RITTER PHARMACEUTICALS, INC. AMENDMENT NO. 2 TO RESEARCH AND DEVELOPMENT AGREEMENT & LICENSE
Exhibit 10.19
XXXXXX PHARMACEUTICALS, INC.
AMENDMENT NO. 2 TO
RESEARCH AND DEVELOPMENT AGREEMENT & LICENSE
This Amendment No. 2 (the “Amendment”) to the Research and Development Agreement & License, dated as of November 17, 2010, and first amended on July 6, 2011 (as amended to date, the “Original Agreement”), is made and entered into as of September 30, 2011, pursuant to Section 13.4 of the Original Agreement, by and among KOLU POHAKU TECHNOLOGIES, LLC, a Delaware limited liability company (together with its successors and assigns, “Kolu Pohaku”); KOLU POHAKU MANAGEMENT, LLC, a Delaware limited liability company (together with its successors and assigns, “KPM”); and XXXXXX PHARMACEUTICALS, INC., a Delaware corporation (together with its successors and assigns, the “Company”). Capitalized terms used in this Amendment that are not otherwise defined herein shall have the respective meanings assigned to them in the Original Agreement.
RECITALS
WHEREAS, the Company, Kolu Pohaku and KPM are parties to the Original Agreement;
WHEREAS, the parties wish to amend the Original Agreement in the manner set forth below in order to fund additional Qualified Research activities in accordance with the terms of the Original Agreement; and
WHEREAS, the Original Agreement may be amended by written agreement of the parties thereto.
NOW, THEREFORE, the parties hereto hereby agree as follows:
AGREEMENT
1. Section 2.19 of the Original Agreement shall be amended and restated in its entirety to read as set forth below:
“Royalty Payments” means the 2010 Royalty Payments, the 2011 Royalty Payments and the 2012 Royalty Payments by Researcher to Kolu Pohaku described in Section 9 herein.
2. 7 of the Original Agreement shall be amended and restated in its entirety to read as set forth below:
R&D Fee.
7.1 2010 R&D Fee. Kolu Pohaku shall pay to the Researcher Seven Hundred and Fifty Thousand Dollars ($750,000.00) as the research and development fee (“2010 R&D Fee”) for performing the KP Research in 2010 through 2014. Two Hundred Fifty Thousand Dollars ($250,000.00) of the R&D Fee shall be payable upon signing of the
Agreement (the “2010 R&D Fee Installment”) and Five Hundred Thousand Dollars ($500,000.00) shall be paid no later than January 10, 2011, provided that the conditions set forth in Section 8 have been satisfied (the “2011 R&D Fee Installment”). Researcher agrees that the 2010 R&D Fee will be disbursed to Researcher in amounts corresponding to, and within five (5) business days of the receipt of each request for a disbursement from Researcher unless Kolu Pohaku objects in writing to such request in such time period (each such amount, a “2010 R&D Disbursement”). Notwithstanding the foregoing sentence, the Parties agree that the 2010 R&D Fee Installment shall be disbursed upon execution of this Agreement and shall be considered a 2010 R&D Disbursement for all purposes hereunder. Researcher agrees that a minimum amount of KP Research will be performed in each year of the Agreement as provided in Exhibit B. Researcher further agrees that the payments set forth in this Agreement shall be full and complete compensation for all obligations and deliverables by Researcher under this Agreement and for all inventions, developments and improvements assigned under this Agreement, if any. Researcher specifically agrees that Kolu Pohaku shall not be responsible for any costs of overhead, salaries, materials or other expenses, except as set forth herein. Not later than March 15 of each year, Researcher shall deliver to Kolu Pohaku a certificate of the Chief Financial Officer of Researcher (i) setting forth in reasonable detail the application of the 2010 R&D Fee performed to date pursuant to the funding of the KP Research, (ii) demonstrating that no less than 100% of such funding was applied toward the KP Research, and (iii) certifying that the KP Research has not been funded from the proceeds of any other third party agreement such that the third party has ownership of any of the results of the KP Research.
7.2 2011 R&D Fee. Kolu Pohaku shall pay to the Researcher Three hundred Thousand Dollars ($300,000.00) as the research and development fee (“2011 R&D Fee”) for performing certain KP Research in 2011. Researcher agrees that the 2011 R&D Fee will be disbursed to Researcher in amounts corresponding to, and within five (5) business days of the receipt of, each request for a disbursement from Researcher unless Kolu Pohaku objects in writing to such request in such time period (each such amount, a “2011 R&D Disbursement”). Researcher further agrees that the payments set forth in this Agreement shall be full and complete compensation for all obligations and deliverables by Researcher under this Agreement and for all inventions, developments and improvements assigned under this Agreement, if any. Researcher specifically agrees that Kolu Pohaku shall not be responsible for any costs of overhead, salaries, materials or other expenses, except as set forth herein. Not later than March 15 of each year, Researcher shall deliver to Kolu Pohaku a certificate of the Chief Financial Officer of Researcher (i) setting forth in reasonable detail the application of the 2011 R&D Fee performed to date pursuant to the funding of the KP Research, (ii) demonstrating that no less than 100% of such funding was applied toward the KP Research, and (iii) certifying that the KP Research has not been funded from the proceeds of any other third party agreement such that the third party has ownership of any of the results of the KP Research.
7.3 2012 R&D Fee. Kolu Pohaku shall pay to the Researcher Two Hundred Fifty Thousand Dollars ($250,000.00) as the research and development fee (“2012 R&D Fee”) for performing certain KP Research in 2012. Researcher agrees that the 2012
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R&D Fee will be disbursed to Researcher upon the effectiveness of this Amendment (such amount, a “2012 R&D Disbursement” and, along with the 2010 R&D Disbursement and 2011 R&D Disbursement, the “R&D Disbursements”). Researcher further agrees that the payments set forth in this Agreement shall be full and complete compensation for all obligations and deliverables by Researcher under this Agreement and for all inventions, developments and improvements assigned under this Agreement, if any. Researcher specifically agrees that Kolu Pohaku shall not be responsible for any costs of overhead, salaries, materials or other expenses, except as set forth herein. Not later than March 15 of each year, Researcher shall deliver to Kolu Pohaku a certificate of the Chief Financial Officer of Researcher (i) setting forth in reasonable detail the application of the 2012 R&D Fee performed to date pursuant to the funding of the KP Research, (ii) demonstrating that no less than 100% of such funding was applied toward the KP Research, and (iii) certifying that the KP Research has not been funded from the proceeds of any other third party agreement such that the third party has ownership of any of the results of the KP Research.
3. Section 9 of the Original Agreement shall be amended by the addition of a new Section 9.4 but shall otherwise remain unchanged:
9.4 2012 Quarterly Royalty Payment. Commencing with an initial payment on March 31, 2015, and continuing through December 31, 2035, at the expiration of each calendar quarter (i.e., March 31, June 30, September 30, December 31, etc.), Researcher shall pay to Kolu Pohaku a royalty payment of Seven Thousand Dollars ($7,000.00) (each a “2012 Royalty Payment”) for the license and use of the results of the KP Research. In the event any Royalty Payment is not paid on or before its due date, interest shall accrue on such amount at the rate of 12% per annum compounded annually.
4. Exhibit A of the Original Agreement shall be amended and restated in its entirety to read as attached to this Amendment.
5. Exhibit B of the Original Agreement shall be amended and restated in its entirety to read as attached to this Amendment.
6. Except as expressly set forth in this Amendment, the Original Agreement shall continue in full force and effect in accordance with its terms.
7. This Amendment may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.
8. All corporate action on the part of the Company and its directors, officers, and stockholders necessary for the authorization, execution, and delivery of this Amendment by the Company has been taken as of the date hereof.
9. This Amendment shall be governed by and construed and enforced in accordance with the laws of the State of Hawaii, without reference to the conflict of laws provisions thereof.
(Signature pages follow)
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IN WITNESS WHEREOF, the parties hereto have duly executed this Amendment as of the date first above written.
| KOLU POHAKU TECHNOLOGIES, LLC | ||
| By | /s/ Xxxxxx Xxxxxx | |
| Xxxxxx Xxxxxx, President | ||
| KOLU POHAKU MANAGEMENT, LLC | ||
| By | /s/ Xxxxxx Xxxxxx | |
| Xxxxxx Xxxxxx, President | ||
| XXXXXX PHARMACEUTICALS, INC. | ||
| By | /s/ Xxxxxx X. Xxxxxx | |
| Xxxxxx Xxxxxx, President and CEO | ||
Signature Page to Amendment
No. 2 to
First Amendment to Research and Development Agreement & License
Exhibit A
Description of KP Research to be performed on behalf of and for the benefit of Kolu Pohaku
[Description of Annual R&D Activities (2010-2014) and Budgets attached hereto]
The KP Research that the Researcher will perform pursuant to the Agreement will be based on and add to or supplement the Research Project described above. The KP Research will be maintained and conducted separately. The details and scope of the research that will constitute KP Research will be provided to Kolu Pohaku in Researcher’s regular reporting and the scope will be directed and further defined based on the results that are achieved.
Exhibit A (continued)
Hawaii Clinical Expenses Pursuant to the 2010 R&D Agreement
| 2010 | 2011 | Total | ||||||||||
| $ | $ | $ | ||||||||||
| Clinical Supply | $ | 60,000 | $ | 15,000 | $ | 75,000 | ||||||
| Clinic | $ | 37,555 | $ | 365,200 | $ | 402,755 | ||||||
| Subject Cost (Attachment A) | $ | 10,000 | $ | 265,000 | $ | 275,000 | ||||||
| Parking Hawaii | $ | 1,000 | $ | 6,000 | $ | 7,000 | ||||||
| Screen Failure | $ | 5,000 | $ | 47,000 | $ | 52,000 | ||||||
| IRB Fees | $ | 1,155 | $ | - | $ | 1,155 | ||||||
| Recruitment Allowance | $ | 10,000 | $ | 23,000 | $ | 33,000 | ||||||
| Start-up Fees | $ | 5,400 | $ | - | $ | 5,400 | ||||||
| HBT Machines | $ | - | $ | 1,200 | $ | 1,200 | ||||||
| Validation Study | $ | 5,000 | $ | 20,000 | $ | 25,000 | ||||||
| Archiving Fees | $ | - | $ | 3,000 | $ | 3,000 | ||||||
| Clinical Research Organization | $ | 14,500 | $ | 229,000 | $ | 243,500 | ||||||
| Project Management | $ | 5,000 | $ | 60,000 | $ | 65,000 | ||||||
| Trial Master File | $ | - | $ | - | $ | - | ||||||
| Data Management (Attachment B) | $ | 5,000 | $ | 17,500 | $ | 22,500 | ||||||
| Statistical Programming (Attachment B) | $ | - | $ | - | $ | - | ||||||
| Statistical Programming (Attachment B) | $ | 2,000 | $ | 22,000 | $ | 24,000 | ||||||
| Clin Study Report (Attachment B) | $ | - | $ | 8,000 | $ | 8,000 | ||||||
| Teleconferences/Team Meetings (Attachment B) | $ | 1,000 | $ | 2,000 | $ | 3,000 | ||||||
| Medical Monitor (Xxx Xxxxxx) | $ | - | $ | 25,000 | $ | 25,000 | ||||||
| Clinical Monitoring | $ | - | $ | 96,000 | $ | 96,000 | ||||||
| Administrative Set-up/Site Management | $ | 1,500 | $ | 10,100 | $ | 11,600 | ||||||
| Initiation Visit | $ | - | $ | 12,000 | $ | 12,000 | ||||||
| Process Monitoring Visit | $ | - | $ | 12,800 | $ | 12,800 | ||||||
| Routine Monitoring Visit | $ | - | $ | 30,400 | $ | 30,400 | ||||||
| Close-Out Visit | $ | - | $ | 11,200 | $ | 11,200 | ||||||
| Pass-through Estimates | $ | - | $ | 18,000 | $ | 18,000 | ||||||
| General Expenses | $ | - | $ | 33,000 | $ | 33,000 | ||||||
| Liability Insurance | $ | - | $ | 18,000 | $ | 18,000 | ||||||
| Travel | $ | - | $ | 15,000 | $ | 15,000 | ||||||
| Totals | $ | 112,055 | $ | 642,200 | $ | 754,255 | ||||||
*Expenses based on estimated performed work
Exhibit A-1
Hawaii Clinical Expenses for 2011
Pursuant to Amendment No. 2 to the R&D Agreement
| Operations | KP Research to be performed | |||||||||||
| 2011 | 2012 | TOTAL | ||||||||||
| General Expenses | $ | 20,000 | $ | 15,000 | $ | 35,000 | ||||||
| Consultants | $ | 20,000 | $ | 15,000 | $ | 35,000 | ||||||
| Subtotal Operations | $ | 40,000 | $ | 30,000 | $ | 70,000 | ||||||
| Clinic | ||||||||||||
| Clinical Supply | $ | 55,000 | $ | - | $ | 55,000 | ||||||
| CRO/Clinic | $ | 280,000 | $ | 130,000 | $ | 410,000 | ||||||
| Clinic Staff | $ | 5,000 | $ | 10,000 | $ | 15,000 | ||||||
| Subtotal Clinic | $ | 340,000 | $ | 140,000 | $ | 480,000 | ||||||
| TOTAL | $ | 380,000 | $ | 170,000 | $ | 550,000 | ||||||
Exhibit B
Minimum Annual KP Research
Pursuant to Amendment No. 2 to the R&D Agreement
| Calendar Year | Annual Minimum KP Research to be performed | |
| 2010 | $50,000 | |
| 2011 |
$400,000 - See Exhibit A $380,000 - See Exhibit A-1 | |
| 2012 | $170,000 – See Exhibit A-1 | |
| 2013 | $37,500 | |
| 2014 | $37,500 |
