Document:

EX-10.25

 Exhibit 10.25 

* Certain confidential information contained in this document, 

marked by brackets, has been omitted and filed separately 

with the Securities and Exchange Commission pursuant to 

Rule 406 of the Securities Act of 1933, as amended. 

DATED May 14, 2015 

(1) EXTAB CORPORATION 

(2) SOPHARMA AD 
  

 
 Technical and
Quality Agreement 
  
  

 
  

*Confidential Treatment Requested 

  

 

 

 THIS TECHNICAL AND QUALITY AGREEMENT (the “Agreement”) is made on 14 May 2015
(the “Effective Date”) 
 BETWEEN:- 
  

	(1)	EXTAB CORPORATION of Corporation Trust Centre 1209 Orange Street, Wilmington, Delaware 19801, USA (“EXTAB”); and 

 

	(2)	SOPHARMA AD of 16, Iliensko Shosse Boulevard, 1220 Sofia, Bulgaria (“SOPHARMA”) 

 each
a “Party” and together the “Parties”. 
 WHEREAS:- 

 

	(A)	The Parties entered into a commercial agreement on the supply of pharmaceutical products on 1 February 2010 (the “Supply Agreement”), under which Sopharma manufactures and supplies the products (as
defined therein) to Extab. 

  

	(B)	Pursuant to the Supply Agreement the Parties wish to outline Sopharma’s detailed obligations in relation to the manufacture and quality of the Products. 

IT IS AGREED as follows: - 
  

	1.	INTERPRETATION 

  

	1.1	In this Agreement:- 

  

			
	“Active Agent”	  	means the active pharmaceutical ingredient, Cytisine (including intermediates, salts, esters and pharmaceutical compositions containing Cytisine;
		
	“Batch Release Documentation”	  	means executed batch records, test records, Certificate of Analysis and Certificate of Compliance;
		
	“Certificate of Analysis”	  	means in respect of a product and/or material, a certificate signed by a qualified and authorised representative of the manufacturer confirming results of analysis of such product and/or material and that such product and/or
material complies with its agreed specification along with the methods by which the analysis was performed;
		
	“Certificate of Compliance”	  	means in respect of the Product, a certificate signed by a qualified and authorised representative of Sopharma confirming that the Active Agent is cGMP compliant;
		
	“Certificate of Conformance”	  	means in respect of the Product, a certificate signed by a qualified and authorised representative of Sopharma confirming that the Product complies with this Agreement and the Specifications;
		
	“Contact Persons Table”	  	means the Parties’ contact details as set out in the table in Schedule 2;

  
 *Confidential Treatment Requested

  
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	“Critical Quality Attributes”	  	means aspects influencing Active Agent purity, potency, stability and drug release and are defined by Raw Material, in-process control, intermediate products and Active Agent’s
Specifications;
		
	“cGMP”	  	means current Good Manufacturing Practice as defined in the laws, regulations and guidance of the European Union and all other corresponding applicable national laws and regulations;
		
	“Deviation”	  	means a critical deviation or OOS or OOT that may directly or indirectly influence the specified Critical Quality Attributes of Raw Material, process intermediates and the Active Agent and/or their regulatory compliance;
		
	“Division of Responsibilities Table”	  	means the table set out in Schedule 1;
		
	“Finished Product”	  	shall nave the meaning set out in the Supply Agreement;
		
	“Master Batch Records”	  	means a record that describes the step by step procedures to be followed during manufacturing the Active Agent, and used to generate each individual batch record that is issued when a given batch of Active Agent is to be
manufactured;
		
	“OOS”	  	means that the Product and/or Active Agent is out of the Specifications;
		
	“OOT”	  	means that the Product and/or Active Agent is out of trend;
		
	“Product”	  	has the meaning set out in the Supply Agreement and includes the Active Agent and the Finished Product;
		
	“Quality Unit”	  	means the group of persons responsible for the quality and safety relating to the Product;
		
	“Raw Materials”	  	means all materials, reagents, solvents, chemicals and similar components intended for use in the production of intermediates or the Active Agent, including [Sopharma to insert specific raw materials]; and
		
	“Specifications”	  	means the specifications of the Active Agent and Finished Product set out in Schedule 3.

  

	1.2	Clause headings shall not affect the interpretation of this Agreement. References to Clauses and Schedules are to the clauses of and schedules to this Agreement. 

 

	1.3	Unless the context otherwise requires, words in the singular include the plural and in the plural include the singular and a reference to one gender shall include a reference to the other genders. 

 

	1.4	A reference to a statute, statutory provision or subordinated legislation is a reference to it as it is in force from time to time, or extended obligation, liability or restriction on, or otherwise adversely affect the
rights of, any party. A reference to a statute or statutory provision shall include any subordinate legislation made from time to time under that statute or statutory provision. 

 
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	1.5	Any words following the terms including, include, in particular or any similar expression shall be constructed as illustrative and shall not limit the sense of the words preceding those terms. 

 

	2.	DIVISION OF RESPONSIBILITIES 

 Each Party shall be responsible for meeting their
respective responsibilities as set out in the Division of Responsibilities table. 
  

	3.	CONTACT PERSONS 

 All communications between the Parties under this Agreement shall be in
accordance with the Contact Persons Table, as appropriate. 
  

	4.	EQUIPMENT AND PROCESS REQUIREMENTS 

  

	4.1	[Sopharma to insert any specific requirements relating to the equipment and/or process (i.e. certificates, equipment materials etc.)] 

 

	5.	METHODS 

  

	5.1	Sopharma is responsible for facility, utility and equipment qualification and ensuring that these items remain within a qualified and validated state. Qualification documentation shall be available for review during an
audit. 

  

	5.2	Sopharma is responsible for maintenance, qualification of the facility and equipment of the Active Agent. 

  

	5.3	Sopharma is responsible for providing the Master Batch Records to Extab for approval prior to and after process execution. 

  

	6.	RAW MATERIALS 

  

	6.1	Sopharma shall be responsible for the purchase, storage, handling, sampling, testing and approval or rejection of materials used in manufacturing the Active Agent pursuant to the Supply Agreement. 

 

	6.2	Sopharma must utilize documented material inspection plans and testing procedures. The results of this inspection and testing must be in accordance with any and all instructions supplied by Extab. 

 

	6.3	Sopharma will inspect and/or test all materials on a batch-by-batch basis. 

 

	6.4	Sopharma shall only purchase materials from approved suppliers. Approval by Extab is required for any change in the supplier of Raw Material. 

 

	6.5	Sopharma will provide the material name, supplier name and a Certificate of Analysis for all Raw Materials used in the manufacturing of the Active Agent to Extab. 

 

	6.6	Raw Materials supplied by qualified vendors can be subject to reduced testing but a minimum identification testing (or visual examination in case of hazardous or highly toxic raw materials) needs to be performed for
each Delivery (as defined in the Supply Agreement) and each batch. 

  

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	7.	MANUFACTURING 

  

	7.1	Sopharma shall manufacture the Product in accordance with this Agreement, the Supply Agreement, cGMP and the Specifications. 

  

	7.2	Manufacturing processes will be performed in cGMP classified areas for the production of the Active Agent. Manufacturing will be performed in accordance to regulatory guidelines and will be documented accordingly.

  

	7.3	Manufacturing Master Batch Records will be prepared by Sopharma and approved by Extab prior to the start of production. 

  

	7.4	Extab representatives will be allowed on-site for support during all manufacturing operations. To the extent possible, Extab will notify Sopharma in advance for prior
arrangements. 

  

	7.5	The Parties agree that the below flow diagram represents the Product manufacturing process: 

[Sopharma to insert flow diagram for Product production] 
  

	8.	RETENTION SAMPLES AND REFERENCE SAMPLES 

  

	8.1	Sopharma will take and retain samples of Raw Materials necessary for full testing requirements. Such samples will be stored for three (3) years past the expiration date of the Raw Material. Extab will be notified
and consulted prior to disposal of any such samples. 

  

	8.2	Sopharma will take and retain samples of the Active Agent equivalent to at least [...***...] times the amount of full testing requirements. The samples and retains will be stored for three (3) years past the
retest date of the Raw Material. Extab will be notified and consulted prior to disposal of any such samples. 

  

	8.3	Sopharma will be responsible for retention, maintenance and management of samples in accordance with cGMP requirements. 

  

	8.4	Sopharma will be responsible for the annual visual inspection of the reserve samples of the Active Agent and communication of the results of the inspection to Extab. 

 

	9.	STORAGE AND PACKAGING PROCESS 

  

	9.1	Sopharma is responsible for managing the storage of Raw Materials used for the manufacture of the Active Agent, all Active Agent process intermediates and the Active Agent at all times and ensuring that the materials
are stored under appropriate conditions and in accordance with cGMP requirements. 

  

	9.2	The Parties agree that the below flow diagram represents the Product packaging process: 

[Sopharma to insert flow diagram for Product packaging process] 
  

	10.	SAFETY, CLEANING AND WASTE MANAGEMENT 

  

	10.1	Extab will disclose any and all available toxicological, eco-toxicological and any Active Agent related safety or adverse event within a reasonable timeframe. 

 

	10.2	Sopharma is responsible for cleaning and waste management of the manufacturing facility in accordance with Extab approved Standard Operating Procedures (SOPs) and in compliance with all local laws and regulations
associated with waste disposal. 

  
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Treatment Requested 

  
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	11.	QUALITY CONTROL 

  

	11.1	New reference standards will not be qualified by Sopharma without prior written authorization from Extab. 

  

	11.2	The in-process control (“IPC”) samples, process intermediate products and the Active Agent will be tested by Sopharma according to the instructions and written
procedures agreed upon by the Parties. 

  

	12.	DEVIATION AND OUT OF SPECIFICATION 

  

	12.1	Any Deviations and/or OOS during manufacturing and/or testing will be communicated to Extab in writing within one (1) week of confirmation. After confirmation of an OOS or Deviation, no additional testing or
sampling shall be performed without prior approval from Extab. 

  

	12.2	Any non-critical deviations from approved procedures for manufacturing and testing of the Active Agent will be assessed and approved by Sopharma’s Quality Unit.

  

	12.3	All Deviation and OOS reports, critical and non-critical, will include the following:- 

  

	 	12.3.1	occurrence date; 

  

	 	12.3.2	list of impacted batch(es); 

  

	 	12.3.3	description of the Deviation or OOS and immediate actions taken; 

  

	 	12.3.4	impact of the Deviation or OOS on Active Agent quality; 

  

	 	12.3.5	investigation summary (if applicable); 

  

	 	12.3.6	root cause (if known); and 

  

	 	12.3.7	corrective and preventive action (if applicable). 

  

	12.4	All Deviation or OOS will be investigated for root cause and fully documented by Sopharma within thirty (30) calendar days of the date of discovery. These investigations will include proper justification,
scientific rationale and data where appropriate. In the event that a Deviation cannot be resolved within thirty (30) calendar days, Sopharma will provide a memorandum to Extab with periodic updates at least every fourteen (14) calendar
days of the investigation’s progress. 

  

	12.5	Extab may participate in any full-scale investigation concerning all Deviations and OOS results. 

  

	12.6	Documentation related to investigations will be retained as part of the batch. Copies of the completed and approved Deviation or OOS reports will be provided to Extab immediately. 

 

	12.7	When deemed necessary, Extab reserves the right to request additional or more in-depth investigation of the Deviation or OOS by Sopharma. 

 

	12.8	In all cases, when a critical Deviation or OOS occurs on a batch, Extab will have the final review and decision-making responsibility as to the impact of the Deviation(s) on the Active Agent which will include
disposition of the affected batches. 

  

	13.	CHANGE CONTROL AND COMPLIANCE 

  

	13.1	All SOPs are managed by Sopharma. 

  

*Confidential Treatment Requested 

  
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	13.2	Sopharma will communicate to Extab without delay and in due time any critical change request(s) in manufacturing and testing of the Active Agent. Extab will approve the change requests prior to implementation.

  

	13.3	Extab shall assess any change request received from Sopharma in a timely manner, and Extab will not unreasonably withhold its approval of the change request. 

 

	13.4	Changes related to creation of documents such as specifications for non-critical Raw Materials or compendial methods do not require Extab approval. Copies of such changes will be
provided to Extab. 

  

	13.5	Reworking shalI be performed according to Extab approved procedures and reported to Extab. Reasons for reprocessing have to be investigated, and the results shall be communicated with Extab. Reworking is only possible
after approval by Extab. 

  

	14.	BATCH RELEASE 

  

	14.1	Sopharma will perform the release of each batch according to in-house Extab approved SOPs. 

  

	14.2	Sopharma will provide a copy of executed batch records and supporting release documentation (i.e. in-process and batch test results, Deviation) for Extab review within thirty
(30) working days after completion of the associated operation. 

  

	14.3	Extab will contact Sopharma with request for corrections, clarifications or other comments and responses shall be forthcoming within ten (10) business days. 

 

	14.4	Sopharma will keep on file Batch Release Documentation for five (5) years after the batch is Delivered. The storage date commences after review and approval of Batch Release Documentation. After five
(5) years, all documents will be archived by Sopharma. During the storage period, these documents must be accessible for review and inspection by Extab and/or regulatory authorities if requested for each batch of the Active Agent.

  

	15.	SHIPMENT AND RELEASE OF ACTIVE AGENT 

  

	15.1	Sopharma will perform alI release testing of the Active Agent according to Extab approved in-house SOPs and the Active Agent’s Specifications. 

 

	15.2	Sopharma is responsible for releasing the Active Agent to Extab. 

  

	15.3	Sopharma will not ship any intermediate or Active Agent for further processing until authorized by Extab. [Extab will provide specific instructions on how to package and ship the material from Sopharma to destinations
specified by Extab]. 

  

	15.4	Sopharma will use Extab approved shipping vendors for the shipment of intermediates and Finished Product. 

  

	16.	RELEASE DOCUMENTATION FOR ACTIVE AGENT 

  

	16.1	Sopharma will provide to Extab a copy of Certificate of Analysis for the respective Active Agent. 

  

	16.2	The following documentation is required for each Delivery:- 

  

	 	16.2.1	Certificate of Analysis; 

  

	 	16.2.2	Certificate of Compliance; 

  

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	 	16.2.3	Certificate of Conformance; and 

  

	 	16.2.4	copies of investigation reports regarding quality incidents (Deviations, OOS results, or similar), as applicable. 

  

	16.3	The Certificate of Analysis in Clause 16.2.1 shall:- 

  

	 	16.3.1	be dated and signed by a responsible person of Sopharma’s Quality Unit: 

  

	 	16.3.2	state that the batch is suitable for release; 

  

	 	16.3.3	include:- 

  

	 	(a)	Sopharma’s name, address, and telephone number (of the manufacturing site); 

  

	 	(b)	Active Agent name; 

  

	 	(c)	Sopharma batch number; 

  

	 	(d)	reference to the Active Agent’s Specification; 

  

	 	(e)	test parameters and corresponding specification requirements; 

  

	 	(f)	test results (numerical, where applicable) for each chemical or physical test performed; and 

  

	 	(g)	date of manufacture, retest date, and date of release of the Active Agent. 

  

	16.4	Upon request, Sopharma will provide to Extab any and all data for assessment of the Active Agent. 

  

	17.	ACTIVE AGENT STABILITY AND RETEST DATE 

 Extab is responsible for (a) monitoring the
stability, and (b) specifying the retest date of the Active Agent. 
  

	18.	SUBCONTRACTING 

  

	18.1	Sopharma, upon agreement with Extab, will be entitled to delegate analytical testing to third parties. 

  

	18.2	Sopharma is fully responsible for the proper qualification of subcontractors and any and all of their acts and/or omissions relating to this Agreement. 

 

	19.	AUDIT 

 Subject to the confidentiality provisions in the Supply Agreement, Extab shall
have the right to inspect and/or audit the Sopharma facility on reasonable notice as it relates to the development, manufacture, testing and control of the Active Agent. Extab will have access to any and all documentation (including lab books,
records, data, hard drives, servers) relating to the Active Agent and may take copies of the same. Extab will schedule a formal quality audit no more than twice per year at times during business hours mutually agreed upon by Extab and Sopharma.
Responses to any observations submitted by Extab to Sopharma must be submitted to Extab within thirty (30) days of receipt of such observations. 
  

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	20.	ACTIVE AGENT COMPLAINTS 

  

	20.1	Extab will inform Sopharma about any Active Agent complaint which may pertain to the manufacturing process of the Active Agent. 

  

	20.2	Sopharma will support Extab’s investigation and corrective action it the complaint is within the scope of the manufacturing process conducted at Sopharma. 

 

	21.	ACTIVE AGENT RECALLS 

  

	21.1	In the event that Sopharma believes that a recall of the Active Agent maybe necessary or appropriate, Sopharma shall immediately notify Extab. The Parties will make joint decisions on the disposition of Active Agent

  

	21.2	Sopharma will not initiate any notifications to health authorities concerning a (potential) non-conformance without the prior agreement of Extab. 

 

	21.3	Extab is responsible for the final decision and the coordination of any recalls or field alert activities relating to the Active Agent. 

 
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	SIGNED by	  	)
		
	a duly authorised officer	  	) /s/ Extab Corporation
		
	for and on behalf of	  	)
		
	EXTAB CORPORATION	  	)
		
	in the presence of:	  	)
		
	Signature of Witness:	  	
		
	Name of Witness:	  	
		
	Address:	  	
		
	Occupation:	  	
		
	SIGNED by	  	)
		
	a duly authorised officer	  	) /s/ Sopharma AD
		
	for and on behalf of	  	)
		
	SOPHARMA AD	  	)
		
	in the presence of:	  	)
		
	Signature of Witness:	  	
		
	Name of Witness:	  	
		
	Address:	  	
		
	Occupation:	  	

  
 *Confidential Treatment Requested

  
 9EX-10.26

 Exhibit 10.26 

CONSULTING AGREEMENT 

THIS CONSULTING AGREEMENT (this “Agreement”) is entered into and is effective as of the 17th day of September, 2015 between Ricanto Limited (“Consultant”), residing at Century House, Wargrave Road,
Henley-on-Thames, Oxfordshire RG9 2LT and EXTAB PHARMA, INC., a Delaware corporation (the “Company”). 

WHEREAS, the Company is engaged in the business of developing clinical programs to obtain regulatory approval of the pharmaceutical
“Tabex”; 
 WHEREAS, Consultant has knowledge and expertise in connection with certain pharmaceuticals relevant to the
production and marketing of Tabex; and 
 WHEREAS, the parties desire to formalize their relationship and set forth their obligations
to the other in connection with such relationship. 
 NOW THEREFORE, in consideration of the mutual promises contained herein and for
other good and valuable consideration, the parties intending legally to be bound agree as follows: 
 1. Term. This Agreement shall
begin on 17th September, 2015 (the “Effective Date”) and continue until terminated by either party in accordance with the terms of paragraph 5 below (“the Term”). 

2. Services. During the Term, Consultant will be available to provide the Company up to 40 hours per week of strategic consulting and
marketing services in connection with those matters which the Company designates, including, but not limited to, advice concerning Sopharma, cytisine supply chain, Clinical development, strategic, regulatory and any other matters relating to Tabex
and cytisine as requested by the Company (the “Services”). 
 3. Consulting Fee. $41,666 per month paid by the 15th of
the following month. 
 4. Business Expenses. During the Term, Consultant shall bear all expenses incurred in connection with the
performance of the Services, except that the Company shall reimburse Consultant for the reasonable travel and entertainment expenses incurred while Consultant is required by the Company to be away from Consultant’s principal place of business,
subject to Consultant providing documentation of the costs so incurred. Consultant’s principal place of business shall be considered to be United Kingdom. 

5. Termination. 
 (a)
Consultant may voluntarily terminate his relationship with the Company during the Term upon 30 days’ written notice, and, upon such event, the Consultant will not provide services to the Company after the
30-day notice period. Upon Consultant’s termination of the relationship with the Company, the Company shall pay the Consulting Fee through the effective date of termination on a pro rata basis. 

  
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 (b) The Company may terminate the relationship with Consultant during the Term for any reason
upon 30 days’ written notice, except where such termination is for “cause” as defined below, in which event termination of the relationship shall be immediately effective upon written notice. In the event of a termination without
cause, or in the event Consultant gives notice pursuant to section (a) above, Company may, at its election, have Consultant continue or not continue to provide services to the Company through the notice period. For the purposes of this
provision, “cause” shall be defined to mean: (i) material breach of any provision of this Agreement, (ii) gross negligence of, or willful dishonesty by, Consultant towards, or fraud upon or deliberate injury to, the Company,
(iii) the Consultant’s being disqualified from or unable to perform its duties hereunder, or (iv) the Consultant’s willful refusal to perform its duties. 

6. Prior Agreements. Consultant has provided to the Company copies of any non- compete,
confidentiality, non-solicitation, or non-hire contracts or provisions currently applicable to Consultant. Consultant represents that he is legally free to accept this
engagement and to perform the services required hereunder. 
 7. Publicity. Any disclosure or public statements regarding the
contents or nature of this agreement shall be coordinated between the parties. 
 8. Independent Contractor – Taxes; Employees of
Consultant. Nothing herein shall be construed as creating any partnership, joint venture or agency relationship between the parties hereto. For the purposes of this Agreement, Consultant and the Company shall each be, and remain at all times,
independent contractors. The Company shall not be responsible for income tax withholding, social security taxes, unemployment insurance, disability or workers’ compensation insurance contributions for Consultant; rather, Consultant shall be
solely responsible for determining the amounts of and making all such payments. 
 9. Confidential Information. Each party
acknowledges that information provided by either party in connection with this Agreement may contain confidential and proprietary data, and disclosure of such information may be damaging to the disclosing party. The term “Confidential
Information”, means any and all technical and business information disclosed in any manner or form including, but not limited to financial plans and records, litigation data, marketing plans, business strategies, trade secrets, present and
proposed products, computer software programs, source code, relationships with third parties, customer lists, information regarding clients and suppliers and Privileged Information. Privileged Information shall mean written or oral information
created or possessed by Company or Company’s clients or its representatives that would be subject to a claim of privilege (e.g. attorney-client, work product, etc.) before a court or other tribunal. 

10. Non-Disclosure. (a) Consultant will not disclose Company’s Confidential
Information to anyone and Company will not disclose Consultant’s confidential information to anyone other than those within the Company who have a need to have access to such Confidential Information under this Agreement. Neither party may use
any of the Confidential Information of the other party for any other purpose than to perform a party’s obligations under the Agreement. Each party will use the same degree of care to protect Confidential Information of the other party as it
uses to protect its own Confidential Information of like importance, but no less than a reasonable degree of care. No license to either party’s Confidential Information is either granted or implied by the disclosure of Confidential Information.
The duties and obligations to protect Confidential Information will survive termination of this Agreement for any reason. 

  
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 (b) Exceptions. The receiving party will not have any obligation with respect to any
Confidential Information of the disclosing party which the receiving party can establish: (i) is or becomes publicly available through no wrongful act of the receiving party; (ii) was lawfully obtained by the receiving party from a third
party without any obligation to maintain the Confidential Information as proprietary or confidential; (iii) was previously known to the receiving party without any obligation to keep it confidential; (iv) was independently developed by the
receiving party; (v) is required to be disclosed pursuant to the law, court order, or duly authorized subpoena, provided that the recipient promptly notifies the other party prior to disclosure, and provided further that the recipient makes
diligent efforts to limit such disclosure to that which is reasonably required; or (vi) is required to be disclosed pursuant to a regulatory agency or for audit purposes, provided that the recipient is notified of the confidential nature of the
Information. 
 11. Non-Solicitation. (a) During the term of this Agreement and for a
period of one (1) year thereafter, Consultant promises and agrees that he will not without the prior written approval of Company (i) employ or hire, or engage as a consultant or subcontractor, any employee or subcontractor of Company or
its affiliates, (ii) solicit any employee or subcontractor of Company or of its affiliates to become an employee or subcontractor of any other party, or (iii) recommend or suggest to any other person or entity that such person or entity so
solicit, employ, hire, or engage any such employee or subcontractor. 
 (b) During the term of this Agreement, Consultant agrees that he
will not provide similar consulting services to any competitor of the Company without first obtaining written agreement to do so from the Company. During the term hereof and for a period of one (1) year from the termination of this Agreement,
the Consultant shall not directly or indirectly interfere with, disrupt, or attempt to interfere with or disrupt, the Company’s relationships, contractual or otherwise, with its customers, or engage in the solicitation or inducement of
customers of the Company to breach, modify, or terminate any agreement(s) or relationship(s) they may have with the Company. 
 (c) Upon
termination of this Agreement, Consultant shall promptly return any originals and copies of any and all documents, whether in hard or soft format, and any other property, belonging to the Company. 

12. Injunctive Relief. The Consultant recognizes and acknowledges that the Confidential Information and
Non-Solicitation obligations have competitive value and that irreparable damage might result to the Company if Confidential Information is improperly disclosed by the receiving party to any non-authorized third party, or if the Non-Solicitation provision is violated. The parties agree that legal proceedings at law or in equity, including injunctive relief, may be
appropriate in the event of a breach of paragraphs 10 or 11. 
 13. Assignment of Rights to Company. The Company shall be the
sole and exclusive owner of all of the results and proceeds of Consultant’s services, work and labor during the Term, including, without limitation, all property of a proprietary nature which Consultant may

  
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develop, create, write or otherwise produce during the Term, which shall be deemed to be works- made-for-hire for
the Company within the meaning of the copyright laws of the United States and the Company shall be deemed to be the sole author thereof in all territories and for all purposes. The Consultant agrees to and does assign to the Company all of the
Consultant’s rights and interests in any confidential/proprietary information which the Consultant may, during the Term, conceive, develop, or produce in connection with the performance of the services hereunder. The Consultant shall, at the
request of the Company, execute such assignments, certificates, or other instruments as the Company may from time to time deem necessary or desirable to evidence, establish, maintain, perfect, enforce, or defend its right to or its title and
interest in or to any such properties. The terms of this paragraph shall continue after the termination of this Agreement. 
 14.
Disputes/Arbitration. In the event any disputes or controversies arise between the parties, the aggrieved party shall advise the other party of the dispute in writing within ten (10) business days. Within ten (10) business days
after written notice is received, an authorized representative for each party shall meet and attempt to resolve the dispute. Any agreement reached relating to the dispute shall be committed to writing and signed by both authorized representatives.
Disputes arising hereunder which cannot be resolved between the parties shall be submitted to binding arbitration by a single arbitrator appointed in accordance with, the then current commercial arbitration rules of the American Arbitration
Association. Any such arbitration shall be conducted in Newark, Delaware unless otherwise agreed by the parties. The parties shall share equally the costs and expenses of any such arbitration. Judgment upon the award rendered by the arbitrator may
be entered in any court having competent jurisdiction. 
 15. Limitation of Authority. Consultant shall have no authority to bind the
Company by or to any obligation, agreement, promise or representation without first obtaining the Company’s prior written approval. 

16. (a) Consultant represents and warrants that all work Consultant performs pursuant to this Agreement will be performed with a professional
level of skill and will conform to the instructions and specifications set forth herein or as orally directed by the Company. 
 (b)
Consultant hereby indemnifies and agrees to hold the Company (and its officers, directors, employees and agents), harmless from and against any loss, liability, damage, cost or expense (including, without limitation, reasonable attorneys’ fees
and expenses) suffered or incurred by any of them and arising out of (i) Consultant’s gross negligence or willful misconduct; (ii) Consultant’s infringement or violation of the proprietary or intellectual property rights of any
third party; or (iii) Consultant’s breach of any of the terms of this Agreement. The Company hereby indemnifies and agrees to hold the Consultant harmless from and against any loss, liability, damage, cost or expense (including, without
limitation, reasonable attorneys’ fees and expenses) suffered or incurred by Consultant arising as of (i) the Company’s gross negligence or willful misconduct; (ii) the Company’s infringement or violation of the proprietary
or intellectual property rights of a third party; or (iii) the Company’s breach of any of the terms of this Agreement. 

  
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 17. Miscellaneous. This Agreement shall be governed by and construed under the laws of the
State of Delaware, without regard to its conflict-of-laws rules. The waiver by either the Company or Consultant of a breach of any provision of this Agreement shall not
operate or be construed as a waiver or any subsequent breach by the Company or Consultant. This Agreement shall be binding upon and shall inure to the benefit of both the Company and Consultant and their respective successors, heirs and legal
representatives; provided, Consultant shall not assign any rights or obligations under this Agreement without the consent in writing of the Company. No amendments or variations of the terms and conditions of this Agreement shall be valid unless the
same is in writing and signed by both of the parties hereto. If any provision of this Agreement is declared by any court of competent jurisdiction to be invalid for any reason, such invalidity shall not affect the remaining provisions of this
Agreement. Such remaining provisions shall be fully severable, and this Agreement shall be construed and enforced as if such invalid provisions had never been a part of this Agreement. This Agreement contains the entire agreement between the
parties, with respect to the subject matter hereof, and supersedes any and all prior agreements, and understandings written or oral, between the Company and Consultant. 

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first above written. 

 

	
	Ricanto Limited
	
	 /s/ Richard Stewart

	By: Richard Stewart

  

	
	EXTAB PHARMA, INC.
	
	 /s/ Extab Pharma

  
 5

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