LICENSE AGREEMENT Between Oragenics Inc and The Texas A& M University System
Exhibit 10.28
Between
and
The Texas A& M University System
This agreement (“Agreement”) is made between Oragenics, Inc., a corporation with principal offices in Tampa, Florida, (“ORAGENICS”) and The Texas A&M University System, an agency of the State of Texas, with principal offices in College Station, Texas, (“SYSTEM”), collectively referred to as “Parties” and individually as “Party.”
1.01 | “LICENSED TECHNOLOGY” means the Parties’ rights in their jointly owned proprietary technology relating to SYSTEM Disclosure of Invention Number TAMUS 3447 entitled “Site Directed Mutagenesis of Mutacin 1140 and Its Effect on Bactericidal Activity,” and for the purposes of this Agreement, MATERIALS. |
1.02 | “PATENT RIGHTS” means the Parties’ rights in each: |
(a) | United States patent application filed for protection of LICENSED TECHNOLOGY; |
(b) | Each divisional, continuation, or continuation-in-part application of the patent applications described in (a) above to the extent the claims are directed to subject matter specifically described in such patent applications; |
(c) | Equivalent patent application in each country other than the United States which claims priority under the applications described in (a) or (b) above; and |
(d) | Patent issuing from the applications described above and each extension or reissue of such patents. |
1.03 | “LICENSED PRODUCT’ or “LICENSED PRODUCTS” means any product, process, or composition of matter that is within the scope of any Valid Claim of PATENT RIGHTS. Valid Claim means and includes a claim of a patent application or an unexpired patent or a patent whose expiration date has been extended by law, so long as the claim has not been held invalid and/or unenforceable in an unappealable decision of a court or other authority of competent jurisdiction. |
1.04 | “MATERIAL” or “MATERIALS” means the Streptococcus mutans JH1140 mutant strains listed in Exhibit A. For the purposes of this Agreement, MATERIALS shall also include any progeny, unmodified derivatives and modifications therefrom, specifically modifications substantially based on, or incorporating a substantial element of, the MATERIALS, or any modifications which are not new or not obviously distinct from the MATERIALS. |
1.05 | “EFFECTIVE DATE’ means the date this Agreement has been executed by the last Party. |
1.06 | “NET SALES’ means ORAGENICS’ and its sublicensees’ receipts for sales of LICENSED PRODUCTS or for services requiring the use of LICENSED PRODUCTS less the sum of the following: |
(a) | sales taxes, tariffs, duties and/or use taxes directly imposed with reference to particular sales; |
(b) | outbound transportation prepaid or allowed; and |
(c) | amounts allowed or credited on returns. |
Commissions paid to individuals, whether independent sales agents or regularly employed by ORAGENICS, and the cost of collections may not be deducted from NET SALES.
1.07 | “TERRITORY” means worldwide. |
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(a) Calendar Year 2014 and each year thereafter prior to the Calendar Year of the first sale of a LICENSED PRODUCT |
$ | 15,000 | ||
(b) Calendar Year of the first sale of a LICENSED PRODUCT and every year thereafter through the expiration of this Agreement |
$ | 100,000 |
In the event that ORAGENICS’ payment of royalties for the Calendar Year due under paragraph 3.02 do not meet or exceed the required minimum annual consideration, ORAGENICS’ royalty payment for the last quarter of the Calendar Year must include payment of the balance needed to achieve the required minimum. If this Agreement expires or is terminated before the end of a Calendar Year, the corresponding minimum annual consideration will be prorated for that year.
4.01 | Sublicenses. ORAGENICS may grant sublicenses to persons, firms or corporations under such conditions as it may arrange, as consistent with this Agreement, as long as each such sublicense comports with all applicable law, rules and regulations and provided that ORAGENICS includes the following in any of its sublicenses and any other provisions that logically would flow-down to any sublicensees: |
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2. | Compliance with Law. [insert sublicensee name] ,must comply with all applicable federal, state and local laws and regulations in its exercise of all rights granted under this Agreement. |
ARTICLE V — ORAGENICS RESPONSIBILITIES
Milestone |
Due Date for First Occurrence |
Milestone Achievement Payment |
||||||
Enrollment of the first patient in a Phase I clinical trial of a Product |
June 1, 2015 | $ | 50,000 | |||||
Successful completion of a Phase II clinical trial of a Product, where “successful completion” means enrollment of the first patient in a Phase III clinical trial of a Product |
June 1, 2019 | $ | 100,000 | |||||
Successful completion of a Phase III clinical trial of a Product, where “successful completion” means receipt of an approved New Drug Application (NDA) from the FDA or foreign equivalent for a Product |
June 1, 2022 | $ | 150,000 | |||||
First sale of a Product |
June 1, 2025 | $ | 400,000 |
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For the purposes of this Section 5.01, a “Product” means a therapeutic composition within the LICENSED PRODUCTS that is selected for entry into clinical trials for a specified indication. Milestone Achievement Payments, according to the above schedule, shall be payable to SYSTEM upon the attainment of the milestone with respect to each Product. LICENSEE shall provide written notification to SYSTEM within thirty (30) days of achieving each milestone.
5.03 | Legal Compliance. ORAGENICS must comply with all applicable federal, state and local laws and regulations in its exercise of all rights granted by SYSTEM under this Agreement. |
5.04 | No Royalties for Sales to U.S. Government. Under 35 USC Section 200-212, ORAGENICS has no duty to pay SYSTEM royalties under this Agreement on NET SALES made to the United States Government, including any United States Government agency. ORAGENICS must reduce the amount charged for a LICENSED PRODUCT sold to the United States Government by an amount equal to the royalty otherwise due SYSTEM. |
5.05 | U.S. Manufacture. Under 35 USC Section 200-212, LICENSED PRODUCTS must be manufactured substantially in the United States of America. |
ARTICLE VI — PROTECTION OF INTELLECTUAL PROPERTY
6.01 | Authorization. As to prosecution, registration, and/or protection of PATENT RIGHTS, SYSTEM hereby authorizes ORAGENICS to: 1) direct the preparation and filing of patent applications, 2) direct the prosecution of broad patent claims for the mutual benefit of ORAGENICS and SYSTEM, 3) maintain U.S. and non-U.S. issued and granted patents, and 4) be invoiced directly by ORAGENICS’ outside patent counsel (as approved by SYSTEM under paragraph 6.02 herein) and/or annuity service providers for patent prosecution and associated maintenance fees and costs. |
6.02 | Selection of Counsel. ORAGENICS may select an outside patent counsel (Counsel) law firm staffed by experienced, reputable, and licensed intellectual property attorneys for the prosecution, registration, protection, and maintenance of PATENT RIGHTS. ORAGENICS will notify SYSTEM of its selection of Counsel. |
6.03 | Contract with Counsel. ORAGENICS shall execute a written agreement with Counsel establishing that: 1) the attorney/client relationship relative to the prosecution, registration, or protection of PATENT RIGHTS will be with SYSTEM and ORAGENICS jointly; 2) Counsel will not take any actions adverse to the interests of SYSTEM in relation to PATENT RIGHTS including, for example and without limitation, any future invalidity or adverse litigation actions; 3) costs for prosecution, registration, or protection of PATENT RIGHTS will be invoiced directly to ORAGENICS with a courtesy copy of the. invoice to SYSTEM; and 4) SYSTEM will not be responsible for payment of invoices relating to prosecution, registration, or protection of PATENT RIGHTS conducted under this Agreement, including, without limitation, attorneys’ fees, costs, official filing fees, and foreign associates’ fees and costs. ORAGENICS shall provide a copy of such written agreement to SYSTEM. Additionally, ORAGENICS shall ensure that Counsel promptly signs the standard Outside Counsel Agreement, which Counsel can obtain from SYSTEM’s Office of General Counsel. |
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6.04 | Approvals. ORAGENICS shall notify SYSTEM before any substantive actions are taken in prosecuting, continuing, or abandoning any patents or patent applications or otherwise affecting PATENT RIGHTS. and ORAGENICS will instruct Counsel to so notify SYSTEM. In addition to other substantive actions, ORAGENICS and SYSTEM must jointly approve the filing of any action or application that seeks to, or effects, changes in inventorship related to PATENT RIGHTS, and will so instruct Counsel. ORAGENICS and SYSTEM must jointly approve how to proceed with any substantive actions relating to and/or affecting PATENT RIGHTS. |
6.05 | Patent Maintenance. During the term of this Agreement, ORAGENICS shall be directly responsible for annual or periodic annuity payments to maintain the pendency of non-U.S. patent applications in countries that require such annual or periodic annuities. Furthermore, during the term of this Agreement, ORAGENICS agrees to continue any required annual and periodic payments for maintenance of U.S. and non-U.S. issued and granted patents that ORAGENICS and SYSTEM jointly agree to procure. |
6.06 | Patent Maintenance Contract. ORAGENICS shall engage Counsel or a reputable annuity service to be responsible for docketing and payment of annual or periodic annuities and maintenance fees for both U.S. and non-U.S. pending applications and U.S. and non-U.S. issued and granted patents during the term of this Agreement. |
6.07 | Confidential Communications. SYSTEM and ORAGENICS have a community of interest with regard to work conducted in relation to PATENT RIGHTS due to their common interest in the generation of enforceable intellectual property rights relating to LICENSED PRODUCTS. Any communications between ORAGENICS and Counsel shall not be confidential vis-à-vis SYSTEM, but shall be otherwise confidential and protected by attorney client privilege. |
6.08 | Correspondence. ORAGENICS shall contemporaneously copy SYSTEM on all correspondence to and from any patent office, U.S. or non-U.S., including all periodic annuities and maintenance fees correspondence, and ORAGENICS agrees to so instruct Counsel to provide copies of such correspondence to SYSTEM. ORAGENICS further agrees that ORAGENICS- failure to timely provide such correspondence will be considered a breach of this Agreement in accordance midi Paragraph 8.03 below. |
6.09 | Information. To aid ORAGENICS in the prosecution, registration, protection, and maintenance of PATENT RIGHTS, SYSTEM at its expense will provide information, execute and deliver documents, and perform other acts as ORAGENICS reasonably requests from time to time. |
6.10 | Abandonment. Should ORAGENICS decide to abandon withdraw, or otherwise cease prosecution or maintenance of any U.S. or non-U.S. patent application or issued or granted patent for any reason (including but not limited to declining to make an annuity or maintenance payment), ORAGENICS shall so notify SYSTEM in writing at least sixty (60) days prior to taking (or not taking) any action which would result in abandonment, withdrawal, or lapse of such patent or application. SYSTEM shall then have the right to continue patent prosecution or maintenance of each such patent or application at its own expense and any such patent application and granted or issued patent there from will be excluded from LICENSED PATENT RIGHTS in this License Agreement. |
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6.11 | Assignee. All patent applications and patents related to this Agreement shall have “The Texas A&M University System” and -Oragenics, Inc.” named as an assignee. |
6.12 | Previous Obligations. All previously approved. authorized, and accrued obligations and instructions under this Agreement, including ORAGENICS’ reimbursement of patent expenses to SYSTEM, shall remain enforceable. All other matters survive per Paragraph 8.04 below. |
6.13 | Obligation to File or Maintain. Should ORAGENICS decide not to file or maintain patent protection, SYSTEM may, at its own expense, without reimbursement from ORAGENICS, file, prosecute, or maintain the patent protection and ORAGENICS hereby agrees that any such patent will be excluded from the rights granted herein. |
ARTICLE VII — PAYMENTS AND REPORTS
7.01 | When Payments are Due. Unless otherwise specified, ORAGENICS must make payments to The Texas A&M University System, in College Station. Texas, not later than sixty (60) days after the last day of the calendar quarter in which they accrue. |
7.02 | Royalty Reports. ORAGENICS must provide a sales report to SYSTEM each quarter, providing information sufficient to allow SYSTEM to calculate amounts due SYSTEM for the reporting period. No quarterly reports are due until sales of LICENSED PRODUCTS begin. After product sales begin, quarterly reports shall be provided even if no royalties accrued during the quarter. |
7.03 | Currency. Payment due to SYSTEM must be paid in U.S. dollars. Royalty payments requiring conversion must use the exchange rate as reported in The Wall Street Journal on the last business day of the royalty reporting period. |
7.04 | Inspection of Books and Records. At its own expense, SYSTEM may no more than once annually inspect ORAGENICS’ books and records as needed to determine royalties payable. ORAGENICS must maintain those books and records for at least three (3) years following the dates of the underlying transactions. Any inspections will be in confidence and conducted during ordinary business hours, and SYSTEM will provide ORAGENICS advance notice no less than two (2) weeks before making an inspection. SYSTEM may employ a Certified Public Accountant for this purpose. If SYSTEM’s audit identifies a shortage of five percent (5%) or more of amounts due to SYSTEM, then ORAGENICS must pay the costs of SYSTEM’s audit. ORAGENICS must pay all amounts due as a consequence of an audit to SYSTEM promptly, with interest. |
7.05 | Interest Charges. SYSTEM may, in its sole discretion, charge daily interest on overdue payments commencing on the 31st day after the payment is due, compounded monthly, at the lower of either 1.5% per month or the highest legal interest rate. The payment of interest will not foreclose SYSTEM from exercising any other rights it may have due to the lateness of any payment. |
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ARTICLE VIII — TERM AND TERMINATION
8.02 | Termination by ORAGENICS. ORAGENICS may terminate this Agreement by providing written notice to SYSTEM at least ninety (90) days before the termination is to take effect. |
ARTICLE IX — INDEMNIFICATION AND REPRESENTATION
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If to SYSTEM:
Associate Vice Chancellor
Office of Technology Commercialization
0000 XXXX
Xxxxxxx Xxxxxxx, Xxxxx, XXX 00000-0000
Phone: 000-000-0000
FAX: 000-000-0000
If to ORAGENICS:
CEO, Oragenics,
0000 Xxxxxxx Xx. Xxxxx 000
Xxxxx, XX 00000
Phone: 000-000-0000
FAX: 000-000-0000
ARTICLE XI — MISCELLANEOUS PROVISIONS
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11.10 | Headings. Headings are solely for convenience of reference and are not part of, and may not be used to construe, this Agreement. |
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The Parties have caused this Agreement to become effective as of the date last executed below.
ORAGENICS, | THE TEXAS A&M UNIVERSITY SYSTEM | |||
/s/ Xxxx Xxxxxxxxx |
/s/ Xxxxx Xxxxxxxx | |||
CEO, Oragenics, Inc. Date: December 6, 0000 |
Xxxxx Xxxxxxxx Associate Vice Chancellor for Commercialization Date: December 20, 2011 |
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Exhibit A
MATERIALS
1. | Streptococcus mutans JH1140 xxxX Trp4Ala |
2. | Streptococcus mutans JH1140 xxxX DhaSAla |
3. | Streptococcus mutans JH1140 xxxX Argl 3Asp |
4. | Streptococcus mutans JH1140 xxxX Trp4insAla |
5. | Streptococcus mutans JH1140 xxxX A Trp4 |
6. | Streptococcus mutans JH1140 xxxX Alas7insAla |
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