Nevada
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333-193328
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46-4013793
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer Identification No.)
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c/o Ortoli Rosenstadt LLP
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10022
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(Address of principal executive offices)
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(Zip Code)
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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the filing of an investigational new drug application (the “IND”) with the US Food and Drug Administration (“FDA”);
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successful interim results of Phase II/III clinical trial of the product candidate;
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FDA acceptance of a new drug application;
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FDA approval of the product candidate; and
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achieving certain worldwide net sales.
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10.1 |
License Agreement on Patent & Know-How Technology, dated April 21, 2017, between Q BioMed Inc. and ASDERA LLC
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99.1 |
Press Release entitled “Q Biomed Announces Licensing Agreement for Development of Drug to Treat Rare Pediatric Disorder”, dated April 25, 2017.
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Q BioMed Inc.
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Date: April 25, 2017
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By:
/s/ Denis Corin
Name: Denis Corin
Title: President
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Effective Date: |
April 21, 2017
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Licensor: |
ASDERA
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Licensee: |
QBioMed Inc (“Licensee”) and/or Q BioMed (Cayman) SEZC, as the case may be
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License Agreement: |
This License Agreement (this “Agreement”) grants Licensee the exclusive global license under the Patent Rights and the Know-How subject to the terms and conditions outlined in herein.
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Affiliate of a Party: |
Any corporation or other entity that controls, is controlled by, or is under common control with such party. For purposes of this definition, “control” means direct or indirect ownership of: (a) in the case of corporate entities, at least fifty percent (50%) of the outstanding voting securities of such entity; or (b) in the case of non-corporate entities, at least fifty percent (50%) with the decision-making authority of such entity.
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Patents: |
Patents shall mean any and all patents and patent applications (as listed in Exhibit (1) hereto) claiming: (i) PRO-MFA, its derivatives and/or their therapeutic uses, including but not limited to: Disruption of Active Language Development (DALD) in toddlers developing Autism Spectrum Disorders (ASDs) (preventing children with ASDs from becoming nonverbal); and (ii) patents and patent applications claiming PRO-MFA as a Licensed Product..
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Patent Rights: |
Patent Rights shall mean the Valid Claims of the Patents (including but not limited to US Serial No. 14/916,665 and EP Serial No. 14841451.9) to the extent that Licensor is legally entitled to grant such rights. “Valid Claim” shall mean a pending, issued or an otherwise unexpired claim within the Patent Rights that has not been held invalid or unenforceable by an un-appealable decision of a court or agency of competent jurisdiction.
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Know-How: |
Research and development information, materials, formulated drug, clinical and technical data, unpatented inventions, trade secrets, know-how and any supportive information related to PRO-MFA under the Patent Rights that are developed or controlled by Licensor as of the signing date of this Agreement and provided to Licensee for the development or manufacture of Licensed Products.
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Licensed Products: |
Products or methods within the Field that: (i) in the absence of the License Agreement, would infringe at least one Valid Claim of the Patent Rights, or (ii) incorporate the Know-How provided to Licensee by Licensor and/or their Affiliates.
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License: |
Subject to the terms of this Agreement, Licensor grants to Licensee an exclusive, worldwide license to make, use, import, sell, and offer to sell Licensed Products under the Patent Rights within the Field, with the right to sublicense so long as Licensee provides a copy of such sublicense on a timely basis accompanied by a notice to Licensor to confirm in writing a good faith, arm’s length transaction with commercially reasonable terms.
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1.
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Exclusive License: Licensee, within 15 days of signing the License Agreement, will issue ASDERA 125,000 shares of its unregistered common stock (“Initial Equity Consideration”). The Initial Equity Consideration is subject to restriction pursuant to the U.S. securities laws for 6 months after signing and leak out provisions of 25% per quarter thereafter. In addition, Licensee will pay ASDERA $50,000 in cash within 15 days of signing this agreement. Licensor agrees that its founder Knut Wittkowski, will advise Licensee as requested in the development of the PRO-MFA asset without additional compensation. Dr. Wittkowski agrees to join the Q BioMed advisory board where he will be eligible for option grants at the discretion of the Licensee. Licensee agrees to reimburse Dr. Wittkowski for any travel requirements that Licensee requests.
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2.
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Licensee is responsible for all further costs to develop and commercialize PRO-MFA, including patent costs.
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Field: |
All Therapeutic uses under the Patent Rights.
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Net Sales |
The total of the gross amount invoiced by any party (whether consisting of cash or any other forms of consideration) for all final sales, less the following deductions (to the extent included in and not already deducted from the gross amount invoiced or otherwise charged): cash, trade or quantity discounts actually granted to third party customer; sales, use, tariff, import/export duties or other excise taxes imposed on particular sales, and value added taxes (“
VAT
”); sales rebates paid or credited to third party customers including managed care rebates and chargebacks; and allowances or credits to third party customers because of rejections or returns. Income taxes are not an allowed deduction under Net Sales. If a sublicensee or development partner is a third party customer, then Licensee will pay Licensor Royalties on Net Sales based on the total gross amount normally charged to other third party customers in arm’s length transactions.
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Additional Milestone Fee: |
Within 30 days of the acceptance of the IND by the FDA, the Licensee will pay to Licensor, $**** in cash and unregistered common stock in any combination thereof subject to a minimum cash component of $****.
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Milestone Payments : |
The following milestone payments will be paid by Licensee to Licensor upon successfully achieving each milestone event given below for each Licensed Product. In the event of a sublicense or material event (eg: sale of the PRO-MFA assets) within two (2) years from the Effective Date, these milestone payments will be creditable against any compensation or royalties owing received by the Licensee and paid to Licensor under such sublicense. These may be paid in cash or fully vested, unregistered common stock priced as of the date the related payment is due.
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Milestones
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Payment
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Successful interim results (**** patient data) of Phase II/III
clinical trial of the Licensed Products.
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$
****
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FDA acceptance of NDA
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$
****
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Receipt of US regulatory approval of the 1
st
Licensed Product
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$ **** | |
Achievement of worldwide Net Sales of $**** of the 1st
Licensed Product
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$
****
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Achievement of worldwide net sales of $**** of the
Licensed Products
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$ **** | |
Achievement of worldwide net sales of $**** of the
Licensed Products
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$ **** |
Royalties: |
At the end of each calendar quarter Licensee will pay Licensor a royalty equal to
****
percent (
****
%) of the Net Sales of all Licensed Products sold by Licensee, its Affiliates and/or its sublicensees to third parties.
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Sublicense Fees: |
Licensee and/or its Affiliates, as the case may be, will pay to Licensor: (a) **** percent (****%) of all monetary consideration received by such party for any sublicense agreement entered into with a sublicensee until the 2nd anniversary of the License Agreement, and (b) **** percent (****%) of all monetary consideration received by such party for any sublicense agreement entered into with a sublicensee after the second anniversary of the License Agreement. Royalties and Milestones shall be excluded from the definition of Sublicense Fees. Any sublicense to an Affiliate will be on the same terms as this Agreement, but for the bifurcation of international versus domestic sales.
Any non-cash consideration received by Licensee and/or its Affiliates from a sublicensee that is not wholly-owned by the Licensee will be valued at its fair market value as of the date of receipt and Licensor will receive the aforementioned respective percentages of the fair market value
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Acquisition: |
Before an outright sale of the ASD-002 asset to a third party,
Licensee and/or its Affiliates, as the case may be, will provide copy of such agreement on a timely basis together with a notice to Licensor to confirm in writing a good faith, arm’s length transaction with commercially reasonable terms.
In the event of an outright sale of the PRO-MFA asset to a third party, such party will pay Licensor: (i) ****% of net proceeds of the transaction; or (ii) ****% of net proceeds of the transaction if the transaction concluded after the **** year anniversary of the Effective Date. Additionally, such party will pay Licensor a perpetual ****% royalty on any further net compensation which is not covered by the aforementioned percentages of upfront sale payments based upon revenue from third party, acquirer, sublicensee or an Affiliate. In the event of outright sale of the asset, the Patent Rights will not be assigned directly to any acquirer, but rather this Agreement and/or any Amended Agreement will be assigned and ownership rights for the Patent Rights will remain in Licensor. As a point of clarification, the proceeds resulting from any sale of the asset shall be those of the Licensee at which time the applicable royalty will be paid to Licensor.
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Diligence, Development and Commercialization : |
Licensee will, subject to the terms of the License Agreement, be in control of the development and commercialization of Licensed Products. Licensee will diligently develop the technology under the
Patent Rights to bring a Licensed Product to market. Licensee understands that such diligence by Licensee is essential for Licensor to realize its value from the commercialization of Patent Rights and Know-How. Hence, Licensee will meet or demonstrate through written evidence of good faith, diligent and commercial best efforts to achieve the following Diligence Milestone:
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Patent Maintenance,
Reimbursement and
Enforcement after executing
the License Agreement:
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Upon signing of this agreement by both Parties, Licensee agrees to pay for all the costs incurred by the Licensor towards filing, prosecution and maintenance of the Patent Rights. Licensor shall control the prosecution and maintenance of the Patent Rights in consultation with Licensee and with patent counsel reasonably acceptable to Licensee. Licensor and its patent counsel will keep Licensee promptly informed about all the details of the patent prosecution and shall copy Licensee on all prosecution related activities. Licensor shall make available to Licensee the serial numbers and filing dates, together with copies of all the applications, including copies of all patent office actions from any patent office, responses and all other communications from any patent office. Licensor will keep Licensee promptly informed of these activities, shall copy Licensee on all prosecution related activities and shall accept any reasonable advice and guidance provided by Licensee regarding patent prosecution strategy and/or documentation drafting related thereto. Licensee will pay for all reasonable documented attorneys’ fees, expenses, official fees and other charges related to the prosecution and maintenance of such Patent Rights.
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Name Use: |
Subject to legal obligations for Licensee to disclose material facts as a result of its status as a publicly listed Licensee on the OTCQB and a filer pursuant to the Securities Act of 1934,
neither party will use for publicity, promotion or otherwise, any logo, name, trade name, service mark or trademark of the other Party or its Affiliates, or any simulation, abbreviation or adaptation of the same, or the name of any employee or agent of the other Party, without that party’s prior, written, express consent. The Parties agree that The Rockefeller University and any of its logos or branding may not be used in any way without the written approval of The Rockefeller University.
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Term & Termination: |
This Agreement shall be effective as of the Effective Date and remain in effect until the later of: (i) the day after expiration of the last to expire Valid Claim within the Patent Rights in any jurisdiction; (ii) expiration of any time provided for market or data exclusivity awarded by the FDA or non-United States FDA counterpart in any jurisdiction; or (iii) twelve (12) years after the first commercial sale of a Licensed Product in a territory outside the United States. Upon its natural expiration, the rights under the License Agreement shall convert into a fully paid-up acquisition that grants Licensee ownership of the Licensed Products without any further compensation due to the Licensor.
Licensee may terminate the License Agreement at any time, in which case all rights in the License Agreement and any FDA documentation, including rights to the IND, Vouchers and NDA will be transferred to the Licensor. will revert to Licensor fully and Licensee will have no further rights to sell any Licensed Product (including the ones that incorporate Licensor’s Know-How), except in the event of termination based on grounds of material breach of the Agreement resulting from gross negligence or willful misconduct of Licensor.
If this Agreement is terminated by Licensor for Licensee’s bankruptcy or material breach, at the option of Licensor all outstanding sublicenses not in default will be assigned by Licensee to Licensor and any FDA documentation, including rights to the IND, Vouchers and NDA will be transferred to the Licensor.
In any situation where a material breach has been alleged by one Party to the other, the non-breaching party must first provide written notice of such alleged breach to the alleged breaching party via the notice provisions herein and the alleged breaching party shall have 30 days to cure such.
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Expenses: |
Each of Licensor and Licensee will bear its own expenses in connection with the preparation, negotiation and delivery of the this Agreement and the Amended Agreement.
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Other: |
Any FDA documentation, including rights to the IND, Vouchers and NDA will be filed in the name of Licensee.
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Wittkowski KM, Sonakya V, Bigio B, Tonn MK, Shic F, Ascano M, Nasca C, Gold-Von Simson G. A novel computational biostatistics approach implies impaired dephosphorylation of growth factor receptors as associated with severity of autism. Transl Psychiatry. 2014;4:e354. PMCID: 3905234. Available from:
http://www.nature.com/articles/tp2013124
.
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Guglielmi L, Servettini I, Caramia M, Catacuzzeno L, Franciolini F, D'Adamo MC, Pessia M. Update on the implication of potassium channels in autism: K(+) channelautism spectrum disorder. Front Cell Neurosci. 2015;9:34. PMCID: 4345917. Available from:
https://doi.org/10.3389/fncel.2015.00034
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