Document:

ex1010.htm

Exhibit 10.10

 

* * *  Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

Tonix Pharmaceuticals, Inc.

250 Pehle Ave.

Park 80 West, Plaza II - Suite 200

Saddle Brook, NJ 07663

October 4, 2010

Lipocine, Inc.

675 Arapeen Drive, Suite 202

Salt Lake City, Utah 84108

Dear Mahesh:

           Reference is made to a certain Feasibility and Option Agreement dated as of June 20, 2007 (the “Agreement”) between Lipocine, Inc. (“Lipocine”) and Tonix Pharmaceuticals, Inc. (formerly known as Krele Pharmaceuticals, Inc.) (“Tonix”).

           The purpose of this letter is to amend certain provisions of the Agreement.  Accordingly, it is hereby agreed as follows:

 

1.           Upon execution of this letter by both parties, Tonix shall pay Lipocine the remaining $[ * * * ] due for Stage I of the Feasibility Program.

2.           The preamble of the Agreement shall be amended to modify Tonix's principal place of business to 2 Park 80 Plaza West, Suite 200, Saddle Brook, NJ 07633.

3.           Section 2 (Feasibility Program) shall be amended as follows:

(a)          The reference to “Exhibit 1” in Section 2.1 shall be deleted and replaced with a reference to “Attachment 1”.

(b)          The following new Section 2.2 shall be added:

“2.2           Stage II of the Feasibility Program.  Tonix shall make a decision to proceed to Stage II of the Feasibility Study (as described in the Protocol) by providing Lipocine with a written notice (the “Stage II Notice”) by no later than five business days following receipt of a mutually acceptable form of license agreement for the license rights covered by the Option consistent with the terms and conditions in Article 3 of the Agreement.  Lipocine shall provide Tonix with a draft of the form of license agreement within thirty (30) days following the date of this letter, and thereafter, Tonix and Lipocine shall expeditiously negotiate the form of license agreement in good faith.  Provided that Lipocine has fulfilled its obligations pursuant to the prior sentence, if Tonix has not provided Lipocine with the Stage II Notice by September 30, 2011, the Agreement shall terminate unless extended by mutual agreement in writing.”

4.           The second through fourth sentences of Section 3.3 (Payments for Exclusive License) shall be deleted and replaced with the following:

           “For the avoidance of doubt, the milestone payments will be paid only once for the first cyclobenzaprine Product of any strength.  If Tonix develops cyclobenzaprine Products of a different strength than the first Product, such Products will be considered additional Products and Tonix will pay [ * * * ]%) of the milestones set forth in Section 3.3(d) below for the second and third additional Products only.”

 

 

 

  

1

  

 

* * *  Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

5.           The last sentence of Section 3.3(d) (Milestones) shall be deleted and replaced with the following:

           “In addition, as provided in Section 3.3 above, if Tonix develops cyclobenzaprine Products that are of a different strength than the first Product, such Products will be considered additional Products and Tonix will pay [ * * * ]%) of the milestones set forth above for the second and third additional Products only.”

 

6.           In order to consistently reflect the modifications in paragraph 3 above, page 2 of Attachment 1 (the Protocol) shall be deleted and replaced with the attached amended page 2.

7.           The second Paragraph on Page 4 of Attachment I, (Cost & Payment Terms) shall be deleted and replaced with the following:

“The cost for Stage II of the feasibility program is $[ * * * ] (plus external costs) with IND. The total cost (plus external costs) w/o IND is $[ * * * ] paid as follows:....”

8.           Except as expressly provided herein, and notwithstanding any prior notices or correspondence between the Parties, all terms, covenants and conditions of the Agreement shall remain in full force and effect, and this amendment and the Agreement  shall be read as one instrument.

           Kindly confirm that the foregoing represents our agreement by signing and returning to the undersigned the enclosed copy hereof, whereupon this letter shall constitute an amendment to the Agreement.

                    

	 	Very truly yours,	 
	 	 	 
	 	TONIX PHARMACEUTICALS, INC.	 
	 	 	 
	 	 	 
	 	 	 	 
	
 

	
By: 

	/s/ SETH LEDERMAN	 
	 	 	Name: Seth Lederman	 
	 	 	Title: Chairman	 
	 	 	Date Signed: ________________________	 

                      

ACCEPTED AND AGREED TO:

LIPOCINE, INC.

By: /s/ MAHESH V. PATEL

     Name:  .Mahesh V. Patel

     Title:     President and CEO

Date Signed: ____________________________________

                                   

                                                                                                                                                                     

  

2

  

ATTACHMENT 1

Improved Oral Delivery of Cyclobenzaprine – Feasibility Proposal

Background

Lipocine Inc. (Lipocine) has proprietary technology, Lip’ralTM, for improved oral absorption of poorly water soluble drugs and elimination of food effects on absorption.  The technology has been validated in clinical and preclinical studies with several different poorly water soluble drugs, and is protected by issued and pending patents.

Tonix Pharmaceuticals, Inc.  (formerly known as Krele Pharmaceuticals, Inc., Tonix) has contracted Lipocine to conduct a feasibility evaluation for the improved oral delivery of Cyclobenzaprine, a muscle relaxant.  Cyclobenzaprine is currently sold under the brand name Flexeril® and there are several generics.  It is available as 5 mg, 7.5 mg and 10 mg tablets.

The specific objectives of the feasibility evaluation are:

	
1.  

	
Develop Lip’ralTM formulations of Cyclobenzaprine at slightly lower strength than the marketed product; select two formulations for a Phase I study.

	
2.  

	
Manufacture, test and release the lots under GMP.  Conduct a Phase I clinical study under a US IND to determine whether the Lipocine formulations are bioequivalent to Flexeril® 5 mg tablet or have faster absorption, faster elimination or the same or lower area under the curve (AUC) than cyclobenzaprine 5 mg.

The feasibility program involves pre-formulation, formulation development and stability evaluation with the goal of selecting two formulations for a Phase I study.  It also includes manufacture, testing and release of clinical lots of the selected formulation and conducting a Phase I study to determine the pharmacokinetics of the Lipocine formulations relative to Flexeril®.

The tasks, timelines and cost of the feasibility program are presented in detail below.

3ex1011.htm

Exhibit 10.11

 

 

 

October 6, 2010

 

 

Seth Lederman, MD

Tonix Pharmaceuticals, Inc.

President

2 Park 80 West Plaza – Suite 200

Saddle Brook, NJ 07663

 

Delivered via email to: seth.lederman@tonixpharma.com

 

Dear Seth,

Frost & Sullivan understands that Tonix Pharmaceuticals (the Client) has decided to proceed with the consulting project entitled Assessment of the U.S. Fibromyalgia Market to Support S1 Filing (Phase 1 & Phase 2), as described in our proposal dated September 27, 2010 (the Project). We are extremely pleased with your decision and look forward to a successful project.

 

Throughout the course of the Project, Frost & Sullivan will update the Client at regular intervals about project status, consulting strategy, research findings, and other project-specific issues, through conference calls or status reports.  We believe this is an important aspect of the overall process.  Our team will adhere to all research objectives, deliverables and timelines outlined in the proposal, with the stipulation that we provide the Client with sufficient interim update reports to help fulfill its needs.

 

As noted in the proposal, the total fees for the both Project phases are as follows:

 

 

The pricing for the work outlined in phase 1 of this proposal is bound to the following terms:

 

The following shows the total Project cost:

 

	 	•	 	
Professional fees:

	
`

	 	$	25,000	 
	 	•	 	
Direct expense (i.e. IMS data):

	 	 	$	15,000	 
	 	•	 	
Travel

	  	 	
directly billed to Client

	 
	 	•	 	
TOTAL:

	  	 	$	40,000	 

 

 

 

 

 

Silicon Valley                                San Antonio                      New York                      Toronto                      London                      Paris           FrankfurtTokyoChennai

 

 

 

  

1

  

 

The pricing for the work outlined in phase 2 of this proposal is bound to the following terms:

 

The following shows the total Project cost:

 

	 	•	 	
Professional fees:

	
`

	 	$	61,400	 
	 	•	 	
Direct expense (data access):

	 	 	$	5,000	 
	 	•	 	
Direct expense (KOL honoraria):

	 	 	$	3,000	 
	 	•	 	
Travel

	  	 	
directly billed to Client

	 
	 	•	 	
TOTAL:

	  	 	$	69,400	 

 

The work will begin as soon as we receive your written authorization in the form of a signature at the bottom of this agreement letter.

 

Please review the following terms to ensure that they meet with your approval.  If you are unsure of any of these terms, or if you would like to discuss them, Frost & Sullivan will be happy to do so.

 

	
1.  

	
Invoicing terms for phase 1 will be 100% of direct costs and 50% of professional fees upfront (=$27,500), and the remaining 50% of professional fees (= $12,500) upon completion of phase 1 as provided in the September 27, 2010 Proposal.

 

	
2.  

	
 Invoicing terms for phase 2 will be 100% of direct costs and 50% of professional fees (=$38,700) at the beginning at phase2 which shall not be started later than 4 weeks after initiation of phase 1.  Initiation of phase 2 will be confirmed by written approval on this document (see below), and the remaining 50% of professional fees (= $30,700) upon completion of phase 2 as provided in the September 27, 2010 Proposal.

 

	
3.  

	
All work requested by the Client outside the scope of this Agreement will be billed on a time and materials basis.  Alternatively, depending on the scope of the additional work, a new contract will be negotiated.  For the avoidance of doubt, assisting the Client with follow-up questions from the U.S. Securities and Exchange Commission concerning disclosure in the Client’s Form S-1 related to the U.S. fibromyalgia markets shall be deemed to be included in the scope of work of this Agreement.

 

	
4.  

	
The stated Project fee includes findings in a Power Point format - three color-copies and one electronic copy of reports produced for the Project.

 

	
5.  

	
All written reports and materials submitted to the Client, including the Power Point presentation, shall become the sole and exclusive property of the Client and its assigns.   Frost & Sullivan understands that all such work has been or shall be prepared by Frost & Sullivan as a consultant within the scope of its engagement by the Client, and constitute a “work made for hire” as defined and used in the Copyright Act of 1976, 17 U.S.C. § 101 et seq.  They may be reproduced in printed and electronic format for internal or external reports, presentations, and other similar purposes by the Client.  However, the Client may not resell the written reports to third parties without Frost & Sullivan’s written consent.

 

	
6.  

	
Frost & Sullivan will strive always to provide first-rate work.  However, there is no representation of certainty, express or implied, by Frost & Sullivan.  This is because the markets we study have varying degrees of fragmentation.  Client acknowledges this and accepts this point.  Client waives any claim to consequential, or punitive damages against Frost & Sullivan based on their reliance on Frost & Sullivan’s work.

 

	
7.  

	
Some data may be considered proprietary by companies to be interviewed, and they may be unwilling to divulge this data to Frost & Sullivan.  Results will be on a “best efforts” basis.

 

	
8.  

	
Client shall have 10 business days following receipt of the final report in which to request clarifications or submit questions that are reasonable and within the original scope of the Project.  The Client will be advised of this 10-day period within which changes/clarifications/questions can be made without added expense upon delivery of the draft report.  Additional work beyond the scope of the Project will be billed on a time and expenses basis.

 

 

 

 

  

2

  

 

	
9.  

	
Either party may terminate this Agreement 30 days following written notice of a material breach by the other party if such breach is not cured with such 30-day period. Termination of this agreement must have a reasonable basis and Client agrees to pay Frost & Sullivan a pro rata fee for tasks accomplished, plus related direct expenses incurred,  prior to notice of termination, less any professional fees paid in advance.

 

	
10.  

	
Frost & Sullivan shall not be liable for delays or failures in performing its obligations resulting from any cause beyond Frost & Sullivan’s reasonable control.  In the event of any material delay beyond Frost & Sullivan’s reasonable control, Frost & Sullivan will notify the Client and specify the revised schedules as soon as practicable.

 

	
11.  

	
Frost & Sullivan’s ability to meet the Project timeline outlined in the proposal may be contingent on Client’s input / approval of certain research items (e.g., questionnaire and discussion guide outlines).  If there are delays beyond the Project timeline by the Client in providing the needed input or approval that materially impact Project efficiency, Frost & Sullivan reserves the right to bill the Client for the delayed time.  Frost & Sullivan will notify the Client in writing of the terms of any additional billing before rendering an invoice.

 

	
12.  

	
Both parties must agree upon any change, extension or reduction in the scope of the Project in writing.  The revised scope will be reflected via either a revised letter of engagement or a time and expenses billing, which will reflect additional billing as required to complete additional work.

 

	
13.  

	
The Client may request Frost & Sullivan to present the results of the Project.  Frost & Sullivan will bill the Client on a time and expenses basis, including preparation, presentation, and travel costs and time.

 

	
14.  

	
For purposes of this Agreement, “Confidential Information” means any information, technical data, trade secrets or know-how, regarding the Client’s products or business, including research, product plans, product registrations, products, services, customers, customer lists, marketing information, software, developments, inventions, specifications, processes, formulas, technology, designs, drawings,  marketing, finances or other business information disclosed by the Client or otherwise, directly or indirectly, in writing, orally or by drawings.  Frost & Sullivan shall not, during or subsequent to the term of this Agreement, use the Confidential Information for any purpose whatsoever other than the performance of the Project on behalf of the Client or disclose the Confidential Information to any third party.  It is understood that Confidential Information shall remain the sole property of the Client.  Frost & Sullivan shall take all reasonable precautions to prevent any unauthorized disclosure of the Confidential Information.  Confidential Information does not include information that is known to Frost & Sullivan at the time of disclosure to Frost & Sullivan as evidenced by written records of Frost & Sullivan, has become publicly known and made generally available through no wrongful act of Frost & Sullivan or has been rightfully received by Frost & Sullivan from a third party who is authorized to make such disclosure.  Upon the termination of this Agreement, or upon the Client’s earlier request, Frost & Sullivan shall return to the Client all of the Confidential Information that Frost & Sullivan may have in Frost & Sullivan’s possession or control.

 

	
15.  

	
Neither party may assign or transfer this Agreement or delegate any of its obligations under this Agreement without the other party’s written consent.  Any attempted assignment, transfer or delegation without such prior written consent will be void.

 

	
16.  

	
Any claim, dispute, or controversy of whatever nature arising out of or relating to this Agreement shall be governed by and construed under the laws of the State of New York, without giving effect to any choice of law principles that would require the application of the laws of a different jurisdiction.

 

	
17.  

	
All waivers must be in writing.  Any waiver or failure to enforce any provision of this Agreement on one occasion will not be deemed a waiver of any other provision or of such provision on any other occasion.

 

	
18.  

	
This Agreement, together with the September 27 proposal, completely and exclusively states the agreement of the parties regarding the Project. This Agreement supersedes, and its terms govern, all prior proposals, agreements or other communications between the parties, oral or written, regarding the subject matter of this Agreement.  This Agreement shall not be modified except by a subsequently dated written amendment signed on behalf of the Client and Frost & Sullivan by their duly authorized representatives.

 

Please sign at the bottom of this page and return fax to the attention of Maik Klasen at (650) 475-1570.  We will commence work promptly at that time.  Thank you for this opportunity to work with you.

 

  

3

  

 

	Phase 1 Approval:	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	Signed:	
/s/SETH LEDERMAN

	 	Signed: 	
/s/ MAIK KLASEN

	 
	 	

TONIX Pharmaceuticals, Inc.

	 	 	

Frost & Sullivan

	 
	Printed:   	
Seth Lederman, MD

	 	Printed:	
Maik Klasen, PhD

	 
	Date:   	October 6, 2010	 	Date:   	 	 
	Title:	President	 	Title: 	Senior Director	 
	Telephone:	212 644-2610	 	Telephone: 	
650 – 475 4505

	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	
Phase 2 Approval:

	 	 	 	 
	 	 	 	 	 	 
	Signed:   	 	 	Signed:  	 	 
	 	TONIX Pharmaceuticals, Inc.	 	 	Frost & Sullivan	 
	Printed: 	Seth Lederman, MD	 	Printed:	Maik Klasen, Ph.D.	 
	Date:	 	 	Date: 	 	 
	Title: 	President	 	Title:  	Senior Director	 
	Telephone: 	
212 644-2610

	 	Telephone: 	
650 – 475 4505

	 

 

 

 

 

 

4

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00195-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00195-of-00352.parquet"}]]