Document:

EX-10.18

 Exhibit 10.18

 

Portions of this exhibit, indicated by the mark “[***],”
have been redacted pursuant to a confidential treatment request.

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

 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”) 

  
 2 

 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.

  
 3 

	(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;

  
 4 

			
		
	“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.

  
 5 

			
	“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;

  
 6 

			
	“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;

  
 7 

			
	“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;

  
 8 

			
		
	“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

  
 9 

			
		  	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

  
 10 

			
		  	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

  
 11 

			
		
	“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;

  
 12 

			
		
	“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;

  
 13 

			
		
	“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;

  
 14 

			
		
	“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;

  
 15 

			
	“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;

  
 16 

			
		
	 “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;

  
 17 

			
		
	 “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

  
 18 

			
		
		  	(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;

  
 19 

			
		
	 “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:

  
 20 

			
		  	  
 (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;

  
 21 

			
		
	 “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;

  
 22 

			
		
	 “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;

  
 23 

			
		
	 “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

  
 24 

	 	
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 

  
 25 

	 	
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: 

  
 26 

	 	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 

  
 27 

	 	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. 

  
 28 

	 	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. 

  
 29 

	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 

  
 30 

	 	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. 

  
 31 

	 	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 

	 	
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 

	 	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 

	 	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 

	 	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 

 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; 

  
 37 

	 	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; 

  
 38 

	 	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 

	 	
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 

	 	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 

	 	
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 

	 	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. 

  
 43 

	 	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 

	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 

	 	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 

	 	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 

	 	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 

  
 48 

	 	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 

	 	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 

	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; 

  
 51 

	 	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 

  
 52 

	 	
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 

  
 53 

	 	
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. 

  
 54 

	 	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. 

  
 55 

 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 

  
 56 

	 	
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.	the Parties will agree the share of the revenue received by SynBio from its sub-licenses to be
paid to Lipoxen by way of a royalty which shall not in any event be less than the [***] 

 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 

  
 57 

	 	
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,

  
 58 

	 	
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; 

  
 59 

	 	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 

  
 60 

	 	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. 

  
 61 

	 	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. 

  
 62 

	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.	Each of the Parties shall make its records and accounts available, on reasonable notice, for
inspection during business hours by an independent chartered accountant nominated by the other Party for the purpose of
verifying the accuracy of any statement or report provided under this Agreement and any payments due under this
Agreement. Such accountant shall be required to keep confidential all information acquired during any such inspection, and to
disclose to the inspecting Party only such details as may be necessary to report on the accuracy of the statement, report or
payment. The inspecting Party shall be responsible for the accountant’s costs unless the accountant certifies that
there is an inaccuracy of more than 5% (five per cent) in any statement or payment, in which case the Party being inspected
shall pay the accountant’s charges in respect of that inspection.

  
 63 

	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 

  
 64 

	 	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 

  
 65 

	 	16.1.4.	shall be made by the due date, failing which the payee may charge interest on any
outstanding amount calculated on a monthly basis at a rate equivalent to 5% above the London Inter-Bank Offer Rate (6 months)

  

	 	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. 

  
 66 

	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. 

  
 67 

	 	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; 

  
 68 

	 	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; 

  
 69 

	 	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 

  
 70 

	 	
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 

  
 71 

	 	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. 

  
 72 

	 	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; 

  
 73 

	 	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; 

  
 74 

	 	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. 

  
 75 

 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. 

  
 76 

 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.	[***] 

  

	 	    	For the attention of Scott Maguire

  

	 	21.10.2.	[***] 

  

	 	    	For the attention of Artur Isaev, Dmitry Genkin or Pyotr Kruglyakov

  
 77 

 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 

  
 78 

	 	
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. 

  
 79 

 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. 

  
 80 

 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. 

  
 81 

 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
		
		 	

	
	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	 	

  
 82 

 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
		
		 	

	
	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
		
		 	

  
 

 

  
 82 

 SCHEDULE 1 

DEVELOPMENT PROGRAM 
 [***] 

  
 83 

 [***] 

  
 84 

 [***] 

  
 85 

 [***] 

  
 86 

 [***] 

  
 87 

 [***] 

  
 88 

 [***] 

  
 89 

 [***] 

  
 90 

 [***] 

  
 91 

 [***] 

  
 92 

 [***] 

  
 93 

 [***] 

  
 94 

 [***] 

  
 95 

 [***] 

  
 96 

 [***] 

  
 97 

 [***] 

  
 98 

 [***] 

  
 99 

 [***] 

  
 100 

 SCHEDULE 2 

[***] 

  
 101 

 SCHEDULE 3 

[***] 

  
 102 

 SCHEDULE 4 

[***] 

  
 103 

 SCHEDULE 5 

[***] 

  
 104 

 [***] 

  
 105 

 [***] 

  
 106 

 [***] 

  
 107 

 [***] 

  
 108 

 [***] 

  
 109 

 [***] 

  
 110 

 SCHEDULE 6 

[***] 

  
 111 

 SCHEDULE 7 

[***] 

  
 112 

 SCHEDULE 8 

[***] 

  
 113 

 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 

  
 114 

 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

  
 115 

			
		  	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.	SynBio shall pay to Lipoxen a royalby of [***] of all SynBio Net Sales. The royalty payable to
Lipoxen pursuant to this paragraph shall:

  

	 	(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.	Lipoxen shall pay to SynBio a royalty of [***] of all Lipoxen Net Sales. The royalty payable to
SynBio pursuant to this paragraph shall:

  

	 	(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 

  
 116 

	 	
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.	Lipoxen shall pay to SynBio [***] all of Lipoxen Net Receipts. The royalty payable to SynBio
pursuant to this paragraph shall:

  

	 	(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.

  
 117 

 SCHEDULE 11 

[***] 

  
 118 

 [***] 

  
 119 

 SCHEDULE 12 

[***] 

  
 120 

 [***] 

  
 121 

 SCHEDULE 13 

[***] 

  
 122 

  

	From:	Xenetic Biosciences pic (formerly Lipoxen plc)
	 	(Company No. 03213174)
	 	London Bioscience Innovation Centre

2 Royal College Street
	 	London NW1 0NHY
	 	 
	 	Lipoxen Technologies Limited
	 	(Company No. 03401495)
	 	London Bioscience Innovation Centre
	 	2 Royal College Street
	 	London NW1 0NH
	 	 
	To:	SynBio LLC
	 	(Main State Registration No. 1117746126321)
	 	Building 2
	 	55/1, Leninsky Prospekt
	 	Moscow
	 	Russian Federation
	 	 

Date:

 

Dear Sirs

 

Amendment Letter

 

We refer to the agreement entitled “Agreement
on Co-Development and the Terms of Exclusive License” entered into by us, Xenetic Biosciences Plc) and Lipoxen Technologies
Limited, and you, SynBio LLC dated 4 August 2011 (the “Agreement”).

 

We propose to make the following amendments to the
Agreement. Unless the context otherwise requires, all words and expressions used in this letter have the same meanings as
those defined in the Agreement.

 

1. In clause 1:

 

The definition for “Product F” shall
be deleted and replaced with the following:

 

[***]

 

2. In clause 15:

 

A new sub-clause 15.2.4 shall be inserted, which
shall read:

 

“any and all costs and expenses reasonably
and directly incurred in relation to the development of the Onochist Technology (which Lipoxen shall be entitled to deduct
from royalties due on Lipoxen Net Sales and Lipoxen Net Receipts in respect of Product F Lipoxen Royalty Products only).”

 

A new clause 15.5 shall be inserted, which shall read:

 

Lipoxen shall have the right
to acquire SynBio’s interest in Product F at a value equivalent to an independent valuation to be conducted by Ernst
and Young or Cambridge Consultants. Such right can be exercised after Ph IIa under a US FSA or EMA trial.

 

3. In paragraph 3 of Schedule 10:

 

A royalty rate of [***] shall be payable
by Lipoxen to SynBio on Lipoxen Net Sales where the supplies of Lipoxen Royalty Products in question are Product F. The
original royalty rate of [***] shall continue to apply in respect of Lipoxen Net Sales of all other Lipoxen Royalty Products.

 

 

    	123

    	 

    

 

4. In paragraph 4 of Schedule 10:

 

A royalty rate of [***] shall be payable
by Lipoxen to SynBio on Lipoxen Net Receipts where they related to Product F Lipoxen Royalty Products. The original royalty
rate of [***] shall continue to apply to Lipoxen Net Receipts in respect of all other Lipoxen Royalty Products.

 

5. In Schedule 13:

 

The following names shall be added:

 

[***]

 

The above amendments are made in consideration of
our payment to you now of [***] (receipt of which you hereby acknowledge) and for other good and valuable consideration.

 

The Agreement shall remain in full force
and effect except to the extent that its terms are varied by this letter. In the event of any conflict between this letter
and the Agreement, the provisions of this letter shall prevail.

 

This letter shall be construed and governed by
the laws which are expressed to apply in clause 21.11 of the Agreement. Any dispute arising out of or in connection with
this letter or subject matter or formation (including but not limited to any non-contractual claims or disputes) shall be
subject to the same dispute resolution process as set out in clauses 21.12 to 21.14 (inclusive) of the Agreement.

 

Please confirm your agreement to the amendments
to the Agreement set out above by countersigning this letter below and returning your signature copy of this letter to us.
Upon your signature to this letter, the above amendments to the Agreement shall be deemed to have taken effect from (and
including) the Commencement Date of the Agreement.

 

This letter may be executed in any number of
counterparts and by different parties on separate counterparts, each of which when so executed and delivered shall be an
original but all counterparts shall together constitute one and the same instrument.

 

AGREED by the parties through their authorised
signatories on the date which first appears in this letter:

 

Signed for and on behalf of Xenetic
Biosciences plc:

 

Signed: _______________________________

 

Pring Name: ___________________________

 

Title: _________________________________

 

 

 

Signed for and on behalf of Lipoxen
Technologies Limited:

 

Signed: _______________________________

 

Pring Name: ___________________________

 

Title: _________________________________

 

 

 

Signed for and on behalf of SynBio
LLC:

 

Signed: _______________________________

 

Pring Name: ___________________________

 

Title: _________________________________

 

 

 

    	124EX-10.19

 Exhibit 10.19 

Portions of this exhibit, indicated
by the mark “[***],” have been redacted pursuant to a confidential treatment request.

DATED 4 August 2011 

(1) SynBio LLC 
 (2) Lipoxen Plc

 SUBSCRIPTION AGREEMENT 

in respect of ordinary shares 
 in
the capital of 
 Lipoxen plc 

 THIS AGREEMENT is made on 4 August
 2011 

BETWEEN: 
 (1) SynBio LLC, a limited liability company
incorporated under the laws of the Russian Federation, Main State Registration Number 1117746126321, having its registered office at building 2, 55/1, Leninsky Prospekt, Moscow, Russian Federation (the “Subscriber”); and 

(2) LIPOXEN PLC a company incorporated under the laws of England and Wales with Company number 03213174 whose registered office is at London Bioscience
Innovation Centre, 2 Royal College Street, London NWl ONH, Great Britain (the “Issuer”). 
 RECITALS 

(A) The Issuer is a public limited company incorporated under the laws of England and Wales. The Issuer’s Ordinary Shares are admitted to trading on AIM.

 (B) The Issuer, Lipoxen Technologies Ltd and the Subscriber are to be participants in a project, pursuant to the terms of a co-development agreement to be entered into between such parties (the “Project”). 
 (C) In connection with the
Project, the Subscriber wishes to invest in the Issuer. 
 (D) Accordingly, the Subscriber has agreed to subscribe, and the Issuer has agreed to issue and
allot to the Subscriber, 110,800,000 new Ordinary Shares subject to the conditions and on the terms of this Agreement. 

 (E) The Parties intend that all the actions in relation to the signing of this Agreement and the issue of shares
to the Subscriber referred to in Recital (D) above will take place in London. 
 (F) Completion of this Agreement is conditional upon certain events,
including, inter alia, approval of certain resolutions at a general meeting of the Issuer’s shareholders. 
 OPERATIVE PROVISIONS 

 

	1.	INTERPRETATION 

 1.1 In this Agreement including in the Recitals and Schedules hereto, the following
words and expressions shall have the following meanings: 
 “Accounting Date” means 31 December 2010; 

“Admission” means the admission of the Subscription Shares to trading on AIM becoming effective in accordance with paragraph 6 of the
AIM Rules, and references to the Subscription Shares being 
 “Admitted” shall be construed accordingly; 

“Agreement” means this agreement as the same may be amended by the Parties hereto in accordance with the provisions hereof; 

“Announcement” means the RNS announcement in relation to information set out in the Circular in the agreed form; 

“AIM” means the market of that name operated by the London Stock Exchange; 

“AIM Rules” means the AIM Rules for Companies published by the London Stock Exchange for the time being in force; 

  
 2 

 “Applicable Law” means the laws, decrees regulations or any type of primary or secondary legislation
which is at the time of this Agreement in force in the United Kingdom or in the Russian Federation, as the case may be; 
 “Business Day” means a
day (not being a Saturday or a Sunday) on which banks generally are open for business in London and Moscow; 
 “Circular” means the circular as
required under, inter alia, Rule 9 of the City Code as agreed by the Panel on Takeovers and Mergers, and to be sent by the Issuer to its shareholders in connection with the transactions hereby contemplated; 

“City Code” means the City Code on Takeovers and Mergers; 

“Co-Development Agreement” means the co-development agreement entered into between the Issuer, the Subscriber and Lipoxen Technologies Ltd on or
around the date hereof; 
 “Co-Development Agreement Condition Precedent” shall have the meaning ascribed in Clause 2.1(B); · 

“Companies Act” means the Companies Act 2006; 

“Completion” means completion of this Agreement as provided in Clause 6; 

“Completion Date” means, unless the Parties shall otherwise agree: 

(A) the first Business Day after Pre-Completion takes place; or 

(B) as the context may require, the date on which Completion takes place; 

  
 3 

 “Conditions Precedent” means the Conditions Precedent set out in Clause 2; 

“Conditions Precedent Date” means 30 September 2011 or such later date as the Parties may agree in writing for satisfaction of the
Conditions Precedent; 
 “Consideration” has the meaning ascribed in Clause 5; 

“Enabling Resolutions” shall have the meaning ascribed in Clause 2.1(D); 

“Encumbrance” means any mortgage, charge, pledge, lien, option, restriction, right of first refusal, right of pre-emption, third party right
or other interest or equity, security interest of any kind or another type of preferential arrangement (including, without limitation, a title transfer and retention arrangement) having similar effect, and “Encumbering” shall be
construed accordingly; 
 “Escrow Deed” means the deed of adherence in relation to arrangements under the Purchase Agreement including,
inter alia, certain of the consideration shares held in escrow, to be entered into on or around the date hereof; 
 “FDS Pharma”
means the limited liability partnership “FDS Pharma LLP”, a legal entity incorporated and existing under the laws of England and Wales, with its registered office at: Hillbrow House, Hillbrow Road, Esher, Surrey, KTlO 9NW, United Kingdom,
registration number LP005073; 

  
 4 

 [***] 

“GM” shall have the meaning ascribed in Clause 2.5(A); 

“GM Notice” means the notice to convene the GM included within the Circular; 

“Group” means the Issuer and Lipoxen Technologies Ltd (and, where the context permits, each of them); 

“Group IP Rights” means: 
 (A) all intellectual
property assets and rights (together the “IP Rights”) in relation to (i) Histone; and (ii) the Polyxen Technology being owned, licensed or otherwise held or used by any Group entity; and 

(B) all IP Rights owned, licensed or
otherwise held or used by any Group entity and “Group IP” shall be construed accordingly, and for these purposes
“intellectual property” means (i) patents; (ii) applications for patents; (iii) designs (registered or
unregistered and including applications for registered designs); (iv) registered trade marks and applications for the registration
of trade marks; (v) rights in know-how, trade secrets and confidential information; (vi) copyright, (vii) rights
in inventions; (viii) rights in scientific, technical and manufacturing data; (ix) rights in plans, specifications and
calculations; (x) unregistered trade marks; (xi) database rights; (xii) domain names; and (xiii) all corresponding,
equivalent or comparable rights existing in any territory or jurisdiction outside the United Kingdom relating to the Group’s
current or proposed business activities, as set out in the Co-Development Agreement;

  
 5 

 “Histone” has the meaning given in the Co-Development
Agreement; 
 “ICTA” means the Income and Corporation Taxes Act 1988; 

“Interim Period” means the period commencing on the date of this Agreement and ending on the earlier to occur of (i) Completion; or
(ii) lapse or termination of this Agreement; 
 “Irrevocable Undertaking” means the irrevocable undertakings and the marketing agreement
entered into by the Issuer’s Majority Shareholders with the Issuer in respect of, inter alia, their voting rights in relation to the Enabling Resolutions; 

“Issuer’s Majority
Shareholders” means: (i) Mr Genkin Dmitry Dmitrievich, citizen of the Russian Federation, [***] and  (ii) Mr
Igor Nikolaev, citizen of the Russian Federation, [***] 

  
 6 

 “Issuer’s Solicitors” means Pinsent Masons LLP of 30 Crown Place, London EC2A 4ES; 

“Issuer’s Warranties” means the warranties set out in Schedule 2; 

Lipoxen Technologies Ltd means a legal entity registered under the laws of England whose registered office is at London Bioscience Innovation Centre, 2
Royal College Street, London, NWl ONH, United Kingdom, company registration number 03401495; 
 “London Stock Exchange” means the London
Stock Exchange plc; 
 “Ordinary Share” means an ordinary share of 0.5p each in the capital of the Issuer and “Ordinary
Shares” shall be construed accordingly; 
 “Parties” means the parties to this Agreement; 

“Patents” means all granted patents and applications for patents (whether owned by, or licensed to, any Group member) expressly referred to
or identified in the Co-Development Agreement; 
 “Polyxen Technology” has the meaning given in the
Co-Development Agreement; 
 “Pre-Completion” means Pre-Completion of this Agreement as provided in Clause 6; 

“Pre-Completion Date” means the date falling at least three Business Days prior to the Completion Date or such other date for Pre-Completion
as the Parties may agree in writing; 

  
 7 

 “Purchase Agreement” has the meaning given in Clause 2.1(C); 

“Related Agreements” means the Co-Development Agreement, the Relationship Deed and any other agreement,
document or instrument contemplated by the foregoing agreements or designated by the Parties m writing as a “Related Agreement”; 

“Relationship Deed” means the agreement to regulate the relationship between the Subscriber and the Issuer in the agreed form; 

“Resolutions Condition Precedent” shall have the meaning ascribed in Clause 2.l(D); 

“RNS” has the meaning given to such term in the AIM Rules; 

“Shareholder Register” means the register of the Issuer’s shareholders that exists under the laws of England and Wales; 

“Share Registrar” means the company which maintains the Shareholder Register; 

“Subscriber’s Solicitors” means White & Case LLP of 5 Old Broad Street, London EC2N lDW; 

“Subscriber’s Warranties” means the warranties set out in Schedule 1; 

“Subscription Price” means the price of 11p per new Ordinary Share; 

“Subscription Shares” means 110,800,000 new Ordinary Shares; 

“SymbioTec” means SymbioTec GmbH located at: Saarbriicken, Gennany, organized in accordance with certificate of acknowledgment No. UR 849/2008 of
October 11, 1988 and existing under the laws of Germany; 

  
 8 

 “Warranties” means the Subscriber’s Warranties and the Issuer’s Warranties. 

1.2 The expression “in the agreed terms” means in the form agreed between the Subscriber and the Issuer and signed for the purposes of
identification by or on behalf of the Subscriber and the Issuer. 
 1.3 Any reference to “writing” or “written” means any
method of reproducing words in a legible and non-transitory form (excluding, for the avoidance of doubt, email). 
 1.4 References to
“include” or “including” are to be construed without limitation. 
 1.5 References to a “company” include
any company, corporation or other body corporate wherever and however incorporated or established. 
 1.6 References to a “person” include
any company, partnership, joint venture, firm, association, trust and any governmental or regulatory authority. 
 1.7 The expressions “body
corporate”, “holding company”, “parent undertaking”, “subsidiary” and “subsidiary undertaking” shall have the meanings given in the Companies Act. 

1.8 The table of contents and headings are inserted for convenience only and do not affect the construction of this Agreement. 

  
 9 

 1.9 Unless the context otherwise requires,
 words in the singular include the plural and vice versa, and a reference to any gender includes all other genders.
 1.10 References to Clauses, paragraphs and Schedules are to Clauses and paragraphs of, and
schedules to, this Agreement. The Schedules form part of this Agreement. 
 1.11
                                         References to any statute or statutory provision include a reference to that statute
                                         or statutory provision as amended, consolidated or replaced from time to time (whether
                                         before or after the date of this Agreement) and include any subordinate legislation made
                                         under the relevant statute or statutory provision.
 1.12 References to any English legal term for any action, remedy, method of financial proceedings, legal document, legal status, court,
official or any legal concept or thing shall, in respect of any jurisdiction other than England, be deemed to include what most nearly approximates in that jurisdiction to the English legal term. 

1.13 The expressions “ordinary course of business” or “business in the ordinary course” mean the ordinary and usual course of business of
the Issuer, consistent in all material respects (including nature and scope) with the prior practice of the Issuer and includes, for the avoidance of doubt, any actions taken or required to be taken by the Issuer in accordance with this Agreement or
any other Related Agreement or as described in the Circular. 

  
 10 

 1.14 In this Agreement references to “US$” or “US Dollars” are references to the lawful
currency for the time being of United States of America; references to “RUB” or “Roubles” are references to the lawful currency for the time being of the Russian Federation; and references to “£” or
“pounds” are references to the lawful currency for the time being of the United Kingdom. 
 1.15 In this Agreement references to any time of day
are to the time in London, England. 
 1.16 In the event of any discrepancy between the English and Russian translations of this Agreement, the English
version shall prevail. 
 2. CONDITIONS PRECEDENT 
 2.1
The provisions of Clauses 4, 5 and 6 of this Agreement are conditional on the following having occurred on or before 2 p.m. (or such other time as the Parties may agree in writing) on the Conditions Precedent Date: 

(A) the Irrevocable Undertaking having been executed by all Parties thereto such that it shall become unconditional in all respects automatically before or
upon signing of this Agreement (the “Irrevocable Undertaking Condition Precedent”); 

  
 11 

 (B) the Issuer, Lipoxen Technologies Ltd and the Subscriber having executed the Co-Development Agreement such
that it shall become unconditional in all respects automatically on Completion of this Agreement (the “Co-Development Agreement Condition Precedent”); 

(C) completion of the purchase by the Issuer of the entire issued share capital of SymbioTec in accordance with the agreement with the vendors executed on or
around the date hereof (the “Purchase Agreement”) (the “Transfer Condition Precedent”); 
 (D) the passing at a general
meeting of the Issuer of all the resolutions set out in the GM Notice (the “Enabling Resolutions”) (the “Resolutions Condition Precedent”); and 

(E) Admission of the Subscription Shares to trading on AIM (the “Admission Condition Precedent”); and 

(F) the Issuer and the Subscriber having executed the Escrow Deed. 

2.2 The Issuer shall use reasonable endeavours to procure the satisfaction of Admission Condition Precedent as soon as practicable and in any event not later
than the latest time on the Conditions Precedent Date. 

  
 12 

 2.3 The Issuer shall use reasonable endeavours to procure that irrevocable undertakings to vote in favour of the
resolutions required to effect the transactions contemplated by this Agreement are entered inter alia into by: (i) Baxter Healthcare SA, a company incorporated under Swiss law, having its registered address at Hertistr.28304 Wallisellen,
Switzerland; (ii) Serum Institute of India Limited, a company incorporated under Indian law, registered: at S. No. 212/2, Off Soli Poonawalla Road, Hadapsar, Pune – 411 028, Maharashtra, India; and (iii) FDS Pharma with the
Issuer such that they shall become unconditional in all respects before or upon completion of this Agreement. 
 2.4 Each Party shall keep the other fully
informed of all progress and developments with regard to satisfaction of the Conditions Precedent for which it is responsible, and in any event shall notify the other Party in writing as soon as practicable after it becomes aware that the same or
any of the Conditions Precedent have been satisfied or have become incapable of satisfaction and produce to the other Party such documentation as reasonably required to evidence such satisfaction or incapability of satisfaction. 

2.5 Without limiting the foregoing, the Issuer undertakes in relation to the Resolutions Condition Precedent that: 

(A) within two (2) Business Days of the date of this Agreement, subject to confirmation from the Panel on Takeovers and Mergers that it requires no
further changes to the drafting of the Circular, it will procure the despatch to its shareholders of a circular substantially in the form of the Circular convening a general meeting of the Issuer (for the purposes, inter alia, of considering
and, if applicable, passing the Enabling Resolutions) (the “GM”) not later than 22 August 2011 unless otherwise agreed by the Parties in writing; 

  
 13 

 (B) at the GM it will procure that the Enabling Resolutions shall be put to the meeting and, unless the same
shall be passed on a show of hands, that a poll is demanded and given effect in respect thereof; 
 (C) that if the GM is adjourned, the date of any
adjourned meeting shall be if practicable, subject to the following provision that it is held in sufficient time to enable satisfaction of the Conditions Precedent on or before the latest time provided in Clause 2.1 PROVIDED THAT no member of the
Issuer’s Group nor any of the directors thereof shall be required to act in breach of their fiduciary duties to any member of the Issuer’s Group and/or its shareholders and/or creditors; 

(D) it will not despatch any circular to its shareholders for the purposes of the foregoing without first providing the Subscriber with a reasonable
opportunity to review and comment on the same, and it will give due consideration to all reasonable requirements of the Subscriber in relation to the contents thereof insofar as they relate to the matters contemplated by this Agreement or are
matters for which the Subscriber or the directors of the Issuer must accept responsibility in accordance with the requirements of the London Stock Exchange, the Companies Act and any other applicable legislation including the City Code; and 

(E) it will, on the day on which the Enabling Resolutions shall be passed (if applicable), provide the Subscriber’s Solicitors with a print thereof, duly
certified by the company secretary or any director of the Issuer as having been duly passed. 

  
 14 

 2.6 The Resolutions Condition Precedent and the Admission Condition Precedent may only be waived if the Issuer
and the Subscriber so agree in writing. The Irrevocable Undertaking Condition Precedent and the Co-Development Agreement Condition Precedent may only be waived if the Subscriber agrees in Co-writing Development Agreement. 

2.7 If by the latest time on the Conditions Precedent Date prescribed in Clause 2.1 the Conditions Precedent have not been satisfied or, in accordance with
Clause 2.6, waived by the applicable Parties, then either Party may serve written notice on the other Party terminating this Agreement, provided that the Issuer may only serve notice to terminate this Agreement where it is not in breach of its
obligations under Clause 2.2 and/or Clause 2.3 of this Agreement. 
 2.8 In the event that either the Issuer or the Subscriber shall serve notice
terminating this Agreement in accordance with Clause 2.7, then except for this Clause 2.8, Clause 1, Clause 9, Clause 12, Clause 13, Clause 14 and Clause 16, all of the provisions of this Agreement shall lapse and cease to have effect. This shall
not affect any accrued rights or liabilities of either the Issuer or the Subscriber in respect of damages for non performance or other breach of any obligation under this Agreement falling due for performance prior to such lapse and/or cessation.

  
 15 

 3. INTERIM PERIOD 

During the Interim Period the Issuer undertakes to conduct its businesses and to procure that Lipoxen Technologies Ltd conducts its business in the ordinary
course. 
 4. SUBSCRIPTION 
 4.1 Subject to Clause 2,
and to receipt of consideration for the Subscription Shares in cleared funds by the Issuer from the Subscriber, the Issuer hereby agrees to issue and allot and the Subscriber hereby agrees to subscribe for the Subscription Shares. 

4.2 The Subscription Shares shall be credited as fully paid up at Completion. 

4.3 Any allotment of Subscription Shares shall be conditional on the same being Admitted. If such condition shall not be capable of satisfaction because of
the failure of the London Stock Exchange to agree to Admission of such Subscription Shares at a date which is practicable prior to the due date for such allotment, then Completion and such allotment shall be postponed to the first Business Day after
the first practicable date for the holding of a meeting of the London Stock Exchange at which it agrees to the Admission of such Subscription Shares. 
 4.4
The Subscription Shares will not rank for any dividends or other distributions declared, paid or made on the ordinary share capital of the Issuer by reference to a record date prior to the Completion Date but, subject thereto, will rank pari
passu in all other respects with the ordinary share capital of the Issuer then in issue. 

  
 16 

 4.5 The Issuer shall not consolidate or sub-divide its ordinary share capital or make any issue by way of
capitalisation or rights to holders of its Ordinary Shares prior to the date of the allotment of any Subscription Shares or the lapse or termination of this Agreement. 

4.6 Nothing in this Agreement shall oblige the Issuer to issue and allot, or the Subscriber to subscribe, any of the Subscription Shares or otherwise complete
this Agreement unless the subscription of all of the Subscription Shares by the Subscriber is completed simultaneously. 
 5. CONSIDERATION 

The consideration for the Subscription Shares shall comprise the Subscription Price in relation to each Subscription Share. 

6. SIGNING, PRE-COMPLETION AND COMPLETION 
 6.1 On or
prior to the execution of this Agreement, a meeting of the board of directors of the Issuer will have been held, at which the board, inter alia: 

(A) approved the entry into this Agreement, the Co-Development Agreement, the Irrevocable Undertaking, the Relationship Deed, the Purchase Agreement, the
Escrow Deed and the Announcement; 
 (B) approved the Circular and resolved to call a GM to consider and, if thought fit, pass the Enabling Resolutions; and

 (C) conditionally only upon Completion: 
 (1) allotted and
resolved to issue the Subscription Shares to the Subscriber in accordance with Clause 4: and 
 (2) resolved to register the Subscription Shares in the name
of the Subscriber. 

  
 17 

 6.2 Immediately following the execution of this Agreement (and in any event within five (5) Business Days of
execution): 
 (A) the Subscriber will deliver to the Issuer three (3) originals of the Co-Development
Agreement, each duly executed by the Subscriber; 
 (B) the Issuer will deliver to the Subscriber: 

(1) three (3) originals of the Co-Development Agreement each duly executed by the Issuer and Lipoxen Technologies Ltd; and 

(2) a certified copy of Irrevocable Undertaking duly executed by the Issuer’s Majority Shareholders. 

6.3 Subject to Clause 2, unless otherwise agreed by the Parties, Pre-Completion shall take place at the offices of the
Issuer’s Solicitors on or before 2.00 p.m. on the Pre-Completion Date and Completion shall take place as provided in Clause 6.9. 
 6.4 [***]

 (A) the Subscriber shall deliver to the Issuer: 
 (1) two
(2) originals of the Relationship Deed each duly executed by the Subscriber; 

  
 18 

 (2) two (2) originals of the Escrow Deed duly executed by the Subscriber; 

(3) an application for the Subscription Shares in the form set out in Schedule 3; 

(4) a certified copy of the resolution of the relevant decision-making body of the Subscriber approving, to the extent required by Applicable Law: 

(a) completion of the subscription of the Subscription Shares; and 

(b) the entry into the Related Agreements to which the Subscriber is a Party; and 

(B) the Issuer shall: 
 (1) deliver to the Subscriber’s
Solicitors a certified copy of the Enabling Resolutions passed at the GM; 
 (2) submit to the London Stock Exchange a completed application in accordance
with Rule 29 of the AIM Rules; and 
 (3) deliver to the Subscriber’s Solicitors two (2) originals of the Escrow Deed executed by the Issuer. 

6.5 Once Pre-Completion has taken place in accordance with the terms set out in Clauses 6.3 and 6.4, Completion hereof shall be conditional only upon
Admission occurring before I 0.00 a.m. on the third Business Day following the Pre-Completion Date taking into account the requirements of Rule 29 of the AIM Rules or such other date as may be agreed by the Pmties. 

6.6 With effect from Completion the Subscriber shall have the right to appoint two (2) non-executive directors to the board of the Issuer in accordance
with the terms 

  
 19 

 
of the Relationship Deed. For the avoidance of doubt, such directors shall not be entitled to any remuneration in respect of their role. 

6.7 Within three (3) Business Days of Admission, the Issuer shall deliver to the Subscriber’s Solicitors a certificate in respect of the
Subscription Shares. 
 6.8 Any documents delivered under Clause 6.4 in anticipation of Completion shall (if not already dated) be delivered undated and
shall remain the absolute property of and shall be held strictly to the order of the delivering or paying Party until Completion shall take place as provided in Clause 6.5, and shall be held by the recipient in accordance with the terms of this
Clause 6.8 and Clause 6.10. 
 6.9 Completion shall take place automatically upon Admission. All deeds, agreements and documents delivered under Clause
6.4 shall thereupon be deemed to have come into effect and shall become the absolute property of the Parties entitled thereto (being the Parties to whose solicitors or agents the relevant deeds agreements documents were delivered) and shall all be
dated with the date of the Completion Date, and shall become unconditional in all respects save in respect of conditions in this Agreement. 
 6.10 If
Admission shall not become effective by the latest time mentioned in Clause 6.5 and the Parties do not before that He time agree to extend the latest time for Completion (in which event the provisions of Clauses 6.7 to 6.11 (inclusive) shall apply
to Completion as so deferred), this Agreement (save for this Clause 6.10 and Clause 6.11) and any allotments, agreements or documents effected or executed pursuant hereto, shall as between the Parties be deemed to be of no effect (save in the case
of this Agreement as 

  
 20 

 
regards any antecedent breach of any obligations hereunder and in respect of this Clause 6.10 and Clause 1, Clause 9, Clause 12, Clause 13, Clause 14 and Clause 16 which shall continue in full
force and effect) and the Parties shall redeliver or procure the redelivery to relevant Parties all documents, agreements, papers and other items delivered by such other Patties pursuant hereto or in anticipation of Completion hereof. 

6.11 The Parties shall procure that their respective solicitors or other agents shall duly retain and deal with all deeds, documents and agreements delivered
to them in accordance with the provisions of this Clause 6. 
 6.12 If on the Completion Date either Party shall fail to comply in any material respect with
its obligations under this Clause 6 (the “Defaulting Party”), the other Party (the “Non-Defaulting Party”) may (provided that such Non-Defaulting Party is in compliance with its obligations under this Clause 6) by
notice in writing to the Defaulting Party (i) defer Completion to a day not more than twenty eight (28) days following the Completion Date (and the provisions of this Clause shall apply to Completion as so deferred; or (ii) proceed to
Completion so far as practicable but without prejudice to the rights of the Non-Defaulting Party hereunder or otherwise. 

  
 21 

 7. WARRANTIES 

7.1 The Subscriber hereby warrants to the Issuer (for the benefit of the Issuer and its successors in title) in the terms of the Subscriber’s Warranties
(set out in Schedule 1). 
 7.2 The Issuer hereby warrants to the Subscriber (for the benefit of the Subscriber and its successors in title) in terms of the
Issuer’s Warranties (set out in Schedule 2). 
 7.3 The Warranties shall be deemed repeated immediately before Completion with reference to the then
existing facts and circumstances. 
 7.4 Each of the Warranties is given independently from and shall not be limited by reference to any other warranty
contained therein or anything else in this Agreement or any other agreement or document referred to herein. 
 7.5 Save as necessary to give effect to the
express terms of this Agreement the Issuer shall not do, allow or procure before Completion anything which is or might cause, constitute or result in a breach of any of the Issuer’s Warranties as repeated immediately prior to Completion. 

7.6 The Issuer shall without delay disclose to the Subscriber in writing any matter or thing which may arise or become known to it after the date thereof
(whether or not prior to Completion) which is or could be a breach of, inconsistent with or may render inaccurate or misleading any of the Issuer’s Warranties as given on exchange hereof and/or immediately prior to Completion provided that
where the Issuer is obliged to make an announcement 

  
 22 

 in respect of such matters under Rule 9, Rule 10 or Rule 11 of the AIM Rules, the Issuer shall upon or
immediately after making such announcement disclose such matter to the Subscriber in accordance with this sub-Clause. 
 8. LIMITATIONS ON LIABILITY

 [***] 
 8.2 No claim for breach of the Issuer’s
Warranties shall be made by the Subscriber: 
 (A) [***] 

[***] 
 8.3 No claim for breach of the Issuer’s Warranties
shall be made unless the claim has been notified in writing to the Issuer on or before the first anniversary of Completion. 

  
 23 

 8.4 The Issuer shall have no liability whatsoever in respect of a claim for breach of the Issuer’s
Warranties to the extent that the fact, matter or circumstance giving rise to the claim: 
 (A) is a matter of public record or available within the public
domain; 
 (B) is published information relating to the Issuer available to the Subscriber; 

(C) is disclosed in the audited annual accounts of the Issuer; 

(D) is disclosed in any announcement of the Issuer; or 
 (E) was
actually known by the Subscriber as at the date of this Agreement: 
 8.5 If the Subscriber becomes aware of any claim, decision, action or demand against
it by a third party which appears likely to give rise to a claim for breach of the Issuer’s Warranties (a “Third Party Claim”) the following provisions shall apply; 

(A) the Subscriber shall as soon as is reasonably practical give written notice of the Third Party Claim to the Issuer; 

(B) the Subscriber shall not make any admission of liability, agreement, settlement or compromise to or with any person in relation to the Third Party Claim
without the prior written agreement of the Issuer; and 
 (C) the Subscriber shall take such action as the Issuer may reasonably request to avoid, dispute,
resist, mitigate, settle, compromise, defend or appeal the Third Party Claim, 

  
 24 

 and provided that: (i) no Third Party Claim shall be settled or compromised by the Subscriber without the
consent of the Issuer; (ii) the Subscriber shall not be required to take any action under this provision unless it is indemnified to its satisfaction by the Issuer in relation to reasonable costs that it may incur in so doing; and
(iii) there is no material reputational damage or material risk to its reputation in taking or avoiding to take any action in connection with such Third Party Claim. 

8.6 Any disclosures made by the Issuer are to be taken as relating to each of the Issuer’s Warranties in this Agreement generally. 

8.7 Except in the case of a fraudulent misrepresentation, no Party shall in relation to the issue of the Subscription Shares under this Agreement be liable in
respect of any representations or warranties or similar assurances which are not contained and expressly given or assumed by them in this Agreement or any agreement or document entered into pursuant hereto or referred to herein. 

9. ENFORCEABILITY AND SEVERABILITY 
 Each of the
agreements, undertakings, covenants, warranties and other obligations of the Parties entered into pursuant hereto (including without limitation under Clause 8) is considered reasonable by the Parties but in the event that any provision or part
thereof shall be held void, unenforceable or in conflict with the law of any state or jurisdiction, it shall be severed from this other document in which it is contained, or otherwise modified to become

  
 25 

 
valid and enforceable insofar as it relates to that state or jurisdiction only. The enforceability and validity of any other parts or provisions of this Agreement and such document shall not be
affected by such severance or modification. 
 10. FURTHER ASSURANCE AND LOCK IN 

10.1 The Issuer hereby agrees for no additional consideration or payment to carry out, execute and deliver any such further acts documents and things as the
Subscriber may reasonably require to vest in the Subscriber the legal and beneficial ownership of the Subscription Shares free from all charges, liens or other adverse interests and to vest the benefit of this Agreement in the Subscriber. 

10.2 The Subscriber hereby undertakes with the Issuer in respect of: 

(A) the Subscription Shares allotted and issued to it pursuant to this Agreement; 

(B) the FDS Pharma Shares; 
 (C) any other Ordinary Shares which
may be acquired by the Subscriber during the twenty four (24) months from the date of Completion; and 
 (D) all other Ordinary Shares into which the
shares referred to in Clause 10.2(A), Clause 10.2(B) or Clause 10.2(C) above are sub-divided or converted, or issued by way of bonus issue or otherwise derived from the same (whether by way of consolidation, sub-division, capitalisation, rights
issue or otherwise), 

  
 26 

 (together in the “Lock-in
 Shares”) that it will retain absolute legal and beneficial title to its holding of such Lock-in Shares free from
 Encumbrances for twenty four (24) months from the date of Completion (the :Lock Up Period”) and shall not during the
 Lock Up Period.

 

(E) offer, dispose or or agree to offer or dispose
of, directly or indirectly, any such Lock-in Shares or any legal or beneficial interest in any such Lock-in Shares, or

 

(F) enter into or agree to enter into any
derivative transaction of any type whatsoever (including without limitation, any swap, contract for differences, option,
warrant, convertible securities or futures transaction to any such Lock-in Shares.

 

Whether such transaction is settled by delivery
of such Lock-in Shares or other securities, in cash or otherwise and, for the purpose of maintaining an orderly market in
the Issuer’s shares, the Subscriber shall not for a further twenty four (24) months thereafter make any such disposal
or arrangement in relation to any Lock-in Shares or enter into any such transaction of the type referred to in Clause 10.2(E)
or Clause 10.2(F) except through the Issuer’s corporate brokers or financial advisors from time to time unless the
Issuer consents in writing that the disposal may be effected otherwise that through such brokers, such consent not to be
unreasonably withheld.

 

 

 

 

  
 27 

  

For the purpose of Clause 10.2,
“dispose” includes mortgaging, pledging, charging, lending, assigning, selling, transferring or
otherwise disposing of the relevant securities or agreeing to dispose of any relevant securities or otherwise Encumbering the
relevant securities.
 The
provisions of this Clause 10.2 shall not apply in respect of: 
 (i) the acceptance of any general offer made to all holders of Ordinary Shares made in
accordance with applicable takeover regulations (if any) or equivalent provisions contained in the articles of association of the Issuer on terms which treat all such holders alike (a “General Offer”); 

(ii) the execution and delivery of an irrevocable commitment or undertaking to accept a General Offer; 

(iii) the implementation of any scheme of arrangement of the Issuer to give effect to a General Offer; or 

(iv) any disposal to any Group Company as part of an internal reorganisation of the Group. 

11. SURVIVAL OF AGREEMENT 
 This Agreement (and in
particular the warranties, covenants, agreements and undertakings of the Subscriber hereunder) shall insofar as the terms thereof remain to be performed or are capable of subsisting remain in full force and effect after and notwithstanding
Completion. 
 12. COSTS 
 Save as expressly otherwise
provided herein, each Party shall pay its own costs 

  
 28 

 and expenses in connection with the preparation and execution of this Agreement. 

13. ANNOUNCEMENTS 
 Save in respect of statutory returns or
matters required to be disclosed by law or regulation or to the London Stock Exchange or to the Panel on Takeovers and Mergers or to other governmental or regulatory authorities, none of the Parties shall make any press statement or other public
announcement in connection with this Agreement without the prior written approval of the text of such statement or announcement, in the case of the Subscriber by the Issuer or, in the case of the Issuer, by the Subscriber’s Solicitors. Where
any statement or announcement is required to be made by law or regulation, the Party required to make such announcement shall, where lawful and reasonably practicable to do so, consult with the other Party and take into account its reasonable
comments in connection with the substance of the announcement. 
 14. NOTICES 

14.1 Any notice or other communication to be given under or in connection with this Agreement (a “Notice”) shall be in the English language in
writing and signed by or on behalf of the Party giving it. A Notice may be delivered personally or sent by reputable international courier to the address provided in Clause 4.3 (with a copy to the fax number), and marked for the attention of the
person specified in that Clause. 
 14.2 A Notice shall be deemed to have been received: 

(A) at the time of delivery if delivered personally; or 
 (B)
five (5) Business Days after the time and date of despatch if sent by reputable international courier, 

  
 29 

 provided that if deemed receipt of any Notice occurs after 6.00 p.m. or is not on a Business Day, deemed
receipt of the Notice shall be 9.00 a.m. on the next Business Day. References to time in this Clause 14.2 are to local time in the country of the addressee. 

14.3 The addresses and fax numbers for service of Notice are: 
  

			
	Issuer:
		
	Name:	  	Lipoxen Plc
		
	Address:	  	18 Pall Mall, 2nd Floor, London SWIY 5LU
		
	For the attention of:	  	Scott Maguire, Chief Executive Officer
		
	 [***] 
	  	 [***] 

	
	Subscriber: 
		
	Name:	  	Limited Liability Company “SynBio”
		
	Address:	  	119333, Russian Federation, Moscow, Leninsky Avenue, 55/1, bldg. 2
		
	For the attention of:	  	P.V. Kruglyakov
		
	 [***] 
	  	 [***] 

 14.4 A Party shall notify the other Party of any change to its details in Clause 14.3 in accordance with the provisions of
this Clause 14, provided that such notification shall only be effective on the later of (i) the date specified in the notification; and (ii) five (5) Business Days after deemed receipt. 

  
 30 

 15. ENTIRE AGREEMENT 

15.l This Agreement, together with the Related Documents and any other documents referred to in this Agreement or any Related Document, constitutes the whole
agreement between the Parties and supersedes any previous arrangements or agreements between them relating to the subscription of the Subscription Shares and, for the avoidance of any doubt, supersedes and extinguishes the heads of terms entered
into between the Issuer and the Subscriber which shall cease to have any further force or effect. 
 15.2 Each Party confirms that it has not entered into
this Agreement or any other Related Document on the basis of any representation, warranty, undertaking or other statement whatsoever which is not expressly incorporated into this Agreement or the relevant Related Document. 

16. GOVERNING LAW AND ARBITRATION 
 16.1 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. 

16.2 Any dispute, controversy or claim arising out of, or in connection with, this Agreement, including a dispute as to the validity or existence of this
Agreement and/or this Clause 16.2, shall be finally resolved by arbitration in London conducted in English under the Rules of Arbitration of the ICC by three (3) arbitrators. Each Party shall nominate one (1) arbitrator and, the third
arbitrator, who will act as chairman, shall be nominated by the two (2) Party-nominated arbitrators. 

  
 31 

 16.3 A Party may apply to the English courts (but not, for the avoidance of doubt, any other courts) for interim
relief and/or conservatory measures (an “Interim Relief Application”) and any such Interim Relief Application shall not be deemed to be incompatible with, or a waiver of, the arbitration agreement. 

16.4 For the purposes of Clause 163, each of the Parties irrevocably submits to the exclusive jurisdiction of the courts of England. 

16.5 Where disputes arise out of or in connection with this Agreement or any Related Agreement which, in the reasonable opinion of the first panel of
arbitrators to be appointed in any of the disputes (the “First Panel”), are so closely connected that it is fair and expedient for them to be resolved in the same proceedings, the First Panel may, upon application by any
Party, order that the proceedings to resolve that dispute shall be consolidated with those to resolve any of the other disputes (whether or not proceedings to resolve those other disputes have yet been instituted). If the First Panel so orders, the
Parties to each dispute which is a subject of their order shall be treated as having consented to that dispute being finally decided: 
 (A) by the First
Panel unless the ICC Court decides that such panel would not be suitable; and 
 (B) in accordance with the procedure specified in the contract pursuant to
which the First Panel was appointed, unless otherwise agreed by all Parties to the consolidated proceedings or ordered by the First Panel, 

  
 32 

 and each Party hereby waives any right to object to the constitution of the First Panel upon such consolidation
on the grounds that it was not entitled to nominate an arbitrator. 
 17. CONTRACTS (RIGHTS OF THIRD PARTIES) ACT 1999 

17.1 The Parties agree and acknowledge that: 
 (A) nothing in
this Agreement is intended to benefit any person who is not a Party to it (a “Non-Party”) and accordingly no Non-Party has any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Agreement; and

 (B) the consent of any Non-Party shall not be required for any amendment to or termination of this Agreement. 

17.2 The provisions of Clause 17.2 do not affect any right or remedy of a third party which exists or is available otherwise than by operation of the
Contracts (Rights of Third Parties) Act 1999. 
 18. COUNTERPART 

This Agreement may be executed in counterparts and shall be effective when each Party has executed a counterpart. Each counterpart shall constitute an original
of this Agreement. 

  
 33 

 IN WITNESS WHEREOF this Agreement has been executed in London, the United Kingdom as a deed of each of the
Parties on the day and year first before written 

  
 34 

 SCHEDULE 1  

(Subscriber’s Warranties) 
 I.
AUTHORITY, CAPACITY AND ENFORCEABILITY 
 1.1 Incorporation. The Subscriber is duly incorporated, organised and validly existing under the laws of
the Russian Federation. 
 1.2 Power and authority. The Subscriber has the legal right, full power and authority and legal capacity to execute and
deliver, and to exercise its rights and to perform its obligations under, this Agreement and all other documents which are executed by it as envisaged by this Agreement. 

1.3 Legal validity. This Agreement and any other documents or Related Agreements to be executed by the Subscriber in connection with this Agreement
constitute and will, when executed , constitute valid and binding agreements in relation to the Subscriber enforceable against it in accordance with their respective terms. This Agreement and the transactions contemplated herein are in compliance
with Applicable Law. 
 1.4 Approvals. The Subscriber has obtained or satisfied all relevant corporate, regulatory and other approvals, or any other
conditions, necessary to execute, deliver and perform its obligations under this Agreement and all other documents which are executed by it as envisaged by this Agreement. 

1.5 No conflict. The execution, delivery and performance of this Agreement and any other documents to be executed by the Subscriber have been

 
duly and validly authorised and will not conflict with or constitute a breach of any law, regulation, agreement or comt order applicable to the Subscriber and in force at the date this Agreement
is signed in a way that would adversely affect the Subscriber’s ability to perform its obligations under this Agreement or such document in any material respect. 

1.6 FSMA. The Subscriber is a person who falls within Articles 19 or 49 of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005
and the Subscriber is purchasing the Subscription Shares for investment only and not for resale or distribution. 
 1.7 Securities Restrictions. The
Subscriber is not resident in the United States, Canada, Japan, the Republic of Ireland, the Republic of South Africa or Australia or in any other territory in which it is unlawful to subscribe for the Subscription Shares and it will not offer, sell
or deliver directly or indirectly any of the Subscription Shares in the United Shares, Canada, Japan, the Republic of Ireland, the Republic of South Africa or Australia or to or for the benefit of any persons who are resident or to any person
purchasing such shares for re-offer or sale of transfer in such jurisdictions. 
 2. INSOLVENCY 

2.1 Order or resolution. No order has been made, petition presented, resolution passed or meeting convened for the winding-up (or other process whereby
the business is terminated and the assets of the company concerned are distributed amongst the creditors and/or shareholders or other contributories) of the Subscriber and so far as the Subscriber is aware there are no cases or proceedings under any
applicable insolvency, reorganisation, or similar laws in any applicable jurisdiction concerning the Subscriber. 

  
 36 

 2.2 Proceedings. No petition has been presented or other proceedings commenced for an administration order
to be made (or any other order to be made by which during the period it is in force, the affairs, business and assets of the company concerned are managed by a person appointed for the purpose by a court, governmental agency or similar body) in
relation to the Subscriber, nor has any such order been made. 
 2.3 Administrator. So far as the Subscriber is aware, no receiver (including an
administrative receiver), liquidator, trustee, administrator, custodian or similar official has been appointed in any applicable jurisdiction in respect of the whole or any part of business or assets of the Subscriber. 

2.4 Insolvent. The Subscriber is not insolvent or unable to pay, or capable of being deemed unable to pay in accordance with any Applicable Law, its
debts as they fall due. 

  
 37 

 SCHEDULE 2 

(Issuer’s Warranties) 
 1. AUTHORITY,
CAPACITY AND ENFORCEABILITY 
 1.1 Incorporation. The Issuer is duly incorporated, organised and validly existing under the laws of England and Wales.

 1.2 Power and authority. The Issuer has the legal right and power, authority and legal, a capacity to execute and deliver, and to exercise its rights and
to perform its obligations under, this Agreement, the Related Agreements and all other documents which are executed by it as envisaged by this Agreement and/or the Related Agreements, and the directors will have, subject to satisfaction of the
Resolutions Precedent, sufficient authority under Section 551 of the Companies Act to issue and allot the Subscription Shares. 
 1.3 Legal validity. This
Agreement, the Related Agreements and any other documents to be executed by the Issuer in connection with this Agreement and the Related Agreements constitute and will, when executed, constitute valid and binding agreements in relation to the Issuer
in accordance with their respective terms. This Agreement, the Related Agreements and the transactions contemplated herein are in compliance with Applicable Law. 

1.4 Approvals. The Issuer has obtained or will obtain upon satisfaction of the Resolutions Condition Precedent or satisfied all corporate, regulatory and
other approvals, or any other conditions, necessary to execute, deliver and perform its obligations under this Agreement, the Related Agreements and all other documents which are executed by it as envisaged by this Agreement. 

 1.5 No conflict. The execution, delivery and performance of this Agreement and the Related Agreements by
the Issuer has been duly and validly authorised and will not conflict with or constitute a breach of any law, regulation, agreement or court order applicable to the Issuer and in force at the date of this Agreement is signed in a way that would
adversely affect the Issuer’s ability to perform its obligations under this Agreement and the Related Agreements in any material respect. 

2. ISSUER’S GROUP 
 2.1 The Issuer is a public
company limited by shares. 
 2.2 As at the date of this Agreement, the Issuer’s entire issued share capital comprises 177,432,255 Ordinary Shares,
before the issue of the Subscription Shares. 
 2.3 At the date of this Agreement and at Completion: 

(A) the Subscription Shares will on issue be credited as fully paid (subject to receipt of payment thereon) free from any and all pre-emptive rights, options,
rights to acquire, mortgages, charges, pledges, liens or other form of security or encumbrance or equity on, over or affecting them and will have the same rights as, and rank pari passu in all respects with, the existing Ordinary
Shares of the Issuer and will rank in full for all dividends and other distributions declared, made or paid on the Subscription Shares after the date of issue; 

(B) the issue of the Subscription Shares will comply with all agreements to which the Issuer is a party or by which it or any of its properties or assets is
bound and will not infringe any restrictions or the terms of any contract, obligation or commitment of the Issuer; 

  
 39 

 (C) at Completion the Issuer and its directors will have power to allot and issue the Subscription Shares in the
manner contemplated by this Agreement without any sanction or consent by members of the Issuer or any class of them and there will be no consents or approvals required by the Issuer for the allotment and issue of the Subscription Shares which have
not been irrevocably and unconditionally obtained; 
 (D) the allotment of the Subscription Shares will comply with the Companies Act, the Financial
Services and Markets Act 2000 (as amended) and the AIM Rules, the City Code and all other relevant laws and regulations of the United Kingdom; 
 2.4 The
issued shares in Lipoxen Technologies Ltd have been issued in proper legal form and are fully paid or credited as fully paid. 
 2.5 The issued shares in
Lipoxen Technologies Ltd are legally and beneficially owned by the Issuer free from all Encumbrances. 
 3. COMPLIANCE WITH LAWS 

3.1 The Issuer has complied in all material respects with all material applicable laws and provisions, in particular, the provisions of the Companies Act and
all returns, particulars, resolutions and other documents required under any legislation to be delivered on behalf of the Issuer to the Registrar of Companies or to any other authority whatsoever have been properly made and delivered within the
requisite time limits. 
 3.2 The Issuer has complied in all material respects with the provisions of the AIM Rules. 

3.3 Neither the Issuer nor any person for whom it is vicariously responsible has committed 

  
 40 

 
any material breach of or failed materially to perform or observe any provision of its Memorandum or Articles of Association or of any legislation in any part of the world or any covenant or
agreement or the terms or conditions of any consent or licence or any judgment or order of a Court or other competent tribunal or authority by which the Issuer is bound or to which it is a party or which affects any of its assets. 

4. RNS ANNOUNCEMENTS  
 The Issuer has made all
announcements required by and in accordance with all applicable laws, including the AIM Rules. Each such announcement and all statements contained therein (other than expressions of opinion, intention or expectation of the directors of the Issuer)
were true and accurate in all material respects, not misleading in any material respect and all expressions of opinion, intention or expectation of the directors of the Issuer contained therein were made on reasonable grounds and were truly and
honestly held by the directors of the Issuer and were fairly based. 
 5. INSOLVENCY  

5.1 No order has been made or resolution passed for the winding up of the Issuer and no provisional liquidator has been appointed. No petition has been
presented or meeting convened for the purposes of winding up the Issuer and no voluntary arrangement has been proposed. The Issuer has not become subject to any analogous proceedings or arrangements under the laws of any applicable jurisdiction.

 5.2 No administrator, administrative receiver or any other receiver or manager has been appointed by any person in respect of the Issuer or all or any of
its assets and no steps have been taken to initiate any such appointment. No analogous appointments have been made or, so far as the Issuer is aware, been initiated under the laws of any applicable jurisdiction. 

  
 41 

 5.3 The Issuer has not received any notice relating to, nor is it or could it be deemed unable to pay its debts
for the purpose of section 123 of the Insolvency Act 1986. 
 6. NO MATERIAL CHANGE  

6.1 Since. the Accounting Date and save as further described in the Circular or in any RNS announcement of the Issuer: 

(A) the business of the Issuer and Lipoxen Technologies Ltd has been carried on in the ordinary course and so as to maintain it as a going concern and there
has been no material adverse change in the financial position or trading or prospects of the Issuer; 
 (B) the Issuer has not made or agreed to make any
payment or entered into any transaction or commitment or incurred any liability except in the ordinary course of its trading and for full value; 
 (C) the
Issuer has not acquired or disposed of or agreed to acquire or dispose of any business or any material asset other than trading stock in the ordinary course of business; and 

(D) no distribution of capital or income has been declared or paid in respect of any share capital or assets of the Issuer. 

6.2 Since the Accounting Date the business of the Issuer or Lipoxen Technologies Ltd has not been materially or adversely affected by the loss of any
important customer(s) or source(s) of supply or any abnormal factor(s) not affecting similar businesses to a similar extent, and the Issuer is not aware of any facts likely to give rise to any such effect whether before or after Completion. 

  
 42 

 7. INTELLECTUAL PROPERTY  

7.1 The Issuer (together with Lipoxen Technologies Ltd) owns all Group IP Rights. 

[***]

 

7.3 Save for [***] so far as the Issuer is
actually aware:
 (A) there has been no act or omission by any Group
member or any person acting on its behalf which will, or could reasonably be expected to, give rise to any material Group IP Rights being or becoming invalid or unenforceable; 

(B) there has not occurred any act, omission or event which would entitle any regulatory authority or other person to cancel, forfeit or modify any material
Group IP Rights; 

  
 43 

 (C) no person has made any claim adverse to the Group’s continuing enjoyment of any material Group IP
Rights; 
 (D) there is, and has been, no actual or threatened infringement (including misuse of confidential information), or any event likely to
constitute infringement, by any third party of any material Group IP Rights; 
 (E) each agreement under which any Group member is authorised to use or
exploit any material Group IP Rights is in full force and effect; 
 (F) no event has occurred or is about to occur which would or could entitle any third
party to terminate any such agreement prematurely; and 
 (G) the carrying on of the Group’s current and proposed activities as described has not, and
will not, result in any material claim by any third party that any Group member or any licensee of any Group member has infringed or will infringe any patent or other intellectual property right. 

7.4 No Group member has granted, nor is obliged to grant, any licence under or in relation to any material Group IP Rights to any person. 

8. PATENTS  
 8.1 Each material Patent is a valid and
subsisting granted patent and is not the subject of any material claim or proceedings which could result in it being invalidated, revoked or restricted in scope. The Issuer is not actually aware of any reason why any such claim or proceedings
may be brought in the future. 

  
 44 

 8.2 The Issuer is not actually aware of any reason why any material Patent that is an application will fail to
result in the grant of a patent with no material reduction in the scope applied for in any country. 

  
 45 

 SCHEDULE 3 

(Form of Application for Subscription Shares) 
  

	To:	The Directors 

 [Issuer] 

 

	From:	[Subscriber] 

 [—] 2011 

Dear Sirs, 
  

	Re:	Subscription for Ordinary Shares in the Capital of [—] (“the Issuer”) 

We write with reference to the Subscription Agreement dated [—] 2011 between
the Issuer and ourselves relating to ordinary shares of 0.5p in the capital of the Issuer (the “Subscription Agreement”). 
 Terms set out in the
Subscription Agreement shall have the same meaning in this Form of Application. 
 In accordance with Clause 6.4(A) of the Subscription Agreement, we
hereby subscribe for [—] new Ordinary Shares of 0.5p each in the capital of the Issuer at the Subscription Price. 

Yours faithfully, 
 For and on behalf of 

[Subscriber] 

  
 46 

 

					
	EXECUTED and DELIVERED as a Deed	 	 )

		
	 by LIPOXEN PLC
	 	 )

			
	 acting by:
	  		 	 )

			
	  
 Director
	  	 

	 	
			
	 Director/Secretary
	  	 

	 	
		
	 EXECUTED and DELIVERED as a Deed
	 	 )

		
	 by SYNBIO LLC
	 	 )

			
	 acting by:
	  		 	 )

		
	 General Director
	 	
	
	[Affix Corporate Seal of the Subscriber]

 

  
 

 

 

  
 47 

					
	EXECUTED and DELIVERED as a Deed	 	)
		
	by LIPOXEN PLC	 	)
			
	acting by:	 		 	)
			
	Director	 		 	
		
	Director/Secretary	 	
		
	EXECUTED and DELIVERED as a Deed	 	)
		
	by SYNBIO LLC	 	)
			
	acting by:	 	 

	 	)
		
	General Director	 	

 [Affix Corporate Seal of the Subscriber] 

 

					
	EXECUTED and DELIVERED as a Deed	  	)
		
	by LIPOXEN PLC	  	
			
	acting by:	  		  	)
			
	Director	  	

	  	
			
	Director/Secretary	  	

	  	
		
	EXECUTED and DELIVERED as a Deed	  	)
		
	by SYNBIO LLC	  	)
			
	acting by:	  	

	  	)
	General Director	  	  	

 

  
 

 

 

  
 [Affix Corporate Seal of the Subscriber]

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00240-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00240-of-00352.parquet"}]]