Document:

Exhibit 10.1

  

  

    

  

  
    

    

    

    

    

    Collaborative Research Agreement

    

    

    

    

    	
             

            PARTIES

             

          
	
             

            UNSW

             

          	
             

            The University of New South Wales ABN 57 195 873 179, a body corporate established pursuant to the University of New South
                Wales Act 1989 (NSW) of UNSW Sydney NSW 2052, Australia

             

          
	
             

            Collaborating Organisation(s)

             

          	
             

            The party or parties with contact details specified in Schedule 1.

             

          
	
             

            Partner Organisation(s)

             

          	
             

            The party or parties with contact details specified in Schedule 1.

             

          
	 	  
	
             

            DETAILS

             

          
	
             

            KEY DATES

             

          
	
             

            Project Start Date (clause 1)

             

          	
             

            On the date the last party signs this agreement.

             

          
	
             

            Project Completion Date (clause 1)

             

          	
             

            23 December 2022

             

          
	
             

            PROJECT

             

          
	
             

            Project (clause 1)

             

          	
            mRNA nanocell delivery system

             

            Milestones:

            • End of month 3 = first batch
                of siRNA ready for formulation experiments

            • End of month 6 = first
                nanocell-siRNA formulation ready for in vitro testing (RPMI cells), > 10 mg siRNA batch ready

            • End of month 9 = physical
                characterisation of nanocell-siRNA formulation completed (size, loading), stability studies initiated (before/after actuation)

            • End of month 12 = in vitro RPMI tests completed, stability studies completed

             

          
	
             

            Project Plan (clause 1.2(a))

             

          	
             

             ☒ Attached at Schedule 3; or

             ☐  As above under ‘Project’.

             

          
	
             

            Ethics/biosafety approval required (clause 1.6)

             

          	
             ☐  YES  ☒ NO

             

          

    

    

    
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        Collaborative Research Agreement
          

        

        

      

    

    
      

      

      Recitals

      	A.	
              UNSW, together with the Collaborating Organisations, has been engaged by the Partner Organisation to undertake the Project

            

      

      

      	B.	
              The Partner Organisation has agreed to make their Total Contributions to UNSW in connection with the Project.

            

      

      

      	C.	
              The Parties agree to conduct the Project on the terms of this agreement.

            

      Terms

      
        	

              	1.	
                The Project

              

        
          

        

        

      

      	1.1	
              The parties must:

            

      	

            	(a)	
              start the Project on the Project Start Date; and

            

      	

            	(b)	
              use reasonable endeavours to complete the Project on or near the Project Completion Date or such other date as may be agreed by the parties.

            

      	1.2	
              The parties must carry out the Project:

            

      	

            	(a)	
              in accordance with the Details and the Project Plan;

            

      	

            	(b)	
              using Specified Personnel;

            

      	

            	(c)	
              with due skill and care in accordance with generally accepted professional, scientific and ethical principles and standards applicable to the Project; and

            

      	

            	(d)	
              in compliance with all applicable laws and regulations.

            

      	1.3	
              The parties acknowledge that research work is of its nature uncertain and that particular outcomes or results from the Project cannot be guaranteed.  No party will be liable to any other party for any loss or damage whether arising from
                that party’s failure to perform work on time or within the estimated costs of the Project or otherwise provided that party has used its reasonable endeavours in all respects in carrying out the Project.

            

      	1.4	
              The parties acknowledge that the Project may require approval by an institutional ethics and/or biosafety committees (or similar) of UNSW or the Collaborating Organisation(s).  The relevant party must use reasonable endeavours to
                promptly obtain that approval.  Before such approvals are obtained, the parties are not required to commence the Project.

            

      	1.5	
              UNSW and the Collaborating Organisation(s) must maintain complete and accurate records regarding the conduct and conclusions of the Project.

            

      
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          Collaborative Research Agreement
            

          

          

        

      

      

      

      
        

        

        	

              	2.	
                Not Used

              

        
          

        	

              	3.	
                General obligations

              

        
          

        

        

      

      	3.1	
              Each party must:

            

      	

            	(a)	
              perform its Project Obligations;

            

      	

            	(b)	
              co-operate with each other party and provide all other assistance, Material, equipment, facilities, resources as may be reasonably necessary to perform the Project; and

            

      	

            	(c)	
              ensure that it and its employees and the employees of its subcontractors (if any) comply with each other party’s usual staff, safety and security practices while attending that party’s premises, as notified by that party or as might
                reasonably be inferred from the use of the premises.

            

      	3.2	
              No party may make any representation to the effect that a party has evaluated, tested, recommended, approved or endorsed any product or service, without the relevant party’s consent.

            

      	3.3	
              A party may only subcontract its obligations under this Agreement to a third party with the prior written consent of each other party. If each other party consents to a party subcontracting in accordance with this clause, the party who
                subcontracts remains primarily responsible for its obligations under this agreement.

            

      
        	

              	4.	
                Contributions

              

        
          

        

        

      

      	4.1	
              Each party must provide its Total Contribution to the Project.

            

      	4.2	
              The Partner Organisation(s) must pay the Cash Contribution to UNSW:

            

      	

            	(a)	
              in relation to the first instalment, promptly after the Project Start Date; and

            

      	

            	(b)	
              in relation to each subsequent instalment, as per Payment Milestones specified in Schedule 2,

            

      following receipt of a Tax Invoice from UNSW.

      	4.3	
              UNSW must pay the Collaborating Organisation(s) the amounts and in the manner specified in Schedule 2, subject to UNSW receiving sufficient Cash Contributions from the Partner Organisation(s).

            

      	4.4	
              Unless specified otherwise, all monetary amounts expressed in this agreement are exclusive of GST.

            

      	4.5	
              A party must pay to the relevant party the amount specified on each Tax Invoice issued in accordance with clauses 4.2 or 4.3 by the due date specified on the Tax Invoice or if no due date is specified, within 30 days after the Tax
                Invoice is issued.

            

      	4.6	
              If any supply under this agreement is a Taxable Supply, the party making the supply may, in addition to any payment for the supply, recover the amount of the GST applicable to the supply.

            

      	4.7	
              Any amount of GST payable for a supply will be payable at the same time as the payment for the supply to which it relates.

            

      
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              	5.	
                Project Management

              

        
          

        

        

      

      	5.1	
              Unless otherwise agreed between the parties, as soon as reasonably practicable after the Project Start Date, the parties must establish a Management Committee comprising:

            

      	

            	(a)	
              2 nominees from UNSW;

            

      	

            	(b)	
              2 nominees from the Collaborating Organisation(s); and

            

      	

            	(c)	
              up to 2 nominees from the Partner Organisation(s).

            

      	5.2	
              A member of the Management Committee nominated by UNSW will chair the Management Committee.

            

      	5.3	
              The Management Committee will have general oversight of the conduct of the Project, including matters relating to the progress, direction and results of the Project and any disclosure of Project Intellectual Property.

            

      	5.4	
              The Management Committee will promptly report to UNSW any Project Intellectual Property developed during the Project.

            

      	5.5	
              The following matters may be considered at the first meeting of the Management Committee:

            

      	

            	(a)	
              frequency and format of meetings to discuss the progress of the Project;

            

      	

            	(b)	
              obligations to take and keep minutes of meetings;

            

      	

            	(c)	
              protocols for making decisions in relation to the conduct of the Project; and

            

      	

            	(d)	
              protocols for identifying, protecting and disclosing Project Intellectual Property.

            

      	5.6	
              The Management Committee may conduct its meetings by teleconference or videoconference.  The Management Committee may make decisions and take action as required under this agreement to carry out the Project.  The decision of a majority
                of the members of the Management Committee will be binding.  In the event of an even number of votes, the chair will have the deciding vote.

            

      	5.7	
              To avoid doubt, the Management Committee does not have the power to make any decisions in relation to Intellectual Property Rights or vary this agreement including to vary:

            

      	

            	(a)	
              the Total Contributions; or

            

      	

            	(b)	
              content or scope of the Project.

            

      
        	

              	6.	
                Assets

              

        
          

        

        

      

      	6.1	
              Except as stated otherwise in the Project Plan, any Asset purchased wholly or partly with the Funds is owned by UNSW.

            

      	6.2	
              For the term of this agreement, each owner of Assets contributed to or acquired for the Project:

            

      	

            	(a)	
              must make the Asset available for use by UNSW and the Collaborating Organisation(s) for purpose of the Project, as reasonably required;

            

      	

            	(b)	
              must not sell, hire, charge, mortgage or otherwise encumber the Asset; and

            

      	

            	(c)	
              is responsible for insurance, maintenance and, if required, repair and replacement of the Asset and any other costs and liabilities associated with the Asset.

            

      
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              	7.	
                Intellectual Property

              

        
          

        

        

      

      	7.1	
              Each party grants to the other parties a non-exclusive, irrevocable, non-transferable, royalty-free licence for the duration of the Project to use their Background Intellectual Property solely for the purpose of conducting the Project. A
                party must not reverse engineer the other party’s Background Intellectual Property.

            

      	7.2	
              Except as otherwise specified in this agreement, each party acknowledges that nothing in this agreement assigns or grants any other rights to another party in any Background Intellectual Property.

            

      	7.3	
              The parties must use reasonable endeavours to ensure that their Specified Personnel promptly notify each other upon creation of Project Intellectual Property.

            

      	7.4	
              Subject to the Partner Organisation making its Total Contributions to UNSW, all Project IP will be jointly owned by the Parties as tenants in common in equal shares (except that a Student owns copyright in his/her thesis).  Each party
                assigns to the other parties an equal share of its right, title and interest in Project IP and agrees to do all things reasonably necessary to give effect to such ownership and assignment (including ensuring its employees, contractors,
                agents and students do the same).

            

      	7.5	
              Each Party grants to each other party an irrevocable, non-transferable, non-exclusive, free of cost licence (not including a right to sub-licence) to use the Project IP for the purposes of conducting the Project for the duration of the
                Project and for its own internal non-commercial purposes following completion of the Project.

            

      	7.6	
              The Parties shall consult with each one another as to whether any Project IP should be Commercialised. To the extent that any Project IP is capable of commercialisation, a commercialisation strategy will be agreed in good faith by the
                owners with the intention that commercialisation revenue is equally shared between the owners.

            

      
        	

              	8.	
                Confidentiality and privacy

              

        
          

        

        

      

      	8.1	
              Each party:

            

      	

            	(a)	
              may use Confidential Information of each other party solely for the purposes of this agreement;

            

      	

            	(b)	
              except as permitted under clause 8.1(c), must keep confidential all Confidential Information of each other party; and

            

      	

            	(c)	
              may disclose Confidential Information of each other party only to employees, contractors and Students who:

            

      	

            	(i)	
              are aware and agree that the Confidential Information of each other party must be kept confidential; and

            

      	

            	(ii)	
              either have a need to know (and only to the extent that each has a need to know), or have been specifically approved by that other party.

            

      	8.2	
              If a party wants to disclose another party’s Confidential Information to a person other than that other party, its employees, contractors or Students (Third Person), that party must require the
                Third Person to enter into a confidentiality agreement on substantially similar terms to those confidentiality requirements specified in clause 8.1.

            

      	8.3	
              Each party must comply with the reasonable directions of each other party in relation to the handling of any Personal Information that the party holds or has held.

            

      
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              	9.	
                Publications

              

        
          

        

        

      

      	9.1	
              Each party is entitled to Publish the results of the Project provided that no Confidential Information owned by a non-publishing party is disclosed.

            

      	9.2	
              The publishing party must provide each other party with a copy of any Publication.

            

      
        	

              	10.	
                Students

              

        
          

        

        

        

        

      

      	10.1	
              Parties who have enrolled Students who are involved in the Project agree that:

            

      	

            	(a)	
              they must ensure that those Students comply with clause 8;

            

      	

            	(b)	
              they must ensure that Project Intellectual Property developed by the Student is owned in accordance with clause 7, provided that the Student will own the copyright in his or her thesis;

            

      	

            	(c)	
              the only restrictions on publishing a Student’s thesis will be those reasonably necessary to protect Confidential Information or the Project Intellectual Property (which in any case must be no longer than 12 months after completion of
                the Project);

            

      	

            	(d)	
              the parties must not inhibit the right of a Student to have his or her thesis examined, but an examiner may be required to sign a confidentiality agreement to protect Confidential Information; and

            

      	

            	(e)	
              before a Student becomes involved in the Project, the parties may require that the Student and the institution in which the Student is enrolled enter into a written agreement, in a form approved by UNSW, setting out the terms on which
                the Student is involved in Project, which must be consistent with the principles in this clause 10.

            

      
        	

              	11.	
                Indemnity, warranties and limitations on liability

              

        
          

        

        

        

        

      

      	11.1	
              The parties exclude:

            

      	

            	(a)	
              from this agreement all conditions, warranties and terms implied by statute, general law or custom, except those that cannot be excluded in law (Non‐excludable Conditions) such as certain
                warranties under the Competition and Consumer Act 2010 (Cth);

            

      	

            	(b)	
              all liability to each other in contract for consequential or indirect damages suffered by the parties, lost profit, loss of anticipated savings or business or goodwill, claims by any third parties or costs and expenses associated with or
                incidental to any of the preceding examples, arising out of, or in connection with, the Project and this agreement even if the parties knew they were possible or they were otherwise foreseeable; and

            

      	

            	(c)	
              all liability to each other in negligence or other non-contractual causes of action in respect of which liability can be excluded for acts or omissions of their respective employees, agents, contractors and Students arising out of or in
                connection with this agreement.

            

      	11.2	
              To the extent permitted by law, a party’s total liability to the other parties for breach of a Non-excludable Condition is limited to any one of the following options:

            

      	

            	(i)	
              supplying, replacing or repairing the goods;

            

      	

            	(ii)	
              paying the cost of supplying, repairing, or replacing the goods;

            

      	

            	(iii)	
              supplying again; or

            

      	

            	(iv)	
              paying the cost of supplying again, the services in respect of which the breach occurred.

            

      
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      	11.3	
              Subject to clause 11.2, the total liability of a party otherwise in connection with this agreement or the Project for loss or damage of any kind whether arising in contract, tort (including negligence), equity, under statute or otherwise
                is limited to the amount equivalent to the Total Contribution of that party.

            

      	11.4	
              Subject to clause 11.2, each party’s liability under this agreement is reduced to the extent that any damage, liability, loss or cost arises from or is attributable to any act or omission of the other party (or parties), its employees,
                agents, contractors or Students.

            

      	11.5	
              Subject to clause 11.1 to 11.4 (inclusive), each party (Indemnifier) indemnifies the other party and its officers, employees, subcontractors, agents and Students (together, ‘those Indemnified’), and agrees to keep them indemnified, against all liability, loss, costs, damages or expense that those Indemnified may suffer or  incur, as a result of wilful misconduct, negligent act or
                omission, or unlawful act or omission on the part of the Indemnifier or its officers, employees, students, subcontractors or agents connected with this agreement.

            

      
        	

              	12.	
                Insurance

              

        
          

        

        

        

        

      

      	12.1	
              Each party must take out, maintain and keep current, at its own cost:

            

      	

            	(a)	
              workers compensation insurance in accordance with applicable law and awards;

            

      	

            	(b)	
              public liability insurance appropriate to the party’s activities for an amount not less than $10 million; and

            

      	

            	(c)	
              professional indemnity insurance for an amount not less than $5 million in respect of a claim for breach of professional duty whether incurred in contract, tort or otherwise or by reason of any act or omission of the party.

            

      	12.2	
              On request, a party must provide evidence to the other parties of the terms and currency of all insurance policies required under this agreement.

            

      	12.3	
              A party may act as its own insurer but only to the extent that it will be able to adequately meet its obligations under this agreement.

            

      
        	

              	13.	
                Dispute resolution

              

        
          

        

        

      

      	13.1	
              No party may start arbitration, tribunal or court proceedings (except proceedings seeking interlocutory relief in a court of competent and applicable jurisdiction) in respect of a Dispute unless it has first complied with this clause.

            

      	13.2	
              The parties will use its best endeavours to co-operatively resolve a Dispute.

            

      	13.3	
              A party claiming that a Dispute has arisen must notify the other parties in writing.  The Dispute must then be referred immediately to the Vice-Chancellor (or delegate) of UNSW and the Collaborating Organisation(s) and General Manager or
                equivalent of the Partner Organisation(s) for resolution.

            

      	13.4	
              If the Dispute is not resolved within three days of such referral, the Dispute will be referred to a panel (Panel) for resolution.  Each party to the Dispute must nominate a senior representative
                for the Panel within three days of the referral to the Panel in accordance with this clause.

            

      	13.5	
              If a Dispute is referred to the Panel in accordance with clause 13.4, the Panel will meet to resolve the Dispute unless the Panel agrees to resolve the Dispute without need for a meeting.

            

      
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      	13.6	
              The Panel may determine its own procedures for meetings.  Decisions of the Panel may only be made by unanimous agreement of the members of the Panel.  Any decision of the Panel will be final and binding on the parties and will be
                provided in writing to the parties.

            

      	13.7	
              If the Panel does not resolve the Dispute within ten days after the Dispute being referred to the Panel, then the Dispute must be referred to mediation in accordance with clauses 13.8 to 13.10.

            

      	13.8	
              The mediator may be appointed either by agreement or failing such agreement within five days after expiry of the period set out in clause 13.7, by reference to the President of the Law Society of New South Wales who will nominate a
                mediator.

            

      	13.9	
              The parties agree that:

            

      	

            	(a)	
              each party will bear their respective costs of the mediation save that the mediator’s fee, fees for mediation rooms and costs of shares equipment facilities and services of the mediation will be shared equally;

            

      	

            	(b)	
              the venue for the mediation will be agreed between the parties or, failing such agreement, will be nominated by the mediator;

            

      	

            	(c)	
              each party may be legally represented if they so wish; and

            

      	

            	(d)	
              the mediation will be conducted without prejudice and complete confidentiality will be preserved in respect of the mediation and any documents and information used at or in relation to the mediation.

            

      	13.10	
              If the Dispute or difference has not been resolved or mediated within 90 days after receipt of the notice specified in clause 13.3, a party may terminate the dispute resolution process by giving written notice to the other parties.

            

      	13.11	
              Prior to the resolution of a Dispute, each party must continue to perform its obligations under this agreement.

            

      
        	

              	14.	
                Term and Termination

              

        
          

        

        

      

      	14.1	
              This agreement commences on the Project Start Date and expires three (3) months after the Project Completion Date unless the agreement is terminated earlier in accordance with this clause 14.

            

      	14.2	
              The parties may immediately terminate this agreement by mutual consent in writing.

            

      	14.3	
              If:

            

      	

            	(a)	
              a party breaches any material term of this agreement not capable of remedy;

            

      	

            	(b)	
              a party breaches any material term of this agreement capable of remedy and fails to remedy the breach within 30 days after receiving written notice requiring it to do so; or

            

      	

            	(c)	
              any event of insolvency occurs in relation to the Partner Organisation(s) (whether or not notified), including any step to appoint a receiver, administrator, trustee in bankruptcy or liquidator,

            

      then:

      	

            	(d)	
              the other party or parties may terminate this agreement in writing; or

            

      	

            	(e)	
              the other party or parties may terminate the defaulting or insolvent party’s involvement in the Project and continue to perform the Project.

            

      
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              	15.	
                Consequences of termination

              

        
          

        

        

        

        

      

      	15.1	
              On termination:

            

      	

            	(a)	
              UNSW will be entitled to cease expenditure on the Project and be entitled to payment of costs and expenses that have been incurred or committed for the Project as at the effective date of termination which will not exceed the amount
                equivalent to the Total Contribution of the other parties for the year in which termination occurs;

            

      	

            	(b)	
              if requested by a party (Requesting Party), the other parties must return to the Requesting Party all:

            

      	

            	(i)	
              Background Intellectual Property of the Requesting Party in the other party’s possession or control; and

            

      	

            	(ii)	
              Confidential Information of the Requesting Party in material form (including those parts of all notes or records of the other party containing Confidential Information of the Requesting Party) in the other party’s possession or control;
                and

            

      	

            	(iii)	
              Property in their possession belonging to another party, and

            

      	

            	(c)	
              if a party terminates this agreement under clause 2, the defaulting party must pay any reasonable costs incurred by the other party or parties directly attributable to the termination of this agreement.

            

      	15.2	
              Clauses 1.3, 3.2, 6 ‐ 13 (inclusive) and 15 and all clauses required to give them effect survive the expiration or termination of this agreement.

            

      
        	

              	16.	
                Notices

              

        
          

        

        

      

      	16.1	
              A party giving notice or notifying under this agreement must do so in writing:

            

      	

            	(a)	
              directed to the recipient’s address specified in the Schedule 1 as altered by any written notice; and

            

      	

            	(b)	
              hand delivered or sent by prepaid post or email to that address.

            

      	16.2	
              A notice given in accordance with this clause is taken to be received:

            

      	

            	(a)	
              if hand delivered, on delivery;

            

      	

            	(b)	
              if sent by prepaid post, 3 days after the date of posting; or

            

      	

            	(c)	
              if sent by email, when the email has entered the recipient’s server.

            

      
        	

              	17.	
                Force Majeure Event

              

        
          

        

        

      

      	17.1	
              If a party (First Party) is partially or wholly precluded from complying with its obligations under this agreement by Force Majeure Event affecting the First Party, then the First Party’s
                obligation to perform in accordance with this agreement will be suspended for the duration of the delay arising out of the Force Majeure Event.

            

      	17.2	
              As soon as possible after a Force Majeure Event arises, the First Party must, if it has not already done so, notify the other parties of the:

            

      	

            	(a)	
              Force Majeure Event;

            

      	

            	(b)	
              extent to which the First Party is unable to perform its obligations under this agreement; and

            

      	

            	(c)	
              likely duration of the First Party’s inability to perform.

            

      	17.3	
              If the Force Majeure Event affecting the First Party is likely to or does continue for 60 days or more, the other parties may terminate this agreement within immediate or later effect by giving the First Party written notice.

            

      
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              	18.	
                No waiver

              

        
          

        

        

      

      	18.1	
              A party’s agreement to waive a right or entitlement under this agreement is only effective if that party gives written notice of that waiver to the party seeking the benefit of the waiver.

            

      	18.2	
              Waiver by a party of anything that another party must do under this agreement is not a waiver of any other right or entitlement under this agreement.

            

      	18.3	
              A failure or delay in exercising a right arising from a breach of this agreement is not a waiver of that right.

            

      
        	

              	19.	
                General

              

        
          

        

        

      

      	19.1	
              This agreement may only be varied in writing by all the parties.

            

      	19.2	
              A party must not assign its rights or obligations under this agreement without the prior written consent of the other parties except that UNSW may assign its rights and obligations under this agreement to NSi by written notice to the
                other parties.

            

      	19.3	
              This agreement constitutes the entire agreement between the parties in relation to its subject matter and supersedes any previous agreement of the parties, or any other communication or representation made, in relation to its subject
                matter.

            

      	19.4	
              If a provision of this agreement is invalid, illegal or unenforceable, then to the extent of the invalidity, illegality or unenforceability, that provision must be ignored in the interpretation of this agreement.  All other provisions of
                this agreement remain in full force and effect.

            

      	19.5	
              Nothing in this agreement creates a relationship of employer and employee, principal and agent, or partnership between the parties.  A party has no authority to act for any other party or to create or assume a responsibility for an
                obligation of any other party.

            

      	19.6	
              A party may execute this agreement by signing a counterpart.  All counterparts constitute one document when taken together. A signed copy of this agreement made by photocopy, facsimile or PDF Adobe format will be considered an original
                and execution of this agreement will have occurred when each party holds such copy signed by the other party or parties to this agreement.

            

      	19.7	
              Each party must:

            

      	

            	(a)	
              do or cause to be done all acts and things necessary or desirable to give effect to; and

            

      	

            	(b)	
              refrain from doing all acts and things that could hinder performance by any party of,

            

      this agreement.

      	19.8	
              This agreement is governed by and must be construed in accordance with the laws of New South Wales.  Each party:

            

      	

            	(a)	
              irrevocably and unconditionally submits to the non-exclusive jurisdiction of the courts of New South Wales and all courts that have jurisdiction to hear appeals from them; and

            

      	

            	(b)	
              waives any right to object to proceedings being brought in those courts for any reason.

            

      
        Page 10

        
          

      

      
        
          

          

          Collaborative Research Agreement
            

          

          

        

      

      

      

      
        

        

        	

              	20.	
                Definitions and Interpretation

              

        
          

        

        

      

      	20.1	
              In this agreement:

            

      Asset means an item of real or personal
          property but does not include Intellectual Property Rights;

      Background Intellectual Property means
          Intellectual Property Rights owned by or licensed to a party as at the Project Start Date, or acquired or developed by a party during the course of the Project independently of the Project, which that party has the right to license to third
          parties and which are necessary for the performance of the Project, including those specified in Schedule 2 or as subsequently notified in writing by the parties;

      Cash Contribution means the cash component of
          the Total Contribution;

      Confidential Information means all know how,
          financial information and other commercially valuable information in whatever form including unpatented inventions, trade secrets, formulae, graphs, drawings, designs, biological materials, samples, devices, models and other materials of whatever
          description which a party claims is confidential to itself and over which it has full control and includes all other such information that may be in the possession of a party’s employees or management.  Information is not confidential if:

      	

            	(a)	
              it is or becomes part of the public domain unless it came into the public domain by a breach of confidentiality;

            

      	

            	(b)	
              it is obtained lawfully from a third party without any breach of confidentiality;

            

      	

            	(c)	
              it is already known by the recipient party (as shown by its written record) before the date of disclosure to it;

            

      	

            	(d)	
              it is independently developed by an employee of the recipient party who has no knowledge of the disclosure under this Agreement;

            

      	

            	(e)	
              required to be disclosed by a court, rule or governmental law or regulation, or the rules of any stock exchange, provided that the party making the disclosure provides prompt written notice to the other party of any such requirement; or

            

      	

            	(f)	
              it is required to be disclosed pursuant to this agreement.

            

      Details means the matters set out in the table
          on the front page(s) of this agreement;

      Dispute means a dispute arising out of or
          relating to this agreement including a dispute about the breach, termination, validity, or subject matter of this agreement, or a claim in equity or in tort relating to the performance or non-performance of this agreement;

      Force Majeure Event affecting a party means a
          circumstance beyond the reasonable control of that party causing that party to be unable to observe or perform on time an obligation under this agreement, including:

      	

            	(a)	
              acts of God, lightning strikes, earthquakes, floods, storms, explosions, fires and any natural disaster; and

            

      	

            	(b)	
              acts of public enemies, terrorism, riots, civil commotion, malicious damage, sabotage, revolution and acts of war and war, general strikes, embargo and power, water or other utility shortage;

            

      GST has the same meaning as in the GST Law;

      
        Page 11

        
          

      

      
        
          

          

          Collaborative Research Agreement
            

          

          

        

      

      

      

      GST Law has the same meaning as in the A New Tax System (Goods and Services Tax) Act 1999 (Cth) as amended or replaced from time to time;

      In-kind Contribution means the in-kind
          component of the Total Contribution;

      Intellectual Property Rights means all rights
          resulting from intellectual activity whether capable of protection by statute, common law or in equity, including copyright, discoveries, inventions, innovations, technical information and data, prototypes, processes, specifications, know‐how,
          patent rights, registered and unregistered trade marks, design rights, circuit layouts, plant varieties, the right to have confidential information kept confidential and all rights and interests of a like nature, together with any and all
          documentation and other material relating to such rights and interests;

      Management Committee means the management
          committee for the Project established under clause 5;

      Material means all materials in any form
          including all data, information, records, documents, databases and software (including source code and object code), other works and material and the subject matter of any category of Intellectual Property Rights;

      Moral Rights means all present and future
          rights of integrity of authorship, rights of attribution of authorship, rights not to have authorship falsely attributed, and rights of a similar nature conferred by statute anywhere in the world;

      NSi means NewSouth Innovations Pty Limited (ABN
          25 000 263 025) a wholly owned subsidiary of UNSW responsible for managing and for entering into agreements in relation to Commercialisation of UNSW’s Intellectual Property;

      Panel has the meaning in clause 13.4;

      Personal Information means information or an opinion (including information or an opinion forming part of a database), whether true or not, and whether recorded in a material form or not, about an
          individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion;

      Publication means to publish by way of a paper,
          article, manuscript, report, poster, internet posting, presentation slides, abstract, video, outline, instruction material or other disclosure of Project Intellectual Property, in printed, electronic, oral or other form and Publish has a corresponding meaning;

      Project means the research project and
          activities described in the Details including the creation of Project Intellectual Property, completed in accordance with this agreement;

      Project Completion Date means the scheduled
          completion date for the Project specified in the Details;

      Project IP means all Intellectual Property
          Rights created or developed as part of performing  the Project, but does not include Intellectual Property Rights in Background Intellectual Property;

      Project Obligations of a party means that
          party’s obligations in relation to the Project as specified in Schedule 2;

      Project Start Date means the start date for
          the Project specified in the Details;

      Specified Personnel means those personnel
          specified in the Schedules to perform the Project;

      
        Page 12

        
          

      

      
        
          

          

          Collaborative Research Agreement
            

          

          

        

      

      

      

      Student means a student who is enrolled at UNSW
          or the Collaborating Organisation(s) and involved in the Project;

      Tax Invoice has the same meaning as in the GST
          Law;

      Taxable Supply has the same meaning as in the
          GST Law; and

      Total Contribution of a party means the aggregate of the Cash Contribution and in-kind contribution to the Project as specified in Schedule 2.

      	20.2	
              Unless that context otherwise requires:

            

      	

            	(a)	
              a word which denotes the singular denotes the plural and vice versa;

            

      	

            	(b)	
              where a word or phrase is given a particular meaning, other parts of speech and grammatical forms of that word or phrase have corresponding meanings;

            

      	

            	(c)	
              a reference to any legislation includes that legislation as amended, re-enacted consolidated or substituted;

            

      	

            	(d)	
              a reference to a person includes a partnership and a body whether corporate or otherwise;

            

      	

            	(e)	
              any use of the verb ‘includes’, or of words such as ‘for example’ or ‘such as’, do not limit anything else that is included in general speech; and

            

      	

            	(f)	
              a reference to a thing or amount is a reference to the whole and each part of it.

            

      	20.3	
              This agreement may not be construed adversely to a party just because that party prepared it.

            

      	20.4	
              If there is any inconsistency between the terms and conditions of this agreement and the provisions of a schedule or annexure to this agreement, the terms and conditions of the agreement will prevail as between those terms and the
                provisions of the schedule will prevail as between the schedule and the annexure.

            

      

      

      
        Page 13

        
          

      

      
        
          

          

          Collaborative Research Agreement
            

          

          

        

      

      

      

      

      

      Executed as an agreement

      

      

      
        	
                Signed for and on behalf of the University of New South Wales by:

                 

                

              	 
	
                /s/ Debbie Docherty

              	 
	
                Signature

                 

                

              	 
	
                Debbie Docherty

              	 
	
                Name (please print)

                 

                

                Manager, Research Grants and Contracts

              	 
	
                Position

                 

                

                04/06/2022

              	 
	
                Date of signing

              	 

      

      

      

      
        Page 14

        
          

      

      
        	
                Signed for and on behalf of the Medlab Clinical Ltd by :

                 

                

              
	
                /s/ Kerem Kaya

              	 
	
                Signature

                 

                

              	 
	
                Kerem Kaya

              	 
	
                Name (please print)

                 

                

                CFO

              	 
	
                Position

                 

                

                04/04/2022

              	 
	
                Date of signing

              	 

      

      

      

      

      

      

      

      
        Page 15

        
          

      

      

      

      
        
          

          

          Collaborative Research Agreement
            

          

          

          

          

        

      

      

      

      

      

      
        	
                Signed for and on behalf of Macquarie University by :

                 

                

              	 
	
                /s/ Dr Ross McLennan

              	 
	
                Signature

                 

                

              	 
	
                Dr Ross McLennan

              	 
	
                Name (please print)

                 

                

                Pro Vice-Chancellor, Research Services

              	 
	
                Position

                 

                

                04 April 2022

              	 
	
                Date of signing

              	 

      

      

      

      

      

      

      

      By signing this agreement, each signatory warrants that they have authority to enter into this agreement on behalf of the party they are stated to represent.

       

        

      

      

      
        Page 16

        
          

      

      
        
          

          

          Collaborative Research Agreement
            

        

      

       

      

       

      

      Schedule 1 – Party Details

      
        	
                The University of New South Wales/Administering Organisation

              
	
                UNSW

              	
                The University of New South Wales ABN 57 1295 873 179, a body corporate established pursuant to the University of New South Wales Act 1989 (NSW) of UNSW Sydney NSW 2052 Australia

              
	
                Notices

              	
                Attention: Director, Research Grants and Contracts

                Address: The University of New South Wales, UNSW Sydney NSW 2052

                email: rgc@unsw.edu.au

              

      

      Medlab Clinical Ltd/Partner Organisation

      

      

      
        	
                Medlab Clinical Ltd

              	
                ABN 51 169 149 071

              
	
                Notices

              	
                Attention:  Dr Sean Hall/CEO

                Address:  Unit 5A, 11 Lord Street, Botany NSW 2019

                Fax:  N/A

                Email:  sean_hall@medlab.co

              

      

      Macquarie University/Collaborating Organisation

      

      

      
        	
                Macquarie University

              	
                ABN 90 952 801 237

              
	
                Notices

              	
                Attention:  Dr Ross McLennan, Pro Vice-Chancellor, Research Services

                Address: Ground Floor 16 Wally’s Walk Macquarie University NSW 2109

                Email: research.postaward@mq.edu.au

              

      

      

      

      

      

      
        Page 17

        
          

      

      
        
          

          

          Collaborative Research Agreement
            

          

          

        

      

       

      

      Schedule 2 – Obligations, Contributions and Budget

      
        	
                Project Obligations

              
	
                Role

              	
                As set out in the Project Plan.

              
	
                Specified Personnel

              	
                Pall Thordarson, Chief Investigator

              
	
                UNSW’s Background Intellectual Property

              	
                None specified.

              

      

      

      

      

      

      
        Partner Organisation(s)

        Medlab Clinical Ltd

         

        

        	
                Project Obligations

              
	
                Role

              	
                As set out in the Project Plan.

              
	
                Specified Personnel

              	
                Luis Vitetta, Director of Medical Research

              
	
                Partner Organisation Background Intellectual Property

              	 
	
                Special Conditions

              
	
                Total of $50,000 to be contributed through Investment COVID-19 R&D Fund Tech Voucher scheme, total $50,000 to be contributed through Partner Organisation’s cash
                  contributions. UNSW will send separate invoices to the Partner Organisation for the respective contributions per the below table:

              
	 	
                Milestone

              	
                Investment NSW funds

              	
                Medlab funds

              
	 	
                Execution of agreement

              	
                $25,000

              	
                $25,000

              
	 	
                Completion of project

              	
                $25,000

              	
                $25,000

              
	
                Total Contributions & Payment Milestones

              
	
                Cash Contribution

              	
                Invoices for the cash contributions will be raised in accordance with special conditions above, clause 4.2, and as per payment Milestones:

              
	 	
                Date Due/Milestone

              	
                Fee in AUD$ (GST exclusive)

              
	 	
                Execution of Agreement

              	
                $50,000

              
	 	
                Completion of project

              	
                $50,000

              
	 	
                Subtotal

              	
                $100,000

              
	 	
                GST

              	
                $10,000

              
	 	
                Total including GST

              	
                $110,000

              
	
                In-kind Contributions

              	 

        

        

        

        

        

        

        Collaborating Organisation(s)

        Macquarie University

         

        

        	
                Project Obligations

              
	
                Role

              	
                As set out in the Project Plan.

              
	
                Specified Personnel

              	
                Prof Daniela Traini

              
	
                Collaborating Organisation’s Background Intellectual Property

              	
                N/A

              
	
                Cash Contribution from Administering Organisation to Collaborating Organisation

              
	
                As per clause 4.3, and as per payment Milestone:

              
	
                Date Due/Milestone

              	
                Fee in AUD$ (GST exclusive)

              	 
	
                Execution of Agreement

              	
                $25,000

              	 
	
                Completion of project

              	
                $25,000

              	 
	
                Subtotal

              	
                $50,000

              	 
	
                GST

              	
                $5,000

              	 
	
                Total including GST

              	
                $55,000

              	 
	 
	
                Total Contributions

              
	
                In-kind Contributions

              	
                In-kind contribution of 0.1FTE, use of facilities and equipment

                 

              

        

        

      

      

    

    
      
        Page 18

        
          

      

      
        
          

          

          Collaborative Research Agreement
            

          

          

        

      

      Schedule 3 – Project Plan

      
        

        

        
          	
                  COVID-19 TechVoucher

                  1. C19 TechVouchers Application Form

                    Application TV00184 From Luis Vitetta - DRAFT

                

          

          

          COVID-19 R&D Fund TechVouchers Summary Critera

          Investment NSW is supporting technology-rich startups, scaleups or small to medium enterprises (SMEs) to collaborate with
            Publicly-Funded Research Organisations (PFROs) to conduct R&D projects that accelerate the commercialisation of products and services that address the impact of COVID-19.

          There are two funding streams available:

          TechVoucher Streams

          Total Project Budget

          Intended Project duration

          NSW Govt contribution (TechVoucher)

          Stream 1: Smaller R&D projects

          $30,000 to $50,000

          up to 6 months

          Maximum $25,000 (remainder matched by the business)

          Stream 2: Larger R&D projects

          $50,001 to $100,000 or more

          up to12 months

          Maximum $50,000 (remainder matched by the business)

          The TechVoucher is the NSW Government contribution of up to 50 per cent of the cost of the R&D project. The business
            co-contribution is a minimum 50 per cent of the project budget.

          A TechVoucher will fund up to 50 per cent of all invoices issued by a PFRO partner to the maximum value of the voucher for
            each Stream. The aim is to reduce the cashflow burden of the R&D project on the business.

          Eligibility Criteria for TechVouchers

            To be eligible, a business must:

          	

                	•	
                  have an ABN registered in NSW and be based in NSW

                

          	

                	•	
                  have fewer than 200 employees

                

          	

                	•	
                  have operated for at least 12 months, based on date of ABN registration

                

          	

                	•	
                  have at least $150,000 insalesrevenue or expenditure within the last 12 months or previous financial year

                

          	

                	•	
                  have ownership that is at least 75% Australianandisnot more than 50% owned by another business

                

          	

                	•	
                  propose a technology-based product or service that addresses the impacts of COVID-19

                

          	

                	•	
                  demonstrate capability and capacity to complete the TechVoucher project within 6 months (Stream 1) or 12 months (Stream 2)

                

          	

                	•	
                  be engaged with an eligible PFRO for R&D collaboration and have obtained a quote from the PFRO for the R&D project

                

          	

                	•	
                  provide evidence of your ability to co-invest at least 50% of eligible project budget

                

          	

                	•	
                  confirmation that the business holds the rights to commercialise the intellectual property arising from the project.

                

          To demonstrate eligibility, a business must also provide:

          	

                	•	
                  an operating profit and loss statement for the last 12 months or previous financial year

                

          	

                	•	
                  brief profiles of key personnel such as a CV or LinkedIn accounts

                

          
            Page 19

            
              

          

          

          

          	
                  COVID-19 TechVoucher

                  1. C19 TechVouchers Application Form

                    Application TV00184 From Luis Vitetta - DRAFT

                

          

          

          	

                	•	
                  nomination of the PFRO which the business intends to enter an agreement for the provision of R&D services

                

          Ineligible business structures are:

          	

                	•	
                  an individual

                

          	

                	•	
                  a partnership

                

          	

                	•	
                  an unincorporated association

                

          	

                	•	
                  a trust

                

          	

                	•	
                  a Commonwealth, State, Territory or local government body (including government business enterprises).

                

          Note: if the business does not have a committed PFRO, it can contact the Global
              NSW  Concierge service for suggestions of PFROs with relevant expertise and contact points prior to submitting this application form.

          Please refer to the COVID-19 TechVoucher Guidelines for complete criteria, requirements and exclusions, including information on eligible PFROs.

          Organisation and Contact Details

          * indicates a required field

          Organisation Details

          Organisation Name *

            Medlab Clinical Ltd

          ABN *

          51 169 149 071

          

          

          	
                  Information from the Australian Business Register

                
	
                  ABN

                	
                  51 169 149 071

                
	
                  Entity name

                	
                  Medlab Clinical Ltd

                
	
                  ABN status

                	
                  Active

                
	
                  Entity type

                	
                  Australian Public Company

                
	
                  Goods & Services Tax (GST)

                	
                  Yes

                
	
                  DGR Endorsed

                	
                  No

                
	
                  ATO Charity Type

                	
                  Not endorsed More information

                
	
                  ACNC Registration

                	
                  No

                
	
                  Tax Concessions

                	
                  No tax concessions

                
	
                  Main business location

                	
                  2015 NSW

                
	
                  Information retrieved at 8:05am today

                

          

          

          Must be an ABN.

          

          

          Organisation Trading Address *

          Unit 5A/11 Lord St,

          Botany NSW 2019 Australia

          Address Line 1, Suburb/Town, State/Province, Postcode, and Country are required.

          
            Page 20

            
              

          

          

          

          

          

          	
                  COVID-19 TechVoucher

                  1. C19 TechVouchers Application Form

                    Application TV00184 From Luis Vitetta - DRAFT

                

          

          

          Organisation Website *

            https://www.medlab.co/

            Must be a URL.

          Which industry does your organisation belong to? *

            Other: Biotechnology

          Contact for Application

          Contact Name *

            Luis Vitetta

          Contact Position *

          Director of Medical Research

          For example CEO, Grant Coordinator, Operations Manager

          Contact Primary Phone Number *

            (02) 8188 0311

          Must be an Australian phone number.

            Include area code for land lines

          Contact Primary Email *

            luis_vitetta@medlab.co

            Must be an email address.

          Eligibility

          * indicates a required field

          You must successfully meet all eligibility criteria to be considered for
            TechVouchers.

          For further information and full program eligibility criteria please refer to the COVID-19
              TechVouchers Guidelines.

          

            

            

          

          	
                  Is the business based in NSW? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	
                  Does the business have fewer than 200 employees? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	
                  Has the business operated for at least 12 months, based on date of ABN registration? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                

          

          

          
            Page 21

            
              

          

          

          

          

          

          

          

          	
                  COVID-19 TechVoucher

                  1. C19 TechVouchers Application Form

                    Application TV00184 From Luis Vitetta - DRAFT

                

          

          

          	
                  Can the business demonstrate at least $150,000 in sales revenue or expenditure within the last 12 months or previous financial year? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	
                  Is the business at least 75% Australian owned? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	
                  Do you (i.e. the business applying for the grant) own 50% or more of the business? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	
                  Have you developed, or are you currently developing, a technology-based product or service that addresses the impact of COVID-19? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	
                  Can the business demonstrate capability and capacity to complete the TechVoucher project within 6 months (Stream 1) or 12 months (Stream 2)? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	
                  Has the business engaged with an eligible PFRO for R&D collaboration and obtained a quote from the PFRO for the R&D project? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	
                  Note: quote must include: 1. project description 2. budget – indicating whether it is Stream 1 or Stream 2 project. The budget must include the resources
                    committed to the project by the business and the PFRO. 3. timeline and a milestone schedule that reflects as a minimum, 6 monthly joint achievements, aligned with Stream 1 or Stream 2 of the TechVoucher.

                
	 	 
	
                  Can the business provide evidence of it's ability to co-invest at least 50% of eligible project budget?

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	
                  Can the business confirm that they hold the rights to commercialise the intellectual property arising from the project?

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	 	 

          

          

          

          

          To demonstrate eligibility, businesses must also provide a profit & loss statement, key personnel
            profiles, and nominate a Publicly Funded Research Organisation (PFRO).

          
            

            

            Please upload a copy of the organisation's profit
                and loss statement for the last 12 months or the last financial year. *

            

            

          

          Filename: Medlab Clinical_FY_20_21 profit and loss statement.pdf

          
            Page 22

            
              

          

          

          

          

          

          	
                  COVID-19 TechVoucher

                  1. C19 TechVouchers Application Form

                    Application TV00184 From Luis Vitetta - DRAFT

                

          

          

          File size: 672.4 kB

          For the last 12 months or the last financial year

          Select the type of evidence you will provide for the key personnel *

          ☑ Upload CV

          □ Provide LinkedIn URL

          Select both if applicable

          
            

            

            Upload a CV for each of the key personnel. *
              

            

            

          

          

          

          
            

            

            Filename: Brief_CV_Vitetta_2021.

              pdf File size: 176.4 kB
              

            

            

          

          

          

          
            

            

            Filename: CV_Quezada.pdf

              File size: 228.8 kB
              

            

            

          

          

          

          Filename: DR_CV_2021rev.pdf

            File size: 180.7 kB

           

          

          
            
 

          
            

            

            

            

          

          Filename: Henson_CV_One page.pdf

          File size: 41.3 kB

          Title each file with the key personnel's name

          Statement of commercialisation outcomes

          Describe how receiving a TechVoucher could advance commercialisation of your
              product/service *

          Receiving a TechVoucher would allow the further exploitation of Medlab Clinical’s NanoCelle(TM) platform in collaboration with the RNA Institute
            based at the University of New South Wales. The NanoCelle(TM) technology describes self-assembled micellular nanoparticles for the delivery of an active pharmaceutical ingredient. Medlab Clinical has been granted patents for its NanoCelle(TM)
            platform technology in multiple jurisdictions, including the USA, Europe, and Australia. The aim of the current research collaborative effort is to utilise the novel drug delivery platform to investigate a nasal delivered ribonucleic acid
            formulation that can prevent the progression of Covid-19 infections by the SARS-CoV-2 virus. The collaborative research program presents an important biologically plausible opportunity with vast public health interest. A collaborative effort
            between Medlab Clinical a biotechnology company based in Sydney and the RNA Institute based at the University of New South Wales provides an occasion for an accelerated collaborative program that may lead to a unique and important public health
            commercial outcome for the preventive treatment of Covid-19 infections. Both organizations have access to certified laboratory facilities with staff members with analytical, biochemistry and clinical expertise to see this project’s early phase
            of development to a successful completion.

          Must be no more than 250 words.

          PFRO Details

          Who is your nominated PFRO partner? *

          
            Page 23

            
              

          

          

          

          

          

          

          

          	
                  COVID-19 TechVoucher

                  1. C19 TechVouchers Application Form

                    Application TV00184 From Luis Vitetta - DRAFT

                

          

          

          University of NSW

          Choose from the dropdown list. If your PFRO is not listed, choose "Other" and provide the name in the

          space provided.

          

          

          	
                  Can your nominated PFRO demonstrate that it receives public funds (whether provided by Commonwealth, State or Local Government) which uses
                      these funds for research? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                
	 	 
	
                  Does your nominated PFRO have operations in NSW? *

                
	
                  ◉

                	
                  Yes

                
	
                  ⚪

                	
                  No

                

          
            

            

            Please upload an official quote from the eligible PFRO which
                includes the project description, budget, timeline and milestone requirements. *

            

            

          

          Filename: RG214254_TechVoucher_Medlab_Thordarson.pdf

          File size: 258.5 kB

          Note: quote must include: 1. project description 2. budget – indicating whether it is Stream 1 or Stream 2 project. The budget
            must include the resources committed to the project by the business and the PFRO. 3. timeline and a milestone schedule that reflects as a minimum, 6 monthly joint achievements, aligned with Stream 1 or Stream 2 of the TechVoucher. Note: PFRO
            quotes that do not include all this information will be deemed unsuccessful.

          Project Details

          * indicates a required field

          Research & Development (R&D) Project Description

          R&D Project Title and brief description *

          The nasal delivery of a nanoparticle elaborated siRNA for the prevention and treatment of

          Covid-19 infections from the SARS-CoV-2 virus.

          Must be no more than 50 words.

          How does your product or service address the health and economic impacts of COVID-19 on
              the people of NSW? *

          This product will complement the vaccine rollout and assist the social economy recover from the crisis by reducing viral replication and
            transmission of Covid-19. In the longer term, this innovative solution could be implemented when vaccine supply chain shortages and delays occur.

          Must be no more than 200 words.

          Assessment Criteria Responses

          Note: responses for the following assessment criteria questions are limited to 150 words each, bullet
            points are preferable.

          Assessment Criteria 1: Project impact

          
            Page 24

            
              

          

          

          

          

          

          

          

          	
                  COVID-19 TechVoucher

                  1. C19 TechVouchers Application Form

                    Application TV00184 From Luis Vitetta - DRAFT

                

          

          

          What is the problem being addressed? *

          The product developed aims to reduce Covid-19 morbidity and mortality. Animal models confirm that novel nasal treatment developed to boost the
            natural human immune system to fight common colds and flu, has proved successful in reducing Covid-19 viral replication test results by 96%. The novel strategy proposes a route of administration with broad protection and reduction in viral
            shedding decreasing community infectivity transmission. Specifically, the intranasal micellular nanoparticle containing the siRNA medicine advantageously will execute its function by complete Watson–Crick base pairing with the virus mRNA
            producing a broad silencing effect of Covid-19 genes. The preventive medicine will either prevent the occurrence of the infection or by halting the infection and thus averting the severe complications that ensue after its onset, especially for
            those in the most vulnerable groups in the community. Moreover, this preventive medicine may also behave as an adjunctive to the vaccines, especially as Covid-19 variants emerge.

          Must be no more than 150 words.

          What is the solution and how is it unique and innovative? *

          Nasal delivered nanoparticles loaded with an siRNA API presents a unique and innovative program for the prevention and treatment of Covid-19
            infections. The advantage of an intranasal delivered medicine will block viral transmission and impede viral replication and release. The competitive market is focused on delivering intranasal delivered vaccines or immunoglobulins to neutralize
            the virus. The advantage with an intranasal micellular-si RNA nanoparticle is fixed on inhibiting viral translation and release benefiting those with early asymptomatic infectivity that importantly will reduce the rate of virus transmission, a
            concomitant benefit from also rapid elicited immune responses. Additionally, the intranasal delivered medicine would reduce the viral burden at the site of virus accumulation and entry. The net effect would result in broad reduction in disease
            severity; an important factor for reducing morbidity and mortality especially in the fragile immunosenescent elderly and those with chronic diseases, the most vulnerable groups in the community.

          Must be no more than 150 words.

          Who is the market user and how large is the opportunity? *

          The market user of the novel intranasal drug suspension would be all adults aged 18 years and over locally and subsequently globally. In NSW
            the elderly, residential care workers and senior Australians in their care would be first line users. Upscaling roll-out of the product listed as a preventive medicine would ultimately be a prescribed self-administered medicine to all adults as
            a measure for reducing community infections and transmission. An equitable global distribution that prevents SARS-CoV-2 replication with a concomitant reduction in transmission could in the interim follow the current Covid-19 vaccine estimated
            cost and delivery, namely from US$2 to US$40. Local and global uptake of the siRNA micellular nanoparticle delivered intranasal spray would effect a net reduction in cost within the short term by reducing use cost barriers. COVAX vaccine
            delivery goal is to ship 2 billion doses by end 2021 and 1 billion doses to low-and-medium income countries.

          Must be no more than 150 words.

          How are you going to collaborate to accelerate commercialisation? *

          Establishing a successful collaboration between Medlab Clinical and the primary partner, the RNA Institute based at the University of New
            South Wales and the secondary partner (Macquarie University) will seek to accelerate patent protection and regulatory processes for the elaborated intranasal administered siRNA nanoparticle suspension. Medlab’s current patented nanotechnology
            platform presents an attractive and strong protection option for a large pharma partner to consider taking to market a viable and stable intranasal siRNA nanoparticle suspension. It is also important to note that 2 PFROs are participating
            together in a collaborative effort.

          Must be no more than 150 words.

          
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          Assessment Criteria 2: Project Effectiveness

          Please provide an example of how your organisation or project team have delivered real
              world solutions. *

          Medlab Clinical’s NanoCelle® has previously delivered a next generation drug delivery platform with patent protection in numerous
              global jurisdictions (https://www.medlab.co/na nocelle/nanocelle_technology). Medlab Clinical has implemented the submicron nanoparticle technology to elaborate various APIs that have included for example
              insulin, amoxycillin and small molecules such as B12, D3 (i.e., J Funct Biomater 2018 Jan 21;9(1):12). NanoCelle® offers a market-ready and commercially viable delivery solution with patent protection in Australia, New Zealand, Canada, UK and
              Europe until 2036. Medlab’s commercial application of the investigative product would follow a similar research-marketing-sales pathway (local and globally) analogous to that which is already established with cannabis-based medicines. Must be no more than 150 words.

          What is the research basis of your product and the evidence that you can provide to show
              the effectiveness of your product? *

          An intranasal delivered siRNA micellular nanoparticle developed to reduce Covid-19 viral replication and cellular release will
              successful reduce Covid-19 morbidity and mortality from severe infections. The Medlab nanotechnology advantage (https://www.medlab.co /nanocelle/nanocelle_technology) has already been utilised in human
              clinical trials with elaborated suspensions demonstrating enhanced API delivery versus oral formulations (Clinical trial); combination suspensions of THC + CBD for the management of cancer pain (clinical trial); and a CBD-dominant
              anti-inflammatory formulation (Clinical trial). Submicron particles elaborated with Medlab’s patented platform would address issues of treating infections through the concept of nano-immunity. The concept employs a design that can rapidly
              access the mucosal tissue, the site of viral entry, inhibiting viral replication and release. Intranasal delivered formulation will block Covid-19 replication reducing the risk of transmission with a non-invasive self-administered medicine
              with high community appeal. An intranasal administered designed to survive ambient temperatures that would simplify logistical aspects of transportation and storage.

          Must be no more than 150 words.

          How close are you to the commercialisation of your product? *

          Medlab Clinical has 6 years of experimentation with nanoparticle size determinations with numerous APIs from small to complex
              molecules (e.g., insulin). Medlab Clinical has elaborated and commercialised nanoparticles of B12 and D3 with sales of 250,000+ vials nationally. Specifically with the current project Medlab Clinical will further investigate an siRNA
              nanoparticle with imaging studies with the aim of producing credible and robust reproducible size/shape/morphology determinations by employing atomic force microscopy and NanoSight techniques. Such determinations will allow for the
              characterization of nanoparticle size and shape, size distribution, degree of nanoparticle aggregation, surface charge and surface area. Credible and robust measurement methods will allow uptake of the elaborated nanoparticles for commercial
              applications. Product commercialisation may take 2-3 years post completion of the current project. This timeline will be dependent on achieving the 3-month milestone of siRNA formulation experiments and the 6-month milestone on the successful
              self-assembly of the siRNA micellular nanoparticle. Must be no more than 150 words.

          What if any are the key uncertainties remaining about the effectiveness of your

          product, and how and when you will resolve these? *

          Nasal pump selection

          • Dependent on particle size and morphology as previously demonstrated for other Medlab

          
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          formulations;

          Intranasal formulation (i.e., looking at possible GRAS stabilizers and preservatives) this could take several iterations.

          • Medlab employs FDA approved excipients in all nanoparticle formulations currently in development and in the market-place and can address stabilizer / preservative issues approved to
              formulation completion with USA partners (e.g., Renaissance Pharma);

          Intranasal deposition of the loaded NanoCelle in vitro using Pharmacopoeia approved apparatuses;

          Test deposition on nasal cells (cell lines and or primary)

          • Collaborations on extent of uptake / biodegradability of micellular nanoparticle siRNA medicine with the intention to transport and release the drug and increase therapeutic efficacy.
              ormulation stability (i.e., 25C/60RH Vs accelerated and fridge);

          Formulation stability (i.e., 25C/60RH Vs accelerated and fridge);

          • Medlab operates certified stability chambers for accelerated studies with in production

          APIs and can address stability issues that ensue.

          Must be no more than 150 words.

          How do you propose to reach your users? *

          Medlab already has in Australia existing national distribution networks within pharmacy and general practice for its cannabis-based medicines
            and previously with its nutraceutical / functional food business. Users will be reached via these established networks. Furthermore, Medlab is building similar networks in the UK and USA. Furthermore, Medlab has a

          marketing and sales team based in Sydney with pharma marketing experience that utilises digital and offline strategies to increase awareness
            around a specific drug (e.g., cannabis-based medicine). Medlab’s pharma marketing has been largely geared at physicians and pharmacists over the last 3 years. This strategy is the planning stages for the USA and UK markets.

          Must be no more than 150 words.

          Who are your closest competitors and how is your product different? *

          The closest competitors to the developed intranasal micellular siRNA nanoparticle medicine are developments of intranasal administered
            vaccines which include University of Oxford; Altimmune; Bharat Biotech; University of Hong Kong; Meissa Vaccines; Codagenix; Centre for genetic engineering biotechnology Cuba

          However, the advantage of the intranasal micellular siRNA nanoparticle medicine is effective inhibition of the Covid-19 virus
            translation and release, a very attractive clinically significant outcome for the widespread reduction in community acquired infection morbidity and mortality.

          Must be no more than 150 words.

          Assessment Criteria 3: Project Delivery

          Who are the team members working on this project and what are their
              capabilities? *

          Professor Luis Vitetta Molecular Biology particularly pro-oxidant cellular systems (30 years) ( https://www.sydney.edu.au/medicine-health/about/our-people/academic-staff/luis-vitetta.ht ml) (https://www.medlab.co/about&partnering/leadership_team/Professor-Luis-Vitetta-3)

          Dr Michelle Quezada Biochemistry expertise

          https://au.linkedin.com/in/michelle-quezada-a6035842?trk=people-guest_people_search-card

          
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          Dr David Rutolo Organic Chemistry expertise in nano-micellular technology (35 years) https://www.medlab.co/about&partnering/leadership_team/Dr.-David-Rutolo-4

          Dr Jeremy Henson Molecular Biology particularly with nucleic acids (20 years) (https://www.
              medlab.co/about&partnering/leadership_team/Dr.-Jeremy-Henson-11)

          Dr Sean Hall Medlab Clinical CEO procurement of research funds (25 years business experience)

          https://www.medlab.co/about&partnering/leadership_team/Dr.-Sean-Hall-1

            Must be no more than 150 words.

          What are the resources your organisation is making
              available for this project? * Six months access to a physical containment laboratory level 2 and consumables to
              elaborate the micellular nanoparticles with in vitro cell line studies planned. Medlab staff input time from 4 members with availability of 0.2 FTE MQ, 0.1 FTE DR, 0.05 FTE JH and 0.05 FTE LV. Total value of human capacity and laboratory
              resources for 6 months is est. $137,500.

          Must be no more than 150 words.

          What additional resources are you seeking for this project (aside from this funding
              application)? *

          Medlab Clinical has submitted an application for funding to the National Institutes of Health (Application ID: 1R01CA273726-01) in the USA
            that if successful the funding will assist with the further development of the micellular nanocelle technology for mucosal delivery of an API.

          Must be no more than 150 words.

          How will your product be deployed into the operational environment rapidly and at scale? *

          As stated Medlab Clinical offers a market ready micellular nanoparticle commercially viable API delivery solution with
            global patent protection in various jurisdictions. With current nanoparticle formulations Medlab reports

          • Stability in market-place products of up to 2 years at room temperature;

          • NanoCelle is highly scalable for high volume production from 50 mL to 1000 Litres;

          • NanoCelle is already commercialised via several Australian and US manufacturers.

          o Specifically Extractas Bioscience, Natural Factors, Creative Essences and Renaissance

          pharma.

          Must be no more than 150 words.

          What capabilities does the business have that enable implementation of the
              commercialisation of the product? *

          Medlab Clinical’s base is in Sydney employing 70 staff (7 located between the UK and USA). The organization operates an OGTR certified
            physical containment laboratory in Sydney and an additional laboratory in Southern California in the USA. Medlab is globally focused with business developments based in the UK, commercialisation in the USA and Australia as well as both clinical
            and regulatory teams in Australia and the USA.

          Must be no more than 150 words.

          Outline the milestones and stage-gates that are present in the project plan
              *

          • End of month 3 = first batch of siRNA ready for formulation experiments

          • End of month 6 = first nanocelle-siRNA formulation ready for in vitro testing (RPMI cells), > 10 mg siRNA batch ready

          • End of month 9 = physical characterisation of nanocelle-siRNA formulation completed

          
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          (size, loading), stability studies initiated (before/after actuation)

          • End of month 12 = in vitro RPMI tests completed, stability studies completed. Must be no more
                than 150 words.

          How does this project fit with your organisation’s strategic goals? *

          This project strategically fits our commercial goals as it furthers the diversity of a novel

          delivery platform which hold global western patents until 2036.

          Must be no more than 150 words.

          Technology Details

          * indicates a required field

          Technology Readiness Level Scale

          Indicate the current development stage of and the expected development stage if you receive the
            TechVoucher funding from 1 - 9.

          For further information on how to complete this scale please see Appendix A of the Guidelines.

          	
                  Technology Readiness Level (now)*

                	
                  ⚪ 1

                	
                  ⚪ 2

                	
                  ⚪ 3

                	
                  ⚪ 4

                	
                  ⚪ 5

                	
                  ⚪ 6

                	
                  ⚪ 7

                	
                  ◉ 8

                	
                  ⚪ 9

                
	
                  Technology Readiness Level (project end) *

                	
                  ⚪ 1

                	
                  ⚪ 2

                	
                  ⚪ 3

                	
                  ⚪ 4

                	
                  ⚪ 5

                	
                  ◉ 6

                	
                  ⚪ 7

                	
                  ⚪ 8

                	
                  ⚪ 9

                

          

          

          Further Documentation

          Please attach any other information you would like to provide to support your
            application.

          Filename: Confidential_NANOCELLE specific_Patent Portfolio October 2021.pdf File size: 1.8 MB

          Additional Information

          * indicates a required field

          	
                  How many people are currently employed by the organisation? *

                
	
                  75

                
	
                  Must be a number.

                
	 
	
                  Do you identify as an Aboriginal/Torres Strait Islander-owned business? *

                
	
                  ⚪

                	
                  Yes

                
	
                  ◉

                	
                  No

                
	
                  ⚪

                	
                  Prefer not to say

                

          
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          Application Terms (“Terms”)

          * indicates a required field

          Your application

          	

                	1.	
                  By submitting an application to the Crown in the Right of the State of New South Wales acting through Investment NSW (ABN 78 520 401 237) (Investment NSW) constitutes an
                    acceptance by you of the Terms and you agree to be bound by the Terms.

                

          	

                	2.	
                  Funding will be provided for eligible and approved projects until the first of:

                

          •

          	

                	•	
                  available funding is exhausted, or

                

          	

                	•	
                  final deadline for applications: Thursday 10th February 2022 at 5:00pm.

                

          	

                	1.	
                  Applications that are incomplete or do not comply with the instructions provided in the application form are invalid and may not be accepted by Investment NSW.

                

          	

                	2.	
                  You agree to bear the costs of preparing and submitting your application without recourse to Investment NSW.

                

          	

                	3.	
                  You confirm that all of the information provided as part of the application is true, correct and valid as at the date of your application.

                

          	

                	4.	
                  You agree to indemnify Investment NSW against and in respect of all damages, losses, expenses and costs (including legal costs on an indemnity basis) which arise out of or
                    relate to any incorrect or invalid information that you provide to Investment NSW through this application.

                

          	

                	5.	
                  If you are found to have made false or misleading claims or statements, or to have obtained improper assistance in relation to your application, Investment NSW may exclude
                    your application from the evaluation process. You should be aware that giving false or misleading information to Investment NSW is a serious offence under the Criminal Code Act 1995 (Cth).

                

          	

                	6.	
                  An application submitted electronically will be treated in accordance with the Electronic Transactions Act 2000 (NSW).

                

          Assessment and approval of your application.

          	

                	1.	
                  Investment NSW reserves the right to verify the information provided by you as part of your application and determine your eligibility for funding.

                

          	

                	2.	
                  Submitting an application does not guarantee approval of funding. Approval of funding is at the sole discretion of the Investment NSW.

                

          	

                	3.	
                  Nothing in this request for applications or your application will be construed as giving rise to any contractual obligations or rights, express or implied, by the issue of
                    this request for applications or the submission of an application by you (other than your agreement to these Terms).

                

          	

                	4.	
                  If your application is successful, the information provided in this application will form part of a funding agreement to be separately agreed and signed with Investment NSW.
                    Until a funding agreement is agreed and signed you are not eligible for any funding.

                

          Funding program

          	

                	1.	
                  Investment NSW reserves the right to alter, amend, suspend, cancel or withdraw the funding program for any reason and in any circumstances in its sole and absolute discretion
                    and without notice to you. Information

                

          	

                	2.	
                  Subject to any applicable law, Investment NSW make no representation or warranty of any kind, express or implied, in relation to any information or material provided in the
                    application form or funding guidelines.

                

          

          

          
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                	3.	
                  The information and material provided by Investment NSW as part of the application form and funding guidelines is of a general nature only and is not legal or other
                    professional advice or intended to be comprehensive. You are responsible for determining the validity, quality and relevance of any information or materials and to take appropriate independent advice before acting or relying on any of
                    it to ensure that it meets your particular requirements.

                

          	

                	4.	
                  Investment NSW does not accept responsibility for any loss or damage, howsoever caused (including through negligence or matters outside its control), which you may directly or
                    indirectly suffer in connection with your use of or reliance on, information or materials contained in the application form or the funding guidelines.

                

          Privacy and disclosure

          	

                	1.	
                  Investment NSW collects the information in your application, which may include “personal information” for the purpose of the Privacy and Personal Information Protection Act
                    1998 (NSW). Investment NSW collects this personal information for the purpose of considering and assessing your application. If your application is successful, your information will also be used to provide the funding to you, assist you
                    in meeting your obligations and for reporting on the programs to which your funding relates.

                

          	

                	2.	
                  Providing your personal information to Investment NSW is voluntary, however if you do not provide this information we will not be able to assess your application and you will
                    not be considered for funding.

                

          	

                	3.	
                  Investment NSW may also disclose your personal information to the following third parties:

                

          	

                	4.	
                  Our Community Pty Limited being the application portal provider to help administer the program;

                

          	

                	5.	
                  O’Connor Marsden & Associates Pty Limited being the probity advisors to assist with this program;

                

          	

                	6.	
                  a representative of an external body to help assess and recommend applications;

                

          	

                	7.	
                  a credit assessment agency to help complete due diligence checks, and

                

          	

                	8.	
                  other NSW government agencies to help assess and recommend applications and introduce unsuccessful applicants to other support programs that may be of assistance to them.

                

          	

                	9.	
                  We may also be required to disclose information by law. For example, Investment NSW is subject to the Government Information (Public Access) Act 2009 (“GIPA Act”), which means
                    the information you provide may be required to be released in response to a request under the GIPA Act. We may also be required to disclose information to oversight and investigative bodies and to the NSW Parliament.

                

          	

                	10.	
                  Please refer to website https://www.dpc.nsw.gov.au/privacy/ for more
                      information on Investment NSW’s privacy policy and your rights to access or correct the information.

                

          	

                	11.	
                  By submitting this application form, you consent to Investment NSW collecting, using and disclosing information about you in the manner described above.

                

          	

                	12.	
                  You must comply with the Privacy Act 1988 (Cth) in relation to any personal information disclosed to you by Investment NSW in connection with this application or the funding
                    program.

                

          	

                	13.	
                  All applications become the property of Investment NSW on submission. Investment NSW may make copies of the application for any purpose.

                

          Declaration

          By ticking the box identified below:

          	

                	1.	
                  I confirm that on behalf of the applicant that:

                

          	

                	2.	
                  I have read and understood the Terms;

                

          	

                	3.	
                  I agree to the Terms;

                

          

          

          
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                	4.	
                  I have read and understood the funding guidelines with respect to assistance under this program; and

                

          	

                	5.	
                  I am authorised to make this application on behalf of the prospective applicant; and

                

          	

                	6.	
                  the information provided in this application is true, correct and valid as at the date of submitting this application.

                

          *

          	
                  ◉

                	
                  I Agree

                

          

          

          Name *

            Luis Vitetta

          Position held *

          Professor and Director of Medical Research

          Date of declaration *

          02/12/2021

          Must be a date.

          

          

        

      

    

    

    

    

  

  Page 32Exhibit 101 - Securities Purchase Agreement

		

			 

		

		
			EXHIBIT 10.1
		

		
			SECURITIES PURCHASE AGREEMENT
		

		
			This Securities Purchase Agreement (this “Agreement”) is dated as of November 18, 2022, between Cassava Sciences, Inc., a Delaware corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”).
		

		
			WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to an effective registration statement under the Securities Act (as defined below), the Company desires to issue and sell to each Purchaser, and each Purchaser, severally and not jointly, desires to purchase from the Company, Securities of the Company as more fully described in this Agreement.
		

		
			NOW, THEREFORE, IN CONSIDERATION of the mutual covenants contained in this Agreement, and for other good and valuable consideration the receipt and adequacy of which are hereby acknowledged, the Company and each Purchaser agree as follows:
		

		
			ARTICLE I.
DEFINITIONS
		

		
			1.1 Definitions.  In addition to the terms defined elsewhere in this Agreement, for all purposes of this Agreement, the following terms have the meanings set forth in this Section 1.1:
		

		
			“Acquiring Person” shall have the meaning ascribed to such term in Section 4.3.
		

		
			“Action” shall have the meaning ascribed to such term in Section 3.1(j).
		

		
			“Affiliate” means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control with a Person as such terms are used in and construed under Rule 405 under the Securities Act.  
		

		
			“Board of Directors” means the board of directors of the Company.
		

		
			“Business Day” means any day other than Saturday, Sunday or other day on which commercial banks in The City of New York are authorized or required by law to remain closed; provided,  however, for clarification, commercial banks shall not be deemed to be authorized or required by law to remain closed due to “stay at home”, “shelter-in-place”, “non-essential employee”  or any other similar orders or restrictions or the closure of any physical branch locations at the direction of any governmental authority so long as the electronic funds transfer systems (including for wire transfers) of commercial banks in The City of New York are generally open for use by customers on such day.
		

		
			“Closing” means the closing of the purchase and sale of the Securities pursuant to Section 2.1.
		

		

		

		 

		

			1

		

		

			 

		

 

		

			 

		

		“Closing Date” means the Trading Day on which all of the Transaction Documents have been executed and delivered by the applicable parties thereto, and all conditions precedent to (i) the Purchasers’ obligations to pay the Subscription Amount and (ii) the Company’s obligations to deliver the Securities, in each case, have been satisfied or waived, but in no event later than the second (2nd) Trading Day following the date hereof.
		

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

		
			“Common Stock” means the common stock of the Company, par value $0.001 per share, and any other class of securities into which such securities may hereafter be reclassified or changed. 
		

		
			“Common Stock Equivalents” means any securities of the Company or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.
		

		
			“Company Counsel” means Orrick, Herrington & Sutcliffe LLP, with offices located at the Orrick Building, 405 Howard Street, San Francisco, California 94105-2669. 
		

		
			“Disclosure Schedules” means the Disclosure Schedules of the Company delivered concurrently herewith.
		

		
			“Disclosure Time” means, (i) if this Agreement is signed on a day that is not a Trading Day or after 9:00 a.m. (New York City time) and before midnight (New York City time) on any Trading Day, 9:01 a.m. (New York City time) on the Trading Day immediately following the date hereof, unless otherwise instructed as to an earlier time by the Placement Agent, and (ii) if this Agreement is signed between midnight (New York City time) and 9:00 a.m. (New York City time) on any Trading Day, no later than 9:01 a.m. (New York City time) on the date hereof, unless otherwise instructed as to an earlier time by the Placement Agent.
		

		
			“DVP” shall have the meaning ascribed to such term in Section 2.1.
		

		
			“Evaluation Date” shall have the meaning ascribed to such term in Section 3.1(s). 
		

		
			“Exchange Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
		

		
			﻿
		

		
			“Exempt Issuance” means the issuance of (a) shares of Common Stock, options or other equity awards to employees, officers or directors of the Company pursuant to any stock or option plan duly adopted for such purpose, by a majority of the non-employee members of the Board of Directors or a majority of the members of a committee of non-employee directors established for such purpose for services rendered to the Company, (b) securities upon the exercise or exchange of or conversion of any Securities issued hereunder and/or other securities exercisable or exchangeable for or convertible into shares of Common Stock issued and outstanding on the date of this Agreement, provided that such 
		

		 

		

			2

		

		

			 

		

 

		

			 

		

		securities have not been amended since the date of this Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of such securities (other than in connection with stock splits or combinations) or to extend the term of such securities, and (c) securities issued pursuant to acquisitions or strategic transactions (including issuances to vendors, customers, or other commercial or strategic partners or potential commercial or strategic partners) approved by a majority of the disinterested directors of the Company, provided that such securities are issued as “restricted securities” (as defined in Rule 144) and carry no registration rights that require or permit the filing of any registration statement in connection therewith during the prohibition period in Section 4.10(a) herein, and provided that any such issuance shall only be to a Person (or to the equityholders of a Person) which is, itself or through its subsidiaries, an operating company or an owner of an asset in a business synergistic with the business of the Company and shall provide to the Company additional benefits in addition to the investment of funds, but shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities. 
		

		
			“FCPA” means the Foreign Corrupt Practices Act of 1977, as amended.
		

		
			“FDA” shall have the meaning ascribed to such term in Section 3.1(hh).
		

		
			“FDCA” shall have the meaning ascribed to such term in Section 3.1(hh).
		

		
			“GAAP” shall have the meaning ascribed to such term in Section 3.1(h).
		

		
			“Indebtedness” shall have the meaning ascribed to such term in Section 3.1(aa).
		

		
			“Intellectual Property Rights” shall have the meaning ascribed to such term in Section 3.1(p).
		

		
			“Liens” means a lien, charge, pledge, security interest, encumbrance, right of first refusal, preemptive right or other restriction.
		

		
			“Lock-Up Agreement” means the 90-day Lock-Up Agreement, dated as of the date hereof, by and among the Company and the directors and officers of the Company, in the form of Exhibit A attached hereto.
		

		
			“Lowenstein” means Lowenstein Sandler LLP, with offices at 1251 Avenue of the Americas, New York, New York 10020.
		

		
			“Material Adverse Effect” shall have the meaning assigned to such term in Section 3.1(b).
		

		
			“Material Permits” shall have the meaning ascribed to such term in Section 3.1(n).
		

		
			“Per Share Purchase Price” equals $30.00, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions of 
		

		 

		

			3

		

		

			 

		

 

		

			 

		

		the Common Stock that occur after the date of this Agreement and prior to the Closing Date.
		

		
			“Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.
		

		
			“Pharmaceutical Product” shall have the meaning ascribed to such term in Section 3.1(hh). 
		

		
			“Placement Agent” means H.C. Wainwright & Co., LLC.
		

		
			“Proceeding” means an action, claim, suit, investigation or proceeding (including, without limitation, an informal investigation or partial proceeding, such as a deposition), whether commenced or threatened.
		

		
			“Prospectus” means the final base prospectus filed for the Registration Statement.
		

		
			“Prospectus Supplement” means the supplement to the Prospectus complying with Rule 424(b) of the Securities Act that is filed with the Commission and delivered by the Company to each Purchaser at the Closing.
		

		
			“Purchaser Party” shall have the meaning ascribed to such term in Section 4.6.
		

		
			“Registration Statement” means the automatic shelf registration statement on Form S-3ASR filed with Commission (File No. 333-252931), including all information, documents and exhibits filed with or incorporated by reference into such registration statement, which registers the sale of the Shares to the Purchasers.
		

		
			“Required Approvals” shall have the meaning ascribed to such term in Section 3.1(e).
		

		
			“Rule 144” means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule. 
		

		
			“Rule 424” means Rule 424 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.
		

		
			  “SEC Reports” shall have the meaning ascribed to such term in Section 3.1(h).
		

		
			“Securities” means the Shares.
		

		
			“Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
		

		

		

		 

		

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		“Shares” means the shares of Common Stock issued or issuable to each Purchaser pursuant to this Agreement.
		

		
			“Short Sales” means all “short sales” as defined in Rule 200 of Regulation SHO under the Exchange Act (but shall not be deemed to include locating and/or borrowing shares of Common Stock). 
		

		
			  “Subscription Amount” means, as to each Purchaser, the aggregate amount to be paid for Shares purchased hereunder as specified below such Purchaser’s name on the signature page of this Agreement and next to the heading “Subscription Amount,” in United States dollars and in immediately available funds.
		

		
			“Subsidiary” means any subsidiary of the Company as set forth on Schedule 3.1(a), and shall, where applicable, also include any direct or indirect subsidiary of the Company formed or acquired after the date hereof.
		

		
			“Trading Day” means a day on which the principal Trading Market is open for trading.
		

		
			“Trading Market” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market or the New York Stock Exchange (or any successors to any of the foregoing).
		

		
			“Transaction Documents” means this Agreement, the Lock-Up Agreement, all exhibits and schedules thereto and hereto and any other documents or agreements executed in connection with the transactions contemplated hereunder.
		

		
			“Transfer Agent” means Computershare Shareowner Services LLC, the current transfer agent of the Company, with a mailing address of 330 N Brand Boulevard, Suite 701, Glendale, California, 91203-2389, and any successor transfer agent of the Company.
		

		
			“Variable Rate Transaction” shall have the meaning ascribed to such term in Section 4.10(b).
		

		
			ARTICLE II.
PURCHASE AND SALE
		

		
			2.1Closing.  On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Purchasers, severally and not jointly,  agree to purchase, up to an aggregate of $50,000,010 of Shares.  Each Purchaser’s Subscription Amount as set forth on the signature page hereto executed by such Purchaser shall be made available for “Delivery Versus Payment” (“DVP”) settlement with the Company or its designee. The Company shall deliver to each Purchaser its respective Shares as determined pursuant to Section 2.2(a), and the Company and each Purchaser shall deliver the other items set forth in Section 2.2 deliverable at the Closing.  Upon satisfaction of the covenants and conditions set forth in Sections 2.2 and 2.3, the Closing shall occur at the offices of Lowenstein or such other location as the parties shall mutually agree, including remotely. Unless otherwise directed by the 
		

		 

		

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		Placement Agent, settlement of the Shares shall occur via DVP (i.e., on the Closing Date, the Company shall issue the Shares registered in the Purchasers’ names and addresses and released by the Transfer Agent directly to the account(s) at the Placement Agent identified by each Purchaser; upon receipt of such Shares, the Placement Agent shall promptly electronically deliver such Shares to the applicable Purchaser, and payment therefor shall be made by the Placement Agent (or its clearing firm) by wire transfer to the Company). Notwithstanding anything herein to the contrary, if at any time on or after the time of execution of this Agreement by the Company and an applicable Purchaser, through, and including the time immediately prior to the Closing (the “Pre-Settlement Period”), such Purchaser sells to any Person all, or any portion, of the Shares to be issued hereunder to such Purchaser at the Closing (collectively, the “Pre-Settlement Shares”), such Purchaser shall, automatically hereunder (without any additional required actions by such Purchaser or the Company), be deemed to be unconditionally bound to purchase, such Pre-Settlement Shares to such Purchaser at the Closing; provided, that the Company shall not be required to deliver any Pre-Settlement Shares to such Purchaser prior to the Company’s receipt of the purchase price of such Pre-Settlement Shares hereunder; and provided further that the Company hereby acknowledges and agrees that the forgoing shall not constitute a representation or covenant by such Purchaser as to whether or not during the Pre-Settlement Period such Purchaser shall sell any shares of Common Stock to any Person and that any such decision to sell any shares of Common Stock by such Purchaser shall solely be made at the time such Purchaser elects to effect any such sale, if any.
		

		
			2.2Deliveries.
		

		
			(a)On or prior to the Closing Date (except as indicated below), the Company shall deliver or cause to be delivered to each Purchaser the following:
		

		
			(i)this Agreement duly executed by the Company;
		

		
			(ii)a legal opinion of Company Counsel, directed to the Placement Agent and the Purchasers, in a form reasonably acceptable to the Placement Agent and Purchasers; 
		

		
			(iii)subject to the last sentence of Section 2.1, the Company shall have provided each Purchaser with the Company’s wire instructions, on Company letterhead and executed by the Chief Executive Officer or Chief Financial Officer;
		

		
			(iv)subject to the last sentence of Section 2.1, a copy of the irrevocable instructions to the Transfer Agent instructing the Transfer Agent to deliver on an expedited basis via The Depository Trust Company Deposit or Withdrawal at Custodian system (“DWAC”) Shares equal to such Purchaser’s Subscription Amount divided by the Per Share Purchase Price, registered in the name of such Purchaser;
		

		
			(v)on the date hereof, the duly executed Lock-Up Agreements; and
		

		
			(vi)the Prospectus and Prospectus Supplement (which may be delivered in accordance with Rule 172 under the Securities Act).
		

		 

		

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			(b)On or prior to the Closing Date, each Purchaser shall deliver or cause to be delivered to the Company, as applicable, the following:
		

		
			(i)this Agreement duly executed by such Purchaser; and
		

		
			(ii)such Purchaser’s Subscription Amount, which shall be made available for DVP settlement with the Company or its designee.
		

		
			2.3Closing Conditions. 
		

		
			(a)The obligations of the Company hereunder in connection with the Closing are subject to the following conditions being met:
		

		
			(i)the accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material Adverse Effect, in all respects) on the Closing Date of the representations and warranties of the Purchasers contained herein (unless as of a specific date therein in which case they shall be accurate in all material respects (or, to the extent representations or warranties are qualified by materiality, in all respects) as of such date); 
		

		
			(ii)all obligations, covenants and agreements of each Purchaser required to be performed at or prior to the Closing Date shall have been performed; and
		

		
			(iii)the delivery by each Purchaser of the items set forth in Section 2.2(b) of this Agreement.
		

		
			(b)The respective obligations of the Purchasers hereunder in connection with the Closing are subject to the following conditions being met:
		

		
			(i)the accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material Adverse Effect, in all respects) when made and on the Closing Date of the representations and warranties of the Company contained herein (unless as of a specific date therein in which case they shall be accurate in all material respects or, to the extent representations or warranties are qualified by materiality or Material Adverse Effect, in all respects) as of such date);
		

		
			(ii)all obligations, covenants and agreements of the Company required to be performed at or prior to the Closing Date shall have been performed; 
		

		
			(iii)the delivery by the Company of the items set forth in Section 2.2(a) of this Agreement; 
		

		
			(iv)there shall have been no Material Adverse Effect with respect to the Company since the date hereof; and
		

		 

		

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			(v)from the date hereof to the Closing Date, trading in the Common Stock shall not have been suspended by the Commission or the Company’s principal Trading Market, and, at any time prior to the Closing Date, trading in securities generally as reported by Bloomberg L.P. shall not have been suspended or limited, or minimum prices shall not have been established on securities whose trades are reported by such service, or on any Trading Market, nor shall a banking moratorium have been declared either by the United States or New York State authorities nor shall there have occurred any material outbreak or escalation of hostilities or other national or international calamity of such magnitude in its effect on, or any material adverse change in, any financial market which, in each case, in the reasonable judgment of such Purchaser, makes it impracticable or inadvisable to purchase the Securities at the Closing.
		

		
			ARTICLE III.
REPRESENTATIONS AND WARRANTIES
		

		
			3.1Representations and Warranties of the Company.  Except as set forth in the Disclosure Schedules, which Disclosure Schedules shall be deemed a part hereof and shall qualify any representation or otherwise made herein to the extent of the disclosure contained in the corresponding section of the Disclosure Schedules, the Company hereby makes the following representations and warranties to each Purchaser:
		

		
			(a)Subsidiaries.  All of the direct and indirect subsidiaries of the Company are set forth on Schedule 3.1(a).  The Company owns, directly or indirectly, all of the capital stock or other equity interests of each Subsidiary free and clear of any Liens, and all of the issued and outstanding shares of capital stock of each Subsidiary are validly issued and are fully paid, non-assessable and free of preemptive and similar rights to subscribe for or purchase securities.  If the Company has no subsidiaries, all other references to the Subsidiaries or any of them in the Transaction Documents shall be disregarded.
		

		
			(b)Organization and Qualification.  The Company and each of the Subsidiaries is an entity duly incorporated or otherwise organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation or organization, with the requisite power and authority to own and use its properties and assets and to carry on its business as currently conducted.  Neither the Company nor any Subsidiary is in violation nor default of any of the provisions of its respective certificate or articles of incorporation, bylaws or other organizational or charter documents.  Each of the Company and the Subsidiaries is duly qualified to conduct business and is in good standing as a foreign corporation or other entity in each jurisdiction in which the nature of the business conducted or property owned by it makes such qualification necessary, except where the failure to be so qualified or in good standing, as the case may be, could not have or reasonably be expected to result in: (i) a material adverse effect on the legality, validity or enforceability of any Transaction Document, (ii) a material adverse effect on the results of operations, assets, business, prospects or condition (financial or otherwise) of the Company and the Subsidiaries, taken as a whole, or (iii) a material adverse effect on the Company’s ability to perform in any material respect on a timely basis its obligations under any Transaction Document (any of (i), (ii) or (iii), a “Material Adverse Effect”) and no Proceeding has been instituted in any 
		

		 

		

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		such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or curtail such power and authority or qualification.
		

		
			(c)Authorization; Enforcement.  The Company has the requisite corporate power and authority to enter into and to consummate the transactions contemplated by this Agreement and each of the other Transaction Documents and otherwise to carry out its obligations hereunder and thereunder.  The execution and delivery of this Agreement and each of the other Transaction Documents by the Company and the consummation by it of the transactions contemplated hereby and thereby have been duly authorized by all necessary action on the part of the Company and no further action is required by the Company, the Board of Directors or the Company’s stockholders in connection herewith or therewith other than in connection with the Required Approvals.  This Agreement and each other Transaction Document to which it is a party has been (or upon delivery will have been) duly executed by the Company and, when delivered in accordance with the terms hereof and thereof, will constitute the valid and binding obligation of the Company enforceable against the Company in accordance with its terms, except (i) as limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited by applicable law.
		

		
			(d)No Conflicts.  The execution, delivery and performance by the Company of this Agreement and the other Transaction Documents to which it is a party, the issuance and sale of the Securities and the consummation by it of the transactions contemplated hereby and thereby do not and will not (i) conflict with or violate any provision of the Company’s or any Subsidiary’s certificate or articles of incorporation, bylaws or other organizational or charter documents, or (ii) conflict with, or constitute a default (or an event that with notice or lapse of time or both would become a default) under, result in the creation of any Lien upon any of the properties or assets of the Company or any Subsidiary, or give to others any rights of termination, amendment, anti-dilution or similar adjustments, acceleration or cancellation (with or without notice, lapse of time or both) of, any agreement, credit facility, debt or other instrument (evidencing a Company or Subsidiary debt or otherwise) or other understanding to which the Company or any Subsidiary is a party or by which any property or asset of the Company or any Subsidiary is bound or affected, or (iii) subject to the Required Approvals, conflict with or result in a violation of any law, rule, regulation, order, judgment, injunction, decree or other restriction of any court or governmental authority to which the Company or a Subsidiary is subject (including federal and state securities laws and regulations), or by which any property or asset of the Company or a Subsidiary is bound or affected; except in the case of each of clauses (ii) and (iii), such as could not have or reasonably be expected to result in a Material Adverse Effect.
		

		
			(e)Filings, Consents and Approvals.  The Company is not required to obtain any consent, waiver, authorization or order of, give any notice to, or make any filing or registration with, any court or other federal, state, local or other governmental authority or other Person in connection with the execution, delivery and performance by the Company 
		
		
 

		

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		of the Transaction Documents, other than: (i) the filings required pursuant to Section 4.2 of this Agreement, (ii) the filing with the Commission of the Prospectus Supplement, (iii) application(s) to each applicable Trading Market for the listing of the Shares for trading thereon in the time and manner required thereby, and (iv) such filings as are required to be made under applicable state securities laws (collectively, the “Required Approvals”).

		
		
			(f)Issuance of the Securities; Registration.  The Shares are duly authorized and, when issued and paid for in accordance with the applicable Transaction Documents, will be duly and validly issued, fully paid and nonassessable, free and clear of all Liens imposed by the Company.  The Company has reserved from its duly authorized capital stock the maximum number of shares of Common Stock issuable pursuant to this Agreement. The Company has prepared and filed the Registration Statement in conformity with the requirements of the Securities Act, which became effective upon filing on February 10, 2021, including the Prospectus, and such amendments and supplements thereto as may have been required to the date of this Agreement.  The Registration Statement is effective under the Securities Act and no stop order preventing or suspending the effectiveness of the Registration Statement or suspending or preventing the use of the Prospectus has been issued by the Commission and no proceedings for that purpose have been instituted or, to the knowledge of the Company, are threatened by the Commission.  The Company, if required by the rules and regulations of the Commission, shall file the Prospectus Supplement with the Commission pursuant to Rule 424(b).  At the time the Registration Statement and any amendments thereto became effective, at the date of this Agreement and at the Closing Date, the Registration Statement and any amendments thereto conformed and will conform in all material respects to the requirements of the Securities Act and did not and will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading; and the Prospectus and any amendments or supplements thereto, at the time the Prospectus or any amendment or supplement thereto was issued and at the Closing Date, conformed and will conform in all material respects to the requirements of the Securities Act and did not and will not contain an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Company was at the time of the filing of the Registration Statement eligible to use Form S-3. The Company is eligible to use Form S-3 under the Securities Act and it meets the requirements for use of Form S-3ASR under the Securities Act.
		

		
			(g)Capitalization.  The capitalization of the Company as of the date hereof is as set forth on Schedule 3.1(g), which Schedule 3.1(g) shall also include the number of shares of Common Stock owned beneficially, and of record, by Affiliates of the Company as of the date hereof.  The Company has not issued any capital stock since its most recently filed periodic report under the Exchange Act, other than pursuant to the exercise of employee stock options under the Company’s stock option plans, the issuance of shares of Common Stock to employees pursuant to the Company’s employee stock purchase plans and pursuant to the conversion and/or exercise of Common Stock Equivalents outstanding as of the date of the most recently filed periodic report under the Exchange Act.  No Person has any right of first refusal, preemptive right, right of participation, or any similar right to participate in the transactions contemplated by the Transaction Documents.  Except as a 
		
		
 

		

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		result of the purchase and sale of the Securities and as set forth on Schedule 3.1(g), there are no outstanding options, warrants, scrip rights to subscribe to, calls or commitments of any character whatsoever relating to, or securities, rights or obligations convertible into or exercisable or exchangeable for, or giving any Person any right to subscribe for or acquire, any shares of Common Stock or the capital stock of any Subsidiary, or contracts, commitments, understandings or arrangements by which the Company or any Subsidiary is or may become bound to issue additional shares of Common Stock or Common Stock Equivalents or capital stock of any Subsidiary.  The issuance and sale of the Securities will not obligate the Company or any Subsidiary to issue shares of Common Stock or other securities to any Person (other than the Purchasers) and will not result in a right of any holder of Company securities to adjust the exercise, conversion, exchange or reset price of such security or instrument upon an issuance of the Securities by the Company or any Subsidiary.  There are no outstanding securities or instruments of the Company or any Subsidiary that contain any redemption or similar provisions, and there are no contracts, commitments, understandings or arrangements by which the Company or any Subsidiary is or may become bound to redeem a security of the Company or such Subsidiary. The Company does not have any stock appreciation rights or “phantom stock” plans or agreements or any similar plan or agreement. All of the outstanding shares of capital stock of the Company are duly authorized, validly issued, fully paid and nonassessable, have been issued in compliance with all federal and state securities laws, and none of such outstanding shares was issued in violation of any preemptive rights or similar rights to subscribe for or purchase securities.  No further approval or authorization of any stockholder, the Board of Directors or others is required for the issuance and sale of the Securities.  There are no stockholders agreements, voting agreements or other similar agreements with respect to the Company’s capital stock to which the Company is a party or, to the knowledge of the Company, between or among any of the Company’s stockholders.

		
		
			(h)SEC Reports; Financial Statements.  The Company has filed all reports, schedules, forms, statements and other documents required to be filed by the Company under the Securities Act and the Exchange Act, including pursuant to Section 13(a) or 15(d) thereof, for the two years preceding the date hereof (or such shorter period as the Company was required by law or regulation to file such material) (the foregoing materials, including the exhibits thereto and documents incorporated by reference therein, together with the Prospectus and the Prospectus Supplement, being collectively referred to herein as the “SEC Reports”) on a timely basis or has received a valid extension of such time of filing and has filed any such SEC Reports prior to the expiration of any such extension.  As of their respective dates, the SEC Reports complied in all material respects with the requirements of the Securities Act and the Exchange Act, as applicable, and none of the SEC Reports, when filed, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading. The Company has never been an issuer subject to Rule 144(i) under the Securities Act. The financial statements of the Company included in the SEC Reports comply in all material respects with applicable accounting requirements and the rules and regulations of the Commission with respect thereto as in effect at the time of filing.  Such financial statements have been prepared in accordance with United States generally 
		
		
 

		

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		accepted accounting principles applied on a consistent basis during the periods involved (“GAAP”), except as may be otherwise specified in such financial statements or the notes thereto and except that unaudited financial statements may not contain all footnotes required by GAAP, and fairly present in all material respects the financial position of the Company and its consolidated Subsidiaries as of and for the dates thereof and the results of operations and cash flows for the periods then ended, subject, in the case of unaudited statements, to normal, immaterial, year-end audit adjustments.

		
		
			(i)Material Changes; Undisclosed Events, Liabilities or Developments.  Since the date of the latest audited financial statements included within the SEC Reports, except as disclosed in a SEC Report filed on or prior to the date hereof, (i) there has been no event, occurrence or development that has had or that could reasonably be expected to result in a Material Adverse Effect, (ii) the Company has not incurred any liabilities (contingent or otherwise) other than (A) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice and (B) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP or disclosed in filings made with the Commission, (iii) the Company has not altered its method of accounting, (iv) the Company has not declared or made any dividend or distribution of cash or other property to its stockholders or purchased, redeemed or made any agreements to purchase or redeem any shares of its capital stock and (v) the Company has not issued any equity securities to any officer, director or Affiliate, except pursuant to existing Company stock option plans.  The Company does not have pending before the Commission any request for confidential treatment of information.  Except for the issuance of the Securities contemplated by this Agreement or as set forth on Schedule 3.1(i), no event, liability, fact, circumstance, occurrence or development has occurred or exists or is reasonably expected to occur or exist with respect to the Company or its Subsidiaries or their respective businesses, prospects, properties, operations, assets or financial condition that would be required to be disclosed by the Company under applicable securities laws at the time this representation is made or deemed made that has not been publicly disclosed at least 1 Trading Day prior to the date that this representation is made.
		

		
			(j)Litigation.  Except as set forth in the SEC Reports, there is no action, suit, inquiry, notice of violation, proceeding or investigation pending or, to the knowledge of the Company, threatened against or affecting the Company, any Subsidiary or any of their respective properties before or by any court, arbitrator, governmental or administrative agency or regulatory authority (federal, state, county, local or foreign) (collectively, an “Action”) which adversely affects or challenges the legality, validity or enforceability of any of the Transaction Documents or the Securities or (ii) could, if there were an unfavorable decision, have or reasonably be expected to result in a Material Adverse Effect.  Except as disclosed in SEC Reports, neither the Company nor any Subsidiary, nor any director or officer thereof, is or has been the subject of any Action involving a claim of violation of or liability under federal or state securities laws or a claim of breach of fiduciary duty.  Except as disclosed in SEC Reports, there has not been, and to the knowledge of the Company, there is not pending or contemplated, any investigation by the Commission involving the Company or any current or former director or officer of the Company.  The Commission has not issued any stop order or other order suspending the 
		

		 

		

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		effectiveness of any registration statement filed by the Company or any Subsidiary under the Exchange Act or the Securities Act.  
		

		
			(k)Labor Relations.  No labor dispute exists or, to the knowledge of the Company, is imminent with respect to any of the employees of the Company, which could reasonably be expected to result in a Material Adverse Effect.  None of the Company’s or its Subsidiaries’ employees is a member of a union that relates to such employee’s relationship with the Company or such Subsidiary, and neither the Company nor any of its Subsidiaries is a party to a collective bargaining agreement, and the Company and its Subsidiaries believe that their relationships with their employees are good.  To the knowledge of the Company, no executive officer of the Company or any Subsidiary, is, or is now expected to be, in violation of any material term of any employment contract, confidentiality, disclosure or proprietary information agreement or non-competition agreement, or any other contract or agreement or any restrictive covenant in favor of any third party, and the continued employment of each such executive officer does not subject the Company or any of its Subsidiaries to any liability with respect to any of the foregoing matters.  The Company and its Subsidiaries are in compliance with all U.S. federal, state, local and foreign laws and regulations relating to employment and employment practices, terms and conditions of employment and wages and hours, except where the failure to be in compliance would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
		

		
			(l)Compliance.  Neither the Company nor any Subsidiary: (i) is in default under or in violation of (and no event has occurred that has not been waived that, with notice or lapse of time or both, would result in a default by the Company or any Subsidiary under), nor has the Company or any Subsidiary received notice of a claim that it is in default under or that it is in violation of, any indenture, loan or credit agreement or any other agreement or instrument to which it is a party or by which it or any of its properties is bound (whether or not such default or violation has been waived), (ii) is in violation of any judgment, decree or order of any court, arbitrator or other governmental authority or (iii) is or has been in violation of any statute, rule, ordinance or regulation of any governmental authority, including without limitation all foreign, federal, state and local laws relating to taxes, environmental protection, occupational health and safety, product quality and safety and employment and labor matters, except in each case as would not have or reasonably be expected to result in a Material Adverse Effect.
		

		
			(m)Environmental Laws.The Company and its Subsidiaries (i) are in compliance with all federal, state, local and foreign laws relating to pollution or protection of human health or the environment (including ambient air, surface water, groundwater, land surface or subsurface strata), including laws relating to emissions, discharges, releases or threatened releases of chemicals, pollutants, contaminants, or toxic or hazardous substances or wastes (collectively, “Hazardous Materials”) into the environment, or otherwise relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport or handling of Hazardous Materials, as well as all authorizations, codes, decrees, demands, or demand letters, injunctions, judgments, licenses, notices or notice letters, orders, permits, plans or regulations, issued, entered, promulgated or approved thereunder (“Environmental Laws”); (ii) have received all permits licenses or other 
		

		 

		

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		approvals required of them under applicable Environmental Laws to conduct their respective businesses; and (iii) are in compliance with all terms and conditions of any such permit, license or approval where in each clause (i), (ii) and (iii), the failure to so comply would be reasonably expected to have, individually or in the aggregate, a Material Adverse Effect.
		

		
			(n)Regulatory Permits.  The Company and the Subsidiaries possess all certificates, authorizations and permits issued by the appropriate federal, state, local or foreign regulatory authorities necessary to conduct their respective businesses as described in the SEC Reports, except where the failure to possess such permits could not reasonably be expected to result in a Material Adverse Effect (“Material Permits”), and neither the Company nor any Subsidiary has received any notice of proceedings relating to the revocation or modification of any Material Permit.
		

		
			(o)Title to Assets.  The Company and the Subsidiaries have good and marketable title in fee simple to all real property owned by them and good and marketable title in all personal property owned by them that is material to the business of the Company and the Subsidiaries, in each case free and clear of all Liens, except for (i) Liens as do not materially affect the value of such property and do not materially interfere with the use made and proposed to be made of such property by the Company and the Subsidiaries and (ii) Liens for the payment of federal, state or other taxes, for which appropriate reserves have been made therefor in accordance with GAAP and, the payment of which is neither delinquent nor subject to penalties.  Any real property and facilities held under lease by the Company and the Subsidiaries are held by them under valid, subsisting and enforceable leases with which the Company and the Subsidiaries are in compliance.
		

		
			(p)Intellectual Property.  To the Company’s knowledge, the Company and the Subsidiaries have, or have rights to use, all patents, patent applications, trademarks, trademark applications, service marks, trade names, trade secrets, inventions, copyrights, licenses and other intellectual property rights and similar rights necessary or required for use in connection with their respective businesses as described in the SEC Reports and which the failure to so have would have a Material Adverse Effect (collectively, the “Intellectual Property Rights”).  None of, and neither the Company nor any Subsidiary has received a notice (written or otherwise) that any of, the Intellectual Property Rights has expired, terminated or been abandoned, or is expected to expire or terminate or be abandoned, within two (2) years from the date of this Agreement, except as would not be reasonably expected to have a Material Adverse Effect.  Neither the Company nor any Subsidiary has received, since the date of the latest audited financial statements included within the SEC Reports, a written notice of a claim or otherwise has any knowledge that the Intellectual Property Rights violate or infringe upon the rights of any Person, except as would not have or reasonably be expected to not have a Material Adverse Effect.  To the knowledge of the Company, all such Intellectual Property Rights are enforceable and there is no existing infringement by another Person of any of the Intellectual Property Rights.  The Company and its Subsidiaries have taken reasonable security measures to protect the secrecy, confidentiality and value of all of their intellectual properties, except where failure to do so would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
		

		 

		

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			(q)Insurance.  The Company and the Subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as are prudent and customary in the businesses in which the Company and the Subsidiaries are engaged, including, but not limited to, directors and officers insurance coverage. Neither the Company nor any Subsidiary has been advised that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business without a significant increase in cost.
		

		
			(r)Transactions With Affiliates and Employees.  Except as set forth in the SEC Reports, none of the officers or directors of the Company or any Subsidiary and, to the knowledge of the Company, none of the employees of the Company or any Subsidiary is presently a party to any transaction with the Company or any Subsidiary (other than for services as employees, officers and directors), including any contract, agreement or other arrangement providing for the furnishing of services to or by, providing for rental of real or personal property to or from, providing for the borrowing of money from or lending of money to or otherwise requiring payments to or from any officer, director or such employee or, to the knowledge of the Company, any entity in which any officer, director, or any such employee has a substantial interest or is an officer, director, trustee, stockholder, member or partner, in each case in excess of $120,000 other than for (i) payment of salary or consulting fees for services rendered, (ii) reimbursement for expenses incurred on behalf of the Company and (iii) other employee benefits, including stock option agreements under any stock option plan of the Company.
		

		
			(s)Sarbanes-Oxley; Internal Accounting Controls.  The Company and the Subsidiaries are in compliance with any and all applicable requirements of the Sarbanes-Oxley Act of 2002, as amended, that are effective as of the date hereof in all material respects, and any and all applicable rules and regulations promulgated by the Commission thereunder that are effective as of the date hereof and as of the Closing Date.  The Company and the Subsidiaries maintain a system of internal accounting controls sufficient to provide reasonable assurance that: (i) transactions are executed in accordance with management’s general or specific authorizations, (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with GAAP and to maintain asset accountability, (iii) access to assets is permitted only in accordance with management’s general or specific authorization, and (iv) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company and the Subsidiaries have established disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Company and the Subsidiaries and designed such disclosure controls and procedures to ensure that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms.  The Company’s certifying officers have evaluated the effectiveness of the disclosure controls and procedures of the Company and the Subsidiaries as of the end of the period covered by the most recently filed periodic report under the Exchange Act (such date, the “Evaluation Date”).  The Company presented in its most recently filed periodic report under the Exchange Act the conclusions of the certifying officers about the effectiveness of the 
		

		 

		

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		disclosure controls and procedures based on their evaluations as of the Evaluation Date.  Since the Evaluation Date, there have been no changes in the internal control over financial reporting (as such term is defined in the Exchange Act) of the Company and its Subsidiaries that have materially affected, or is reasonably likely to materially affect, the internal control over financial reporting of the Company and its Subsidiaries.
		

		
			(t)Certain Fees.  Except for fees payable by the Company to the Placement Agent, no brokerage or finder’s fees or commissions are or will be payable by the Company or any Subsidiary to any broker, financial advisor or consultant, finder, placement agent, investment banker, bank or other Person with respect to the transactions contemplated by the Transaction Documents.  The Purchasers shall have no obligation with respect to any fees or with respect to any claims made by or on behalf of other Persons for fees of a type contemplated in this Section that may be due in connection with the transactions contemplated by the Transaction Documents.
		

		
			(u)Investment Company. The Company is not, and is not an Affiliate of, and immediately after receipt of payment for the Securities, will not be or be an Affiliate of, an “investment company” within the meaning of the Investment Company Act of 1940, as amended.  The Company shall conduct its business in a manner so that it will not become an “investment company” subject to registration under the Investment Company Act of 1940, as amended.
		

		
			(v)Registration Rights.  No Person has any right to cause the Company or any Subsidiary to effect the registration under the Securities Act of any securities of the Company or any Subsidiary.
		

		
			(w)Listing and Maintenance Requirements.  The Common Stock is registered pursuant to Section 12(b) or 12(g) of the Exchange Act, and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the registration of the Common Stock under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating such registration.  The Company has not, in the 12 months preceding the date hereof, received notice from any Trading Market on which the Common Stock is or has been listed or quoted to the effect that the Company is not in compliance with the listing or maintenance requirements of such Trading Market. The Company is, and has no reason to believe that it will not in the foreseeable future continue to be, in compliance with all such listing and maintenance requirements. The Common Stock is currently eligible for electronic transfer through the Depository Trust Company or another established clearing corporation and the Company is current in payment of the fees to the Depository Trust Company (or such other established clearing corporation) in connection with such electronic transfer.
		

		
			(x)Application of Takeover Protections.  The Company and the Board of Directors have taken all necessary action, if any, in order to render inapplicable any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or other similar anti‐takeover provision under the Company’s certificate of incorporation (or similar charter documents) or the laws of its state of incorporation that is or could become applicable to the Purchasers as a result of the Purchasers and the 
		

		 

		

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		Company fulfilling their obligations or exercising their rights under the Transaction Documents, including without limitation as a result of the Company’s issuance of the Securities and the Purchasers’ ownership of the Securities.
		

		
			(y)Disclosure.  Except with respect to the material terms and conditions of the transactions contemplated by the Transaction Documents, the Company confirms that neither it nor any other Person acting on its behalf has provided any of the Purchasers or their agents or counsel with any information that it believes constitutes or might constitute material, non-public information which is not otherwise disclosed in the Prospectus Supplement.   The Company understands and confirms that the Purchasers will rely on the foregoing representation in effecting transactions in securities of the Company.  All of the disclosure furnished by or on behalf of the Company to the Purchasers regarding the Company and its Subsidiaries, their respective businesses and the transactions contemplated hereby, including the Disclosure Schedules to this Agreement, is true and correct in all materials respects as of the date made and does not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading.  The Company acknowledges and agrees that no Purchaser makes or has made any representations or warranties with respect to the transactions contemplated hereby other than those specifically set forth in Section 3.2 hereof.
		

		
			(z)No Integrated Offering. Assuming the accuracy of the Purchasers’ representations and warranties set forth in Section 3.2, neither the Company, nor any of its Affiliates, nor any Person acting on its or their behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security, under circumstances that would cause this offering of the Securities to be integrated with prior offerings by the Company for purposes of any applicable shareholder approval provisions of any Trading Market on which any of the securities of the Company are listed or designated.
		

		
			(aa)Solvency.  Based on the consolidated financial condition of the Company as of the Closing Date, after giving effect to the receipt by the Company of the proceeds from the sale of the Securities hereunder, (i) the fair saleable value of the Company’s assets exceeds the amount that will be required to be paid on or in respect of the Company’s existing debts and other liabilities (including known contingent liabilities) as they mature, (ii) the Company’s assets do not constitute unreasonably small capital to carry on its business as now conducted and as proposed to be conducted including its capital needs taking into account the particular capital requirements of the business conducted by the Company, consolidated and projected capital requirements and capital availability thereof, and (iii) the current cash flow of the Company, together with the proceeds the Company would receive, were it to liquidate all of its assets, after taking into account all anticipated uses of the cash, would be sufficient to pay all amounts on or in respect of its liabilities when such amounts are required to be paid.  The Company does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account the timing and amounts of cash to be payable on or in respect of its debt).  The Company has no knowledge of any facts or circumstances which lead it to believe that it will file for reorganization or liquidation under the bankruptcy or reorganization laws of any jurisdiction within one year 
		
		
 

		

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		from the Closing Date.  The SEC Reports set forth as of the date hereof all outstanding secured and unsecured Indebtedness of the Company or any Subsidiary, or for which the Company or any Subsidiary has commitments.  For the purposes of this Agreement, “Indebtedness” means (x) any liabilities for borrowed money or amounts owed in excess of $50,000 (other than trade accounts payable incurred in the ordinary course of business), (y) all guaranties, endorsements and other contingent obligations in respect of indebtedness of others, whether or not the same are or should be reflected in the Company’s consolidated balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business; and (z) the present value of any lease payments in excess of $50,000 due under leases required to be capitalized in accordance with GAAP.  Neither the Company nor any Subsidiary is in default with respect to any Indebtedness.

		
		
			(bb)Tax Status.  Except for matters that would not, individually or in the aggregate, have or reasonably be expected to result in a Material Adverse Effect, the Company and its Subsidiaries each (i) has made or filed all United States federal, state and local income and all foreign income and franchise tax returns, reports and declarations required by any jurisdiction to which it is subject, (ii) has paid all taxes and other governmental assessments and charges that are material in amount, shown or determined to be due on such returns, reports and declarations and (iii) has set aside on its books provision reasonably adequate for the payment of all material taxes for periods subsequent to the periods to which such returns, reports or declarations apply.  There are no unpaid taxes in any material amount claimed to be due by the taxing authority of any jurisdiction, and the officers of the Company or of any Subsidiary know of no basis for any such claim.
		

		
			(cc)Foreign Corrupt Practices.  Neither the Company nor any Subsidiary, nor to the knowledge of the Company or any Subsidiary, any agent or other person acting on behalf of the Company or any Subsidiary, has (i) directly or indirectly, used any funds for unlawful contributions, gifts, entertainment or other unlawful expenses related to foreign or domestic political activity, (ii) made any unlawful payment to foreign or domestic government officials or employees or to any foreign or domestic political parties or campaigns from corporate funds, (iii) failed to disclose fully any contribution made by the Company or any Subsidiary (or made by any person acting on its behalf of which the Company is aware) which is in violation of law, or (iv) violated in any material respect any provision of FCPA.
		

		
			(dd)Accountants.  The Company’s independent registered public accounting firm is Ernst &Young LLP.  To the knowledge and belief of the Company, such accounting firm is a registered public accounting firm as required by the Exchange Act.
		

		
			(ee) Acknowledgment Regarding Purchasers’ Purchase of Securities.  The Company acknowledges and agrees that each of the Purchasers is acting solely in the capacity of an arm’s length purchaser with respect to the Transaction Documents and the transactions contemplated thereby.  The Company further acknowledges that no Purchaser is acting as a financial advisor or fiduciary of the Company (or in any similar capacity) with respect to the Transaction Documents and the transactions contemplated thereby and any advice given by any Purchaser or any of their respective representatives or agents in 
		

		 

		

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		connection with the Transaction Documents and the transactions contemplated thereby is merely incidental to the Purchasers’ purchase of the Securities.  The Company further represents to each Purchaser that the Company’s decision to enter into this Agreement and the other Transaction Documents has been based solely on the independent evaluation of the transactions contemplated hereby by the Company and its representatives.
		

		
			(ff)Acknowledgment Regarding Purchaser’s Trading Activity.  Anything in this Agreement or elsewhere herein to the contrary notwithstanding (except for Sections 3.2(f) and 4.14 hereof), it is understood and acknowledged by the Company that: (i) none of the Purchasers has been asked by the Company to agree, nor has any Purchaser agreed, to desist from purchasing or selling, long and/or short, securities of the Company, or “derivative” securities based on securities issued by the Company or to hold the Securities for any specified term; (ii) past or future open market or other transactions by any Purchaser, specifically including, without limitation, Short Sales or “derivative” transactions, before or after the closing of this or future private placement transactions, may negatively impact the market price of the Company’s publicly-traded securities; (iii) any Purchaser, and counter-parties in “derivative” transactions to which any such Purchaser is a party, directly or indirectly, presently may have a “short” position in the Common Stock, and (iv) each Purchaser shall not be deemed to have any affiliation with or control over any arm’s length counter-party in any “derivative” transaction.  The Company further understands and acknowledges that (y) one or more Purchasers may engage in hedging activities at various times during the period that the Securities are outstanding and (z) such hedging activities (if any) could reduce the value of the existing stockholders' equity interests in the Company at and after the time that the hedging activities are being conducted.  The Company acknowledges that such aforementioned hedging activities do not constitute a breach of any of the Transaction Documents.
		

		
			(gg)Regulation M Compliance.  The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of any of the Securities, (ii) sold, bid for, purchased, or, paid any compensation for soliciting purchases of, any of the Securities, or (iii) paid or agreed to pay to any Person any compensation for soliciting another to purchase any other securities of the Company, other than, in the case of clauses (ii) and (iii), compensation paid to the Placement Agent in connection with the placement of the Securities.
		

		
			(hh)FDA.  As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse 
		
		
 

		

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		Effect.  Except as disclosed in the SEC Reports, there is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect.    The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA.  The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company. 

		
		
			(ii)Cybersecurity.  (i)(x) To the Company’s knowledge, there has been no security breach or other compromise of or relating to any of the Company’s or any Subsidiary’s information technology and computer systems, networks, hardware, software, data (including the data of its respective customers, employees, suppliers, vendors and any third party data maintained by or on behalf of it), equipment or technology (collectively, “IT Systems and Data”) and (y) the Company and the Subsidiaries have not been notified of, and has no knowledge of any event or condition that would reasonably be expected to result in, any security breach or other compromise to its IT Systems and Data; (ii) the Company and the Subsidiaries are presently in compliance with all applicable laws or statutes and all judgments, orders, rules and regulations of any court or arbitrator or governmental or regulatory authority, internal policies and contractual obligations relating to the privacy and security of IT Systems and Data and to the protection of such IT Systems and Data from unauthorized use, access, misappropriation or modification, except as would not, individually or in the aggregate, have a Material Adverse Effect; (iii) the Company and the Subsidiaries have implemented and maintained commercially reasonable safeguards to maintain and protect its material confidential information and the integrity, continuous operation, redundancy and security of all IT Systems and Data; and (iv) the Company and the Subsidiaries have implemented backup and disaster recovery technology consistent with industry standards and practices.
		

		
			(jj)Stock Option Plans. Each stock option granted by the Company under the Company’s stock option plan was granted (i) in accordance with the terms of the Company’s stock option plan and (ii) with an exercise price at least equal to the fair market value of the Common Stock on the date such stock option would be considered granted 
		

		 

		

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		under GAAP and applicable law. No stock option granted under the Company’s stock option plan has been backdated.  The Company has not knowingly granted, and there is no and has been no Company policy or practice to knowingly grant, stock options prior to, or otherwise knowingly coordinate the grant of stock options with, the release or other public announcement of material information regarding the Company or its Subsidiaries or their financial results or prospects.
		

		
			(kk)Office of Foreign Assets Control.  Neither the Company nor any Subsidiary nor, to the Company's knowledge, any director, officer, agent, employee or affiliate of the Company  or any Subsidiary is currently subject to any U.S. sanctions administered by the Office of Foreign Assets Control of the U.S. Treasury Department (“OFAC”).
		

		
			(ll)U.S. Real Property Holding Corporation.  The Company is not and has never been a U.S. real property holding corporation within the meaning of Section 897 of the Internal Revenue Code of 1986, as amended, and the Company shall so certify upon Purchaser’s request.
		

		
			(mm)Bank Holding Company Act.  Neither the Company nor any of its Subsidiaries or Affiliates is subject to the Bank Holding Company Act of 1956, as amended (the “BHCA”) and to regulation by the Board of Governors of the Federal Reserve System (the “Federal Reserve”).  Neither the Company nor any of its Subsidiaries or Affiliates owns or controls, directly or indirectly, five percent (5%) or more of the outstanding shares of any class of voting securities or twenty-five percent or more of the total equity of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve.  Neither the Company nor any of its Subsidiaries or Affiliates exercises a controlling influence over the management or policies of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve.
		

		
			(nn)Money Laundering.  The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with applicable financial record-keeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, applicable money laundering statutes and applicable rules and regulations thereunder (collectively, the “Money Laundering Laws”), and no Action or Proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any Subsidiary with respect to the Money Laundering Laws is pending or, to the knowledge of the Company or any Subsidiary, threatened.
		

		
			3.2Representations and Warranties of the Purchasers.  Each Purchaser, for itself and for no other Purchaser, hereby represents and warrants as of the date hereof and as of the Closing Date to the Company as follows (unless as of a specific date therein, in which case they shall be accurate as of such date):
		

		
			(a)Organization; Authority.  Such Purchaser is either an individual or an entity duly incorporated or formed, validly existing and in good standing under the laws of the jurisdiction of its incorporation or formation with full right, corporate, partnership, limited liability company or similar power and authority to enter into and to consummate the transactions contemplated by the Transaction Documents and otherwise to carry out its 
		

		 

		

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		obligations hereunder and thereunder. The execution and delivery of the Transaction Documents and performance by such Purchaser of the transactions contemplated by the Transaction Documents have been duly authorized by all necessary corporate, partnership, limited liability company or similar action, as applicable, on the part of such Purchaser.  Each Transaction Document to which it is a party has been duly executed by such Purchaser, and when delivered by such Purchaser in accordance with the terms hereof, will constitute the valid and legally binding obligation of such Purchaser, enforceable against it in accordance with its terms, except: (i) as limited by general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited by applicable law.
		

		
			(b)Understandings or Arrangements.  Such Purchaser is acquiring the Securities as principal for its own account and has no direct or indirect arrangement or understandings with any other persons to distribute or regarding the distribution of such Securities (this representation and warranty not limiting such Purchaser’s right to sell the Securities pursuant to the Registration Statement or otherwise in compliance with applicable federal and state securities laws).  Such Purchaser is acquiring the Securities hereunder in the ordinary course of its business.
		

		
			(c)Purchaser Status.  At the time such Purchaser was offered the Securities, it was, and as of the date hereof it is an “accredited investor” as defined in Rule 501(a)(1), (a)(2), (a)(3), (a)(7), (a)(8), (a)(9), (a)(12), or (a)(13) under the Securities Act.  
		

		
			(d)Experience of Such Purchaser.  Such Purchaser, either alone or together with its representatives, has such knowledge, sophistication and experience in business and financial matters so as to be capable of evaluating the merits and risks of the prospective investment in the Securities, and has so evaluated the merits and risks of such investment.  Such Purchaser is able to bear the economic risk of an investment in the Securities and, at the present time, is able to afford a complete loss of such investment.
		

		
			(e)Access to Information. Such Purchaser acknowledges that it has had the opportunity to review the Transaction Documents (including all exhibits and schedules thereto) and the SEC Reports and has been afforded, (i) the opportunity to ask such questions as it has deemed necessary of, and to receive answers from, representatives of the Company concerning the terms and conditions of the offering of the Securities and the merits and risks of investing in the Securities; (ii) access to information about the Company and its financial condition, results of operations, business, properties, management and prospects sufficient to enable it to evaluate its investment; and (iii) the opportunity to obtain such additional information that the Company possesses or can acquire without unreasonable effort or expense that is necessary to make an informed investment decision with respect to the investment.  Such Purchaser acknowledges and agrees that neither the Placement Agent nor any Affiliate of the Placement Agent has provided such Purchaser with any information or advice with respect to the Securities nor is such information or advice necessary or desired.  Neither the Placement Agent nor any Affiliate has made or makes any 
		

		 

		

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		representation as to the Company or the quality of the Securities and the Placement Agent and any Affiliate may have acquired non-public information with respect to the Company which such Purchaser agrees need not be provided to it.  In connection with the issuance of the Securities to such Purchaser, neither the Placement Agent nor any of its Affiliates has acted as a financial advisor or fiduciary to such Purchaser.
		

		
			(f)Certain Transactions and Confidentiality.  Other than consummating the transactions contemplated hereunder, such Purchaser has not, nor has any Person acting on behalf of or pursuant to any understanding with such Purchaser, directly or indirectly executed any purchases or sales, including Short Sales, of the securities of the Company during the period commencing as of the time that such Purchaser first received a term sheet (written or oral) from the Company or any other Person representing the Company setting forth the material terms of the transactions contemplated hereunder and ending immediately prior to the execution hereof.  Notwithstanding the foregoing, in the case of a Purchaser that is a multi-managed investment vehicle whereby separate portfolio managers manage separate portions of such Purchaser’s assets and the portfolio managers have no direct knowledge of the investment decisions made by the portfolio managers managing other portions of such Purchaser’s assets, the representation set forth above shall only apply with respect to the portion of assets managed by the portfolio manager that made the investment decision to purchase the Securities covered by this Agreement.  Other than to other Persons party to this Agreement or to such Purchaser’s representatives, including, without limitation, its officers, directors, partners, legal and other advisors, employees, agents and Affiliates, such Purchaser has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction).  Notwithstanding the foregoing, for the avoidance of doubt, nothing contained herein shall constitute a representation or warranty, or preclude any actions, with respect to locating or borrowing shares in order to effect Short Sales or similar transactions in the future.
		

		
			The Company acknowledges and agrees that the representations contained in this Section 3.2 shall not modify, amend or affect such Purchaser’s right to rely on the Company’s representations and warranties contained in this Agreement or any representations and warranties contained in any other Transaction Document or any other document or instrument executed and/or delivered in connection with this Agreement or the consummation of the transactions contemplated hereby.    Notwithstanding the foregoing, for the avoidance of doubt, nothing contained herein shall constitute a representation or warranty, or preclude any actions, with respect to locating or borrowing shares in order to effect Short Sales or similar transactions in the future.
		

		
			ARTICLE IV.
OTHER AGREEMENTS OF THE PARTIES
		

		
			4.1Integration.  The Company shall not sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that would be integrated with the offer or sale of the Securities for purposes of the rules and regulations of any Trading Market such that it would require shareholder approval prior to the closing of such other transaction unless shareholder approval is obtained before the closing of such subsequent transaction. 
		

		

		

		 

		

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		4.2Securities Laws Disclosure; Publicity.  The Company shall (a) by the Disclosure Time, issue a press release disclosing the material terms of the transactions contemplated hereby, and (b) file a Current Report on Form 8-K, including the Transaction Documents as exhibits thereto, with the Commission within the time required by the Exchange Act.  From and after the issuance of such press release, the Company represents to the Purchasers that it shall have publicly disclosed all material, non-public information delivered to any of the Purchasers by the Company or any of its Subsidiaries, or any of their respective officers, directors, employees, Affiliates or agents, including, without limitation, the Placement Agent, in connection with the transactions contemplated by the Transaction Documents.  In addition, effective upon the issuance of such press release, the Company acknowledges and agrees that any and all confidentiality or similar obligations under any agreement, whether written or oral, between the Company, any of its Subsidiaries or any of their respective officers, directors, agents, employees, Affiliates or agents, including, without limitation, the Placement Agent, on the one hand, and any of the Purchasers or any of their Affiliates on the other hand, shall terminate and be of no further force or effect. The Company understands and confirms that each Purchaser shall be relying on the foregoing covenant in effecting transactions in securities of the Company. The Company and each Purchaser shall consult with each other in issuing any other press releases with respect to the transactions contemplated hereby, and neither the Company nor any Purchaser shall issue any such press release nor otherwise make any such public statement without the prior consent of the Company, with respect to any press release of any Purchaser, or without the prior consent of each Purchaser, with respect to any press release of the Company, which consent shall not unreasonably be withheld or delayed, except if such disclosure is required by law, in which case the disclosing party shall promptly provide the other party with prior notice of such public statement or communication.  Notwithstanding the foregoing, the Company shall not publicly disclose the name of any Purchaser, or include the name of any Purchaser in any filing with the Commission or any regulatory agency or Trading Market, without the prior written consent of such Purchaser, except (a) as required by federal securities law in connection with the filing of final Transaction Documents with the Commission and (b) to the extent such disclosure is required by law or Trading Market regulations, in which case the Company shall provide the Purchasers with prior notice of such disclosure permitted under this clause (b) and reasonably cooperate with such Purchaser regarding such disclosure.
		

		
			4.3Shareholder Rights Plan.  No claim will be made or enforced by the Company or, with the consent of the Company, any other Person, that any Purchaser is an “Acquiring Person” under any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or similar anti-takeover plan or arrangement in effect or hereafter adopted by the Company, or that any Purchaser could be deemed to trigger the provisions of any such plan or arrangement, by virtue of receiving Securities under the Transaction Documents or under any other agreement between the Company and the Purchasers.
		

		
			4.4Non-Public Information.   Except with respect to the material terms and conditions of the transactions contemplated by the Transaction Documents, which shall be disclosed pursuant to Section 4.2, the Company covenants and agrees that neither it, nor any other Person acting on its behalf will provide any Purchaser or its agents or counsel with any information that constitutes, or the Company reasonably believes constitutes, material non-public information, unless prior thereto such Purchaser shall have consented in writing to the receipt of such information and agreed in writing with the Company to keep such information confidential.  
		

		 

		

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		The Company understands and confirms that each Purchaser shall be relying on the foregoing covenant in effecting transactions in securities of the Company.  To the extent that the Company, any of its Subsidiaries, or any of their respective officers, directors, agents, employees or Affiliates delivers any material, non-public information to a Purchaser without such Purchaser’s consent, the Company hereby covenants and agrees that such Purchaser shall not have any duty of confidentiality to the Company, any of its Subsidiaries, or any of their respective officers, directors, employees, Affiliates or agents, including, without limitation, the Placement Agent, or a duty to the Company, any of its Subsidiaries or any of their respective officers, directors, employees, Affiliates or agents, including, without limitation, the Placement Agent, not to trade on the basis of, such material, non-public information, provided that the Purchaser shall remain subject to applicable law. To the extent that any notice provided pursuant to any Transaction Document constitutes, or contains, material, non-public information regarding the Company or any Subsidiaries, the Company shall simultaneously with the delivery of such notice file such notice with the Commission pursuant to a Current Report on Form 8-K.  The Company understands and confirms that each Purchaser shall be relying on the foregoing covenant in effecting transactions in securities of the Company.
		

		
			4.5Use of Proceeds.  The Company shall use the net proceeds from the sale of the Securities hereunder for working capital purposes and shall not use such proceeds: (a) for the satisfaction of any portion of the Company’s debt (other than payment of trade payables in the ordinary course of the Company’s business and prior practices), (b) for the redemption of any Common Stock or Common Stock Equivalents, or (c) in violation of FCPA or OFAC regulations.
		

		
			4.6Indemnification of Purchasers.   Subject to the provisions of this Section 4.6, the Company will indemnify and hold each Purchaser and its directors, officers, shareholders, members, partners, employees and agents (and any other Persons with a functionally equivalent role of a Person holding such titles notwithstanding a lack of such title or any other title), each Person who controls such Purchaser (within the meaning of Section 15 of the Securities Act and Section 20 of the Exchange Act), and the directors, officers, shareholders, agents, members, partners or employees (and any other Persons with a functionally equivalent role of a Person holding such titles notwithstanding a lack of such title or any other title) of such controlling persons (each, a “Purchaser Party”) harmless from any and all losses, liabilities, obligations, claims, contingencies, damages, costs and expenses, including all judgments, amounts paid in settlements, court costs and reasonable attorneys’ fees and costs of investigation that any such Purchaser Party may suffer or incur as a result of or relating to (a) any breach of any of the representations, warranties, covenants or agreements made by the Company in this Agreement or in the other Transaction Documents or (b) any action instituted against the Purchaser Parties in any capacity, or any of them or their respective Affiliates, by any stockholder of the Company who is not an Affiliate of such Purchaser Party, with respect to any of the transactions contemplated by the Transaction Documents (unless such action is based upon a breach of such Purchaser Party’s representations, warranties or covenants under the Transaction Documents or any agreements or understandings such Purchaser Party may have with any such stockholder or any violations by such Purchaser Party of state or federal securities laws or any conduct by such Purchaser Party which is finally judicially determined to constitute fraud, gross negligence or willful misconduct).  If any action shall be brought against any Purchaser Party in respect of which indemnity may be sought pursuant to this Agreement, such Purchaser Party shall promptly 
		

		 

		

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		notify the Company in writing, and the Company shall have the right to assume the defense thereof with counsel of its own choosing reasonably acceptable to the Purchaser Party.  Any Purchaser Party shall have the right to employ separate counsel in any such action and participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of such Purchaser Party except to the extent that (i) the employment thereof has been specifically authorized by the Company in writing, (ii) the Company has failed after a reasonable period of time to assume such defense and to employ counsel or (iii) in such action there is, in the reasonable opinion of counsel, a material conflict on any material issue between the position of the Company and the position of such Purchaser Party, in which case the Company shall be responsible for the reasonable fees and expenses of no more than one such separate counsel.  The Company will not be liable to any Purchaser Party under this Agreement (y) for any settlement by a Purchaser Party effected without the Company’s prior written consent, which shall not be unreasonably withheld or delayed; or (z) to the extent, but only to the extent that a loss, claim, damage or liability is attributable to any Purchaser Party’s breach of any of the representations, warranties, covenants or agreements made by such Purchaser Party in this Agreement or in the other Transaction Documents. The indemnification required by this Section 4.6 shall be made by periodic payments of the amount thereof during the course of the investigation or defense, as and when bills are received or are incurred, provided that the Indemnified Party executes an undertaking to reimburse amounts paid if indemnification is unavailable hereunder. The indemnity agreements contained herein shall be in addition to any cause of action or similar right of any Purchaser Party against the Company or others and any liabilities the Company may be subject to pursuant to law.
		

		
			4.7Reservation of Common Stock. As of the date hereof, the Company has reserved and the Company shall continue to reserve and keep available at all times, free of preemptive rights, a sufficient number of shares of Common Stock for the purpose of enabling the Company to issue Shares pursuant to this Agreement.   
		

		
			4.8Listing of Common Stock. The Company hereby agrees to use reasonable best efforts to maintain the listing or quotation of the Common Stock on the Trading Market on which it is currently listed, and prior to or concurrently with the Closing, the Company shall apply to list or quote all of the Shares on such Trading Market and promptly secure the listing of all of the Shares on such Trading Market. The Company further agrees, if the Company applies to have the Common Stock traded on any other Trading Market, it will then include in such application all of the Shares, and will take such other action as is necessary to cause all of the Shares to be listed or quoted on such other Trading Market as promptly as possible.  The Company will then take all action reasonably necessary to continue the listing and trading of its Common Stock on a Trading Market and will comply in all respects with the Company’s reporting, filing and other obligations under the bylaws or rules of the Trading Market.  The Company agrees to maintain the eligibility of the Common Stock for electronic transfer through the Depository Trust Company or another established clearing corporation, including, without limitation, by timely payment of fees to the Depository Trust Company or such other established clearing corporation in connection with such electronic transfer.
		

		
			4.9Reserved.  
		

		
			4.10Subsequent Equity Sales.  
		

		 

		

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			(a)From the date hereof until ninety (90) days after the Closing Date, neither the Company nor any Subsidiary shall (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock or Common Stock Equivalents or (ii) file any registration statement or amendment or supplement thereto, other than the Prospectus Supplement or filing a registration statement on Form S-8 in connection with any employee benefit plan.
		

		
			(b)From the date hereof until ninety (90) days after the Closing Date, the Company shall be prohibited from effecting or entering into an agreement to effect any issuance by the Company or any of its Subsidiaries of Common Stock or Common Stock Equivalents (or a combination of units thereof) involving a Variable Rate Transaction.  “Variable Rate Transaction” means a transaction in which the Company (i) issues or sells any debt or equity securities that are convertible into, exchangeable or exercisable for, or include the right to receive additional shares of Common Stock either (A) at a conversion price, exercise price or exchange rate or other price that is based upon and/or varies with the trading prices of or quotations for the shares of Common Stock at any time after the initial issuance of such debt or equity securities, or (B) with a conversion, exercise or exchange price that is subject to being reset at some future date after the initial issuance of such debt or equity security or upon the occurrence of specified or contingent events directly or indirectly related to the business of the Company or the market for the Common Stock or (ii) enters into, or effects a transaction under, any agreement, including, but not limited to, an equity line of credit or an “at-the-market offering,” whereby the Company may issue securities at a future determined price.  Any Purchaser shall be entitled to obtain injunctive relief against the Company to preclude any such issuance, which remedy shall be in addition to any right to collect damages. 
		

		
			(c)Notwithstanding the foregoing, this Section 4.10 shall not apply in respect of an Exempt Issuance, except that no Variable Rate Transaction shall be an Exempt Issuance.
		

		
			4.11Equal Treatment of Purchasers.  No consideration (including any modification of this Agreement) shall be offered or paid to any Person to amend or consent to a waiver or modification of any provision of this Agreement unless the same consideration is also offered to all of the parties to this Agreement.  For clarification purposes, this provision constitutes a separate right granted to each Purchaser by the Company and negotiated separately by each Purchaser, and is intended for the Company to treat the Purchasers as a class and shall not in any way be construed as the Purchasers acting in concert or as a group with respect to the purchase, disposition or voting of Securities or otherwise.
		

		
			4.12Certain Transactions and Confidentiality. Each Purchaser, severally and not jointly with the other Purchasers, covenants that neither it nor any Affiliate acting on its behalf or pursuant to any understanding with it will execute any purchases or sales, including Short Sales of any of the Company’s securities during the period commencing with the execution of this Agreement and ending at such time that the transactions contemplated by this Agreement are first publicly announced pursuant to the initial press release as described in Section 4.2.  Each Purchaser, severally and not jointly with the other Purchasers, covenants that until such time as the transactions contemplated by this Agreement are publicly disclosed by the Company 
		

		 

		

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		pursuant to the initial press release as described in Section 4.2, such Purchaser will maintain the confidentiality of the existence and terms of this transaction and the information included in the Disclosure Schedules (other than as disclosed to its legal and other representatives).  Notwithstanding the foregoing and notwithstanding anything contained in this Agreement to the contrary, the Company expressly acknowledges and agrees that (i) no Purchaser makes any representation, warranty or covenant hereby that it will not engage in effecting transactions in any securities of the Company after the time that the transactions contemplated by this Agreement are first publicly announced pursuant to the initial press release as described in Section 4.2, (ii) no Purchaser shall be restricted or prohibited from effecting any transactions in any securities of the Company in accordance with applicable securities laws from and after the time that the transactions contemplated by this Agreement are first publicly announced pursuant to the initial press release as described in Section 4.2 and (iii) no Purchaser shall have any duty of confidentiality or duty not to trade in the securities of the Company to the Company, any of its Subsidiaries, or any of their respective officers, directors, employees, Affiliates, or agent, including, without limitation, the Placement Agent, after the issuance of the initial press release as described in Section 4.2.  Notwithstanding the foregoing, in the case of a Purchaser that is a multi-managed investment vehicle whereby separate portfolio managers manage separate portions of such Purchaser’s assets and the portfolio managers have no direct knowledge of the investment decisions made by the portfolio managers managing other portions of such Purchaser’s assets, the covenant set forth above shall only apply with respect to the portion of assets managed by the portfolio manager that made the investment decision to purchase the Securities covered by this Agreement.
		

		
			4.13Lock-Up Agreements. The Company shall not amend, modify, waive or terminate any provision of any of the Lock-Up Agreements except to extend the term of the lock-up period and shall enforce the provisions of each Lock-Up Agreement in accordance with its terms. If any party to a Lock-Up Agreement breaches any provision of a Lock-Up Agreement, the Company shall promptly use its best efforts to seek specific performance of the terms of such Lock-Up Agreement.
		

		
			ARTICLE V.
MISCELLANEOUS
		

		
			5.1Termination.  This Agreement may be terminated by any Purchaser, as to such Purchaser’s obligations hereunder only and without any effect whatsoever on the obligations between the Company and the other Purchasers, by written notice to the other parties, if the Closing has not been consummated on or before the fifth (5th) Trading Day following the date hereof; provided,  however, that no such termination will affect the right of any party to sue for any breach by any other party (or parties).
		

		
			5.2Fees and Expenses.  Except as expressly set forth in the Transaction Documents to the contrary, each party shall pay the fees and expenses of its advisers, counsel, accountants and other experts, if any, and all other expenses incurred by such party incident to the negotiation, preparation, execution, delivery and performance of this Agreement.  The Company shall pay all Transfer Agent fees (including, without limitation, any fees required for same-day processing of any instruction letter delivered by the Company and any exercise notice delivered 
		

		 

		

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		by a Purchaser), stamp taxes and other taxes and duties levied in connection with the delivery of any Securities to the Purchasers.
		

		
			5.3Entire Agreement.  The Transaction Documents, together with the exhibits and schedules thereto, the Prospectus and the Prospectus Supplement, contain the entire understanding of the parties with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, oral or written, with respect to such matters, which the parties acknowledge have been merged into such documents, exhibits and schedules.
		

		
			5.4Notices.  Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be in writing and shall be deemed given and effective on the earliest of: (a) the time of transmission, if such notice or communication is delivered via email attachment at the email address as set forth on the signature pages attached hereto at or prior to 5:30 p.m. (New York City time) on a Trading Day, (b) the next Trading Day after the time of transmission, if such notice or communication is delivered via email attachment at the email address as set forth on the signature pages attached hereto on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, (c) the second (2nd) Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service or (d) upon actual receipt by the party to whom such notice is required to be given.  The address for such notices and communications shall be as set forth on the signature pages attached hereto.
		

		
			5.5Amendments; Waivers.  No provision of this Agreement may be waived, modified, supplemented or amended except in a written instrument signed, in the case of an amendment, by the Company and Purchasers which purchased at least 50.1% in interest of the Shares based on the initial Subscription Amounts hereunder (or, prior to the Closing, the Company and each Purchaser) or, in the case of a waiver, by the party against whom enforcement of any such waived provision is sought, provided that if any amendment, modification or waiver disproportionately and adversely impacts a Purchaser (or group of Purchasers), the consent of such disproportionately impacted Purchaser (or group of Purchasers) shall also be required.  No waiver of any default with respect to any provision, condition or requirement of this Agreement shall be deemed to be a continuing waiver in the future or a waiver of any subsequent default or a waiver of any other provision, condition or requirement hereof, nor shall any delay or omission of any party to exercise any right hereunder in any manner impair the exercise of any such right. Any proposed amendment or waiver that disproportionately, materially and adversely affects the rights and obligations of any Purchaser relative to the comparable rights and obligations of the other Purchasers shall require the prior written consent of such adversely affected Purchaser. Any amendment effected in accordance with this Section 5.5 shall be binding upon each Purchaser and holder of Securities and the Company.
		

		
			5.6Headings.  The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof.
		

		
			5.7Successors and Assigns.  This Agreement shall be binding upon and inure to the benefit of the parties and their successors and permitted assigns.  The Company may not assign this Agreement or any rights or obligations hereunder without the prior written consent of each 
		

		 

		

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		Purchaser (other than by merger).  Any Purchaser may assign any or all of its rights under this Agreement to any Person to whom such Purchaser assigns or transfers any Securities, provided that such transferee agrees in writing to be bound, with respect to the transferred Securities, by the provisions of the Transaction Documents that apply to the “Purchasers.”
		

		
			5.8No Third-Party Beneficiaries.  The Placement Agent shall be the third party beneficiary of the representations and warranties of the Company in Section 3.1 and the representations and warranties of the Purchasers in Section 3.2.  This Agreement is intended for the benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other Person, except as otherwise set forth in Section 4.6 and this Section 5.8.
		

		
			5.9Governing Law.  All questions concerning the construction, validity, enforcement and interpretation of the Transaction Documents shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles of conflicts of law thereof.  Each party agrees that all legal Proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Agreement and any other Transaction Documents (whether brought against a party hereto or its respective affiliates, directors, officers, shareholders, partners, members, employees or agents) shall be commenced exclusively in the state and federal courts sitting in the City of New York.  Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting in the City of New York, Borough of Manhattan for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any Action or Proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such Action or Proceeding is improper or is an inconvenient venue for such Proceeding.  Each party hereby irrevocably waives personal service of process and consents to process being served in any such Action or Proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof.  Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law.   If any party shall commence an Action or Proceeding to enforce any provisions of the Transaction Documents, then, in addition to the obligations of the Company under Section 4.6, the prevailing party in such Action or Proceeding shall be reimbursed by the non-prevailing party for its reasonable attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such Action or Proceeding.
		

		
			5.10Survival.  The representations and warranties contained herein shall survive the Closing and the delivery of the Securities.
		

		
			5.11Execution.  This Agreement may be executed in two or more counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to each other party, it being understood that the parties need not sign the same counterpart.  In the event that any signature is delivered by e-mail delivery (including any electronic signature covered by the U.S. 
		

		 

		

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		federal ESIGN Act of 2000, Uniform Electronic Transactions Act, the Electronic Signatures and Records Act or other applicable law, e.g., www.docusign.com) or other transmission method, such signature shall be deemed to have been duly and validly delivered and shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such signature page were an original thereof.
		

		
			5.12Severability.  If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction to be invalid, illegal, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions set forth herein shall remain in full force and effect and shall in no way be affected, impaired or invalidated, and the parties hereto shall use their commercially reasonable efforts to find and employ an alternative means to achieve the same or substantially the same result as that contemplated by such term, provision, covenant or restriction. It is hereby stipulated and declared to be the intention of the parties that they would have executed the remaining terms, provisions, covenants and restrictions without including any of such that may be hereafter declared invalid, illegal, void or unenforceable.
		

		
			5.13Rescission and Withdrawal Right.  Notwithstanding anything to the contrary contained in (and without limiting any similar provisions of) any of the other Transaction Documents, whenever any Purchaser exercises a right, election, demand or option under a Transaction Document and the Company does not timely perform its related obligations within the periods therein provided, then such Purchaser may rescind or withdraw, in its sole discretion from time to time upon written notice to the Company, any relevant notice, demand or election in whole or in part without prejudice to its future actions and rights.
		

		
			5.14Replacement of Securities.  If any certificate or instrument evidencing any Securities is mutilated, lost, stolen or destroyed, the Company shall issue or cause to be issued in exchange and substitution for and upon cancellation thereof (in the case of mutilation), or in lieu of and substitution therefor, a new certificate or instrument, but only upon receipt of evidence reasonably satisfactory to the Company of such loss, theft or destruction.  The applicant for a new certificate or instrument under such circumstances shall also pay any reasonable third-party costs (including customary indemnity) associated with the issuance of such replacement Securities.
		

		
			5.15Remedies.  In addition to being entitled to exercise all rights provided herein or granted by law, including recovery of damages, each of the Purchasers and the Company will be entitled to specific performance under the Transaction Documents.  The parties agree that monetary damages may not be adequate compensation for any loss incurred by reason of any breach of obligations contained in the Transaction Documents and hereby agree to waive and not to assert in any Action for specific performance of any such obligation the defense that a remedy at law would be adequate.
		

		
			5.16Payment Set Aside.  To the extent that the Company makes a payment or payments to any Purchaser pursuant to any Transaction Document or a Purchaser enforces or exercises its rights thereunder, and such payment or payments or the proceeds of such enforcement or exercise or any part thereof are subsequently invalidated, declared to be fraudulent or preferential, set aside, recovered from, disgorged by or are required to be refunded, repaid or otherwise restored to the Company, a trustee, receiver or any other Person under any 
		

		 

		

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		law (including, without limitation, any bankruptcy law, state or federal law, common law or equitable cause of action), then to the extent of any such restoration the obligation or part thereof originally intended to be satisfied shall be revived and continued in full force and effect as if such payment had not been made or such enforcement or setoff had not occurred.
		

		
			5.17Independent Nature of Purchasers’ Obligations and Rights.  The obligations of each Purchaser under any Transaction Document are several and not joint with the obligations of any other Purchaser, and no Purchaser shall be responsible in any way for the performance or non-performance of the obligations of any other Purchaser under any Transaction Document.  Nothing contained herein or in any other Transaction Document, and no action taken by any Purchaser pursuant hereto or thereto, shall be deemed to constitute the Purchasers as a partnership, an association, a joint venture or any other kind of entity, or create a presumption that the Purchasers are in any way acting in concert or as a group with respect to such obligations or the transactions contemplated by the Transaction Documents.  Each Purchaser shall be entitled to independently protect and enforce its rights including, without limitation, the rights arising out of this Agreement or out of the other Transaction Documents, and it shall not be necessary for any other Purchaser to be joined as an additional party in any Proceeding for such purpose.  Each Purchaser has been represented by its own separate legal counsel in its review and negotiation of the Transaction Documents.  For reasons of administrative convenience only, each Purchaser and its respective counsel have chosen to communicate with the Company through Lowenstein.  Lowenstein does not represent any of the Purchasers and only represents the Placement Agent.  The Company has elected to provide all Purchasers with the same terms and Transaction Documents for the convenience of the Company and not because it was required or requested to do so by any of the Purchasers.  It is expressly understood and agreed that each provision contained in this Agreement and in each other Transaction Document is between the Company and a Purchaser, solely, and not between the Company and the Purchasers collectively and not between and among the Purchasers.
		

		
			5.18Liquidated Damages.  The Company’s obligations to pay any partial liquidated damages or other amounts owing under the Transaction Documents is a continuing obligation of the Company and shall not terminate until all unpaid partial liquidated damages and other amounts have been paid notwithstanding the fact that the instrument or security pursuant to which such partial liquidated damages or other amounts are due and payable shall have been canceled.
		

		
			5.19Saturdays, Sundays, Holidays, etc.  If the last or appointed day for the taking of any action or the expiration of any right required or granted herein shall not be a Business Day, then such action may be taken or such right may be exercised on the next succeeding Business Day.
		

		
			5.20Construction. The parties agree that each of them and/or their respective counsel have reviewed and had an opportunity to revise the Transaction Documents and, therefore, the normal rule of construction to the effect that any ambiguities are to be resolved against the drafting party shall not be employed in the interpretation of the Transaction Documents or any amendments thereto. In addition, each and every reference to share prices and shares of Common Stock in any Transaction Document shall be subject to adjustment for reverse and forward stock 
		

		 

		

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		splits, stock dividends, stock combinations and other similar transactions of the Common Stock that occur after the date of this Agreement.
		

		
			5.21WAIVER OF JURY TRIAL.  IN ANY ACTION, SUIT, OR PROCEEDING IN ANY JURISDICTION BROUGHT BY ANY PARTY AGAINST ANY OTHER PARTY, THE PARTIES EACH KNOWINGLY AND INTENTIONALLY, TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, HEREBY ABSOLUTELY, UNCONDITIONALLY, IRREVOCABLY AND EXPRESSLY WAIVES FOREVER TRIAL BY JURY. 
		

		
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		IN WITNESS WHEREOF, the parties hereto have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
		

		
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						Cassava Sciences, Inc.

					
					
						Address for Notice:
C/O Cassava Sciences, Inc.

					
						6801 N. Capital of TX Hwy

					
						Building 1, Suite 300

					
						Austin, TX 78731

				
	
					
						By: /s/ Remi Barbier________________________

					
						     Name: Remi Barbier

					
						     Title: Chief Executive Officer

					
						With a copy to (which shall not constitute notice):

					
					
						 

					
						E-Mail: xxxx

					
						 

				
	
					
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						Orrick, Herrington & Sutcliffe LLP

					
						405 Howard St.

					
						San Francisco, CA 94105

					
						Attn: Brett Cooper

					
						Email: bcooper@orrick.com

					
						 

					
						 

					
						 

					
					
						 

				

		
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		[PURCHASER SIGNATURE PAGES TO SAVA SECURITIES PURCHASE AGREEMENT]
		

		
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			IN WITNESS WHEREOF, the undersigned have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
		

		
			Name of Purchaser: ________________________________________________________
		

		
			Signature of Authorized Signatory of Purchaser: _________________________________
		

		
			Name of Authorized Signatory: _______________________________________________
		

		
			Title of Authorized Signatory: ________________________________________________
		

		
			Email Address of Authorized Signatory: _________________________________________
		

		
			Address for Notice to Purchaser:
		

		
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			Address for Delivery of Securities to Purchaser (if not same as address for notice):
		

		
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			Subscription Amount: $_________________
		

		
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			Shares: _________________
		

		
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			EIN Number: ____________________
		

		
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			☐  Notwithstanding anything contained in this Agreement to the contrary, by checking this box (i) the obligations of the above-signed to purchase the securities set forth in this Agreement to be purchased from the Company by the above-signed, and the obligations of the Company to sell such securities to the above-signed, shall be unconditional and all conditions to Closing shall be disregarded, (ii) the Closing shall occur by the second (2nd) Trading Day following the date of this Agreement and (iii) any condition to Closing contemplated by this Agreement (but prior to being disregarded by clause (i) above) that required delivery by the Company or the above-signed of any agreement, instrument, certificate or the like or purchase price (as applicable) shall no longer be a condition and shall instead be an unconditional obligation of the Company or the above-signed (as applicable) to deliver such agreement, instrument, certificate or the like or purchase price (as applicable) to such other party on the Closing Date.
		

		
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