On November 29, 2019 the Aytu BioScience, Inc., (the “Company”) and Acerus Pharmaceuticals Corporation (“Acerus”), both referred herein as “the Parties”, closed the July 29, 2019 Amended and Restated License and Supply Agreement (the “Agreement”) by virtue of entering into a Waiver and Amendment (the “Amendment” to the agreement), both Parties agreed to waive certain conditions to the Agreement that were required before the Agreement could become effective, including the requirement that Acerus raise at least $10 million of gross proceeds of additional capital through one or more series of transactions to occur over a six month period from the signing of the Agreement on July 29, 2019. In addition to closing the Agreement, both Parties agreed for Acerus to assume five current sales employees from the Company as of December 2, 2019. These staff will operate as Acerus employees, but they will remain on the Company’s payroll until the earlier of the date on which Acerus is ready to fully assume the personnel or June 30, 2020. Finally, Acerus agreed to reimburse amounts equaling Acerus’s share of certain regulatory expenses paid by the Company related to the Company’s low testosterone treatment,Natesto®.

The foregoing description of the Amendment is qualified in its entirety by the full text of the Amendment, a copy of which is attached hereto as Exhibit 10.1.

Item 7.01 Regulation FD Disclosure

On December 2, 2019, the Company announced the launch of the company’s co-promotion with Acerus, which is expected to accelerate the growth of Natesto® in the United States. Through this expanded commercial relationship, Acerus has launched a U.S.-based specialty sales force promoting Natesto to urologists and endocrinologists. This agreement significantly increases sales force coverage of targeted testosterone prescribers and puts a higher promotional focus on urologists and endocrinologists. Further, this revised partnership enables the Company to increase its Natesto promotional efforts in primary care and other specialties.

To accelerate the launch of Acerus’ U.S. commercial team, the Company has agreed to transfer five current sales employees to Acerus as of December 2, 2019. These staff will operate as Acerus employees, but they will remain on the Company’s payroll until the earlier of the date on which Acerus is ready to fully assume the personnel or June 30, 2020.

Item 9.01 Financial Statements and Exhibits.

(d) The following exhibit is being filed herewith:

* A copy of the press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. The information contained in the accompanying Exhibit 99.1 is being furnished to Item 7.01 of this Current Report on Form 8-K and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information contained in the press release shall not be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in such filing.

AYTU BIOSCIENCE, INC Exhibit
EX-10.1 2 aytu_ex101.htm WAIVER AND AMENDMENT TO THE JULY 29,…
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About AYTU BIOSCIENCE, INC. (OTCMKTS:AYTU)

Aytu BioScience, Inc. is a commercial-stage healthcare company focused on acquiring, developing and commercializing products in the field of urology. The Company focuses on hypogonadism, prostate cancer, urinary tract infections and male infertility. The Company markets ProstaScint (capromab pendetide), a radio imaging agent indicated to detect the prostate specific membrane antigen (PSMA) in the assessment and staging of prostate cancer. The Company also markets Primsol (trimethoprim hydrochloride), a trimethoprim-only oral solution for urinary tract infections. The Company’s pipeline includes MiOXSYS, an in vitro diagnostic device. MiOXSYS system is a point-of-care semen analysis system, used for diagnosis and management of male infertility. The Company holds the United States rights to Natesto (testosterone), a formulation of testosterone delivered through a nasal gel. Natesto is used for the treatment of hypogonadism (low testosterone) in men.