Product shall not become
part of Stage 2 unless it meets the Success Criteria. The Scientific
Subcommittee shall in accordance with clause 8 determine:

 

  3.5.1. the Success Criteria;

 

  3.5.2. whether a Product meets the Success Criteria; and

 

  3.5.3. a Specification for each of the Products to enter Stage 2.

 

  3.6. The Parties agree that SynBio shall not create or develop any Products
using cell lines:

 

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  3.6.1. to which SynBio does not own the worldwide right to use the relevant
cell line; and/or

 

  3.6.2. in relation to which SynBio is unable to transfer the cell lines and
the rights to use it to Lipoxen in the Lipoxen Market.

 

  3.7. The Parties acknowledge that in creating Product A, SynBio shall be
entitled to develop the product using either:-

 

  3.7.1. the cell line used by SIIL to make EPO if, and to the extent that,
Lipoxen is able to, obtain rights to and a technology transfer of the cell line
used by SIIL; and/or

 

  3.7.2. any other suitable cell line which complies with clause 3.6 above.

 

4. STAGE 2: CLINICAL TRIALS IN SYNBIO MARKET

 

  4.1. SynBio shall conduct the SynBio Stage 2 Trials in the SynBio Market in
accordance with the Timetable, the Development Program and the Specification.
SynBio shall be entitled to manage the SynBio Stage 2 Trials through its
in-house regulatory department or via an Appointed CRO.

 

  4.2. Without prejudice to the generality of clause 4.1, SynBio shall:

 

  4.2.1. submit the CTA (Clinical Trials Application) to the regulatory
authorities in the SynBio Market for permission to conduct the SynBio Stage 2
Trials in relation to each of the Products on or before the dates set out in
Schedule 8 of this Agreement; and

 

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  4.2.2. to the extent allowed by the applicable law commence the SynBio Stage 2
Trials within 6 (six) calendar months of receiving permission from the
regulatory authorities in the SynBio Market to conduct the relevant SynBio
Trial.

 

  4.3. SynBio shall:

 

  4.3.1. be responsible for all costs and expenses for conducting the Synbio
Stage 2 Trials, including the costs and expenses of any Appointed CRO which
Synbio may appoint; and

 

  4.3.2. at its own cost and expense, at its premises, manufacture sufficient
quantities of the SynBio Products meeting the Specifications for use in the
SynBio Stage 2 Trials, at all times in accordance with the Timetable and the
Development Plan.

 

  4.4. SynBio shall keep Lipoxen fully informed of all decisions it makes and
all plans it has to conduct the SynBio Stage 2 Trials. SynBio shall comply with
all instructions provided by the Scientific Subcommittee in relation to conduct
of the SynBio Stage 2 Trials which are reasonably required to ensure that the
SynBio Stage 2 Trials are conducted in accordance with all applicable US and
European Union laws, regulations, codes of practice, principles and guidelines,
including EMEA and FDA requirements.

 

  4.5. If SynBio chooses to utilize services of an Appointed CRO, SynBio shall
enter into a written agreement with the Appointed CRO which s shall.

 

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  4.5.1. provide that all Intellectual Property Rights generated pursuant to the
SynBio Stage 2 Trials shall be owned either by Lipoxen and/or SynBio and/or
jointly by the Parties in accordance with the terms of this Agreement;

 

  4.5.2. enable SynBio to comply with its obligations under this Agreement; and

 

  4.5.3. be capable of assignment to third parties, including to Lipoxen, in
accordance with the terms of this Agreement.

 

  4.6. SynBio undertakes that:

 

  4.6.1. all SynBio Products used in the SynBio Stage 2 Trials will be
manufactured in accordance with GMP and that all of the SynBio Stage 2 Trials
will be conducted in accordance with GCP;

 

  4.6.2. any and all data obtained from the SynBio Stage 2 Trials shall be made
available to Lipoxen in accordance with this Agreement and clause 5.6; and

 

  4.6.3. it will comply and procure that the CRO complies with all instructions
provided by the Scientific Subcommittee in relation to conduct of the SynBio
Stage 2 Trials which are reasonably required to ensure that the SynBio Stage 2
Trials are conducted in accordance with all applicable US and European Union
laws, regulations, codes of practice, principles and guidelines, including EMEA
and FDA requirements.

 

  4.7. SynBio shall obtain the prior written approval of the Scientific
Subcommittee of any and all protocols to be used in the SynBio Stage 2 Trials
and shall comply with all reasonable instructions of the Scientific Subcommittee
in relation to such protocols.

 

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5. STAGE 2: CLINICAL TRIALS IN LIPOXEN MARKET

 

  5.1. Subject to clause 5.8, Lipoxen shall use Diligent and Reasonable Efforts
to conduct the Lipoxen Stage 2 Trials in the Lipoxen Market in accordance with
the Timetable, the Development Program and the Specification. Lipoxen shall be
entitled to manage the Lipoxen Stage 2 Trials through its in-house regulatory
department or via an Appointed CRO.

 

  5.2. Without prejudice to the generality of clause 5.1, Lipoxen shall use
Diligent and Reasonable Efforts to:

 

  5.2.1. submit the CTA (Clinical Trials Application) to the regulatory
authorities in the Lipoxen Market for permission to conduct the Lipoxen Stage 2
Trials in relation to each of the Lipoxen Development Products on or before the
dates set out in Schedule 8 of this Agreement; and

 

  5.2.2. to the extent allowed by the applicable law and to the extent
regulators approve, commence the Lipoxen Stage 2 Trials within 12 (twelve)
calendar months of receiving permission from the regulatory authorities in the
Lipoxen Market to conduct the relevant Lipoxen Stage 2 Trial.

 

  5.3. Lipoxen shall:

 

  5.3.1. be responsible for all costs and expenses for conducting the Lipoxen
Stage 2 Trials, including the costs and expenses of any Appointed CRO which
Lipoxen may appoint; and

 

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  5.3.2. at its own cost and expense, manufacture or have manufactured
sufficient quantities of the Lipoxen Products meeting the Specifications for use
in the Lipoxen Stage 2 Trials, at all times in accordance with the Timetable and
the Development Plan.

 

  5.4. Lipoxen shall keep Synbio informed via meetings of the Scientific
Subcommittee of material decisions it makes and all plans it has to conduct the
Lipoxen Stage 2 Trials. Lipoxen shall comply with all instructions provided by
SynBio in relation to conduct of the Lipoxen Stage 2 Trials which are reasonably
required to ensure that the Lipoxen Stage 2 Trials are conducted in accordance
with all applicable US and European Union laws, regulations, codes of practice,
principles and guidelines, including EMEA and FDA requirements.

 

  5.5. If Lipoxen chooses to utilize services of an Appointed CRO, Lipoxen shall
enter into a written agreement with such Appointed CRO which shall:-

 

  5.5.1. provide that all Intellectual Property Rights generated pursuant to the
Lipoxen Stage 2 Trials that may be considered Arising IPR to be owned by the
Parties in accordance with the terms of this Agreement;

 

  5.5.2. enable Lipoxen to comply with its obligations under this Agreement; and

 

  5.5.3. be capable of assignment to third parties, including to SynBio in
accordance with the terms of this Agreement.

 

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  5.6. Lipoxen undertakes that:

 

  5.6.1. all Lipoxen Products used in the Lipoxen Stage 2 Trials will be
manufactured in accordance with GMP or applicable laws and regulations and that
all of the Lipoxen Stage 2 Trials will be conducted by an Appointed CRO that
follows GCP;

 

  5.6.2. any and all data obtained from the Lipoxen Stage 2 Trials shall be made
available to SynBio in accordance with this Agreement; and

 

  5.6.3. it will not knowingly conduct, or permit the Appointed CRO to conduct,
a Lipoxen Stage 2 Trial in a manner that is inconsistent with GB, US and
European Union laws, regulations, codes of practice, principles and guidelines,
including EMEA and FDA requirements.

 

  5.7. Lipoxen shall obtain the prior written approval of the Scientific
Subcommittee of any and all protocols to be used in the Lipoxen Stage 2 Trials
and shall comply with all reasonable instructions of the Scientific Subcommittee
in relation to such protocols. For the avoidance of doubt, the Parties agree
that an instruction of the Scientific Subcommittee shall not be reasonable if it
conflicts with the advice of an Appointed CRO.

 

  5.8.

The parties agree that the Scientific Subcommittee shall determine whether
Product A shall be developed by Lipoxen using the Serum cell line (as defined by
the SIIL Agreement) or another cell line which produces EPO. If the Scientific
Subcommittee determines that another cell line shall be used

 

32

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  by Lipoxen, Lipoxen shall not be bound to perform the obligations set out in
the table in Schedule 1 headed “Product A: PSA-EPO (Developed by LPX)” and the
Scientific Subcommittee shall proptly devise and replace the table with a new
table which relates to and is suitable for the alternative cell line producing
EPO.

 

6. STAGE 3: FURTHER CLINICAL DEVELOPMENT

 

  6.1. The Scientific Subcommittee shall promptly review the results of the
SynBio Stage 2 Trials and shall decide which, if any, Products have met the
Success Criteria and which shall therefore move into Stage 3.

 

  6.2. Subject to clause 6.3, the Scientific Subcommittee shall decide the
strategy and responsibilities of the Parties for full- scale pharmaceutical and
clinical development of the Products during Stage 3: (a) in relation to the
Lipoxen Development Products in the Lipoxen Market; and (b) in relation to the
Products in the SynBio Market, but the Parties agree that the principles set out
in this clause 6 shall be adopted.

 

  6.3. SynBio will have exclusive rights and arrangements entirely at its own
cost to conduct clinical development of the SynBio Products in the SynBio
Market.

 

  6.4. SynBio shall be responsible pursuant to instructions from the Scientific
Subcommittee for any and all applications for marketing authorizations to be
made to the regulatory authorities in the SynBio Market in respect of the
Products, which applications for the avoidance of doubt, shall be made in the
name of SynBio.

 

  6.5. Lipoxen will have exclusive rights and responsibility entirely at its own
cost to conduct clinical development of the Lipoxen Development Products in the
Lipoxen Market. For the avoidance of doubt, Lipoxen shall not be obliged to
conduct or fund (whether pursuant to Stage 1, Stage 2, Stage 3 or otherwise):

 

33

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  6.5.1. clinical trials in relation to any product which is not a Lipoxen
Development Product;

 

  6.5.2. clinical trials in the SynBio Market, unless Trials not joint of EMEA
regulated trials;

 

  6.5.3. clinical trials in relation to the Lipoxen Development Products in more
than one country in the Lipoxen Market and shall at its entire discretion select
the most appropriate country in the Lipoxen Market in which to carry out
clinical development of the Lipoxen Development Products;

 

  6.5.4. conduct clinical trials in relation to any Lipoxen Development Products
for which there are safety, toxicity, efficacy or pharmacokinetics issues or for
which the conduct of a clinical trial would be prohibited by laws and/or
regulations in force in the Lipoxen Market; and

 

  6.5.5. any clinical trials in relation to the Lipoxen Development Products
beyond Phase IIa other than at its entire discretion.

 

  6.6. Lipoxen shall be responsible pursuant to instructions from the Scientific
Subcommittee for any and all applications for marketing authorizations to be
made to the regulatory authorities, including EMEA and FDA, in Lipoxen Market in
respect of the Lipoxen Development Products, which applications for the
avoidance of doubt, shall be made in the name of Lipoxen.

 

34

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  6.7. Lipoxen and/or its Affiliates shall be responsible at their entire
discretion for any and all exploitation of the Lipoxen Development Products in
the Lipoxen Market including, without limitation, negotiations with third
parties and the determination of licensing arrangements with third parties for
exploitation of the Lipoxen Development Products.

 

  6.8. SynBio shall as when requested by Lipoxen during the term of this
Agreement promptly provide to Lipoxen in writing:-

 

  6.8.1. the Results relating to the Products created by or on behalf of SynBio;
and

 

  6.8.2. up to date Clinical Dossiers relating to each of the Products.

 

  6.9. Lipoxen shall as when requested by SynBio during the term of this
Agreement promptly provide to SynBio in writing, to the extent it is not
restricted by confidentiality obligations owed to third parties, via meetings of
the Scientific Subcommittee:

 

  6.9.1. the results relating to the Lipoxen Trials; and

 

  6.9.2. any clinical dossiers created by or on behalf of Lipoxen relating to
the Lipoxen Development Products.

 

7. MANUFACTURE AND SUPPLY

Supply by SynBio

 

  7.1. If and when requested to do so by Lipoxen, SynBio agrees to manufacture
and supply to Lipoxen and/or any licensees of Lipoxen the Molecules and/or the
Products for the purposes of pre-clinical and clinical development of the
Products.

 

  7.2. The Parties agree that Lipoxen shall not be obliged to exercise its
rights under clause 7.1 at any particular time or at all but if Lipoxen does
exercise its rights, the Parties will enter into a manufacture and supply
agreement on reasonable commercial terms.

 

35

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  7.3. The Parties agree that the price at which SynBio will supply the
Molecules and/or Products to Lipoxen will be determined in accordance with
clauses 7.4 and 7.5.

 

  7.4. [***]

 

  7.5. [***]

 

  7.6. [***]

 

36

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Supply by Lipoxen

 

  7.7. If requested in writing to do so by SynBio, Lipoxen shall use its
reasonable commercial endeavours, subject to clauses 7.8 to 7.10 below, to
supply:

 

  7.7.1. PSA to SynBio for use in the research and development of SynBio
Products; and/or

 

  7.7.2. EPO to SynBio for use in the research and development of Product A.

 

  7.8. The Parties agree that SynBio shall not be obliged to exercise its rights
under clause 7.7 at any particular time or at all but if SynBio does exercise
its rights, the Parties will enter into a supply Agreement on reasonable
commercial terms which will comply with the provisions of clause 7.9 and 7.10 of
this Agreement and the provisions of any agreement between Lipoxen and SIIL
relating to the Supply Products.

 

  7.9. SynBio acknowledges that any products supplied to SynBio by Lipoxen will
be sourced by Lipoxen from SIIL and accordingly:

 

  7.9.1. Lipoxen will only provide the Supply Products on an “as is” basis
without any warranties of any kind other than a warranty that between delivery
of the Supply Products to Lipoxen by SIIL and delivery of the Supply Products to
SynBio, Lipoxen has not altered the Supply Products in any way;

 

  7.9.2. each of the Parties expressly disclaims all express and implied
warranties with respect to such Supply Products, including without limitation
any warranty of merchantability or fitness for a particular purpose, safety,
efficacy, potency, purity and/or activity and/or that its use would not infringe
the Intellectual Property Rights of a third party;

 

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  7.9.3. Lipoxen shall not be liable for any failure to supply the Supply
Products to the extent such failure is a result of any act or omission of SIIL,
including any breach of SIIL’s supply obligations to Lipoxen;

 

  7.9.4. Lipoxen will not be obliged to supply any Supply Products to SynBio in
accordance with any specification other than those specifications which have
been specified in written agreements between SIIL and Lipoxen existing at the
time of supply.

 

  7.10. SynBio shall pay to Lipoxen (in sufficient time to enable Lipoxen to
fulfill payment obligations to SIIL in respect of the relevant Supply Products):

 

  7.10.1. compensation for any and all costs and expenses which Lipoxen
reasonably incurs in relation to the supply of the Supply Products (including
the price paid to SIIL for the Supply Products, transport costs and insurance
costs); and

 

  7.10.2. [***]

 

  7.11. Lipoxen shall provide SynBio at its request documents confirming the
expenditures specified in clauses 7.10.1 – 7.10.2 of this Agreement.

 

8. CONDUCT, REPORTING AND DECISION MAKING

 

Conduct

 

  8.1. Each of SynBio and Lipoxen shall perform its obligations under this
Agreement:

 

  8.1.1. in accordance with the Development Program;

 

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  8.1.2. to the best of its ability in a professional manner consistent with
industry standards;

 

  8.1.3. in accordance with the standard of care customarily observed with
regard to such activities;

 

  8.1.4. in a timely manner and in accordance with the Timetable;

 

  8.1.5. in accordance with all reasonable instructions received from the other
Party;

 

  8.1.6. in compliance with all applicable laws, rules and regulations,
including without limitation, where applicable, GMP, current good clinical or
laboratory practices and GCP.

Reporting

 

  8.2. SynBio and Lipoxen shall, and shall procure that Appointed CROs shall,
during the term of this Agreement:

 

  8.2.1. keeping (including keeping by all their respective employees) of
detailed written records of its progress with the Development Program and, at
the request of the other Party, promptly provide the other Party with access to
and/or copies of such records;

 

  8.2.2.

supply to the other Party at least once every three months with an interim
written report in accordance with the form to be determined by the Scientific
Subcommittee, describing the progress of the Development Program including,
without limitation,

 

39

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  details of all material Arising IPR which has been made and containing
recommendations regarding the future progress of the Development Program;

 

  8.2.3. notwithstanding clause 8.2.3 above, keep the other Parties fully
informed of the progress of the Development Program and of all Arising IPR;

 

  8.2.4. immediately notify the other Parties in writing if there is an
unexpected technical or scientific problem which may make it difficult or
impossible to achieve or is likely to cause a material delay to the Development
Program, including any adverse events arising pursuant to the Clinical Trials.

 

  8.3. SynBio will allow, and/or will procure that the Appointed CRO’ will
allow, Lipoxen and/or its employees to:

 

  8.3.1. visit SynBio facilities and/or the Appointed CRO’s facilities; and

 

  8.3.2. review SynBio and/or the Appointed CRO’s records relating to the SynBio
Trials at reasonable times and with reasonable frequency during normal business
hours:

in each case to: (a) verify compliance by SynBio and/or the Appointed CRO with
the terms of this Agreement; and/or (b) observe the progress of the Development
Program.

 

  8.4. Lipoxen will allow, and/or will procure that the Appointed CRO will
allow, SynBio and/or its employees to:

 

  8.4.1. visit Lipoxen’s facilities and/or the Appointed CRO’s facilities; and

 

40

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  8.4.2. review Lipoxen’s and/or the Appointed CRO’s records relating to the
Lipoxen Trials at reasonable times and with reasonable frequency during normal
business hours:

in each case to: (a) verify compliance by Lipoxen and/or the Appointed CRO with
the terms of this Agreement; and/or (b) observe the progress of the Development
Program.

 

  8.5. SynBio shall, or shall procure that the Appointed CRO shall, update the
Scientific Subcommittee on the progress of the SynBio Trials on a monthly basis
(if it coincides with meetings of the Scientific Subcommittee) via a telephone
conference call with the Scientific Subcommittee.

 

  8.6. Lipoxen shall, or shall procure that the Appointed CRO shall, update the
Scientific Subcommittee on the progress of the Lipoxen Trials on a monthly (if
it coincides with meetings of the Scientific Subcommittee) basis via a telephone
conference call with the Scientific Subcommittee.

 

  8.7. The Parties shall promptly implement an intranet using Microsoft Project
to monitor progress of the Parties pursuant to the Development Program. The
Parties agree that:

 

  8.7.1. each of the Parties shall update the intranet on a weekly basis; and

 

  8.7.2. each of the parties shall have constant access.

 

  8.8.

If a Party fails to comply with the provisions of clause 8.7 the representatives
on the Scientific Subcommittee of the Party in breach shall lose their right,
pursuant to clause 8.18.4

 

41

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  of this Agreement, to vote at meetings of the Scientific Subcommittee for the
period during which such Party is in breach.

 

  8.9. Subject to the exceptions set out in clause 18.2 of this Agreement,
Lipoxen and SynBio shall ensure confidentiality of all data obtained on the
basis of or in connection with any of the activities listed in clauses 8.3 and
8.4 above and enter into confidentiality agreements with any third parties that
receive access to such data.

Scientific Subcommittee

 

  8.10. The Parties shall establish a Scientific Subcommittee consisting of four
individuals, comprising two representatives of Lipoxen and two representatives
of SynBio. The initial representatives of each of Lipoxen and SynBio are
identified in Schedule 9. Lipoxen shall be entitled at any time to use two of
the four people listed in Schedule 10. The expenses of the Lipoxen
representatives shall be borne by Lipoxen and the expenses of the SynBio
representatives shall be borne by SynBio.

 

  8.11. Lipoxen and SynBio may from time to time change its representatives on
the Scientific Subcommittee by notifying the other Parties in writing in
advance. The replacement shall be suitably qualified and capable of fulfilling
the responsibilities of a member of the Scientific Subcommittee under this
Agreement.

 

  8.12. Lipoxen shall during the term of this Agreement be entitled to appoint
one of its representatives on the Scientific Subcommittee as the chair person of
the Scientific Subcommittee.

 

  8.13. The Scientific Subcommittee will be responsible for the overall
management of the Development Program and shall meet at least once every month
either in person or through teleconference or in any other mode to discuss the
progress of the Development Program.

 

42

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  8.14. The Scientific Subcommittee shall:

 

  8.14.1. on or promptly after the Commencement Date, meet and: (a) review the
tables in Schedule 1 of this Agreement and introduce any amendments which are
reasonably require; and (b) agree the Specifications and Success Criteria for
the Products. The tables in Schedule 1 of this Agreement and the Success
Criteria shall be established on the basis of the legal requirements of the
Lipoxen Market and the SynBio Market applicable to the Product relating to its
development, marketing, distribution and sale and on the basis of business
evaluations and analysis made by the Parties; and

 

  8.14.2. at the relevant time during the Development Program determine whether
the Products meet the Success Criteria.

 

  8.15. All material decisions of the Scientific Subcommittee shall be recorded
in writing.

 

  8.16. Subject to the provisions of the Subscription Agreement and the
Relationship Deed, the Parties agree that valid decisions made by the Scientific
Subcommittee shall be binding upon the Parties in so far as they relate to:

 

  8.16.1. development of the Lipoxen Development Products in accordance with
this Agreement;

 

  8.16.2. development of the SynBio Products in accordance with this Agreement;
and

 

  8.16.3. implementation of the Development Plan.

 

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  8.17. The Parties shall agree mutually when to conduct the monthly meetings of
the Scientific Subcommittee. In addition and/or if the Parties cannot agree a
date for the monthly meetings, each Party shall be entitled to convene a meeting
of the Scientific Subcommittee on giving not less than one calendar months’
written notice to the other Party.

 

  8.18. The Parties agree that:

 

  8.18.1. meetings of the Scientific Subcommittee may occur by telephone
conference call;

 

  8.18.2. the quorum for a meeting of the Scientific Subcommittee shall be two
representatives of each Party;

 

  8.18.3. no valid meeting of the Scientific Subcommittee may be held unless a
quorum is present and the Parties have agreed the date of the meeting in writing
or all Parties have received not less than one calendar months written notice of
the meeting (or such shorter notice period as the Parties shall previously agree
in writing);

 

  8.18.4. each person present at a meeting of the Scientific Subcommittee shall
have a single vote; and

 

  8.18.5. the chair person of the Scientific Subcommittee shall have the casting
vote in relation to any decisions to be made by the Scientific Subcommittee.

 

  8.19. If a decision of the Scientific Subcommittee is binding on the Parties
as set out in clause 8.16, no additional negotiations or corporate approvals
(except for those required by law) shall be required to implement the decision
of Scientific Subcommittee. In particular, should such a decision of the
Scientific Subcommittee require execution of an amendments / annex / schedule to
this Agreement in accordance with this Agreement or applicable law, the Parties
shall promptly execute it.

 

44

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9. INTELLECTUAL PROPERTY RIGHTS

General

 

  9.1. Any and all Arising IPR that relates specifically to Histone, the
Oncohist Technology, Serum EPO (as defined in the SIIL Agreement), the Serum
Cell Line, (as defined in the SIIL Agreement), PSA, the PSA Manufacturing
Technology and/or the PolyXen Technology shall belong to Lipoxen including, for
the avoidance of doubt, any and all Arising IPR relating to:

 

  9.1.1. conjugation of the Molecules and PSA and the resulting conjugates;

 

  9.1.2. the manufacture and uses of Histone; and

 

  9.1.3. PSA and the PSA Manufacturing Process.

 

  9.2. Notwithstanding provisions of Clause 9.1. above any Arising IPR that
relates specifically to the, Molecules and/or the manufacture of the Molecules
(in each case excluding Histone and SIIL EPO) shall belong to SynBio.

 

  9.3. Any and all trade marks and trade names used by Lipoxen in relation to
the Lipoxen Development Products and otherwise shall belong to Lipoxen and
SynBio acknowledges that it does not receive a licence under this Agreement to
use any such trade marks and trade names.

 

45

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  9.4. SynBio shall be responsible for applying for and obtaining trade mark
registrations in the SynBio Market. SynBio shall not use any trade mark or trade
name that is the same as or confusingly similar to any trade mark or trade name
used by Lipoxen in the Lipoxen Market.

 

  9.5. Lipoxen shall be responsible for applying for and obtaining trade mark
registrations in the Lipoxen Market. Lipoxen shall not use any trade mark or
trade name that is the same as or confusingly similar to any trade mark or trade
name used by SynBio in the SynBio Market.

 

  9.6. Any Arising IPR that is not owned by either Party pursuant to clauses 9.1
to 9.3 shall be owned jointly by the Parties.

 

  9.7. Each of the Parties shall have control of the protection, exploitation
and use of the Arising IPR that it owns pursuant to clauses 9.1 to 9.3 and shall
decide in its entire discretion whether and how to file and prosecute patent
applications in relation to the relevant Arising IPR and, subject to any express
rights granted to the other party under this Agreement, whether and to whom to
grant licences to third parties.

 

  9.8. The Parties shall collaborate to agree the appropriate method for the
protection, development and exploitation of the Joint Arising IPR. Any and all
patent applications in relation to the Joint Arising IPR shall be made and
controlled by Lipoxen in the joint names of the Parties and the cost of such
applications and any patents that result from such applications shall be shared
equally by the Parties.

 

46

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  9.9. For the avoidance of doubt, the Parties agree that:

 

  9.9.1. Lipoxen shall have a perpetual royalty free right to use and exploit
(which right shall include the right to grant licences to third parties in the
Lipoxen Market without the consent of SynBio) the Joint Arising IPR in the
Lipoxen Market; and

 

  9.9.2. SynBio shall have a perpetual royalty free right to use and exploit
(which right shall not include the right to grant licences to third parties in
the SynBio Market without the consent of Lipoxen) the Joint Arising IPR in the
SynBio Market.

 

  9.10. The Parties agree that Lipoxen shall own all right, title and interest
in the CMO Arising IPR.

Molecules and SynBio Cell Lines

 

  9.11. SynBio warrants and undertakes to Lipoxen that:

 

  9.11.1. it possesses and has or will have a valid and subsisting world wide
right to the use of cell lines for the production of each and all of the
Molecules;

 

  9.11.2. the cell lines referred to in clause 9.11.1 produce the relevant
Molecules in sufficient quantity and quality to enable clinical development of
the Products in accordance with the terms of this Agreement;

 

47

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  9.11.3. SynBio’s rights under the cell lines referred to in clause 9.11.1
permit SynBio (or a third party authorized by SynBio) to make, use, distribute,
market, sell and supply the Molecules for any indication and by any route of
administration worldwide;

 

  9.11.4. it is not aware of any contractual or other restriction that would
prevent SynBio from transferring the cell lines referred to in clause 9.11.1 to
Lipoxen (or a licensee of Lipoxen) for use by Lipoxen (or its licensee) in
accordance with clause 9.11.3;

 

  9.11.5. it has the right to grant the licence set out in clause 10.1 of this
Agreement.

 

  9.12. As and when requested to do so by Lipoxen, SynBio shall provide written
evidence to Lipoxen (which shall include copies of the agreements under which
SynBio is entitled to use the cell lines referred to in clause 9.11.1) that
SynBio is not in breach of the terms of clause 9.11.

 

  9.13. Lipoxen shall have the right at any time to terminate this Agreement on
a Molecule by Molecule and/or Product by Product basis with immediate effect on
written notice to SynBio if SynBio is in breach of clause 9.8 and/or 9.9 of this
Agreement in relation to any Molecule that relates to the relevant Product.

Lipoxen Technology

 

  9.14. Lipoxen undertakes to SynBio that Lipoxen:

 

  9.14.1. owns or has valid exclusive, world wide right to use (which right
shall include the right to grant sub-licenses) the PolyXen Patents existing at
the Commencement Date; and

 

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  9.14.2. will use its best endeavours to acquire the rights (by way of
ownership or licence) to the Oncohist Technology prior to the expiry of Stage 2
on terms that are reasonably acceptable to Lipoxen.

 

  9.15. As and when requested to do so by SynBio, Lipoxen shall provide written
evidence to SynBio that Lipoxen is not in breach of the terms of clause 9.14.

 

  9.16. SynBio shall have the tight at any time to terminate this Agreement on a
Product by Product basis to the extent the relevant breach affects the relevant
Product with immediate effect on written notice to Lipoxen:

 

  9.16.1. in relation to the SynBio Products if Lipoxen is in breach of clause
9.14.1; and/or 9.15;

 

  9.16.2. in relation to Product F if Lipoxen is in breach of clause 9.14.2 of
this Agreement and SynBio ceases to be licensed to use the Oncohist Technology
pursuant to the Oncohist Licence Agreement.

Third Party Intellectual Property Rights

 

  9.17. Each Party shall immediately notify the other Party in writing if it
becomes aware of any third party Intellectual Property Rights relating to any of
the Products (“Third Party IP Rights”).

 

  9.18. The Parties shall co-operate to evaluate the strength and validity of
any Third Party IP Rights and the Scientific Subcommittee shall decide how to
address the Third Party IP Rights.

 

49

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  9.19. If the Scientific Subcommittee decides to challenge or take a license of
the Third Party IP Rights, Lipoxen shall be responsible, subject to clauses 9.22
and 9.23 at the joint cost of the Parties, for using its reasonable endeavours
to implement any action recommended by the Scientific Subcommittee.

 

  9.20. Either Party may terminate this Agreement on 30 (thirty) days written
notice to the other Party in relation to a particular Product if, in its
reasonable opinion, a Third Party IP Right exists which would have a material
effect on the research and/or development of the relevant Product, in the case
of Lipoxen, in the Lipoxen Market, and in the case of SynBio, in the SynBio
market.

 

  9.21. For the avoidance of doubt, subject to clauses 9.22 and 9.23 any and all
costs and/or expenses reasonably and properly incurred by the Parties in
relation to a Third Party IP Right, including any license fees and/or costs of
evaluating and challenging a Third Party IP Right, shall be shared equally
between the Parties.

 

  9.22. If a Third Party IP Right relates to a Molecule or a SynBio Cell Line,
the Parties agree that all of the costs and/or expenses reasonably and properly
incurred by the Parties in relation to the relevant Third Party IP Right will be
born by SynBio.

 

  9.23. If a Third Party IP Right relates to the use of the PolyXen Technology
to produce Products A-F, the Parties agree that all of the costs and/or expenses
reasonably and properly incurred by the Parties in relation to the relevant
Third Party IP Right will be borne by Lipoxen.

 

50

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10. GRANT OF RIGHTS TO LIPOXEN

 

  10.1. SynBio grants to Lipoxen during the term of this Agreement, subject to
the provisions of this Agreement, an exclusive license, with the right to grant
sub-licenses, in the Lipoxen Market to research, develop, make, have made,
market, supply, sell and distribute Products using:

 

  10.1.1. the SynBio Cell Lines;

 

  10.1.2. the SynBio Background IP; and

 

  10.1.3. the SynBio Arising IPR.

 

  10.2. For the avoidance of doubt, Lipoxen shall have during the term of this
Agreement the rights:

 

  10.2.1. to use, and

 

  10.2.2. to grant Lipoxen licensees the right to use without the prior written
consent of SynBio,

the Clinical Dossiers relating to the Products in the Lipoxen Market which will
be provided to Lipoxen by SynBio pursuant to clause 6.8 of this Agreement.

Sub-licensing

 

  10.3. Lipoxen shall be entitled to sub-license and/or sub-contract its rights
under clauses 10.1 and 10.2 of this Agreement to any person without the prior
written consent of SynBio, and provided that:

 

  10.3.1. any sub-licence or Lipoxen’s rights under clauses 10.1 and 10.2
granted by Lipoxen will terminate on termination of this Agreement and expire on
expiry of this Agreement;

 

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  10.3.2. the provisions of the sub-licence agreement will be consistent with
the terms of this Agreement;

 

  10.3.3. Lipoxen will only be entitled to receive monetary consideration for
the grant of a sub-licence;

 

  10.3.4. Lipoxen shall remain liable for any acts and/or omissions of its
sublicensees as if such acts and omissions had been made by Lipoxen under this
Agreement; and

 

  10.3.5. [***]

No Other License

 

  10.4. It is acknowledged and agreed that no license is granted by SynBio to
Lipoxen other than the license expressly granted by the provisions of this
clause 10. Without prejudice to the generality of the foregoing, SynBio reserves
all rights under the Molecules, the SynBio Cell Lines and the SynBio Background
IP:

 

  10.4.1. in relation to any products which are not Products; and

 

  10.4.2. outside the Lipoxen Market.

Quality

 

  10.5.

Lipoxen shall ensure that all of the Products sold or supplied by it are of

 

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  satisfactory quality and comply with all applicable laws and regulations in
each part of the Lipoxen Market.

Transfer of the SynBio Technology

 

  10.6. At Lipoxen’s request, at any time during the term of this Agreement or
thereafter, SynBio shall at its own cost promptly disclose and/or transfer to
Lipoxen, its licensee and/or an Appointed CRO, using a method of know how
transfer reasonably acceptable to Lipoxen, all information and materials
(including samples of the respective Molecules and SynBio Cell Lines) that are
reasonably required to enable Lipoxen to fulfill its obligations under this
Agreement and/or to exploit the Lipoxen Arising IPR, the Joint Arising IPR and
the license granted under clauses 10.1 and 10.2.

 

  10.7. The Parties agree that as a result of the technology transfer described
in clause 10.7 it is the intention of the Parties that Lipoxen and/or its
licensee and/or an Appointed CRO will be able to manufacture the Molecules and
the Products using the SynBio Cell Lines:

 

  10.7.1. to GMP standards;

 

  10.7.2. in a manner that would satisfy regulatory requirements of EMEA and/or
the FDA; and

 

  10.7.3. to a standard and a scale which is equivalent to that practiced by
SynBio in the SynBio Market at the transfer date, as demonstrated by three
successive, successful batches.

 

  10.8.

The Parties shall procure that they will agree the best method for achieving the
technology transfer described in clause 10.7 within 30 (thirty) days of Lipoxen
calling for the technology transfer and

 

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  SynBio will thereafter co-operate with Lipoxen to implement the technology
transfer. SynBio acknowledges that any transfer will involve:

 

  10.8.1. the delivery of physical documents which record the relevant know how,
including manuals and standard operating procedures;

 

  10.8.2. the delivery of manufacturing process details;

 

  10.8.3. the delivery of analytical methods for starting materials, in-process
testing and finished product;

 

  10.8.4. the delivery of analytical results/certificates of analysis from the
last three of the Molecules and/or Products with samples of these batches for
testing;

 

  10.8.5. the delivery of technical regulatory dossiers relating to the relevant
technology, including batch records, development reports and production process
documentation;

 

  10.8.6. the delivery of any cell lines and other proprietary materials used by
the SynBio in the relevant process, including the SynBio Cell Lines;

 

  10.8.7. the detailed inspection of SynBio’s laboratories and manufacturing
facilities engaged in the manufacture of the relevant Molecules and/or Products
by Lipoxen Technologies, its Customer’s and their representatives;

 

  10.8.8. the secondment of SynBio scientists to the laboratory or manufacturing
facility of Lipoxen and/or its licensees and/or its Appointed CRO;

 

  10.8.9. responding to queries from Lipoxen and/or its licensees orally and in
writing.

 

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  10.9. SynBio agrees that if SynBio is in breach of any of the terms of clause
10.7 to 10.9, Lipoxen shall be entitled to withhold payments due to SynBio
pursuant to Schedule 10 of this Agreement until such time as the breach has been
remedied by SynBio.

 

11. GRANT OF RIGHTS TO SYNBIO

PolyXen License

 

  11.1. Lipoxen hereby grants to SynBio during the term of this Agreement,
subject to the provisions of this Agreement, an exclusive license outside the
Excluded Field in the SynBio Market to research, develop, manufacture, have
manufactured, use, sell, supply and otherwise exploit the SynBio PolyXen
Products using:

 

  11.1.1. the PolyXen Patents and the PolyXen Know How;

 

  11.1.2. the Lipoxen Arising IPR;. and

 

  11.1.3. any and all CMO Arising IPR which is owned by Lipoxen or in relation
to which Lipoxen has a right to grant a licence.

 

  11.2. The license granted pursuant to clause 11.1 shall expire on a Product by
Product basis on the later of the following dates:

 

  11.2.1. the date upon which no Valid Claim of the PolyXen Patents and/or the
Lipoxen Arising IPR and/or the CMO Arising IPR exists in the SynBio Market which
covers or relates to the relevant Product; or

 

  11.2.2. ten (10) years from the first commercial sale of the relevant Product
in the SynBio Market.

 

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PSA Technology Licence

 

  11.3. Lipoxen grants to SynBio a non-exclusive licence to use the PSA Patents
and the PSA Know How in the SynBio Market for the term of this Agreement to
manufacture PSA:

 

  11.3.1. for use in the development and exploitation of Products by SynBio;
and/or

 

  11.3.2. for supply to Lipoxen and/or licensee’s of the PolyXen Technology.

Sub-licence of SIIL Technology

 

  11.4. Lipoxen shall, if requested in writing to do so by SynBio, grant to
SynBio in the SynBio Market an exclusive sub-licence of the rights granted to
Lipoxen by SIIL pursuant to clause 7.1 of the SIIL Agreement. The Parties shall
enter into a further agreement setting out the terms of any such sub-licence
which shall be entirely consistent with the terms of the SIIL Agreement.

Sub-licensing

 

  11.5. SynBio shall not be entitled to sub-license and/or sub-contract its
rights under: (a) clause 11.3 to any person in any event; and (b) otherwise
granted under this Agreement to any person without the prior written consent of
Lipoxen, such consent not to be unreasonably withheld or delayed, and provided
that if consent is granted by Lipoxen:

 

  11.5.1.

the term of any sub-licence granted by SynBio will not exceed the term of

 

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  this Agreement and will terminate on termination of this Agreement and will
expire on expiry of this Agreement;

 

  11.5.2. the provisions of the sub-licence agreement will be consistent with
the terms of this Agreement and will prevent further sub-licensing;

 

  11.5.3. SynBio will only be entitled to receive monetary consideration for the
grant of a sub-licence;

 

  11.5.4. SynBio shall remain liable for any acts and/or omissions of its
sub-licensees as if such acts and omissions had been made by SynBio under this
Agreement; and

 

  11.5.5. [***]

No Other License

 

  11.6. It is acknowledged and agreed that no license is granted by Lipoxen to
SynBio other than the licenses expressly granted by the provisions of this
clause 11. Without prejudice to the generality of the foregoing, Lipoxen
reserves all rights under the Lipoxen Patents, the Lipoxen Know How and the
Lipoxen Arising IPR:

 

  11.6.1. in relation to any products which are not SynBio Products;

 

  11.6.2. outside the SynBio Market; and

 

  11.6.3. anywhere in the world in the Excluded Field.

Quality

 

  11.7.

SynBio shall ensure that all of the SynBio Products sold or supplied by it are
of

 

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  satisfactory quality and comply with all applicable laws and regulations in
each part of the SynBio Market,

Responsibility for development and exploitation

 

  11.8. SynBio shall be exclusively responsible for the technical and commercial
development and exploitation of the SynBio Products under the PolyXen Technology
in the SynBio Market and accordingly SynBio shall indemnity Lipoxen in the terms
of clause 17.4.

 

  11.9. SynBio shall be responsible at its own cost for conducting all
pre-clinical and clinical trials which are required to register or obtain
marketing authorisations for SynBio Products in the SynBio Market.

Transfer of the PolyXen Technology

 

  11.10. At SynBio’s request, at any time during the term of this Agreement
Lipoxen shall once only at its own, subject to clause 11.4.2, cost promptly
disclose and/or transfer to SynBio, its licensee and/or an Appointed CRO, all
PolyXen Know How in Lipoxen’s possession that it is legally entitled to disclose
and which is reasonably necessary to enable SinBio to undertake Stage 1. The
transfer of know how described in clause 11.10 shall in the first instance be
achieved by electronic transfer by Lipoxen to SinBio and shall include the
transfer to SinBio by Lipoxen of, so far as they fall within the scope of clause
11.10, the items specified in Schedule 11 of this Agreement.

Transfer of the PSA Technology

 

  11.11.

At SynBio request, once only at any time during the term of this Agreement and
conditional upon the Parties first agreeing reasonably commercial terms upon
which SynBio shall supply PSA to Lipoxen and licensees of the PolyXen
Technology, Lipoxen shall promptly transfer to SynBio, using a method of know
how transfer reasonably acceptable to SynBio,

 

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  any and all PSA Manufacturing Know How in Lipoxen’s possession which is
reasonably necessary to enable SynBio to exercise its rights 11.3.

 

  11.12. For the avoidance of doubt, Lipoxen shall not be obliged to transfer to
SynBio and SynBio shall not be entitled to use the PSA Cell Line and the PSA
Technology, until the Parties have agreed the terms of and executed an agreement
in writing under which SynBio shall supply PSA to Lipoxen and licensees of the
PolyXen Technology on reasonable commercial terms.

 

  11.13. If following the electronic transfer referred to in clause 11.10,
SynBio notifies Lipoxen in writing that in its reasonable opinion the technology
transfer is not complete, the Parties will agree the best method for completing
the technology transfer described in clause 11.10 within 30 (thirty) days of
SynBio calling for the technology transfer and Lipoxen will thereafter
co-operate with SynBio to complete the technology transfer. The parties
acknowledge that completion of the technology transfer may subject to clause
11.14.2 and 11.14.3, involve (to the extent the relevant items are within the
possession and control of Lipoxen):

 

  11.13.1. the delivery of physical documents which record the relevant know
how, including manuals and standard operating procedures;

 

  11.13.2. the delivery of manufacturing process details;

 

  11.13.3. the delivery of analytical methods for starting materials, in-process
testing and finished product;

 

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  11.13.4. the delivery of analytical results/certificates of analysis;

 

  11.13.5. the delivery of technical regulatory dossiers relating to the
relevant technology, including batch records, development reports and production
process documentation;

 

  11.13.6. the delivery of any cell lines and other proprietary materials used
by Lipoxen in the relevant process;

 

  11.13.7. the detailed inspection of Lipoxen’s laboratories and manufacturing
facilities engaged in the manufacture of the relevant Product, its Customer’s
and their representatives;

 

  11.13.8. the secondment of Lipoxen scientists to the laboratory or
manufacturing facility of SynBio and/or its licensees and/or its Appointed CRO;

 

  11.13.9. responding to queries from SynBio and/or its licensees orally and in
writing.

 

  11.14. The parties agree that:-

 

  11.14.1. if Lipoxen is in breach of any of the terms of clause 11.13.7 to
11.3.9, SynBio shall be entitled to withhold payments due to Lipoxen pursuant to
Schedule 10 of this Agreement until such time as the breach has been remedied by
Lipoxen;

 

  11.14.2. if Lipoxen is obliged to spend more than the Know How Transfer Time
to achieve the technology transfers pursuant to clauses 11.10 and 11.11, it
shall be entitled to charge SinBio for any time spent in excess of the Know How
Transfer Time on a charge out basis. SinBio shall be entitled to specify the
manner in which such man-hours of training shall be divided between the various
SinBio Products; and

 

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  11.14.3. Lipoxen shall not be obliged to carry out any practical transfer of
the technology marked with a in Schedule 12 of this Agreement.

Transfer of the SIIL Technology

 

  11.15. If requested to do so by SynBio and subject to SynBio compensating
Lipoxen for any payments to SIIL trigerred by the relevant technology transfer,
Lipoxen will use its reasonable endeavours to ensure that SynBio enjoys the
benefit of any technology transfer implemented by Lipoxen pursuant to clause 7.4
of the SIIL Agreement.

 

12. SYNBIO DILIGENCE

 

  12.1. SynBio shall diligently proceed to develop and commercially exploit
SynBio Products to the maximum extent in the SynBio Market.

 

  12.2. Without prejudice to the generality of SynBio’s obligations under clause
12.1, SynBio shall use its best endeavours to meet the milestones set out in
Schedule 12 at the times set out in Schedule 12.

 

  12.3. During the term of this Agreement, SynBio shall provide Lipoxen with a
written report at the end of each three (3) months period setting out the
results of all research and development carried out by SynBio in such period in
relation to the SynBio Products.

 

  12.4. During the term of this Agreement, SynBio shall provide to Lipoxen an
annual written development plan, showing all past, current and projected
activities taken or to be taken by SynBio to bring SynBio Products to market and
to maximise the sale of SynBio Products in the SynBio Market. Lipoxen’s receipt
or approval of any such plan shall not be taken to waive or qualify SynBio’s
obligations under clauses 12.1 and 12.2.

 

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  12.5. SynBio shall immediately notify Lipoxen by telephone, confirmed by fax,
if it becomes aware of any circumstances that are likely to significantly delay
the achievement of the milestones set out in Schedule 12.

 

13. LIPOXEN DILIGENCE

 

  13.1. Lipoxen shall use Diligent and Reasonable Efforts to proceed to develop
and commercially exploit Lipoxen Development Products to the maximum extent as
permitted by regulators in the Lipoxen Market.

 

  13.2. Without prejudice to the generality of Lipoxen’s obligations under
clause 13.1, Lipoxen shall use Diligent and Reasonable Efforts to meet the
milestones set out in Schedule 12 at the times set out in Schedule 12.

 

  13.3. During the term of this Agreement, Lipoxen shall provide SynBio with a
written report at the end of each three (3) months period setting out the
results of all research and development carried out by Lipoxen in such period in
relation to the Lipoxen Products.

 

  13.4. During the term of this Agreement, Lipoxen shall provide to SynBio via
Lipoxen PLC board meetings an annual written development plan, showing all past,
current and projected activities taken or to be taken by Lipoxen to bring
Lipoxen Products to market and to maximise the sale of Lipoxen Products in the
Lipoxen Market. SynBio shall immediately notify Lipoxen by telephone, confirmed
by fax, if it becomes aware of any problems that are likely to significantly
delay the achievement of the milestones set out in Schedule 12.

 

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14. RECORDS AND ACCOUNTS

 

  14.1. Lipoxen and SynBio shall during the term of this Agreement and for a
period of five (5) years thereafter, keep at their normal place of business
detailed and up-to-date records and accounts showing:

 

  14.1.1. any and all costs and expenses it has incurred in relation to the
Development Program, including its costs and expenses relating to the Clinical
Trials;

 

  14.1.2. any and all costs and expenses it has borne in relation to Third Party
IP Rights; and

 

  14.1.3. the quantity, description, and value of Products sold by it, on a
country-by- country basis, and being sufficient to ascertain the payments due
under this Agreement.

 

  14.2. [***]

 

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15. COSTS AND REVENUE SHARING

 

  15.1. Lipoxen and SynBio shall each be entirely responsible for their own
Stage 1 Costs, Stage 2 Costs and Stage 3 Costs which they incur.

 

  15.2. Prior to calculating and accounting to SynBio for the royalties set out
in Schedule 10 of this Agreement Lipoxen shall be entitled to deduct from
Lipoxen Net Sales and Lipoxen Net Receipts:

 

  15.2.1. any and all costs and expenses reasonably incurred by Lipoxen in
relation to any clinical trials relating to Lipoxen Royalty Products;

 

  15.2.2. any costs and expenses borne by Lipoxen pursuant to clauses 9.21
and/or 9.23 of this Agreement; and

 

  15.2.3. any and all license fees, milestones and royalties paid to third
parties by Lipoxen (or an Affiliate of Lipoxen) in relation to the Oncohist
Technology, including any and all sums paid to the Parties listed in Schedule 13
of this Agreement.

 

  15.3. Prior to calculating and accounting to Lipoxen for the royalties set out
in Schedule 10 of this Agreement, SynBio shall be entitled to deduct from SynBio
Net Sales:

 

  15.3.1. any and all costs and expenses reasonably incurred by SynBio in
relation to any clinical trials relating to SynBio Royalty Products; and

 

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  15.3.2. any costs and expenses borne by SynBio pursuant to clauses 9.21 and/or
9.22.

 

  15.4. Subject to clauses 15.2 and 15,3, the Parties agree that the revenues
from the Products shall be shared by the Parties as set out in Schedule 10 of
this Agreement.

 

16. PAYMENT TERMS

 

  16.1. All sums due under this Agreement:

 

  16.1.1. are exclusive of value added tax or any other sales tax or duties,
which if and where applicable will be paid by the payer to the payee in addition
to any sum in respect of which they are calculated;

 

  16.1.2. shall be paid in US dollars to the credit of the payee’s bank account,
details of which shall be notified to the payer as and when necessary;

 

  16.1.3. shall be made without deduction of income tax or other taxes charges
or duties that may be imposed, except insofar as the payer is required to deduct
the same to comply with applicable laws. The Parties shall co- operate and take
all steps reasonably and lawfully available to them, at the expense of the
payee, to avoid deducting such taxes and to obtain double taxation relief. If
the payer is required to make any such deduction it shall provide the payee with
such certificates or other documents as it can reasonably obtain to enable the
payee to obtain appropriate relief from double taxation of the payment in
question; and

 

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  16.1.4. [***]

 

  16.2. If either Party is obliged pursuant to a government order or otherwise
to withhold payment of any sum due under this Agreement to the other Party, the
payer shall use its best endeavors to release the payment to the other Party. If
the payment has not been released within thirty (30) days of its due date for
payment, the payee shall be entitled to deduct the payment from any sums to the
payer from the payee pursuant to this Agreement.

 

  16.3. Subject to clause 16.1, the Parties agree that each Party shall be
responsible for paying any taxes arising pursuant to or in relation to this
Agreement for which the Party is primarily liable.

 

  16.4. The Parties agree that they will use their best endeavors to collaborate
to establish a corporate structure for the licensing of the Products and for the
receipt of any revenues that is tax efficient for the Parties.

 

  16.5. Each Party shall provide to the other within thirty (30) days of the end
of each Quarter with a royalty statement for that Quarter which contains
sufficient information to enable the other Party to calculate and verify any
sums due to it pursuant to clause 15.4 and Schedule 10 of this Agreement.

 

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17. LIABILITY

 

  17.1. SynBio shall be responsible for all risks and liability arising from or
in relation to the SynBio Trials and/or SynBio’s development, sale and/or supply
of SynBio Products in the SynBio Market, including any and all third party
claims relating to the SynBio Products under product liability laws. SynBio
shall maintain appropriate insurance to cover any such liability. SynBio shall,
if requested to do so by Lipoxen, provide evidence to Lipoxen that it has
complied with the terms of this clause.

 

  17.2. Lipoxen shall be responsible for all risks and liability arising from or
in relation to the Lipoxen Trials and/or Lipoxen’s development, sale and/or
supply of Lipoxen Products in the Lipoxen Market, including any and all third
party claims relating to the Lipoxen Products under product liability laws.
Lipoxen shall maintain appropriate insurance to cover any such liability.
Lipoxen shall, if requested to do so by SynBio, provide evidence to SynBio that
it has complied with the terms of this clause.

 

  17.3. Lipoxen shall indemnify and shall keep SynBio indemnified against any
and all liability, damages, claims, proceedings and expenses (including, but not
limited to, legal expenses and expert’s fees) arising out of or in connection
with the Lipoxen Trials and/or Lipoxen‘s development, sale and/or supply of
Lipoxen Products in the Lipoxen Market provided that Lipoxen shall not be liable
under this clause 17.3 for any and all liability, damages, claims, proceedings
and expenses (including but not limited to, legal expenses and expert’s fees)
that arise directly as a result of (a) express instructions received from SynBio
in relation to conduct of the Lipoxen Trials; (b) a breach of this Agreement by
SynBio; and/or (c) the negligence of SynBio.

 

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  17.4. SynBio shall indemnify and shall keep Lipoxen indemnified against any
and all liability, damages, claims, proceedings and expenses (including, but not
limited to, legal expenses and expert’s fees) arising out of or in connection
with the SynBio Trials and/or SynBio’s development, sale and/or supply of SynBio
Products in the SynBio Market provided that SynBio shall not be liable under
this clause 17.4 for any and all liability, damages, claims, proceedings and
expenses (including but not limited to, legal expenses and expert’s fees) that
arise directly as a result of (a) express instructions received from Lipoxen in
relation to conduct of the SynBio Trials, (b) breach of this Agreement by
Lipoxen; and/or (c) the negligence of Lipoxen.

 

  17.5. All statements, representations (other than fraudulent
misrepresentations), warranties, terms and conditions (whether express or
implied) as to the suitability and/or usefulness of the Lipoxen Technology for
any particular purpose including without limitation the development of SynBio
Products are hereby excluded to the maximum extent permissible by law.

 

  17.6. Without prejudice to the generality of Clause 17.5, Lipoxen does not
give any warranty, representation or undertaking:

 

  17.6.1. as to the efficacy, usefulness, safety or commercial or technical
viability of the Lipoxen Technology and/or any products made or processes
carried out using the Lipoxen Technology;

 

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  17.6.2. as to the volumes or quality of the SynBio Products which may be
manufactured through the use of the Lipoxen Technology;

 

  17.6.3. that any of the Lipoxen Patents are or will be valid or that any of
the Lipoxen Patents will proceed to grant;

 

  17.6.4. that the Lipoxen Technology can be freely exploited in all or any
parts of the SynBio Market; and/or

 

  17.6.5. that the Lipoxen Technology will not infringe the Intellectual
Property Rights or other rights of any third party.

 

18. CONFIDENTIALITY AND PUBLICATION

 

  18.1. Each Party (the “Receiving Party”) undertakes:

 

  18.1.1. to maintain as secret and confidential all Confidential Information
obtained directly or indirectly from the other Party (“Disclosing Party”) in the
course of performing of obligations or in anticipation of this Agreement;

 

  18.1.2. to use and disclose the Confidential Information of the other Party
only for the purposes of this Agreement and/or in so far as such use and/or
disclosure is reasonably required to enable the Party to exploit its rights
under this Agreement;

 

  18.1.3. to disclose the Confidential Information of the other Party only to
those of its employees, contractors, and sub-licensees to whom and to the extent
that such disclosure is reasonably necessary for the purposes of exploiting its
rights and complying with its obligations under this Agreement, including
disclosure to the appointed CRO and professional consultants;

 

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  18.1.4. to comply with the obligations of this clause 18 for so long as it has
knowledge of any Confidential Information received or derived from the other
Party which period shall, for the avoidance of doubt, survive termination or
expiry of this Agreement.

 

  18.2. The provisions of clause 18.1 shall not apply to Confidential
Information which the Receiving Party can prove:

 

  18.2.1. was, prior to its receipt by the Receiving Party from the Disclosing
Party, in the possession of the Receiving Party and at Us free disposal;

 

  18.2.2. is subsequently disclosed to the Receiving Party without any
obligations of confidence by a third party who has not derived it directly or
indirectly from the Disclosing Party;

 

  18.2.3. is or becomes generally available to the public through no act or
default of the Receiving Party or its agents, employees, Affiliates or
sub-licensees;

 

  18.2.4. the Receiving Party is required to disclose to the courts of any
competent jurisdiction, or to any government regulatory agency or financial
authority, provided that the Receiving Party shall:

 

  (i) inform the Disclosing Party as soon as is reasonably practicable of its
obligation to disclose such information; and

 

  (ii)

at the Disclosing Party’s request seek to persuade the court, agency

 

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  or authority to have such information treated in a confidential manner, where
this is possible under the court, agency or authority’s procedures.

 

  18.3. The Receiving Patty shall procure that all of its employees, contractors
who have access to any of the Disclosing Party’s Confidential Information, shall
be made aware of and subject to these obligations and shall have entered into
written undertakings of confidentiality at least as restrictive as those set out
in this clause 18.

 

  18.4. The Parties agree that any publications relating to the Results shall be
approved in advance by the Scientific Subcommittee. Any publications shall
acknowledge both Parties appropriately, and Lipoxen shall have the first right
to submit any paper for publication.

 

19. DURATION AND TERMINATION

 

  19.1. This Agreement shall commence on the Commencement Date and shall
continue until it expires in accordance with Clause 2.6 of this Agreement or
terminated in accordance with terms of this Agreement.

 

  19.2. Without prejudice to any other right or remedy any Party may terminate
this Agreement by notice in writing to the other Party (“Other Party”), such
notice to take effect as specified in the notice:

 

  19.2.1. if the Other Party is in material breach of this Agreement and, in the
case of a breach capable of remedy, the breach is not remedied within 90
(ninety) days of the Other Party receiving notice specifying the breach and
requiring its remedy; and/or

 

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  19.2.2. if (A) the Other Party becomes insolvent or unable to pay its debts as
and when they become due, or (B) an order is made or a resolution is passed for
the winding up of Other Party (other than voluntarily for the purpose of solvent
amalgamation or reconstruction), or (C) a liquidator, administrator,
administrative receiver, receiver, or trustee is appointed in respect of the
whole or any part of the Other Party’s assets or business, or (D) the Other
Party makes any composition with its creditors, or (E) the Other Party ceases to
continue its business, or (F) as a result of debt and/or maladministration the
Other Party takes or suffers any similar or analogous action in any
jurisdiction.

 

  19.3. If SynBio is in breach of clauses 4.2.1 or 4.2.2 of this Agreement in
relation to one or more SynBio Products then, if SynBio does not remedy the
breach within three (3) months of receiving written notice of the breach from
Lipoxen, Lipoxen shall be entitled to terminate this Agreement in relation to
the SynBio Product or SynBio Products to which the breach relates with immediate
effect by notice in writing to SynBio.

 

  19.4. If Lipoxen is in breach of clauses 5.2.1 or 5.2.2 of this Agreement in
relation to one or more Lipoxen Products then, if Lipoxen does not remedy the
breach within three (3) months of receiving written notice of the breach from
SynBio, SynBio shall be entitled to terminate this Agreement in relation to the
Lipoxen Product or Lipoxen Products to which the breach relates with immediate
effect by notice in writing to Lipoxen.

 

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  19.5. Lipoxen may terminate this Agreement in accordance with clause 9.13 in
relation to a Product.

 

  19.6. Either Party may terminate this Agreement by immediate written notice in
writing to the other Party in relation to a specific Product if the Scientific
Subcommittee decides that the relevant Product does not meet the relevant
Success Criteria for the Product.

 

  19.7. Any Party may terminate this Agreement with immediate effect by giving
written notice to the other party if this other Party or any of its Affiliates
commences legal proceedings, or assists any third party to commence legal
proceedings, to challenge the validity of any of the patents of the other Party
or to challenge the secrecy or substantiality of any of the other Party’s
know-how.

 

20. CONSEQUENCES OF TERMINATION

 

  20.1. Upon termination or expiry of this Agreement for any reason:

 

  20.1.1. the Parties shall provide to each other detailed reports setting out
the progress each has made with the Development Program;

 

  20.1.2. the Parties shall return to each other all data, know-how and
materials provided to each other by the other Party, or generated by the Parties
in connection with the Development Program;

 

  20.1.3. any rights or remedies of any of the Parties arising from any breach
of this Agreement shall continue to be enforceable;

 

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  20.1.4. SynBio shall no longer be licensed to use the Lipoxen Technology and
shall immediately cease any activity requiring a license under this Agreement;

 

  20.1.5. SynBio shall no longer be entitled to exercise the sub-licence set out
in clause 11.4 and shall immediately cease any activity requiring a sub-licence
under the SIIL Agreement;

 

  20.1.6. subject to clause 20.1.7, Lipoxen shall no longer be licensed to use
the SynBio Background IP, SynBio Arising IPR and SynBio Cell Lines (excluding
the SIIL Cell Line as defined in the SIIL Agreement) and shall immediately cease
any activity requiring a license from SynBio under this Agreement;

 

  20.1.7. the following clauses shall continue in full force and effect: 1, 6.8,
9.1 to 9.9, 10.2, 10.7 to 10.9, 14, 15 (in so far as it relates to liability
arising prior to termination) 16, 17, 18, 20, 21;

 

  20.1.8. each Party shall if requested in writing to do so by the other Party
comply with any technology transfer provisions of this Agreement relating to any
Intellectual Property Rights and materials (such as cell lines) which the
requesting party has a right to own and/or use following termination and/or
expiry of this Agreement and in relation to which a satisfactory technology
transfer has not previously occurred;

 

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  20.1.9. each Party shall return to the other within a reasonable period of
time all Confidential Information and any copies thereof disclosed to it by the
other Party.

 

  20.1.10. Upon expiry or termination of this Agreement in relation to one or
more Products, the consequences set out in clause 20.1 shall apply but only in
so far as they relate to the relevant Product.

 

21. GENERAL

Amendment

 

  21.1. This Agreement may only be amended in writing signed by duly authorized
representatives of the Parties or by the Scientific Subcommittee as is expressly
set out in this Agreement.

Assignment and third party rights

 

  21.2. Other than as is expressly set out in this Agreement, none of the
Parties shall assign, mortgage, charge or otherwise transfer any rights or
obligations under this Agreement without the prior written consent of the other
Party.

 

  21.3. Any of the Parties may assign all its rights and obligations under this
Agreement to any Person to which it transfers all of its assets or business,
provided that the assignee undertakes to the other Parties to be bound by and
perform the obligations of the assignor under this Agreement.

Waiver

 

  21.4. No failure or delay on the part of any Party to exercise any right or
remedy under this Agreement shall be construed or operate as a waiver thereof,
nor shall any single or partial exercise of any right or remedy preclude the
further exercise of such right or remedy.

 

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Invalid clause

 

  21.5. If any provision or part of this Agreement is held to be void or
invalid, amendments to this Agreement may be made by the addition or deletion of
wording as appropriate to remove the void or invalid part or provision but
otherwise retain the provision and the other provisions of this Agreement to the
maximum extent permissible under applicable law. The Parties shall endeavor to
agree amendments to such void or invalid provisions in a reasonable manner so as
to achieve the original intention of the Parties.

Change of Control

 

  21.6. Any substantial change in the management and control of either of the
Parties and/or any merger of either of the Parties with another entity shall not
result in termination of this Agreement and it shall be the responsibility of
the then existing management of the Party to see that the continuity of this
Agreement is maintained in all respects and the agreement shall continue to be
in force.

Formal licenses

 

  21.7. The Parties shall execute such formal licenses, documents as may be
necessary or appropriate for registration of the rights granted under this
Agreement with Patent Offices and other relevant authorities. The Parties shall
use reasonable endeavors to ensure that, to the extent permitted by relevant
authorities and unless required to submit this Agreement by any order of law,
this Agreement shall not form part of any public record.

 

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Role of Parties

 

  21.8. The Parties hereto expressly understand and agree that Lipoxen and
SynBio are independent contractors in the performance of each and every part of
this Agreement and nothing contained herein shall be construed as creating any
agency, partnership or other form of joint enterprise between the Parties.

Interpretation

 

  21.9. In this Agreement:

 

  21.9.1. the headings are used for convenience only and shall not affect its
interpretation;

 

  21.9.2. references to persons shall include incorporated and unincorporated
persons; references to the singular include the plural and vice versa; and
references to the masculine include the feminine;

 

  21.9.3. references to clauses and Schedules mean clauses of, and schedules to,
this Agreement; and

 

  21.9.4. references to the grant of “exclusive” rights shall mean that the
person granting the rights shall neither grant the same rights (in the same
field and territory) to any other person, nor exercise those rights itself.

Notices

 

  21.10. Any notice to be given under this Agreement shall be in writing and
shall be sent by first class mail or air mail, or by fax (confirmed by first
class mail or air mail) to the address of the relevant Party set out at the head
of this Agreement, or to the relevant fax number set out below, or such other
address or fax number as that Party may from time to time notify to the other
Parties in accordance with this clause. The fax numbers of the Parties are as
follows:

 

  21.10.1. [***]

 

       [***]

 

  21.10.2. [***]

 

       [***]

 

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Notices sent as specified in clause 21.13 shall be deemed to have been received
three working days after the day of posting (in the case of inland first class
mail), or ten working days after the date of posting (in the case of air mail),
or on the next working day after transmission (in the case of fax messages, but
only if a transmission report is generated by the sender’s fax machine recording
a message from the recipient’s fax machine, confirming that the fax was sent to
the number indicated above and confirming that all pages were successfully
transmitted).

Governing Law and Settlement of Disputes

 

  21.11. This Agreement, including any non-contractual obligations arising out
of or in connection with this Agreement, shall be governed by and construed in
accordance with English law. This provision does not affect the application of
the mandatory rules of Russian law established under Article 1192 of the civil
Code of the Russian Federation to this Agreement which apply in any event.

 

  21.12.

If any dispute, controversy or claim of whatever nature arises under, out of or
in connection with this Agreement, including any question regarding its
existence, validity or termination or any non-contractual obligations arising
out of or in connection with this Agreement (a “Dispute”), the Parties shall use
all reasonable endeavours to resolve the matter amicably. If one Party gives the
others notice that a Dispute has arisen and the Parties are unable to resolve
the

 

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  Dispute within thirty (30) days of service of the notice then the Dispute
shall be referred to the respective chief executive officers of the Parties who
shall attempt to resolve the Dispute. No Party shall resort to arbitration
against any other Party under this Agreement until thirty (30) days after such
referral.

 

  21.13. All Disputes which are unresolved pursuant to Clause 21.14 and which a
Party wishes to have resolved shall be referred upon the application of any
Party to, and finally settled by, arbitration under the Rules of Arbitration of
the London Court of International Arbitration (“LCIA”) (the “Rules”) in force at
the date of this Agreement, which Rules are deemed to be incorporated by
reference to this Clause. The number of arbitrators shall be three (3),
appointed in accordance with the Rules. The LCIA Court may appoint arbitrators
from among the nationals of any country, whether or not a Party is a national of
that country. The seat of the arbitration shall be London. The language of this
arbitration shall be English.

 

  21.14. The arbitrators shall have the power to grant any legal or equitable
remedy or relief available under law, including injunctive relief (whether
interim and/or final) and specific performance and any measures ordered by the
arbitrators may be specifically enforced by any court of competent jurisdiction.
Each Party retains the right to seek interim or provisional measures, including
injunctive relief and including pre-arbitral attachments or injunctions, from
any court of competent jurisdiction and any such request shall not be deemed
incompatible with the agreement to arbitrate or a waiver of the right to
arbitrate. For the avoidance of doubt, this Clause is not intended to limit the
powers of the court exercisable in support of arbitration proceedings pursuant
to s.44 of the Arbitration Act 1996.

 

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Severability

 

  21.15. If any provision of this Agreement is found by the competent court
illegal, invalid or unenforceable in any respect under the applicable law, then
such provision (insofar as it is invalid or not enforceable) shall be deemed as
not included in this Agreement, but this does not invalidate the remaining
provisions of this Agreement. The Parties shall make every reasonable effort to
replace the invalid or not enforceable provision or provisions (if applicable)
with valid and enforceable which is as close as possible to the proposed action
of the invalid or unenforceable provision.

Further action

 

  21.16. Each Party agrees to execute, acknowledge and deliver such further
instruments, and do all further similar acts, as may be necessary or appropriate
to carry out the purposes and intent of this Agreement.

Announcements

 

  21.17. Neither Party shall make any press or other public announcement
concerning any aspect of this Agreement, or make any use of the name of the
other Party in connection with or in consequence of this Agreement, without the
prior written consent of the other Party. The Parties agree that any agreed
announcements will refer to Open joint-stock company “RUSNANO”, a legal entity
organized and existing under the laws of the Russian Federation, with main state
registration number (OGRN) 1117799004333, located at: Russia, Moscow, 117036,
avenue of 60-letiya Oktyabrya, 10A as the Party to the Project.

 

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Entire agreement

 

  21.18. This Agreement, including its Schedules, the Subscription Agreement and
the Relationship Deed sets out the entire agreement between the Parties relating
to its subject matter and supersedes all prior oral or written agreements,
arrangements or understandings between them relating to such, subject matter.
The terms of the Subscription Agreement and the Relationship Deed shall take
precedence to the extent that there is any conflict between the terms of the
Subscription Agreement and/or the Relationship Deed and the terms of this
Agreement.

 

  21.19. The Parties acknowledge that they are not relying on any
representation, agreement, term or condition which is not set out in this
Agreement.

 

  21.20. Nothing in this Agreement shall exclude any of the Parties’ liability
for fraudulent misrepresentation.

Third parties

 

  21.21. With the exception of any rights expressly created in this Agreement in
favor of Affiliates of Lipoxen, this Agreement does not create any right
enforceable by any person who is not a Party to it.

Translations

 

  21.22. The Parties agree that a translation of this Agreement into the Russian
language (the “Translation”) shall be prepared and be fully equal but to the
extent that there is any conflict between the terms of this Agreement and the
terms of the Translation, the Parties agree that the terms of this Agreement
shall prevail.

 

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AGREED by the Parties through their authorized signatories on the date written
above:

 

For and on behalf of Lipoxen PLC Signed   /s/ M. Scott Maguire Print name   M.
Scott Maguire Title   CEO   LOGO [g708796exr_pg082.jpg] For and on behalf of
Lipoxen Technologies Limited Signed   /s/ M. Scott Maguire Print name   M. Scott
Maguire Title   CEO For and on behalf of SynBio LLC Signed   Print name   Title
 

 

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AGREED by the Parties through their authorized signatories on the date written
above:

 

For and on behalf of Lipoxen PLC Signed   Print name   Title   For and on behalf
of Lipoxen Technologies Limited Signed   Print name   Title   For and on behalf
of SynBio LLC Signed   /s/ Kruglyakov Peter Print name   Kruglyakov Peter Title
  General Director

--------------------------------------------------------------------------------

AGREED by the Parties through their authorized signatories on the date written
above:

 

For and on behalf of Lipoxen PLC Signed   /s/ Colin Hill Print name   Colin Hill
Title   DIRECTOR   LOGO [g708796exr_pg084a.jpg] For and on behalf of Lipoxen
Technologies Limited Signed   /s/ M. Scott Maguire Print name   M. Scott Maguire
Title   CEO For and on behalf of SynBio LLC Signed   /s/ Peter Kruglyakov Print
name   Peter Kruglyakov Title   CEO   LOGO [g708796exr_pg084b.jpg]

 

LOGO [g708796exr_pg084c.jpg]

 

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SCHEDULE 1

DEVELOPMENT PROGRAM

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85

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96

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97

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98

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SCHEDULE 2

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101

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SCHEDULE 3

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SCHEDULE 4

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103

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SCHEDULE 5

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106

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107

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108

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SCHEDULE 6

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SCHEDULE 7

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SCHEDULE 8

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SCHEDULE 9

MEMBERS OF THE SCIENTIFIC SUBCOMMITTEE

SYNBIO

Dmitry Genkin, Peter Kruglyakov

LIPOXEN

Two of any of the following four:

Brian Richards

David Moss

Scott Maguire

Sanjay Jain

 

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SCHEDULE 10

REVENUE SHARING

 

1. For the purposes of this Schedule 11, the following words shall have the
following meaning:

 

“Lipoxen Net

Sales”

   the amount received by Lipoxen and/or its Affiliates from third parties in
respect of supplies of Lipoxen Royalty Products in arms length transactions (or
the amount that would have been received if the transactions had been at arms
length) less the following items provided they are shown in writing on the
relevant invoice or in other documentary evidence: sales taxes, costs of
delivery, customary trade discounts actually granted, amounts actually repaid or
credited for defective or returned and, in the case of export orders, any import
duties or similar applicable governmental levies and any government rebates
charged on the purchase price of the Lipoxen Royalty Products;

“Lipoxen Net

Receipts”

   all signing fees, milestones, royalties and other licence fees (excluding
research and development fees) received by Lipoxen and/or its Affiliates from
sub-licensees in respect of rights acquired by the sub-licensee to market, sell
and supply Lipoxen Royalty Products, less any less any Value Added Tax or other
sales tax and any direct and/or third party costs and/or expenses incurred by
Lipoxen in procuring payment of such sums;

“SynBio Net

Sales”

   the amount received by SynBio and/or its Affiliates from third parties in
respect of sales and/or

 

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   supplies of SynBio Royalty Products in arms length transactions (or the
amount received if the transactions had been at arms length) less the following
items provided they are shown in writing on the relevant invoice or in other
documentary evidence: sales taxes, costs of delivery, customary trade discounts
actually granted, amounts actually repaid or credited for defective or returned.

 

2. [***]

 

  (a) become due 30 (thirty) days after the expiry of the Quarter in which the
SynBio Royalty Products to which the royalty relate were sold and/or supplied by
SynBio;

 

  (b) be payable for a period which, on a Product by Product basis, shall
commence on first commercial sale of the relevant Product in the SynBio Market
and shall expire on whichever is later: (a) the date of expiry of the licence in
relation to the relevant Product granted to SynBio pursuant to clause 11.1 of
this Agreement; and/or (b) fen (10) years from the date of first commercial sale
of the relevant Product in the SynBio Market.

 

3. [***]

 

  (a) become due 30 (thirty) days after the expiry of the Quarter in which the
relevant Lipoxen Net Sales were received by Lipoxen; and

 

  (b)

be payable for a period which, on a Lipoxen Royalty Product by Lipoxen Royalty
Product basis, shall commence on first commercial sale of the relevant Lipoxen
Royalty Product in the Lipoxen Market and shall expire on whichever is later:
(a) the date of expiry of

 

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  the licence in relation to the relevant Lipoxen Royalty Product granted to
Lipoxen pursuant to clause 10.7 of this Agreement; and/or (b) ten (10) years
from the date of first commercial sale of the relevant Lipoxen Royalty Product
in the Lipoxen Market.

 

4. [***]

 

  (a) become due 30 (thirty) days after the expiry of the Quarter in which the
relevant Lipoxen Net Receipts were received by Lipoxen; and

 

  (b) be payable for a period which, on a Product by Product basis, shall
commence on the receipt by Lipoxen of the Clinical Dossier relating to the
relevant Product and shall expire 10 (ten) years thereafter.

 

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SCHEDULE 11

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SCHEDULE 12

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121

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SCHEDULE 13

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