LICENSE AND TECHNOLOGY AGREEMENTS | 3 Months Ended |
Dec. 31, 2014 |
Notes to Financial Statements | |
NOTE 4 - LICENSE AND TECHNOLOGY AGREEMENTS | The Company's intangible assets consists of technology enhancements and licensing payments for its worldwide exclusive licensed rights to OvaDx®, a noninvasive proteomics diagnostic screening test for the early detection of ovarian cancer. The intravenous of “finger stick” blood sample detects early and late stage ovarian cancer of all sub-types. Since the test is performed in a digital platform and compared against known bio-markers, it gives a definitive “yes or no” answer. This test is expected to be approved by the U.S. Food and Drug Administration (FDA) as the first pre-symptomatic screening test for ovarian cancer in the United States, detecting all types and all stages of ovarian cancer with high sensitivity and specificity. |
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Technology Assignment Agreement with Arrayit Corporation |
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On July 18, 2009, the Company entered into a Technology Assignment Agreement with Arrayit Corporation (the “Tech Transfer Agreement”), whereby Arrayit Corporation assigned to the Company, exclusively throughout the world, all right, title and interest in the technology behind the microarray-based test for the detection and monitoring of ovarian cancer (the “Intellectual Property). The consideration under the Tech Transfer Agreement for the Intellectual Property was 80% of the Company’s issued and outstanding shares of capital stock existing at the time of the agreement, or 19,350,000 shares of common stock. The term of the agreement is indefinite. |
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Licensing Agreement with Wayne State University |
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On December 7, 2009, the Company entered into a worldwide licensing agreement and sponsored research agreement with Arrayit Corporation and Wayne State University (“WSU”) in Detroit, Michigan, for the continued research and development of a protein microarray-based diagnostic test for the early detection of ovarian cancer. WSU’s research involving ovarian cancer has been focused on the specific expression of genes associated with ovarian cancer (the “License Agreement”). For more than ten years, WSU has used Arrayit Corporation’s microarray technology to help identify key biomarkers using a novel process that has allowed them to isolate biomarkers unique to ovarian cancer. As a result, Arrayit has been able to build on this approach and is now in the late stage development phase of a simple blood test for the early detection of ovarian cancer that uses approximately 100 unique proteomic biomarkers in a microarray-based serologic detection of ovarian cancer markers that accumulate in the bloodstream as a result of the body’s natural immune response to developing ovarian tumors. The approach is based on the premise that cancer is a complex illness whose evolution over time is determined by a complex set of factors that depend both on the etiology of the illness and its interaction with the immune system of the specific patient. The main hypothesis is that any single marker will not have the ability to capture the complexities of this interaction, whereas a broad set of markers has a much better potential to do so. This approach allows ovarian tumors to be detected at Stage I of the illness, up to five years before symptoms occur in patients, which allows early medical intervention and a marked improvement in prognosis. WSU shall have the right to terminate the agreement if it reasonably determines that the Company is not diligently utilizing the licensed patents or the license agreement will expire as the patents expire. |
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Under the terms of the License Agreement, the Company is obligated to make a one-time payment of $125,000 to WSU within 30 days after the approval of the first licensed product by the FDA or another comparable agency, and is obligated to make royalty payments of up to 5% of the net revenues of the licensed products on a quarterly basis, or a minimum royalty payments as set forth below under the First Amendment. |
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On March 1, 2014, the Company and WSU entered into an amendment to the License Agreement in order to reflect the new name of the Company and to amend certain provisions (the “First Amendment”) as follows: |
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· | Update the list of licensed patents; |
· | Waive and update certain diligence milestones; |
· | Establish a payment schedule for certain past due patent costs due to WSU by the Company; |
· | Establish a payment schedule for certain accrued patent expenses incurred b WSU totaling $118,586; |
· | Require the Company to pay ongoing patent expenses; |
· | Waive the minimum royalty of $50,000 for each of 2011, 2012 and 2013 and adjust minimum annual royalties to $25,000 for 2014 and 2015, $50,000 for 2016 and 2017, $150,000 for 2018 and 2019 and $300,000 for 2020 and each year thereafter; |
· | Amend the list of material obligations; |
· | Waive certain interest and late fees; and |
· | Update addresses of record for both WSU and the Company. |
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As of December 31, 2014 and September 30, 2014, the carrying value of the rights to OvaDx® and payments to WSU under the License Agreement was $1,693,000, consisting of enhancements to the original initial rights licensed assigned to the Company resulting from the Tech Transfer Agreement with Arrayit Corporation as well as licensing payments made to WSU. The Company paid for these enhancements by the issuance of 10,000,000 common shares to Arrayit in August 2014, as well as cash payments to WSU during 2014 and 2013. It will be assessed over time for changes in valuation. The Company is not amortizing the value of the license. The Company will amortize the license upon FDA approval. |
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Exclusive Services Agreement Between Arrayit Corporation and the Company |
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On September 10, 2009, the Company entered into an Exclusive Services Agreement with Arrayit Corporation (the “Services Agreement”), whereby the Company will utilize the services of Arrayit Corporation to manufacture and provide the Company with a commercial supply of a microarray-based test for the detection and monitoring of ovarian cancer. The term of the Services Agreement was for five (5) years, with election to extend by the Company for an additional five (5) years period. Thereafter, the Services Agreement shall renew automatically for successive two-year periods, unless either Arrayit Corporation or the Company notifies the other of its election not to renew at least twelve (12) months prior to the expiration of the term. The term has been extended through September 2019. On August 6, 2014, the Company and Arrayit Corporation agreed that, upon any sales of OvaDx® and if desired by the purchase, that Arrayit Corporation would agree to include the manufacturing rights in the sale for no additional consideration. |