Document:

Exhibit 10.61

 

THIS WARRANT AND ANY SECURITIES ACQUIRED UPON THE EXERCISE OF THIS WARRANT HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR ANY STATE SECURITIES LAWS AND NEITHER THE SECURITIES NOR ANY INTEREST THEREIN MAY BE OFFERED, SOLD, TRANSFERRED, PLEDGED OR OTHERWISE DISPOSED OF EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER SUCH ACT OR SUCH LAWS OR AN EXEMPTION FROM REGISTRATION UNDER SUCH ACT AND SUCH LAWS THAT, IN THE OPINION OF COUNSEL FOR THE HOLDER, WHICH COUNSEL AND OPINION ARE REASONABLY SATISFACTORY TO COUNSEL FOR THIS CORPORATION, IS AVAILABLE.

	  	
Warrant to Purchase

	  	  
	
Date: ____________

	
28,125

	  	  
	  	
Shares of Common Stock,

	  	
as herein described

	  	  
	
No. 315

	  

OurPet’s

Company

___________________________

Common Stock Purchase Warrant

___________________________

Article 1.     General Provisions.

 

Section 1.01           This certifies that, for good and valuable consideration, OurPet’s Company, a corporation organized under the laws of Colorado (the “Company”), grants to  Steven and Evangelia Tsengas (the “Warrantholder”), the right to purchase from the Company 28,125 validly issued, fully paid and nonassessable shares (the “Warrant Shares”) of the Company’s Common Stock, without par value, on or after the date that funds are issued to the Company pursuant to the Regional 166 Loan (the “166 Loan”) approved by the Controlling Board of the State of Ohio (the “Effective Date”) and on or before June 28, 2015 (the “Expiration Date”), at the exercise price of $0.807 (U.S. dollars) per share (the “Exercise Price”), all subject to the terms, conditions and adjustments herein set forth.

 

  

  

  

 

Exhibit 10.61

 

Article 2.     Duration, Vesting and Exercise of Warrants.

 

Section 2.01           Duration; Vesting of Warrants.  The vested portion of this Warrant may be exercised, in whole or in part, at any time on or after the Effective Date and prior to the close of business on the Expiration Date.  Subject to adjustment from time to time as provided in Section 4 below, this Warrant shall vest and become exercisable over a period of thirty-six (36) months beginning on the Effective Date, in which 1/36th of the Warrant Shares granted to the Warrantholder shall vest each calendar month thereafter. At the end of the thirty-sixth (36th) month all of the Warrant Shares granted herein shall be fully vested and exercisable.  In the event that, prior to the Warrant Shares becoming fully vested and exercisable, the Company’s lender terminates the guaranty provided by Warrantholder which secures the Company’s 166 Loan with such lender, then the vesting schedule set forth above shall terminate and no further Warrant Shares shall vest and become exercisable.  In the event that the 166 Loan terminates without funding, then this Warrant shall be cancelled without further action required by the Company.

 

Section 2.02            Exercise of Warrant.

 

(a)           This warrant may be exercised, in whole or in part, by surrendering it, together with a Notice of Exercise, duly executed, accompanied by a certified or official bank check (or such other form of payment as the Company may accept) in payment of the Exercise Price.  Warrants may be surrendered at the Company’s corporate offices indicated in Section 7.10 hereof, or as such corporate office may be relocated from time to time.

 

(b)           Notwithstanding the foregoing, the Warrantholder may, without the payment of cash or other consideration (other than the surrender of the right to purchase certain Warrant Shares implicit in the following formula), exercise this Warrant for “Net Warrant Shares”. The Warrantholder shall provide written notice to the Company specifying the gross number of Warrant Shares as to which this Warrant is then exercised. The number of Net Warrant Shares deliverable upon such exercise will be determined by the following formula: Net Warrant Shares = [WS x (CP - EP)]/CP, where “WS” is the gross number of Warrant Shares as to which this Warrant is to be exercised; “CP” is the average price of the Common Stock  (as currently traded on the NASDAQ over-the-counter bulletin board or “OTCBB”) on the ten (10) trading days preceding the date of the request to exercise this Warrant; and “EP” shall mean the then applicable Exercise Price.

 

(c)           This Warrant shall be exercisable during the period provided in Section 2.01 at any time or in whole or from time to time in part.  As soon as practicable after the Warrant has been so exercised, the Company shall issue and deliver or cause to be delivered to, or upon the order of, the holder of the Warrant, in such name or names as may be directed by such holder, a certificate or certificates for the number of full Warrant Shares to which such holder is entitled and, if this Warrant shall not have been exercised in full, a new Warrant for the number of shares of Common Stock as to which this Warrant shall not have been exercised, subject to the surrender of the right to purchase certain Warrant Shares implicit in the exercise of this Warrant under Section 2.02(b).  This warrant, when so surrendered, shall be cancelled by or on behalf of the Company.

 

  

  

  

 

Exhibit 10.61

 

Section 2.03            Common Stock Issued Upon Exercise of Warrant.

 

(a)           All Warrant Shares shall be duly authorized, validly issued, fully paid and nonassessable.  The Company shall pay all documentary stamp taxes attributable to the initial issuance of Warrant Shares.  The Company shall not be required, however, to pay any tax imposed in connection with any transfer involved in the issue of the Warrant Shares in a name other than that of that holder of this Warrant upon exercise.  In such case, the Company shall not be required to issue any certificate for Warrant Shares until the person or persons requesting the same shall have paid to the Company the amount of any such tax or shall have established to the Company’s satisfaction that the tax has been paid or that no tax is due.

 

(b)           Irrespective of the date of issue of certificates for any Warrant Shares acquired upon exercise of this Warrant, each person in whose name any certificate is issued shall be deemed to have become the holder of record of the Warrant Shares represented thereby on the date on which this Warrant was exercised and payment of the Exercise Price was tendered as provided in Section 2.02 with respect to such Warrant Shares.

 

Article 3.      Restrictions on Transfer; Restrictive Legends.

 

Section 3.01            Restrictions on Transfer. This Warrant may not be offered, sold, transferred, pledged or otherwise disposed of in whole or in part, to any person; provided that the Warrantholder may offer, sell or transfer this Warrant to any Affiliate (defined herein) of the Warrantholder, subject to compliance with any applicable securities laws. “Affiliate” means any person who is an “affiliate” as defined in Rule 12b-2 of the General Rules and Regulations under the Securities and Exchange Act of 1934.

Section 3.02            Restrictive Legends. Except as otherwise permitted by this Article 3, each stock certificate for Warrant Shares issued upon the exercise of any Warrant and each stock certificate issued upon the direct or indirect transfer of any such Warrant Shares shall be stamped or otherwise imprinted with a legend in substantially the following form:

THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY STATE SECURITIES LAWS AND NEITHER THE SECURITIES NOR ANY INTEREST HEREIN MAY BE OFFERED, SOLD, TRANSFERRED, PLEDGED OR OTHERWISE DISPOSED OF EXCEPT PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER SUCH ACT OR SUCH LAWS OR AN EXEMPTION FROM REGISTRATION UNDER SUCH ACT AND SUCH LAWS THAT, IN THE OPINION OF COUNSEL FOR THE HOLDER, WHICH COUNSEL AND OPINION ARE REASONABLY SATISFACTORY TO COUNSEL FOR THIS CORPORATION, IS AVAILABLE.

Section 3.03           Removal of Legend. Notwithstanding the foregoing, the Warrantholder may require the Company to issue a Warrant or a stock certificate for Warrant Shares, in each case without a legend, if either (a) such Warrant or such Warrant Shares, as the case may be, have been registered for resale under the Securities Act, (b) the Warrantholder has delivered to the Company an opinion of legal counsel (from a firm reasonably satisfactory to the Company) which opinion shall be addressed to the Company and be reasonably satisfactory in form and substance to the Company’s counsel, to the effect that such registration is not required with respect to such Warrant or such Warrant Shares, as the case may be, or (c) such Warrant or Warrant Shares are sold in compliance with Rule 144 or Rule 144(k) (or any successor provision then in effect) under the Securities Act, the Company receives customary representations to such effect and the Company receives an opinion of counsel to the Company in customary form that such legend may be removed.

  

  

  

 

Exhibit 10.61

 

Article 4.    Anti-Dilution Provisions.

 

Section 4.01            Stock Dividends, Splits, Combinations.  If at any time after the date of the issuance of this Warrant, the Company (a) declares a dividend or other distribution payable in Common Stock or subdivides its outstanding Common Stock into a larger number or (b) combines its outstanding Common Stock into a smaller number, then (i) the number of Warrant Shares to be delivered upon exercise of this Warrant will, upon the occurrence of an event set forth in clause (a) above, be increased and, upon the occurrence of an event set forth in clause (b) above, be decreased so that such Warrantholder will be entitled to receive the number of Common Stock that such Warrantholder would have owned immediately following such action had this Warrant been exercised immediately prior thereto and (ii) the Exercise Price in effect immediately prior to such dividend, other distribution, subdivision or combination, as the case may be, shall be adjusted proportionately by multiplying such Exercise Price by a fraction, of which the numerator shall be the number of Warrant Shares purchasable upon exercise of this Warrant immediately prior to such adjustment and of which the denominator shall be the number of Warrant Shares purchasable immediately thereafter.

Section 4.02            Distribution of Stock, Other Securities, Evidence of Indebtedness.  In case the Company shall distribute to the holders of Common Stock, shares of its capital stock (other than Common Stock for which adjustment is made under Section 4.01), stock or other securities of the Company or any other Person, evidences of indebtedness issued by the Company or any other Person, assets (excluding cash dividends) or options, warrants or rights to subscribe for or purchase the foregoing, then, and in each such case, immediately following the record date fixed for the determination of the holders of Common Stock entitled to receive such distribution, (a) the Exercise Price then in effect shall be adjusted by multiplying the Exercise Price in effect immediately prior to such record date by a fraction (i) the numerator of which shall be such the average price of one share of Common Stock on the OTCBB on the ten (10) trading days preceding such record date (“Current Market Price”) less the then fair market value (as determined by the Board of Directors or a duly appointed committee thereof) of the portion of the stock, other securities, evidences of indebtedness so distributed or of such options, warrants or rights applicable to one share of Common Stock (but such numerator shall not be less than 0.10) and (ii) the denominator of which shall be the Current Market Price of one share of Common Stock on such record date  and (b) the number of Warrant Shares shall be adjusted to equal (i) the number of Warrant Shares for which this Warrant is exercisable immediately prior to such adjustment multiplied by the Exercise Price then in effect, divided by (ii) the Exercise Price as adjusted pursuant to clause (a) above. Such adjustment shall become effective at the opening of business on the business day following the record date for the determination of stockholders entitled to such distribution.

 

  

  

  

 

Exhibit 10.61

 

Section 4.03           Reorganization, Merger, Sale of Assets.  In case of any capital reorganization or reclassification or other change of outstanding Common Stock (other than a change in par value), any consolidation or merger of the Company with or into another entity (other than a consolidation or merger of the Company in which the Company is the resulting or surviving entity and which does not result in any reclassification or change of outstanding Common Stock) or the sale of all or substantially all of the assets of the Company to an unrelated third party, upon exercise of this Warrant, the Warrantholder shall have the right to receive the kind and amount of shares of stock or other securities or property to which a holder of the number of Common Stock of the Company deliverable upon exercise of this Warrant would have been entitled upon such reorganization, reclassification, consolidation, merger or sale had this Warrant been exercised immediately prior to such event; and, in such case, appropriate adjustment (as determined in good faith by the Board of Directors or a duly appointed committee thereof) shall be made in the application of the provisions of this Article 4 with respect to the rights and interest thereafter of the Warrantholder, to the end that the provisions set forth in this Article 4 (including provisions with respect to changes in and other adjustments of the Exercise Price and number of Warrant Shares) shall thereafter be applicable, as nearly as reasonably may be, in relation to any shares of stock or other property thereafter deliverable upon exercise of this Warrant.

Section 4.04           Carryover.  Notwithstanding any other provision of this Article 4, no adjustment shall be made to the number of Common Stock to be delivered to the Warrantholder (or to the Exercise Price) if such adjustment represents less than 1% of the number of shares to be so delivered, but any lesser adjustment shall be carried forward and shall be made at the time and together with the next subsequent adjustment that together with any adjustments so carried forward shall amount to 1% or more of the number of shares to be so delivered; provided however, that, upon exercise of this warrant pursuant to Article 2, any adjustment called for by Sections 4.01, 4.02 or 4.03 which has not been made as a result of this Section 4.04 shall be made.

Section 4.05           No Adjustment for Dividends.  Except as provided in Sections 4.01, 4.02 and 4.03, no adjustment in respect of any dividends shall be made during the term of this Warrant or upon the exercise of this Warrant. Notwithstanding any other provision hereof, no adjustments shall be made on Warrant Shares issuable on the exercise of this Warrant for any cash dividends paid or payable to holders of record of Common Stock prior to the date as of which the Warrantholder shall be deemed to be the record holder of such Warrant Shares.

Section 4.06           Notice of Adjustment.  Whenever the number of Warrant Shares or the Exercise Price of such Warrant Shares shall be adjusted, as provided in Section 4.01, the Company shall forthwith file, at the principal office of the Company (or at such other place as may be designated by the Company), a statement, certified by the chief financial officer of the Company, showing in detail the facts requiring such adjustment, the computation by which such adjustment was made and the Exercise Price that shall be in effect after such adjustment. The Company shall also cause a copy of such statement to be sent by first class mail postage prepaid, to the Warrantholder, at such Warrantholder’s address as shown in the records of the Company.

 

  

  

  

 

Exhibit 10.61

 

Section 4.07            Form of Warrant.  This Warrant need not be changed because of any adjustment to the Exercise Price or any change in the amount or nature of securities issuable or deliverable pursuant to this Article 4.  The Company may, however, in its discretion, at any time change the form of Warrants to reflect any such change in the amount or nature of securities issuable or deliverable upon exercise, provided such change in form does not otherwise affect the substance thereof.

 

Article 5.     Other Provisions for Protection of Warrantholders.

 

Section 5.01            Reservation of Shares.  The Company shall at all times reserve and keep available such number of shares of its authorized but unissued Common Stock as shall from time to time be sufficient to permit the exercise of all outstanding Warrants.  If at any time the number of authorized but unissued shares of Common Stock shall not be sufficient for such purpose, the Company will take such action as, in the opinion of its counsel, may be necessary to increase its authorized but unissued Common Stock to such number of shares as shall be sufficient for such purpose.

 

Section 5.02            Lost and Misplaced Warrant Certificates.  If any Warrant becomes lost, stolen, mutilated or destroyed, the Company will, on such terms as to indemnify or otherwise as it may in its discretion impose, issue a new Warrant of like denomination, tenor and dates as the Warrant so lost, stolen, mutilated or destroyed.  Any such new Warrant shall constitute an original contractual obligation of the Company, whether or not the allegedly lost, stolen, mutilated or destroyed Warrant shall at any time be enforceable by anyone.

 

Section 5.03           Enforcement of Warrant Rights.  All rights of action are vested in the respective holders of the Warrants.  Any holder of any Warrant may, in his own behalf and for his own benefit, enforce, and may institute and maintain any suit, action or proceeding against the Company suitable to enforce, or otherwise in respect of, his right to exercise his Warrant for the purchase of the number of Warrant Shares issuable or deliverable in exchange therefor.

 

Article 6.      Transfer and Ownership of Warrants.

 

Section 6.01            Negotiability and Ownership.  The Warrants have been, and, if the Warrants are exercised, the Warrant Shares will be, acquired for the account of the holder for investment and not with a view to resale or further distribution thereof.  This Warrant shall be transferable by the holder hereof only in compliance with applicable securities laws.  Any attempted transfer in contravention of this Section shall be null and void.  Any such transferee may be required to execute an investment letter containing representations and warranties as to his or her investment intent, financial sophistication and ability to bear the risk of any investment in the Warrants or the Warrant Shares and to satisfy the Company of the bona fide nature of such representations.

 

Section 6.02            Exchange of Warrants.  At any time after the issuance and prior to expiration, this Warrant may be surrendered at the corporate offices of the Company for exchange and, upon cancellation hereof, one or more new Warrants shall be issued as requested by the holder for the same aggregate number of shares.

 

  

  

  

 

Exhibit 10.61

 

Article 7.     Miscellaneous Provisions.

 

Section 7.01           Closing of Books.  The Company will at no time close its transfer books against the transfer of any warrant or of any shares of Common Stock issued or issuable upon the exercise of any warrant in any manner which interferes with the timely exercise of this Warrant.

 

Section 7.02            Modification and Waiver.  Any provision of this Warrant may be amended and the observance thereof waived only with the written consent of the Company and the Warrantholder.

 

Section 7.03            Ownership of Warrant.  The Company may deem and treat the person in whose name this Warrant is registered as the holder and owner hereof (notwithstanding notations of ownership or writing hereon made by anyone other than the Company) for all purposes and shall not be affected by any notice to the contrary, until presentation of this Warrant for registration of transfer.

 

Section 7.04            Entire Agreement.  This Warrant constitutes the entire agreement between the Company and the Warrantholder with respect to this Warrant.

 

Section 7.05           Binding Effect; Benefit.  This Warrant shall inure to the benefit of and shall be binding upon the Company and the Warrantholder and their respective successors and assigns. Nothing in this Warrant, expressed or implied, is intended to or shall confer on any person other than the Company and the Warrantholder, or their respective successors or assigns, any rights, remedies, obligations or liabilities or by reason of this Warrant.

 

Section 7.06            Severability.  Any term or provision of this Warrant which is invalid or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such invalidity or unenforceability without rendering invalid or unenforceable the terms and provisions of this Warrant or affecting the validity or enforceability of any of the terms or provisions of this Warrant in any other jurisdiction.

 

Section 7.07           No Rights or Liabilities as Stockholder.  Nothing contained in this Warrant shall be determined as conferring upon the Warrantholder any rights as a stockholder of the Company or as imposing any liabilities on the Warrantholder to purchase any securities whether such liabilities are asserted by the Company or by creditors or stockholders of the Company or otherwise.

 

Section 7.08           No Impairment.  The Company will not, by amendment of its articles or through reorganization, consolidation, merger, dissolution, sale of assets or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking of all such action as may be necessary or appropriate in order to protect the rights of the holder of this Warrant against impairment.

 

Section 7.09            Descriptive Headings.  The description headings of the several articles, sections and paragraphs of this Warrant are inserted for convenience only and shall not be deemed a part of this Warrant or to affect the meaning or interpretation of this Warrant.

 

  

  

  

 

Exhibit 10.61

 

Section 7.10            Governing Law.  This Warrant shall be construed and enforced in accordance with, and the rights of the parties shall be governed by, the laws of the State of Ohio, without regard to conflict of laws principles.

 

Section 7.11            Notices.  Any notice given pursuant to this Agreement to be given to the Company shall be sufficiently given if sent by first-class mail, postage prepaid, addressed (until Holder of record is advised in writing of any other address) as follows:

 

OurPet’s Company

1300 East Street

Fairport Harbor, Ohio 44077

IN WITNESS WHEREOF, the Company has caused this Warrant to be signed by its duly authorized officer as of the date set forth on the cover.

 

	  	
OURPET’S COMPANY

	 
	  	  	  	 
	  	
By:

	
  

	 
	  	
Its:

	
  

	 

 

  

  

  

 

Exhibit 10.61

 

ASSIGNMENT

 

To be executed by the registered Warrantholder to effect a transfer of the within Warrant, subject to the restrictions imposed by Section 3.01 of the Warrant.

 

FOR VALUE RECEIVED, the undersigned registered holder hereby sells, assigns and transfers unto

 

	  	
  

	  	
(name)

	  	
  

	 	 
	  	
  

	  	
(address)

the right to purchase the Common Stock evidenced by the within Warrant, and does irrevocably constitute and appoint ________________________ to transfer the said right on the books of the Company, with full power of substitution.

 

Dated:                                         

 

SIGNATURE                                                                                    

 

NOTICE:  The signature to this Assignment must correspond with the name as written upon the face of the within Warrant, in every particular, without alteration or change whatsoever, and must be guaranteed by a bank or trust company, or be a firm having membership on a registered national securities exchange.

 

  

  

  

 

Exhibit 10.61

 

EXERCISE OF WARRANT

 

The undersigned, _____________________________________, pursuant to the provisions of the within Warrant, hereby elects to purchase ______________ shares of Common Stock of OurPet’s Company, covered by the within Warrant, and tenders herewith payment of the Exercise Price in full in the form of certified or bank cashier's check or wire transfer.

Please issue a certificate or certificates for such Common Stock in the following name or names and denominations:

If said number of shares are not all the shares of Common Stock issuable upon exercise of the attached Warrant, a new Warrant is to be issued in the name of the undersigned for the balance remaining of such shares less any faction of a share paid in cash.

	  	
  

	  	
(Signature)

	  	
 

	 	 
	  	
 

	  	
(Address)

	
Dated:                                         

	  

NOTICE:  The signature to this Exercise of Warrant must correspond with the name as written upon the face of the within Warrant, in every particular, without alteration or change whatsoever.

 

[This form shall be modified by the Warrantholder and the Company as appropriate in the event Warrantholder exercises the Warrant, in whole or in part, in accordance with Section 2.02(b) of the Warrant.]Unassociated Document

10.1      Patent Application and Assignment dated December 15, 2010

 

 

Attorney Docket No.

ASSIGNMENT

For good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the undersigned inventor has sold and assigned, and by these presents hereby sells and assigns, unto:

	
Company Name :

	
SafeCode Drug Technologies Corp.

	
Address              :

	
113 Barksdale, Newark 19711, USA

(hereinafter ASSIGNEE) all right; title and interest for the United States, territories and possessions, and for all other countries of the world, in and to his invention relating to:

“Voice Template Protector for administering medicine”

as set forth in his United States Patent Application (check one)

_X_     executed concurrently herewith,

___     executed on

___     Serial No.                                            Filed:

in and to said United States Patent Application including any and all divisions or continuations thereof and in and to any and all Letters Patent of the United States, which may issue on any such application or for said invention, including any and all reissues or extensions thereof, and all applications for industrial property protection, including, without limitation, all applications for patents, utility models, and designs which may hereafter be filed for said invention in any country or countries, together with the right to file such applications and the right to claim for the same the priority rights derived from said United States application under the Patent Laws of the United States, the International Convention for the Protection of Industrial Property, or any other international agreement or the domestic laws of the country in which any such application is filed, as may be applicable; and all forms of industrial property protection, including, without limitation, patents, utility models, inventors’ certificates and designs which may be granted for said invention in any country or countries and all extensions, renewals and reissues thereof, to be held and enjoyed by said ASSIGNEE, its successors, legal representatives and assigns to the full end of the term or terms for which any and all such Letters patent may be granted as fully and entirely as would have been held and enjoyed by the undersigned had this Assignment not been made.

 

  

  

  

THE UNDERSIGNED HEREBY authorizes and requests the Commissioner of Patents and Trademarks of the United States, and any Official of any country or countries foreign to the United States, whose duty it is to issue patents or other evidence or forms of industrial property protection on applications as aforesaid, to issue the same to the said ASSIGNEE, its successors, legal representatives and assigns, in accordance with the terms of this instrument.

THE UNDERSIGNED HEREBY covenants and agrees that he has full right to convey the entire interest herein assigned, and that he has not executed, and will not execute, any agreement in conflict herewith.

THE UNDERSIGNED HEREBY further covenants and agrees that he will communicate to the said ASSIGNEE, its successors, legal representatives and assigns, any facts known to him respecting said invention, and testify in any legal proceeding, sign all lawful papers, execute all divisional, continuing, reissue and foreign applications, make all rightful oaths, and generally do everything possible to aid the said ASSIGNEE, its successors, legal representatives and assigns, to obtain and enforce proper protection for said invention in all countries.

The undersigned hereby grants to the attorneys and agents of the Law Office of McAndrews Held and Malloy the power to insert into this Assignment any further identification, which may be necessary or desirable to comply with the rules of the U.S. Patent and Trademark office, or any regulatory office in any country of the world, for recordation of this Assignment.

 

	
INVENTOR :

	
Uri Tagger

	
CITIZENSHIP :

	
Israeli

	
RESIDENCE :

	
14 Beit Hashoeva St.

Even Yehuda

Israel

	
POST OFFICE ADDRESS :

	
Same as Residence

	
INVENTOR'S SIGNATURE :

	  
	
DATE :

	
December 15, 2010

Note: If signed abroad, prima facie evidence of execution may optionally be obtained by execution of this document before a U.S. Consul or before a local officer authorized to administer oaths whose authority is proved by a certificate from a U.S. Consul.  If signed domestically, do so before a Notary Public.  Otherwise the execution by the inventors should be witnessed by at least two witnesses who sign here:

 

ASSIGNOR:

 

	
Signature:

	
/S/ URI TAGGER

	
Date:

	
DECEMBER 15 2010

	 	Name:  URI TAGGER	 	 
	  	 	  	  
	

SafeCode Drug Technologies Corp.

	 	 
	 	 	 	 
	
Signature :

	
/S/ JOEL KLOPFER

	
Date:

	
DECEMBER 15 2010

	  	
Name:  JOEL KLOPFER

	  	  

 

WITNESSES:

	
Signature:

	
/S/ ITAMAR ZER

	
Date:

	
DECEMBER 15 2010

	 	Name:  ITAMAR ZER	 	 
	  	 	  	  
	
Signature :

	
/S/ DAVID MORAD

	
Date:

	
DECEMBER 15 2010

	  	
Name:  DAVID MORAD

	  	  

 

  

  

  

 

Agreement

It is hereby agreed between SafeCode Drug Technologies Corp. from 113 Barksdale, Newark 19711, USA ("SafeCode Drug Technologies Corp" or "the Company") and between Uri Tagger from 14 Beit Hashoeva St., Even Yehuda, Israel ("hereinafter: "Uri") as follows:

In consideration for assigning all rights in the patent application, SafeCode Drug Technologies Corp. will pay Uri 10% of all sales generated from products related to the patent application titled “Voice Enabled Protector for administering medicine”.

Uri undertakes to sign any document and/or application papers to be filed in respect of the above mentioned patent application and assist the company as it requires in all maters relating to the registration of the patent.

The term 'Sales' shall mean all gross revenues less sales and excise taxes and duties paid by SafeCode Drug Technologies Corp.

 

	
/S/ Joel Klopfer

	 	 	
/S/ Uri Tagger

	 
	
SafeCode Drug Technologies Corp

	 	 	
Uri Tagger

	 

 

  

  

  

 

 VOICE TEMPLATE PROTECTOR FOR ADMINISTERING MEDICINE

FIELD OF INVENTION

[0001] This invention is generally directed to systems for imporving the safety in medication use. Specifically, the invention is directed to the use of matching drug name voice templates as a threshold mechanism for unlocking a medication container.

BACKGROUND OF THE INVENTION

[0002] In 2005 alone, causes of prescription error that involve some aspect of communication (e.g., verbal orders, illegible handwriting abbreviations, look-alike or sound-alike names) comprised 37% of all error causes, considered by some to be the top error cause. In some cases, the problem of sound alike drugs is further compounded when the dosesand packages for these drugs are similar. These errors can occur at any point in the medication use system.  In certain circumstances, such as in ER triage and other pressure situation, the transcription errors may be compounded further and lead in severe cases to fatalities. By 2006, the number of Look-alike/Sound alike (LASA) drug pairs (e.g. Mellaril/Elavil, Paxil/ Taxol, Prilosec/Prozac, and Celebrex/ Celexa) was reported to be over 3000 and the number of transcription errors resulting in fatalities due to LASA was reported to be over 350.

[0003] The LASA problem may be exacerbated when drugs are imported from overseas. Americans traveling outside the United States or purchasing drugs over the internet return with, or receive medications purchased abroad. They may think these medications are identical to US products with brand names that are the same or similar, but often this is not the case. Examples include Dianben (metformin) and Diovan (valsartan) in Spain, Avanza (mirtazapine) and Avandia (rosiglitazone) in Australia, and Trip (nortriptyline) and Triz (cetirizine) in India.

[0004] By 2010, of the more than 5 million wrong-drug errors that occur each year, many were reported to be caused by similar-sounding mixed-up names. These prescription errors of, for example confusing the migraine drug Topamax with the blood pressure drug Toprol-XL, or the antihistamine Zyrtec with the antipsychotic Zyprexa, continue to plague healthcare professionals, causing substantial morbidity and mortality.

 

  

  

  

[0005] There is a need for an additional layer of protection during the medication use system to address these issues.

SUMMARY OF THE INVENTION

[0006] In one embodiment, the invention provides a This invention is generally directed to systems for imporving the safety in medication use. Specifically, the invention is directed to the use of matching drug name voice templates as a threshold mechanism for unlocking a medication container.

 

 

[0007] In another embodiment, the invention provides a system for providing patient-specific drugs, comprising: a drug container, wherein the drug container comprises  a locking means; a patient identifying barcode; a drug name identifier; and a computer interface; and a computer, wherein the drug container is connected to the computer and the locking means opens in response to a signal from the computer.

[0008] In one embodiment, the invention provides a system for providing patient-specific drugs, comprising: a drug container, wherein the drug container comprises  a locking means; a patient identifying barcode; a drug name identifier, wherein the drug name identifier comprises: a computer readable medium containing a stored word template or templates identifying the drug trade name, the compound name or both; and a processing unit capable of sending the stored template or templates to a computer; and a computer interface; and a computer, wherein the drug container is connected to the computer through the computer interface and the locking means opens in response to a signal from the computer following a positive comparison between the stored template or templates and a voice sample identifying the drug provided by a reference person, such as the drug prescriber or the drug administrator.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The invention will be better understood from a reading of the following detailed description taken in conjunction with the drawings in which like reference designators are used to designate like elements, and in which:

[00010] Figure 1 shows a schematic representation of an embodiment of the system; and

[00011] Figure 2 shows the function of the pattern matching block of the isolated-word speech recognition system used to determine the similarity between the input word pattern 700 and the stored patterns of the drug brand name, generic drug name or their combination.

 

  

  

  

DETAILED DESCRIPTION OF THE INVENTION

[00012] This invention relates in one embodiment to systems for imporving the safety in medication use. In another embodiment, the invention relates to the use of matching drug name voice templates as a threshold mechanism for unlocking a medication container.

[00013] In one embodiment, provided herein is a system for providing patient-specific drugs, comprising: a drug container, wherein the drug container comprises  a locking means; a patient identifying barcode; a drug name identifier; and a computer interface; and a computer, wherein the drug container is connected to the computer and the locking means opens in response to a signal from the computer.

[00014] Placement and use of the patient identifying bar-code as described hereinabove, is provided in United States Patent Number 7,347,841 incorporated herein by reference in its entirety.

[00015] Reference is now made to figure 1, showing the system 100, comprising a lockable drug container 200, wherein the drug to be prescribed 300 is located. The drug container 200 is locked with a locking means 400, capable of opening the container upon receiving a signal from a computer 600 located in the vicinity of the container 200.  Drug 300 identifying means such as a patient identifying bar-code 502 in one embodiment, is displayed on container 200 and is capable of being scanned by an appropraiet reader to verify the patient receiving the drug 300 is the correct patient. Drug name identifier 501 is affixed in the container or on the container and is in communication with a processing unit 500 and a computer interface 501. The computer interface may be a hard wire connected via USB cable or any other appropriate communication means between the container 200 and the computer 600. This may be a wireless communication device as well. Upon receiving a signal from the computer 600, the lock 400 on container 200 may open and allow drug 300 to be administered to a patient in need thereof. In one embodiment, drug container 200 is a pill box, a syringe, infusion bag and valve, a vial, an ampule or a combination thereof.

[00016] In another embodiment, provided herein is a system for providing patient-specific drugs, comprising: a drug container 200, wherein the drug container comprises  a locking means 400; a patient identifying barcode 502; a drug name identifier 500, wherein the drug name identifier 500 comprises: a computer readable medium containing a stored word template or templates identifying the drug 300 trade name, the compound name or both; and a processing unit capable of sending the stored template or templates to a computer 600; and a computer interface 501; and a computer 600, wherein the drug container 200, such as a drug dispensing machine is connected to the computer through the computer interface 501 and the locking means 400 opens in response to a signal from the computer 600 following a positive comparison between the stored template or templates and a voice sample identifying the drug provided 700 by a reference person, such as the drug prescriber or the drug administrator.

[00017] In another embodiment, the term "voice templates" refers to a software program and associated data structures for enabling a user easily to build and maintain voice responses associated with a drug brand name, generic drug name or their combination. Such templates may be decomposed "voice elements" by the user into of various types, the characteristics and behavior of which will be determined by their specific type, as designated by the user, and the characteristic of the voice response record with which they are associated and compared to.

[00018] The computer 600 includes in one embodiment typical hardware such as a motherboard, central processing unit, random access memory, a hard disk, network card, power supply and visual display unit. In another embodiment, computer 600 also includes a microphone 700 for receiving voice commands and recording voice templates. In addition to the hardware, the hard disk of each computer 600 is loaded with an operating system and browser software which interact with the systems described herein to allow computer 600 to connect to the Internet and access a centralized depository of stored voice templates of drug brand name, generic drug name or their combination. The computer 600 includes in one embodiment, driver software for an audio recording program, such as voice recognition software for interacting with the microphone to record the voice templates.  As previously discussed, the communication system between the drug identifying means 500 is in the form of a public access packet-switched network, such as the Internet. Computer 600  is able in another embodiment to exchange data (e.g. XML code and packetised voice messages) with the voice template stored on the drug identifying means 500 using a packet-switched network protocol, such as the TCP/IP protocol. In an alternative embodiment (not shown), the communication system may additionally comprise a third generation ("3G") or GPRS enabled mobile telephone network connected to the packet-switched network which can be utilised to access the voice template stored on the drug identifying means 500. In such an embodiment, computer 600 would have wireless capabilities for transmitting the voice input. The wireless computing devices may include, for example, mobile phones, personal computers having wireless cards and any other mobile communication device which facilitates voice recordation functionality. In  another embodiment, the present invention may employ an 802.11 based wireless network or some other personal virtual network.

 

  

  

  

[00019] In one embodiment, provided herein is a system for providing patient-specific drugs, comprising: a drug container 200, wherein the drug container comprises  a locking means 400; a patient identifying barcode 502; a drug name identifier 500, wherein the drug name identifier 500 comprises: a computer readable medium containing a stored word template or templates identifying the drug 300 trade name, the compound name or both; and a processing unit capable of sending the stored template or templates to a computer 600; and a computer interface 501; and a computer 600, wherein the drug container 200 is connected to the computer through the computer interface 501 and the locking means 400 opens in response to a signal from the computer 600 following a positive comparison between the stored template or templates and a voice sample identifying the drug provided 700 by a reference person, wherein using a predetermined algorithm (see e.g. FIG. 2), the computer 600 digitizes the reference voice and compares the pattern of the stored drug name, brand name, compound name or their combination against at least one reference voice encoded to enable the comparison.

[00020] In one embodiment, a voice template may be created by using parameters such as cepstral coefficients in an acoustic vector sequence obtained by performing acoustic analysis on speech signals output from a speaker. In another embodiment, the algorithm used to provide the positive comparison between the digitizes the stored drug name, brand name, compound name or their combination and at least one reference voice encoded to enable the comparison, is dynamic time warping (DTW). DTW refers in one embodiment to the technique used to account for speaker variations and concerns the operation of compressing or stretching the temporal pattern of speech signals to take speaker variations into account.  In certain embodiments, pattern or Template of each word identifying the drug brand name, generic drug name or their combination is stored as a time sequence of features (frames), derived using speech analysis techniques such as source filter model in one embodiment, or Perceptual-linear-predictive technique in another embodiment, or relative spectral PLP technique in yet another embodiment. Recognition is performed in one embodiment by comparing the acoustic pattern of the drug brand name, generic drug name or their combination to be recognized with the stored patterns and choosing the word which it matches best as the recognized word. In another embodiment, an ‘average’ set of patterns is previously stored in the drug identifier 500 and no training is required of a speaker. The function of the pattern matching block of the isolated-word speech recognition system in the figure below is to determine the similarity between the input word pattern and the stored word patterns.

[00021] In one embodiment, the locking means 400 used with the drug container 200, will open upon the determination that there is a match between the stored template of the drug brand name, generic drug name or their combination and the reference voice provided by the drug prescriber, the drug administrator, the patient or any other similarly situated healthcare professional.

[00022] In one embodiment, provided herein is a method for providing a specific drug to a specific patient, comprising the step of obtaining a computer readable from a prescribing healthcare professional, the computer readable media having a word template of a drug brand name, generic drug name or their combination stored thereon, obtaining a drug container 200, wherein the drug container comprises a locking means 400; a patient identifying barcode 502; a drug name identifier 500, wherein the drug name identifier 500 comprises: a computer readable medium containing a stored word template or templates identifying the drug 300 trade name, the compound name or both; and a processing unit capable of sending the stored template or templates to a computer 600; and a computer interface 501; and a computer 600, wherein the drug container 200 is connected to the computer through the computer interface 501 and the locking means 400 opens in response to a signal from the computer 600; comparing the word template stored on the drug identifier against the drug brand name, generic drug name or their combination stored on the computer readable media obtained from the prescribing phycian and  following a positive comparison between the stored template or templates and the readable media templae, opening the lock to the drug container 200 and retreiving the drug 300.

 

  

  

  

[00023] In one embodiment, the templates of the drug brand name, generic drug name or their combination, are derived by first obtaining a large number of sample patterns from a cross-section of healthcare providers in a given facility where the drugs are to be administered; of different sex, age-group and dialect, and then clustering these to form a representative pattern for each of the drug brand name, generic drug name or their combination. A representative pattern can be created by averaging all the patterns in a cluster. A dynamic time-warping algorithm is employed in another embodiment to compute a time-alignment function which takes into account the different time-scales. In another embodiment, a representative pattern is selected from the middle of each cluster. Because of the great variability in speech, it is generally impossible to represent each word cluster with a single pattern. Thus, in one embodiment each cluster is sub-divided into sub-clusters and a number of tokens for each drug brand name, generic drug name or their combination, i.e. up to twelve, is stored in the drug identifying means. In one embodiment, all tokens of each stored drug brand name, generic drug name or their combination are matched against the drug brand name, generic drug name or their combination obtained from the prescribing healthcare provider stored at the time of prescription on the computer readable media.

[00024] In one embodiment, the computer used in the systems and methods provided herein comprises a CPU; a speech recognition means for recognizing an inputted speech, and storage means for storing a plurality of templates of drug brand name, generic drug name or their combination, wherein: said CPU displays a set of templates of drug brand name, generic drug name or their combination that are related to a first inputted speech recognized by said speech recognition means; said speech recognition means recognizes a second inputted speech while the set of templates of drug brand name, generic drug name or their combination are being displayed, by comparing with acoustic analysis of the displayed templates and selecting a template similar to said second inputted speech; and said CPU decodes said recognized result and sends a signal to the locking means 400 to open a drug container 200.

[00025] In one embodiment, the computer readable medium, is a computer readble recording medium having stored thereon an inputted drug name, a generic drug name, or a combination thereof. In another embodiment, the inputted drug brand name, generic drug name or their combination is recorded by a prescribing physician.

[00026] Having described preferred embodiments of the invention with reference to the accompanying examples, it is to be understood that the invention is not limited to the precise embodiments, and that various changes and modifications may be effected therein by those skilled in the art without departing from the scope or spirit of the invention as defined in the appended claims.

 

  

  

  

What is claimed is:

	
1.  

	
A system for providing patient specific drugs, comprising:

	
a.  

	
A drug container, wherein the drug container comprises

	
i.  

	
a locking means;

	
ii.  

	
a patient identifying barcode;

	
iii.  

	
a drug name identifier; and

	
iv.  

	
a computer interface; and

	
b.  

	
a computer, wherein the drug container is connected to the computer and the locking means opens in response to a signal from the computer.

	
2.  

	
The system of claim 1, wherein the drug name identifier comprises:

	
a.  

	
A computer readable medium containing a stored word template identifying the drug brand name, generic drug name or their combination; and

	
b.  

	
A processing unit capable of sending the template to the computer

	
3.  

	
The system of claim 2, wherein using a predetermined algorithm, the computer compares the pattern of the recorded voice against at least one reference voice.

	
4.  

	
The system of claim 3, wherein the reference voice is provided by a person prescribing the drug, the drug administering person or both.

	
5.  

	
The system of claim 4, wherein the algorithm uses dynamic time warping (DTW).

	
6.  

	
The system of any one of claims 1-5, wherein the locking means will open upon the determination that there is a match between the stored word template and the reference voice.

	
7.  

	
The system of any one of claims 1-5, wherein the drug container is a pill box, a syringe, infusion bag and valve, a vial, an ampule or a combination thereof.

 

  

  

  

ABSTRACT OF THE INVENTION

[00027] This invention relates generally to systems for imporving the safety in medication use. Specifically, the invention relates to the use of matching drug name voice templates as a threshold mechanism for unlocking a medication container.

 

  

  

  

Figure 1

Figure 2

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