LICENSE AGREEMENT by and between EMORY UNIVERSITY and INHIBIKASE THERAPEUTICS, INC.
Exhibit 10.1
by and between
EMORY UNIVERSITY
and
TABLE OF CONTENTS
| Article 1 | DEFINITIONS | 1 |
| Article 2 | GRANT OF LICENSE | 5 |
| Article 3 | CONSIDERATION FOR LICENSE | 7 |
| Article 4 | REPORTS AND ACCOUNTING | 10 |
| Article 5 | PAYMENTS | 12 |
| Article 6 | DILIGENCE AND COMMERCIALIZATION | 12 |
| Article 7 | PATENT PROSECUTION | 13 |
| Article 8 | INFRINGEMENT | 15 |
| Article 9 | LIMITED WARRANTY AND EXCLUSION OF WARRANTIES | 16 |
| Article 10 | DAMAGES, INDEMNIFICATION AND INSURANCE | 16 |
| Article 11 | CONFIDENTIALITY | 18 |
| Article 12 | TERM AND TERMINATION | 19 |
| Article 13 | ASSIGNMENT | 21 |
| Article 14 | ARBITRATION | 21 |
| Article 15 | MISCELLANEOUS | 21 |
| Article 16 | NOTICES | 23 |
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THIS LICENSE AGREEMENT is made and entered into as of the 8th day of June 2010 (hereinafter referred to as the “Effective Date”) by and between EMORY UNIVERSITY, a nonprofit Georgia corporation with offices located at 0000 Xxxxxxx Xxxx XX, 0xx Floor, Mailstop 1599/001/lAZ Xxxxxxx, Xxxxxxx 00000 (hereinafter referred to as “EMORY”) and INHIBIKASE THERAPEUTICS, INC., a Delaware corporation having a principal place of business located at 0000 Xxxxxx Xxxx Xxxxxxx, Xxxxx 000, Xxxxxx, XX (hereinafter referred to as “COMPANY”). EMORY and COMPANY shall be hereinafter referred to singularly as “Party” and together as “Parties.”
WHEREAS, EMORY and Xxxxxx Xxxxxx have previously entered into an Option Agreement (EMORY agreement number OPT.09.003) having an effective date of February 6th, 2009;and
WHEREAS, Xxxxxx Xxxxxx has assigned his Option Agreement to COMPANY; and
WHEREAS, COMPANY would like to exercise its right under the Option Agreement to take an Exclusive License to the technology covered in the Option Agreement; and
WHEREAS, EMORY wishes to grant COMPANY such rights in accordance with the terms and conditions of this Agreement.
NOW, THEREFORE, for and in consideration of the mutual covenants and the promises herein contained, the Parties, intending to be legally bound, hereby agree as follows:
The following terms as used herein shall have the following meaning:
1. “Affiliate” shall mean any corporation or non-corporate business entity which controls, is controlled by, or is under common control with a Party. A corporation or non-corporate business entity shall be regarded as in control of another corporation if it owns, or directly or indirectly controls, at least fifty (50%) percent of the voting stock of the other corporation, or (i) in the absence of the ownership of at least fifty percent (50%) of the voting stock of a corporation or (ii) in the case of a non- corporate business entity, or non-profit corporation, if it, directly or indirectly, the power to direct, or cause the direction of, the management or policies of such corporation or non-corporate business entity, as applicable.
2. “Agreement” or “License Agreement” shall mean this Agreement, including all APPENDICES attached to this Agreement.
3. “Commercialization” or “Commercialize” shall mean activities directed to the manufacturing, obtaining pricing and reimbursement approvals, marketing, promoting, distributing, importing or selling a Licensed Product.
4. “Development” or “Develop” shall mean all activities related to non-clinical and clinical research and development, including, without limitation, toxicology, pharmacology and other discovery efforts, test method development and stability testing, process development, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, clinical studies or trials (including pre- and post-approval studies and investigator sponsored clinical studies or trials), regulatory affairs, and regulatory approval and clinical study or trial regulatory activities (excluding, however, regulatory activities directed to obtaining pricing and reimbursement approvals).
5. “Development Information” shall mean toxicology, pharmacokinetic, efficacy, clinical and other technical data and all correspondence to and from regulatory agencies relating to approval of such Licensed Products generated by COMPANY and/or its Affiliates, contractors and agents in the course of COMPANY's efforts to develop such Licensed Products and/or obtain government approval for the Sale of such Licensed Products.
6. “Development Plan” shall mean that initial plan in which the milestones are set forth for the Development of such Licensed Products as are generally understood and contemplated as of the Effective Date, which plan is described in APPENDIX A as attached hereto and incorporated herein by reference.
7. “Dollars” shall mean United States dollars.
8. “Field of Use” shall include the prevention, diagnosis, treatment or control of human and animal infectious diseases or related conditions other than Tuberculosis.
9. “Fixed Dose” shall mean a specific, unchanging amount of medicine.
10. “Founder” shall mean Xxxxxx Xxxxxx, PhD and Xxxxxx Xxxxxx, PhD.
11. “Option Invention” shall mean any patentable addition, enhancement, modification, development, alteration, technical advance to Licensed Patents or Licensed Technology to the extent any such improvement is owned or controlled by EMORY and developed by either (a) Xxxxxx Xxxxxx, Ph.D. while employed by EMORY or (b) any other individual who has an obligation to assign his or her rights to inventions to EMORY and who is under such Inventor's direct supervision or working in his or her respective laboratory or collaborating with any of the foregoing.
12. “lndemnitees” shall mean the Inventors, EMORY, its directors, officers, employees and students, and their heirs, executors, administrators, successors and legal representatives.
13. “Inventors” shall mean the named inventors of the Licensed Patents.
14. “Know How” shall mean any knowledge, information and materials, whether proprietary or not and whether patentable or not, including, without limitation, ideas, concepts, formulas, methods, processes, techniques, technical information, specifications, standard operating procedures, research or studies and any results thereof, tests or testing and any results thereof, designs, compositions, plans, data, inventions, discoveries, works of art or authorship, materials (including, without limitation, organic and inorganic materials, to include chemicals, compounds and biological materials); and any and all derivative technology or inventions and records (whether in document or electronic form) relating thereto.
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15. “Licensed Patents” shall mean the patent applications identified in APPENDIX B, together with any and all patents issuing thereon and any and all additions, renewals, patents of additions, supplemental protection certificates, reexaminations, substitutions, extensions, divisionals, continuations, continuations-in-part (to the extent that the claimed subject matter of such continuations-in-part are disclosed and enabled in the parent patent application), foreign counterparts of such patent applications and patents that issue thereon anywhere in the world, including reexamined and all extensions, reexaminations and reissuances of patents.
16. “Licensed Product(s)” shall mean any process, service or product, within the Field of Use, the manufacture, use, or sale of which is covered by any Valid Claim or incorporates, relies upon or otherwise uses any Licensed Technology.
17. “Licensed Technology” shall mean the Know How developed by the Inventors to the extent that (i) such Know-How is required for or otherwise necessary in the practice of the Licensed Patents for the manufacture, use, development, testing, marketing, export, import, offer for sale or sale or other Development or Commercialization of any Licensed Product and (ii) EMORY possesses the right to license such use.
18. “Licensed Territory” means the world.
19. “Net Selling Price” shall mean the gross selling price paid by a Third Party to COMPANY or any Affiliate or sublicensee thereof for the Sale of Licensed Products, less the following deductions:
i. Customary trade, quantity and cash discounts actually allowed and taken;
ii. Pricing adjustments, replacements, rebates relating to or other credits actually given for damaged, rejected, recalled or returned Licensed Products or billing errors;
iii. Freight, transportation and insurance costs, if separately itemized on the invoice paid by the purchaser; and
iv. Import, export or other customs duties; excise, turnover, inventory, value- added, sales or use taxes or other governmental charges (but excluding what are commonly known as income taxes.
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Where a Sale is deemed consummated by a gift, use, or other disposition of Licensed Products for other than a selling price stated in cash, the gross selling price for purposes of determining the “Net Selling Price” shall be determined based on the average gross selling price billed by COMPANY for comparable Licensed Products during the three (3) month period immediately preceding such Sale, without reduction of any kind. If no Sales of Licensed Products have occurred in the preceding three (3) months, then the parties shall, in good faith, negotiate the cash value of such Sale. In the event that the parties cannot agree on the Net Selling Price within ninety (90) days of beginning such negotiations, the Net Selling Price shall be determined by a mutually agreeable qualified appraiser. Notwithstanding any provision in this Agreement to the contrary, in no event shall the phrase “Net Sales Price” include any Licensed Products (i) used internally by COMPANY or any Affiliate or sublicensee thereof( , for research, clinical trials or other Development purposes); or (ii) the Sale or other transfer of Licensed Product to Emory or the United States Government or any agency thereof under reservation or rights retained by either such institution under this Agreement. Notwithstanding the foregoing in this Section, amounts received by COMPANY, its Affiliates or sublicensees of COMPANY or its Affiliates for the sale of Licensed Products among COMPANY, its Affiliates and sublicensees for resale shall not be included in the computation of Net Selling Price hereunder.
20. “Per Share Fair Market Value” of COMPANY's equity shall be the per share amount paid by an investor to COMPANY in the most recent round of financing within the six (6) month period immediately preceding an equity purchase by a Sublicensee. If no round of financing occurred in the immediately preceding six (6) month period, the Per Share Fair Market Value of COMPANY's equity shall be agreed upon by the parties. In the event that COMPANY and EMORY cannot agree on the Per Share Fair Market Value within thirty (30) days of COMPANY's receipt of such Premium Equity Payments, said price shall be determined by a mutually agreeable qualified appraiser. In the event COMPANY owes EMORY a portion of such Premium Equity Payment, COMPANY shall have the option of remitting payment to EMORY in the form of equity in COMPANY, based on the Per Share Fair Market Value.
21. “Person” shall mean any individual, partnership, limited partnership, limited liability partnership, limited liability company, corporation, trust, association, non-profit or charitable organization or other entity, or an unincorporated organization, a governmental entity or any department or agency thereof.
22. “Premium Equity Payments” shall mean the positive difference, if any, between the gross amount paid for equity in COMPANY by a Sublicensee and the Per Share Fair Market Value (as defined below) of said equity multiplied by the number of shares purchased by the Sublicense.
23. “Sale” or “Sold” shall mean the sale, transfer, exchange, use or other disposition of Licensed Products, whether by gift or otherwise, by COMPANY or any Affiliates or Sublicenses thereof to any Third Party; provided, however, that in no event shall such term include (i) the sale, payment, transfer, exchange or disposition to or other use by EMORY under its reservation of rights provided in Section 2.3 of this Agreement or the U.S government under its rights described under Section 2.2 of this Agreement, including, without limitation, the U.S. Government Licenses, or (ii) the use during or for clinical trials or other research relating to the Licensed Products. For purposes of this definition, “Sales” of Licensed Products shall be deemed consummated upon the first to occur of: (a) receipt of payment from a purchaser for such Licensed Products; or (b) if for commercial purposes, then upon the transfer, exchange, use or other disposition, whether by gift or otherwise, for which payment is not made by a purchaser of any such Licensed Products.
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24. ”Term” shall have the meaning ascribed thereto in Section 12.1 of this Agreement.
25. “Third Party” shall mean any Person other than a Party or any of its Affiliates.
26. “U.S. Government Licenses” shall mean the non-exclusive license to the U.S. Government or agencies thereof pursuant to NIH grant No. AI056067copies of which are attached hereto as APPENDIX C.
27. “Valid Claim” shall mean a claim in an unexpired patent or pending patent application included in the Licensed Patents so long as such patent shall not have been irrevocably abandoned or held invalid in an unappealable decision of a court or other authority of competent jurisdiction.
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4. Sublicenses. COMPANY may grant sublicenses to sublicensees, who may in tum grant sub-sublicenses so long as and on the condition that any such sublicensee or sub-sublicensee, as the case may be, be approved in advance and in writing by EMORY following notice and request of any such approval by Licensee or sublicensee, which approval shall not be unreasonably denied or delayed; provided further, that any delay in responding to any such request for approval beyond thirty (30) days shall be deemed an approval of such Person for such purpose. All such sublicenses (and sub-sublicenses) shall be further conditioned on each such agreement being consistent with the terms and conditions of this Agreement, provided that COMPANY shall remain responsible for the operations of its sublicensees that are relevant to this Agreement as if such operations were carried out by COMPANY, including, but not limited to, the payment of all fees and royalties due under this Agreement, whether or not such payments are made to COMPANY by its sublicensees. COMPANY shall (a) use commercially reasonable efforts to enforce the terms of any such agreement against the sublicensee, (b) require the sublicensee to indemnify EMORY and maintain liability coverage to the same extent that COMPANY is so required pursuant to Section 10.2 of this Agreement and (c) retain the right for EMORY to audit any such sublicensee to the same extent that COMPANY is so required pursuant to Section 4.5 of this Agreement. COMPANY may also grant any such sublicensee the right to cure any payment default on the part of COMPANY under this Agreement. COMPANY shall provide EMORY with copies of all sublicense agreements within thirty (30) days of their execution date. In the event of any termination of this Agreement by XXXXX, XXXXX shall deemed the “licensor” under any and all sublicenses having been entered into or otherwise granted by COMPANY so long as any such sublicense conforms to the requirements of this Agreement and such Sublicensee shall not otherwise be in default under the terms of its Sublicense, in which case EMORY shall be bound to the terms of any such sublicense as if it were a party thereto, unless mutually agreed in writing otherwise by EMORY and Sublicensee. Such Sublicensee shall not become a direct licensee of EMORY should the Sublicensee challenge the validity or enforceability of any Licensed Patent.
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III. CONSIDERATION FOR LICENSE
c) Subscription Agreement. Shares of such common stock shall be distributed by COMPANY to EMORY in accordance with a Subscription Agreement, a form of which is attached to this Agreement, which shall be made and entered into by COMPANY and EMORY as of the Effective Date of this License Agreement. In such Subscription Agreement, COMPANY will (i) distribute stock to EMORY, which shares shall be subsequently transferred by COMPANY as directed by EMORY to non-FOUNDER INVENTORS, and (ii) grant the right to EMORY and non-FOUNDER INVENTORS to transfer and assign its shares of the COMPANY's common stock in accordance with applicable securities laws, which shall include, without limitation, the right to transfer and assign a portion of the shares to Inventors, and any other person who may be identified at a later time and named on the Licensed Patents; and (iii) grant the right to obtain such registration rights as may be granted from time to time to Xxxxxx Xxxxxx, Ph.D.
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d) Failure of Valid Claim. Notwithstanding any provision in this License Agreement to the contrary, if a Licensed Product is no longer protected by a Valid Claim in any particular country, then all payments required thereafter for the Sale of any such Licensed Product in that particular country under this License Agreement shall be reduced to zero (0).
3. Royalty Stacking and Combination Products.
a) COMPANY is not obligated to pay multiple royalties to EMORY based on the fact that any Licensed Product or the manufacture, use, lease or sale thereof is covered by more than one Licensed Patent under this Agreement.
b) If, in order to practice the rights granted to it under this Agreement, COMPANY or any Affiliate or sublicensee thereof is required or otherwise determines from advice from competent counsel to enter into or to utilize one or more other licenses or technologies with Third Parties for which royalties or other license-related payments are also paid (“Other Royalties”), then the amounts to be paid under this Agreement may be reduced by an amount equal to one-half of such Other Royalties, but in no event shall the royalties payable under Sections 3.2 and 3.5 of this Agreement be reduced by more than fifty percent (50%) of any such royalty otherwise payable thereunder, as the case may be. Such determination of reduction of royalty payments due EMORY shall be made on a country-by-country and Licensed Product-by- Licensed Product basis.
c) In the event a Licensed Product is sold in a Fixed Dose in combination with one or more other active pharmaceutical ingredients that are not the subject of Licensed Patents, then the Net Selling Price for that Licensed Product shall be calculated by multiplying the Net Selling Price for such combination product by the fraction A/(A+B), where “A” is the Net Selling Price for the Licensed Product sold separately and “B” is the Net Selling Price for the other active ingredient(s) sold separately. In the event that the other active ingredient is not sold separately, then the Net Selling Price for that Licensed Product shall be calculated by multiplying the Net Selling Price for the combination product by the fraction A/C, where “A” is the gross invoice amount for the Licensed Product, if sold separately, and “C” is the gross invoice amount for the combination product. In the event that no such separate sales are made, the Net Sales Price for royalty determination shall be mutually agreed by the Parties in good faith.
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7. Annual Maintenance Fees. COMPANY shall pay EMORY an annual license maintenance fee of $5,000. The first payment is due within sixty (60) days of the first anniversary of the Effective Date of this License Agreement and will continue until the first commercial Sale of a Licensed Product, after which such payment obligation shall terminate and obligations under Sections 3.2 and 3.4 apply.
8. Reimbursement for Patent Expenses.
a) Pre-existing Patent Fees and Costs. Upon the earlier to occur of COMPANY having raised $1,000,000 in equity financing or the first anniversary of the Effective Date, COMPANY shall reimburse EMORY for all reasonable and actually incurred external out-of- pocket fees, costs, and expenses paid by EMORY prior to the Effective Date for the filing, prosecution and maintenance of the Licensed Patents (current estimate: $159,296.01).
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i. The gross selling price and the number of units of all Licensed Products (identified by product number/name) Sold by COMPANY and each of its Affiliates and sublicensees, in each country of the Licensed Territory during the reporting period, together with the calculations of Net Selling Price in accordance with Section 1.19;
ii. Lease or rental revenue (if applicable) from the Sale of the Licensed Products;
iii. The royalties payable in Dollars, which shall have accrued hereunder in respect to such Sales;
iv. The exchange rates, if any, in determining the amount of Dollars;
v. A summary of all reports provided to COMPANY by COMPANY'S sublicensees, including the names and addresses of all sublicensees and distributors;
vi. The amount of any consideration received by COMPANY from sublicensees and an explanation of the contractual obligation satisfied by such consideration; and
vii. The occurrence of any event triggering a Milestone Payment or any other payment in accordance with Article 3.
Royalty Reports shall be made semiannually until the first Sale of a Licensed Product by COMPANY or its Affiliates and sublicensees and quarterly thereafter. Semiannual reports shall be due within sixty (60) days of the close of every second and fourth COMPANY fiscal quarter. Quarterly reports shall be due within sixty (60) days of the close of every COMPANY fiscal quarter. COMPANY shall keep accurate records in sufficient detail to enable royalties and other payments payable hereunder to be determined. COMPANY shall be responsible for all royalties and late payments that are due to EMORY that have not been paid by COMPANY'S Affiliates and sublicensees. COMPANY'S sublicensees shall have, and shall be notified by COMPANY that they have, the option of making any royalty payment directly to EMORY, with any such payment being treated as if made directly by and credited to COMPANY.
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i. the amount of such underpayment; and
ii. if such underpayment exceeds five (5%) percent of the total royalties owed for the fiscal year then being reviewed, the reasonably and actually incurred necessary fees and expenses of such independent public accountant performing the audit. Otherwise, EMORY's accountant's fees and expenses shall be borne by EMORY.
In no event shall any such payment constitute waive of COMPANY'S right to dispute the determination made by any such accountant.
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Emory University
Attn: Director, Office of Technology Transfer
0000 Xxxxxxx Xxxx XX, 0xx Xxxxx
Mailstop 1599-001-IAZ
Xxxxxxx, Xxxxxxx 00000
Facsimile: (000) 000-0000
Any payment in excess of one hundred thousand ($100,000.00) dollars or originating outside of the United States shall be made by wire transfer to an account of EMORY designated by EMORY from time to time and royalty reports shall be sent by facsimile or express courier to the Director, Office of Technology Transfer on the same date.
VI. DILIGENCE AND COMMERCIALIZATION
1. Diligence and Commercialization. COMPANY shall use its commercially reasonable efforts, either directly or through Affiliates or sublicensees, throughout the Term of this Agreement to comply with COMPANY's Development Plan and Commercialize at least one Licensed Product. COMPANY's reasonable efforts to commercialize Licensed Products using no less than that which is customary in COMPANY's industry.
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2. Development Milestones. COMPANY, either directly or indirectly through its Affiliates and sublicensees, shall adhere to the schedule of Development milestones and dates set forth in the Development Plan. If COMPANY, either directly or indirectly through its Affiliates or sublicensees, fails to achieve in all material respects any such Development milestone set forth in the Development Plan by the date associated therewith, EMORY may, upon at least ninety (90) days' prior written notice, terminate or partially terminate this Agreement and grant Third Parties identical or lesser rights in the Licensed Patents and Licensed Technology as granted to COMPANY hereunder, unless within such ninety (90) day period, COMPANY achieves in all material respects any such milestone. COMPANY may submit to EMORY revisions to its Development milestones, which revisions EMORY shall have the right to approve.. MORY shall not unreasonable withhold, delay, condition or deny its consent to any such rev1s1on of such Development milestones when requested in writing in advance by COMPANY or any Affiliate or sublicensee thereof, if (i) the request is reasonably supported by credible evidence of scientific or technical difficulties or delays, including, if any, in the clinical studies or regulatory process that are outside of the control of COMPANY or any affiliate or sublicensee; (ii) COMPANY (either directly or indirectly through any applicable Affiliate or sublicensee thereof) is proposing and agrees to implement reasonably satisfactory and effective means of addressing such difficulties or delays, including utilizing its available commercially reasonable financial and technical resources or raising or securing additional resources; and (iii) COMPANY or any Affiliate or Sublicensee thereof has in good faith made commercially reasonable efforts to meet said objective(s) and continue to do so. In making any such determination, EMORY shall take into account the normal course of such programs conducted with sound and reasonable business practices and judgment and shall take into account the reports provided hereunder by COMPANY or any Affiliate or sublicensee thereof. Satisfaction of a later-in-time milestone shall be deemed to constitute satisfaction of any prior-in-time milestone.
3. Sublicensee Performance. EMORY agrees that performance by an Affiliate or sublicensee of Company's diligence or milestone obligations as set forth herein or as may be amended from time to time, shall be deemed to be performance by COMPANY of its diligence or milestone obligations under this License Agreement, including, but not limited to, those set forth in this Article 6.
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4. EMORY may, at its own expense, file patent applications in those countries in which COMPANY elects not to file such applications and such applications shall not be subject to any license granted to COMPANY hereunder. If COMPANY should fail to timely make reimbursement for patent expenses as required in Section 3.8 (b) of this Agreement, EMORY, in addition to its other remedies under the Agreement, shall have no further obligation to prosecute or maintain such Licensed Patents for which COMPANY failed to make timely reimbursement. COMPANY, upon ninety (90) days advance written notice to EMORY, may advise EMORY that it no longer wishes to pay expenses for filing, prosecuting or maintaining one or more Licensed Patents. EMORY may, at its option, elect to pay such expenses or permit such Licensed Patents to become abandoned or lapsed . If EMORY elects to pay such expenses, such patents/patent applications shall not be subject to any license granted to COMPANY hereunder.
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After reimbursement or reduction for all fees and costs relating thereto, any recovery or settlement received for punitive or exemplary damages shall be shared between EMORY and COMPANY on the basis of an allocation in which Company receives seventy (70%) percent of such proceeds and divides the remaining thirty (30%) percent of such proceeds between the owners of the infringed patents licensed to COMPANY in a percentage relative to the number of such patent owners, and any other recovery or settlement received, including compensatory damages or damages based on a loss of revenues that exceeds the out-of-pocket costs and expenses incurred by COMPANY (hereinafter “Net Recovery”), shall be deemed to be the proceeds of Sales of Licensed Products in the fiscal quarter received by COMPANY and COMPANY shall pay to EMORY an amount representing the royalty which would have been paid by COMPANY in accordance with the provisions of Article 3 had such Net Recovery been accrued by COMPANY as Sales.
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IX. LIMITED WARRANTY AND EXCLUSION OF WARRANTIES
EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT, EMORY DOES NOT MAKE ANY REPRESENTATION OR WARRANTY OF ANY KIND WITH RESPECT TO THE LICENSED PATENTS, LICENSED TECHNOLOGY OR LICENSED PRODUCTS AND EXPRESSLY DISCLAIMS ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND ANY OTHER IMPLIED WARRANTIES WITH RESPECT TO THE CAPABILITIES, SAFETY, UTILITY, OR COMMERCIAL APPLICATION OF THE LICENSED PATENTS, LICENSED TECHNOLOGY OR LICENSED PRODUCTS.
X. DAMAGES, INDEMNIFICATION AND INSURANCE
1. No Liability. EMORY shall not be liable to COMPANY or COMPANY'S Affiliates, or customers and/or sublicensees of COMPANY or COMPANY'S Affiliates, for compensatory, special, incidental, indirect, consequential or exemplary damages resulting from the manufacture, testing, design, labeling, use or sale of Licensed Products. COMPANY shall have no liability to or duty to indemnify EMORY for any clinical activity that is authorized by EMORY without COMPANY's knowledge or participation.
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i. insures Indemnitees for all claims, damages, and actions mentioned in Section 10.2 of this Agreement;
ii. includes a contractual endorsement providing coverage for all liability which may be incurred by lndemnitees in connection with this Agreement; and
iii. requires the insurance carrier to provide EMORY with no less than thirty (30) days' written notice of any change in the terms or coverage of the policy or its cancellation; and
iv. provides lndemnitees product liability coverage in an amount no less than Two Million Dollars ($2,000,000.00) per occurrence for bodily injury and One Million Dollars ($1,000,000.00) per occurrence for property damage, subject to a reasonable aggregate amount.
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i. COMPANY and its Affiliates and sublicensees shall retain in confidence and use only for purposes of this Agreement, any written information and data supplied by EMORY to COMPANY under this Agreement and marked as proprietary;
ii. EMORY shall retain in confidence and use only for purposes of this Agreement any written information and data supplied by COMPANY or on behalf of COMPANY to EMORY and marked as proprietary under this Agreement.
For purposes of this Agreement, all such information and data which a party is obligated to retain in confidence shall be called “Information.”
i. to keep the Information confidential for at least the same time periods and to the same extent as each party is required to keep the Information confidential; and
ii. to use the Information only for such purposes as such parties are authorized to use the Information.
Each party or its Affiliates or sublicensees may disclose Information to the government or other regulatory authorities to the extent that such disclosure is necessary for the prosecution and enforcement of patents, or authorizations to conduct clinical trials or commercially market Licensed Products, provided that such party is otherwise entitled to engage in such activities under this Agreement.
i. is or becomes patented, published or otherwise part of the public domain, other than by unauthorized acts of a party obligated not to disclose such Information;
ii. is disclosed to the receiving party or its Affiliates or sublicensees by a third party provided that such Information was not obtained by such third party directly or indirectly from the other party under this Agreement; or
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iii. prior to disclosure under this Agreement, was already in the possession of the receiving party, its Affiliates or sublicensees, provided that such Information was not obtained directly or indirectly from the other party under this Agreement; or
iv. results from research and development by the receiving party or its Affiliates or sublicensees, independent of disclosures from the other party of this Agreement, provided that the persons developing such information have not had exposure to the information received from the disclosing party; or
v. is required by law to be disclosed by the receiving party, provided that the receiving party uses its best efforts to notify the other party immediately upon learning of such requirement in order to give the other party reasonable opportunity to oppose such requirement; or
vi. COMPANY and EMORY agree in writing may be disclosed.
This Article 11 shall be construed as an agreement ancillary to the other provisions of this Agreement, and the existence of any claim or cause of action of one party against the other, whether predicated on this Agreement or otherwise, shall not constitute a defense to the enforcement of Article 11, except that either Party has a right to disclose Information to any panel or court in a proceeding against the other Party under Article 14 of this Agreement
i. failure of COMPANY to make any payment required pursuant to this Agreement when due; or
ii. failure on the part of COMPANY to satisfy when due its diligence obligations as set forth in Article 6 herein; or
iii. failure of COMPANY to render reports to EMORY as required by this Agreement; or
iv. the institution of any proceeding by COMPANY under any bankruptcy, insolvency or moratorium law; or
v. any assignment by COMPANY of substantially all of its assets for the benefit of creditors; or
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vi. placement of COMPANY'S assets in the hands of a trustee or a receiver unless the receivership or trust is dissolved within thirty (30) days thereafter; or
vii. a decision of which EMORY is notified in writing by COMPANY or COMPANY'S assignee of rights under this Agreement to quit the business of developing or selling Licensed Products; or
viii. the breach by COMPANY of any other material term of this Agreement; or
ix. failure to execute the Subscription Agreement within sixty (60) days of the Effective Date of this Agreement; or
x. institution of any proceedings by COMPANY, an Affiliate or sublicensee that challenges the validity or enforceability (but not scope) of any Licensed Patent.
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COMPANY may grant, transfer, convey, or otherwise assign any or all of its rights and obligations under this Agreement in conjunction with the transfer of all, or substantially all, of the business assets or interests of COMPANY, whether by merger or otherwise, to which this Agreement relates. EMORY's written consent, which shall not be unreasonably withheld, shall be required prior to any other assignment of COMPANY'S rights or obligations under this Agreement. This Agreement shall be assignable by EMORY to a nonprofit Emory-controlled corporation which promotes the research purposes of EMORY, provided, however, that Emory shall remain obligated and any such assignment is conditioned on the assignee assuming the duties and obligations of Emory under the terms of this Agreement and EMORY notifies COMPANY of any such assignment in writing.
Any dispute related to this License Agreement shall be settled by arbitration. Arbitration shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association by three arbitrators, one to be appointed by EMORY, one to be appointed by COMPANY, and one to be appointed by the two arbitrators appointed by EMORY and COMPANY. Arbitration shall take place in Atlanta, Georgia, and the decision of the arbitrators shall be enforceable, but not appealable, in any court of competent jurisdiction. Each Party shall bear its own fees and expenses incurred in connection with such arbitration, which shall be subject to reimbursement by the party which does not prevail in such proceeding promptly upon the termination thereof in the event that the Party initiating such proceeding is the prevailing party. Notwithstanding the forgoing, each Party has the right before or, if the arbitrator(s) cannot hear the matter within an acceptable period, during the arbitration to seek from the appropriate court provisional remedies such as attachment, preliminary injunction and replevin, to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration, subject to all legally applicable requirements.
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6. Place of Execution. This Agreement and any subsequent modifications or amendments hereto shall be deemed to have been executed in the State of Georgia, U.S.A.
7. Governing Law. This Agreement and all amendments, modifications, alterations, or supplements hereto, and the rights of the parties hereunder, shall be construed under and governed by the laws of the State of Georgia and the United States of America. Only courts in the State of Georgia, U.S.A., shall have jurisdiction to hear and decide any controversy or claim between the parties arising under or relating to this Agreement.
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All notices, statements, and reports required to be given by one Party to the other shall be in writing and shall be hand delivered, sent by private overnight mail service, or sent by registered or certified U.S. mail, postage prepaid, return receipt requested and addressed as follows:
| If to EMORY: |
Emory University Office of Technology Transfer 0000 Xxxxxxx Xxxx XX, 0xx Xxxxx Mailstop 1599/001/lAZ Xxxxxxx, Xxxxxxx 00000 Attn: Director Facsimile: (000) 000-0000 |
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| If to COMPANY: |
0000 Xxxxxx Xxxx Xxxxxxx Xxxxx 000 Xxxxxx, XX 00000 Attn: CEO
|
| With a copy to: |
XxXxxxxx Law Group, PC XX Xxx 000000 Xxxxxxxx, Xxxxxxx 00000 Attn: Xx. Xxxxx XxXxxxxx, Esq. |
Such notices or other communications shall be effective upon receipt by an employee, agent or representative of the receiving Party authorized to receive notices or other communications sent or delivered in the manner set forth above. Either Party hereto may change the address to which notices to such Party are to be sent by giving notice to the other Party at the address and in the manner provided above. Any notice may be given, in addition to the manner set forth above by facsimile provided that the party giving such notice obtains acknowledgement by facsimile that such notice has been received by the Party to be notified. Notice made in this manner shall be deemed to have been given when such acknowledgement has been transmitted.
IN WITNESS WHEREOF, EMORY and COMPANY have caused this Agreement to be signed by their duly authorized representatives as of the day and year indicated below.
| EMORY UNIVERSITY | COMPANY | |||||
| By: | /s/ Xxxx X. Xxxxxx | By: | /s/ Xxxxxx Xxxxxx | |||
| Name: | Xxxx X. Xxxxxx, Ph.D | Name: | Xxxxxx Xxxxxx, PhD | |||
| Title: Associate Vice President for Research and Director Office of Technology Transfer | Title: President & CEO | |||||
| Date: | June 8, 2010 | Date: | June 8, 2010 | |||
| READ AND UNDERSTOOD | ||||||
| By: | /s/ Xxx Xxxxxx | |||||
| Name: | Xxx Xxxxxx, Ph.D. | |||||
| Title: Associate Professor | ||||||
| Date: | June 8, 2010 | |
| LIC.09.024 | ||
-24-
APPENDIX A
COMPANY'S DEVELOPMENT PLAN
i) Three (3) years to first IND filing on a product or service covered by any Licensed Patent or Licensed Technology.
ii) Seven (7) years to first proof-of-concept clinical trial for a product or service covered by any Licensed Patent or Licensed Technology.
iii) Eleven (11) years to first Phase III trial for a product or service covered by any Licensed Patent or Licensed Technology.
iv) Fifteen (15) years to first NOA filing for a product or service covered by any licensed patent or technology.
APPENDIX B
(TM) LICENSED PATENTS
Emory technology references 04088, 06121, 09038 and 09039 shall be included in this exclusive license. Current patent(s) and applications associated with these technologies are listed below.
|
Xxxxx Xxxx XX 00000 Compositions and Methods of Use of Tyrosine Kinase Inhibitors to Treat Infections caused by HIV-1, by Mycobacterium Tuberculosis, and by Polyoma and Related Viruses | ||||||
| Emory Ref. | Country | Serial No | File Date | Patent No | Issue Date | Xxxxxx |
| 00000 Xxxx | Xxxxxx Xxxxxx | 60/614,203 | 09/29/2004 | Expired | ||
| 00000 xx | Xxxxxx Xxxxxx | 10/586,382 | 01/20/2005 | Xxxxxxx | ||
| 00000 XXX | XXX | XXX/XX0000/0x000 | 01/20/2005 | Pending | ||
| 04088 EPO | EPO | 0570591.6 | 01/20/2005 | Xxxxxxx | ||
| 00000 XXX | Xxxxxx | 2,554,201 | 01/20/2005 | Xxxxxxx | ||
| 00000 XXX | Xxxxxxxxx | 2005209231 | 01/20/2005 | Pending | ||
| 00000 XXX | Xxxxx | 2006-551238 | 01/20/2005 | Pending | ||
|
Xxxxx Xxxx XX 00000 Development of Novel Tyrosine Kinase Inhibitors for Treating Infectious Diseases | ||||||
| Emory Ref. | Country | Serial No | File Date | Patent No | Issue Date | Xxxxxx |
| 00000 Xxxx | Xxxxxx Xxxxxx | 60/824,540 | 09/05/2006 | Expired | ||
| 00000 XXX | XXX | XXX/XX0000 /77578 | 09/05/2007 | Pending | ||
Xxxxx Xxxx XX 00000 Use of Tyrosine Kinase Inhibitors to Treat Mycobacterium Tuberculosis and Related Infections | ||||||
| Emory Ref. | Country | Serial No | File Date | Patent No | Issue Date | Xxxxxx |
| 00000 | Xxxxxx Xxxxxx | XXX | XXX | Xxxxxxx | ||
|
Xxxxx Xxxx XX 00000 Use of Tyrosine Kinase Inhibitors as Therapeutics for Polyomavirus Infections | ||||||
| EMORY Ref. | Country | Serial No | File Date | Patent No | Issue Date | Xxxxxx |
| 00000 | Xxxxxx Xxxxxx | XXX | XXX | Pending | ||
APPENDIX C (TK)
U.S. GOVERNMENT LICENSE(S)
License to the United States Government
APPENDIX D
CAPITALIZATION TABLE
Post-Emory University and Duke University License Execution
|
Shareholders |
Number of Inhibikase common shares |
Percentage Ownership as of the _ day of May 2010 |
| Xxxxxx X. Xxxxxx, Ph.D. | 5,900,000 | 59.0% |
| Xxxxxx X. Xxxxxx, Ph.D. | 100,000 | 1% |
| Xxxxx XxXxxxxx | 200,000 | 2% |
| Xxxxxxxx Blank, MD | 100,000 | 1% |
| EMORY University -License 10.021 | 500,0001 | 5% |
| EMORY University - License 09.024 | 450,0001 | 4.5% |
| EMORY University - License 09.024 | 50,0002 | 0.5% |
| Xxx Xxxxxx, PhD | 2,000,000J | 20% |
| Duke University | 700,0004 | 7% |
| Total | 10,000,000 | 100% |
1Shares shown for issuance is based on agreed-upon percentage calculated taking into account the assumption that Company will successfully enter into license with Duke University and, thus, issue to Duke the shares referenced, and resolution of agreement with Xxx Xxxxxx, Ph.D.
2In addition to the reservation under (1), above, shares shown are subject to TB being added to scope of EU license
3Shares shown are contingent upon Company reaching agreement with Xx. Xxxxxx, to include, among other things, being granted in accordance with a consulting agreement.
4Sharesshown are contingent on execution of a License Agreement with Duke University for complementary technology. Failure of any of the foregoing contingencies will require an adjustment in the number of shares proposed to be issued under the above-referenced chart.
All Licensed Products covered by a Valid Claim, except as noted in Article 3.3.
Percentage of Net Selling Price 3.75 %
APPENDIX F
MINIMUM ANNUAL ROYALTIES
| Calendar Year after First Sale | Minimum Annual Royalty | |||
| Year 1 | $ | 10,000 | ||
| Year2 | $ | 20,000 | ||
| Year 3 and subsequent years | $ | 40,000 | ||
APPENDIX G (TM)
Sublicense Revenue
| Sublicense Executed | Percentage | |||
| Prior to completion of first Phase I Clinical Trial | 12 | % | ||
| After initiation of first Phase II Clinical Trial until initiation of first Phase III Clinical Trial | 8 | % | ||
| After initiation of first Phase III Clinical Trial until first License Product Regulatory Approval | 6 | % | ||
| After first Licensed Product Regulatory Approval | 4 | % | ||
Appendix H
MILESTONE PAYMENTS
| Event | Milestone Payment | |||
| Commencement of first Phase I Clinical Trial | $ | 40,000 | ||
| Commencement of first Phase III Clinical Trial | $ | 80,000 | ||
| FDA Acceptance of first Licensed Product NDA | $ | 160,000 | ||
APPENDIX I
RIGHT OF FIRST OFFER AGREEMENT
In the event EMORY desires to license a technology that is an Option Invention or to license the field of Tuberculosis (the “Offered Technology”), EMORY shall deliver written notice thereof (the “First Offer Notice”) to COMPANY. The First Offer Notice shall describe with reasonable specificity the Offered Technology. The First Offer Notice shall constitute an offer by EMORY to license such Offered Technology to COMPANY, and COMPANY, if it desires to accept such offer, shall, within thirty (30) days after delivery of the First Offer Notice, give EMORY written notice to such effect (the “Acceptance Notice”). Such technology shall be added to this Agreement by way of an amendment thereto.
If COMPANY shall fail to deliver or otherwise declines the Acceptance Notice within the time period provided, COMPANY shall be deemed to have waived its right to accept the offer reflected in the First Offer Notice as to the Offered Technology, but not as to other technology covered by the Option Invention, and EMORY may thereafter offer to license the Offer Technology without any further obligation whatsoever thereunder to COMPANY.
In the event that COMPANY gives EMORY an Acceptance Notice, then, on such business day as COMPANY shall set forth in the Acceptance Notice, which shall be not less than thirty (30) days nor more than one hundred twenty (120) days after the giving of the Acceptance Notice, COMPANY and EMORY shall enter into an amendment of this Agreement for the license of the Offered Technology.
EXHIBIT “A”
COMPANY'S FORM OF
STOCK SUBSCRIPTION AGREEMENT
INHIBIKASE THERAPEUTICS, INC. SUBSCRIPTION AGREEMENT
| To: | Xxxxxx Xxxxxx, Ph.D. President & CEO Inhibikase Therapeutics, Inc. |
From: Emory University
Emory University (the “Subscriber”) hereby irrevocably agrees to acquire from Inhibikase Therapeutics, Inc. (the “Company”) the number of shares of Common Stock of the Company (the “Shares”) shown beside the duly authorized signature below in partial consideration of the license granted to Company for certain intellectual property rights of the Subscriber, on the following terms and conditions (the “Subscription”).
To induce Subscriber to make this Subscription and acquire the Shares from Company, Company hereby represents and warrants that it has all requisite authority to sell and issue the Shares.
To induce Company to accept this Subscription and issue the Shares to Subscriber, I, the Subscriber, hereby represent, warrant, covenant to and agree with Company as follows:
i) Subscriber has had a reasonable opportunity to ask questions of and receive answers from the Company concerning the terms and conditions of the offering of Shares, and to obtain additional information, to the extent possessed or obtainable without unreasonable effort or expense by the Company, necessary to verify the accuracy of the information provided. All such questions have been answered to the full satisfaction of Subscriber. Subscriber acknowledges that in making its decision to acquire Shares, Subscriber is relying solely on the information provided by the Company to Subscriber in writing. Subscriber understands that no offering statement, prospectus or offering circular containing information with respect to the Company or the Shares has been or is to be prepared, and Subscriber has made its own inquiry and analysis with respect to the Company and the Shares. Subscriber acknowledges that neither the Company nor any of its representatives have made any representation or warranty to Subscriber concerning the tax consequences of Subscriber's acquisition of, or subsequent disposition of, the Shares
ii) Subscriber has such knowledge and experience in financial and business matters as to enable Subscriber to (a) utilize the information made available to it in connection with the offering of Shares, (b) evaluate the merits and risks associated with an acquisition of the Shares, and (c) make an informed decision with respect thereto.
iii) Subscriber (a) has adequate means of providing for its current needs and possible contingencies, (b) has no need for liquidity in connection with its acquisition of the Shares, (c) is able to bear the economic risks for an indefinite period and has the capacity to protect its own interests in connection with an acquisition of the Shares, (d) can afford the complete loss of the price for the Shares subscribed for hereunder, and (e) is subscribing for the acquisition of the Shares based on its personal relationship and acquaintance with Company's management.
iv) Subscriber recognizes that the acquisition of the Shares involves certain risks.
v) Subscriber understands that (a) neither the offering nor the sale of the Shares has been registered under the securities laws of any state or the Securities Act of 1933, as amended (the “Act”), in reliance upon exemptions from the registration provisions of the Act and such laws, (b) the Shares acquired by Subscriber must be held indefinitely unless the sale or transfer thereof is subsequently registered under the Act and such laws, or an exemption from such registration is available, (c) Subscriber is an “accredited investor” as that term is defined in the Act, and (d) Company and the President will rely upon the representations and warranties made by Subscriber in this Subscription in order to establish such exemption from the registration provisions of the Act and applicable state securities laws.
vi) Subscriber will not transfer any Shares without registration under the Act and applicable state securities laws unless the transfer is exempt from registration under the Act and such laws.
vii) The Shares are being acquired solely for Subscriber's own account and not for the account of any other person or entity, and no other person or entity has or will have a direct or indirect beneficial interest in such Shares. The Shares are being acquired for investment purposes only, and not for distribution, assignment, sale or transfer to others.
viii) Subscriber realizes that Subscriber may not be able to sell or dispose of its Shares because there will be no public market for such Shares in the foreseeable future.
ix) The foregoing representations, warranties and covenants, and all other information that Subscriber has provided to the Company concerning Subscriber and Subscriber's financial condition are true, complete and accurate as of the date hereof. If in any respect such information, representations, warranties and covenants are not true and accurate at any time prior to the date of the issuance of Shares to Subscriber, Subscriber will give written notice of such fact to the President specifying which information, representations, warranties or covenants are not true and accurate and the reasons therefore.
x) Subscriber understands that the stock certificates representing the Shares subscribed to hereby will contain substantially the following restrictive legends:
“The shares evidenced by this Certificate have been acquired for investment and have not been registered under any state securities act or under the Securities Act of 1933 (the “1933 Act”) pursuant to and in reliance on the exemption contained in Sections 4(2) of the 1933 Act, as amended, and Rule 506, Regulation D promulgated by the SEC thereunder as not involving any public offering. These securities cannot be sold, transferred or pledged in the absence of such registration unless the company receives an opinion of counsel reasonably acceptable to the company stating that such sale or transfer is exempt from the registration and prospectus delivery requirements of all applicable state and federal securities acts.”
11. This Agreement is enforceable against Subscriber in accordance with its terms.
Subscriber shall not transfer or assign this Subscription, or any of Subscriber's interests herein, to any other person; shall not cancel, terminate or revoke this Subscription (except as otherwise specifically permitted under applicable state securities laws), and this Subscription shall be binding upon Subscriber's administrators, heirs, successors and assigns. This Subscription constitutes the entire agreement between the parties hereto with respect to the subject matter hereof, and this Subscription may be amended only by a writing executed by both of the parties hereto. This Subscription shall be enforced, governed and construed in all respects in accordance with the laws of the State of Georgia, without regard to its conflicts of law principles. Within five (5) days after the receipt of a written request from the President, Subscriber shall provide such information, and execute and deliver such documents, as reasonably may be necessary to comply with any and all laws, ordinances and regulations to which Company is subject. The representations and warranties of Subscriber set forth herein shall survive the sale of the Shares to Subscriber pursuant to this Subscription.
Upon receipt and subject to its acceptance of this Subscription, Company will forward to Subscriber an Acceptance of Subscription in writing or otherwise by notification.
IN WITNESS WHEREOF, Subscriber has executed and acknowledged this Subscription as of the date set forth below.
EMORY UNIVERSITY
By:
Print Name:
Title:
Number of Shares:
Employer ID Number:
Address:
Executed at: Atlanta, Georgia this _ day of _ 2010.
The undersigned, as President and Chief Executive Officer of Inhibikase Therapeutics, Inc. (“Company”), hereby accepts and agrees to on behalf of Company the foregoing Subscription of Emory University (the “Subscriber”) for _____shares of Company's Common Stock for and in consideration for the consideration described therein. Subject to applicable securities laws and this Subscription, Company will transfer the Common Stock issued to Emory hereunder as directed by EMORY to transferees, which may include, without limitation, the Inventors (as such term is defined in that certain License Agreement entered into by and between Company and Emory as of even date herewith (the “License Agreement”)) and any other person who may be identified at a later time and named on the Licensed Patents (the “License Agreement”); and agrees grant the right to obtain such registration rights as may be granted from time to time to Xxxxxx Xxxxxx, Ph.D.
IN WITNESS WHEREOF, the undersigned, as President, has accepted such Subscription on behalf of Company as of the_ day of March 2010.
| Inhibikase Therapeutics, Inc. |
| By: |
| Name: Xxxxxx Xxxxxx, Ph.D. | |
| Title: President & CEO |
EXHIBIT “B”
EMORY'S FORM OF
MATERIAL TRANSFER AGREEMENT
The following form of MTA has not been reviewed by Company and remains subject to its review, comment and agreement during the 60 day period following the Effective Date.
MATERIALS TRANSFER AGREEMENT
THIS AGREEMENT is made and entered into as of this _ day of __________by and between Emory University, a non-profit Georgia corporation with offices located at 0000 Xxxxxxx Xxxx X.X., 0xx Xxxxx, Xxxxxxx, Xxxxxxx 00000 XXX (hereinafter referred to as “EMORY”) and a non-profit institution with offices located at (hereinafter referred to as “INSTITUTION”).
INSTITUTION, through its below identified Scientist (hereinafter INSTITUTION's Scientist''), has requested that EMORY, through its below identified Scientist (hereinafter “EMORY's Scientist'') provide INSTITUTION the below described MATERIAL. INSTITUTION's Scientist shall use the MATERIAL solely in connection with INSTITUTION's Research Project as described with specificity below.
INSTITUTION's Scientist:
Email address:
Phone:
Fax:
INSTITUTION Scientist's Shipping Address:
INSTITUTION Scientist's Shipping Carrier and Account Number:
Shipping Carrier: _
Shipping Account Number: _
EMORY's Scientist:
For the purposes of this Agreement, MATERIAL shall mean:
For the purposes of this Agreement, INSTITUTION's Research Project shall mean:
i) MATERIAL: ORIGINAL MATERIAL, PROGENY, and UNMODIFIED DERIVATIVES. The MATERIAL shall not include: (a) MODIFICATIONS, or (b) other substances created by the INSTITUTION through the use of the MATERIAL which are not MODIFICATIONS, PROGENY, or UNMODIFIED DERIVATIVES.
iv) MODIFICATIONS: Substances created by the INSTITUTION which contain/incorporate the MATERIAL.
vi) NONPROFIT ORGANIZATION(S): A university or other institution of higher education or an organization of the type described in section 50l(c)(3) of the Internal Revenue Code of 1954 (26
vii) U.S.C. 50l(c)) and exempt from taxation under section 50l(a) of the Internal Revenue Code (26 U.S.C. 50l(a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute. As used herein, the term also includes government agencies.
II. Terms and Conditions of this Agreement:
i) EMORY retains ownership of the MATERIAL, including any MATERIAL contained or incorporated in MODIFICATIONS.
ii) The INSTITUTION retains ownership of: (a) MODIFICATIONS (except that, EMORY retains ownership rights to the MATERIAL included therein), and (b) those substances created through the use of the MATERIAL or MODIFICATIONS, but which are not PROGENY, UNMODIFIED DERIVATIVES or MODIFICATIONS (i.e., do not contain the ORIGINAL MATERIAL, PROGENY, UNMODIFIED DERIVATIVES). If either 2 (a) or 2 (b) results from the collaborative efforts of EMORY and the INSTITUTION, joint ownership may be negotiated.
iii) The INSTITUTION and the INSTITUTION SCIENTIST agree that the MATERIAL:
a) is to be used solely for teaching and academic research purposes;
b) will not be used in human subjects, in clinical trials, or for diagnostic purposes involving human subjects without the written consent of EMORY;
c) is to be used only at the INSTITUTION organization and only in the INSTITUTION SCIENTIST's laboratory under the direction of the INSTITUTION SCIENTIST or others working under his/her direct supervision; and
d) will not be transferred to anyone else within the INSTITUTION organization without the prior written consent of EMORY.
iv) The INSTITUTION and the INSTITUTION SCIENTIST agree to refer to EMORY any request for the MATERIAL from anyone other than those persons working under the INSTITUTION SCIENTIST's direct supervision. To the extent supplies are available, EMORY or EMORY SCIENTIST agrees to make the MATERIAL available, another agreement having terms consistent with the terms of this Agreement, to other scientists (at least those at NONPROFIT ORGANIZATION(S)) who wish to replicate the INSTITUTION SCIENTIST's research; provided that such other scientists reimburse EMORY for any costs relating to the preparation and distribution of the MATERIAL.
v) (a) The INSTITUTION and/or the INSTITUTION SCIENTIST shall have the right, without restriction, to distribute substances created by the INSTITUTION through the use of the ORIGINAL MATERIAL only if those substances are not PROGENY, UNMODIFIED DERIVATIVES, or MODIFICATIONS.
b) Under a separate agreement at least as protective of EMORY's rights), the INSTITUTION may distribute MODIFICATIONS to NONPROFIT ORGANIZATION(S) for research and teaching purposes only.
c) Without written consent from EMORY, the INSTITUTION and/or the INSTITUTION SCIENTIST may NOT provide MODIFICATIONS for COMMERCIAL PURPOSES. It is recognized by the INSTITUTION that such COMMERCIAL PURPOSES may require a commercial license from EMORY and EMORY has no obligation to grant a commercial license to its ownership interest in the MATERIAL incorporated in the MODIFICATIONS. Nothing in this paragraph, however, shall prevent the INSTITUTION from granting commercial licenses under the INSTITUTION's intellectual property rights claiming such MODIFICATIONS, or methods of their manufacture or their use.
vi) The INSTITUTION acknowledges that the MATERIAL is or may be the subject of a patent application. Except as provided in this Agreement, no express or implied licenses or other rights are provided to the INSTITUTION under any patents, patent applications, trade secrets or other proprietary rights of EMORY, including any altered forms of the MATERIAL made by EMORY. In particular, no express or implied licenses or other rights are provided to use the MATERIAL, MODIFICATIONS, or any related patents of EMORY for COMMERCIAL PURPOSES.
vii) If the INSTITUTION desires to use or license the MATERIAL or MODIFICATIONS for COMMERCIAL PURPOSES, the INSTITUTION agrees, in advance of such use, to negotiate in good faith with EMORY to establish the terms of a commercial license. It is understood by the INSTITUTION that EMORY shall have no obligation to grant such a license to the INSTITUTION, and may grant exclusive or non-exclusive commercial licenses to others, or sell or assign all or part of the rights in the MATERIAL to any Third Party(ies), subject to any pre-existing rights held by others and obligations to the Federal Government.
viii) The INSTITUTION is free to file patent application(s) claiming inventions made by the INSTITUTION through the use of the MATERIAL but agrees to notify EMORY upon filing a patent application claiming MODIFICATIONS or method(s) of manufacture or use(s) of the MATERIAL.
ix) Any MATERIAL delivered pursuant to this Agreement is understood to be experimental in nature and may have hazardous properties. EMORY MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS.
x) Except to the extent prohibited by law, the INSTITUTION assumes all liability for damages which may arise from its use, storage or disposal of the MATERIAL. EMORY will not be liable to the INSTITUTION for any loss, claim or demand made by the INSTITUTION, or made against the INSTITUTION by any other party, due to or arising from the use of the MATERIAL by the INSTITUTION, except to the extent permitted by law when caused by the gross negligence or willful misconduct of EMORY.
xi) This agreement shall not be interpreted to prevent or delay publication of research findings resulting from the use of the MATERIAL or the MODIFICATIONS. The INSTITUTION SCIENTIST agrees to provide appropriate acknowledgement of the source of the MATERIAL in all publications.
xii) The INSTITUTION agrees to use the MATERIAL in compliance with all applicable statutes and regulations, including Public Health Service and National Institutes of Health regulations and guidelines such as, for example, those relating to research involving the use of animals or recombinant DNA.
xiii) This Agreement will terminate on the earliest of the following dates: (a) when the MATERIAL becomes generally available from third parties, for example, though reagent catalogs or public depositories or (b) on completion of the INSTITUTION's current research with the MATERIAL, or (c) on thirty (30) days written notice by either party to the other, or (d) on the following date; provided that:
(i) if termination should occur under 13(a), the INSTITUTION shall be bound to EMORY by the least restrictive terms applicable to the MATERIAL obtained from the then- available resources; and
(ii) if termination should occur under 13(b) or (d) above, the INSTITUTION will discontinue its use of the MATERIAL and will, upon direction of EMORY, return or destroy any remaining MATERIAL. The INSTITUTION, at its discretion, will also either destroy the MODIFICATIONS or remain bound by the terms of this agreement as they apply to MODIFICATIONS; and
(iii) in the event EMORY terminates this Agreement under 13(c) other than for breach of this Agreement or for cause such as an imminent health risk or patent infringement, EMORY will defer the effective date of termination for a period of up to one year, upon request from the INSTITUTION, to permit completion of research in progress. Upon the effective date of termination, or if requested, the deferred effective date of termination, INSTITUTION will discontinue its use of the MATERIAL and will, upon direction of EMORY, return or destroy any remaining MATERIAL. The INSTITUTION, at its discretion, will also either destroy the MODIFICATIONS or remain bound by the terms of this agreement as they apply to MODIFICATIONS.
xiv) Paragraphs 6, 9, and 10 and 16 shall survive termination.
xv) The MATERIAL is provided at no cost, or with an optional transmittal fee solely to reimburse EMORY for its preparation and distribution costs. If a fee is requested by EMORY, the amount will be_.,$ ,....
xvi) INSTITUION and INSTITUTION SCIENTIST acknowledge their understanding that the MATERIAL and MODIFICATIONS may be subject to export control laws and regulations of the United States of America, including the Export Administration Regulations (EAR), the International Traffic in Arms Regulations (ITAR), and the Foreign Assets Control regulations. Further, INSTITUTION shall be responsible for obtaining the appropriate licenses or other authorizations, if required, for exports or reexports of the MATERIAL or MODIFICATIONS and, if applicable, for the provision of technology related to the MATERIAL or MODIFICATIONS, including the provision of such technology to a foreign national in the United States or abroad.
[Signature Page Follows]
| AGREED BY: | ||||
| EMORY UNIVERSITY | INSTITUTION | |||
| By: | By: | |||
| Name: | Name: | |||
| Title: | Title: | |||
| Date: | Date: | |||
| Address: | ||||
| Email: | ||||
| Phone: | ||||
| READ AND UNDERSTOOD BY: | ||||
| EMORY’S SCIENTIST | INSTITUTION’s SCIENTIST | |||
| By: | By: | |||
| Name: | Name: | |||
| Title: | Title: | |||
| Date: | Date: | |||
Please return two (2) signed execution copies to:
Attention: MTA Specialist
Emory University
Office of Technology Transfer
0000 Xxxxxxx Xxxx X.X., 00x Xxxxx
Xxxxxxx, Xxxxxxx 00000
Email: xxx@xxxxx.xxx
