LICENSE AND SUPPLY AGREEMENT
Exhibit 10.14
This License and Supply Agreement (the “Agreement”), effective as of January 9, 2009 (the “Effective Date”), is entered into by and between BioHelix Corporation, a Massachusetts corporation with principal offices at 00 Xxxxx Xxxx, Xxxxxxx, Xxxxxxxxxxxxx 00000 (“BioHelix”), and Great Basin Scientific Corporation, a Nevada corporation with principal offices at 000 Xxxxx Xxxx Xxxxxx, Xxxxx 000, Xxxx Xxxx Xxxx, XX 00000, (“Great Basin”).
A. Whereas BioHelix has developed the Product (as defined below) for amplification of analytes;
ARTICLE 1
1.1 “Affiliate” means any entity that directly or indirectly owns, is owned by or is under common ownership with a party hereto, where “owns” or “ownership” means direct or indirect possession and/or control of at least fifty percent (50%) of the outstanding voting securities of a corporation or a comparable equity interest in any other type of entity.
1.2 “Assay Products” includes ASRs, RUOs and IVD Kits manufactured by Great Basin and covered by Biohelix Intellectual Property Rights that are intended for use in the identification, screening, diagnosis, staging, predisposition, prognosis, monitoring, or treatment of the disease in the Field, and comprise any combination of: (i) reagents; (ii) controls and calibrators, (iii) ancillary materials (e.g. buffers, reporter dyes, capture sequence, etc.); and (iv) labeling and instructions for use; all as necessary to perform a Test or Tests for purposes of generating clinical test results.
1.3 “Calendar Year” shall mean each twelve-month (12-month) period during the term of this Agreement that begins on January 1, and ends on December 31.
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1.4 “Consumer Price Index” (“CPI”) means the index of consumer prices, as published by the United States Department of Labor, used to measure the change in the cost of basic goods and services in comparison with a previous base period.
1.5 “End User” shall mean a consumer of Assay Products that obtains Assay Products for the purpose of generating Test results on behalf of itself or third parties and not for the purpose of re-selling the Assay Products. For purposes of clarification, End Users shall not include Great Basin or any of its affiliated entities to the extent such entities do not perform Tests on behalf of third parties. In the event that Great Basin or any of its Affiliates perform Tests on behalf of third parties, Great Basin or such entity shall be considered an End User only with respect to such testing services.
1.6 “Field(s)” means human diagnostic testing using the amplification method disclosed and defined in the BioHelix Intellectual Property Rights, in combination with Great Basin’s solid surface chip based detection methods, for the detection of any two pathogens identified in writing within 6 months of the execution of this agreement by Great Basin to BioHelix, including screening for the presence, identity, subtype and antibiotic resistance profile of the aforementioned pathogens.
1.7 “BioHelix Intellectual Property Rights” means the (i) issued patents and patent applications listed in Exhibit B and future patents related to the Method and the Product or claiming priority to such issued patents and patent applications, and all extensions, supplemental protection certificates, registrations, confirmations, reissues, reexaminations, renewals, divisionals, continuations, or continuations-in-part thereof; (ii) all counterparts to any of the foregoing issued by or filed in any country or other jurisdiction (together with (i), the “Licensed Patents”); and (iii) copyrights, trademarks, trade secrets, and know-how, to the extent each of (i), (ii) and (iii) relate to the Method and the Product, and any improvements, variations and successor versions of the Method and the Product.
1.8 “Method” means Helicase-dependent amplification (“HDA”) as defined in the BioHelix Intellectual Property Rights.
1.9 “Net Sales” means the total amounts invoiced by Great Basin, its subsidiaries and affiliates, for all Tests sold for value in arm’s length transactions to non-Affiliate Subdistributors and End Users less all (i) trade, cash and volume discounts and rebates; (ii) allowances given or made for rejection or return of a previously sold Assay Product or for retroactive price reductions; (iii) customs duties, sales taxes and/or use taxes, value added taxes, excise taxes and/or duties or tariffs and/or other similar taxes imposed upon the sale, transportation or delivery of Assay Products; and (iv) freight, insurance and other direct shipment expenses; (v) royalties paid to any third party pursuant to a third party license agreement (excluding affiliates), if any, for Assay Products or components of Assay Products in any country provided that the royalty payable to BioHelix shall not be reduced under this subsection (v) by more than fifty percent (50%) of the Royalties (as defined in Section 2.2). Net Sales shall not include: (i) reasonable amounts of Assay Products furnished to a third party for which payment is not intended to be received, including, but not limited to, Assay Products distributed in connection with clinical trials or testing (before or after regulatory approval), as promotional, sample or free goods, or as charitable distributions.
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1.10 “Quarter” means a period of three consecutive months of a Calendar Year starting on January 1, April 1, July 1, or October 1.
1.11 “Products” include all products listed in Exhibit A.
1.12 “Specifications” means the Product Specifications set forth in Exhibit A.
1.13 “Territory” means all countries worldwide.
1.14 “Test” means a single use of the Product in the amplification of an analyte within the Field.
ARTICLE 2
2.1b Option Grant. ******
* * * * * *
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ARTICLE 3
3.3 Specifications. BioHelix will provide Great Basin with written Product Specifications for the Product or Products to be supplied. The parties may from time to time amend the Product Specifications by mutual written agreement without the necessity of amending this Agreement. Such amended Specifications shall then be deemed the Specifications applicable under this Agreement.
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(a) Great Basin shall pay BioHelix for Products at the prices set forth in Exhibit A (the “Product Prices”) in effect as of the date of the order. BioHelix shall charge Great Basin the price applicable to Great Basin’s most recent forecasted volumes for the date on which the order was made.
(b) BioHelix may increase the prices no more than once every 12 months and by no more than the rate of inflation for the previous 12 month period as published in the CPI by the U.S. Department of Labor, provided that any annual price increase may not exceed three (3) percent of the prices in the previous 12 month period. BioHelix shall provide to Great Basin three months advance notice of a pending price increase, including the amount of the price increase.
(a) Any and all amounts payable hereunder do not include any government taxes (including without limitation sales, use, excise, and value added taxes) or duties imposed by any governmental agency that are applicable to the export, import, or purchase of the Product (other than taxes on the net income of BioHelix), and Great Basin shall bear all such taxes and duties. Unless BioHelix is otherwise required to remit by law, Great Basin shall be responsible for remittance of all taxes and duties owed to applicable authorities. When BioHelix has the legal obligation to collect and/or pay such taxes, the appropriate amount shall be added to, and separately stated on, Great Basin’s invoice and paid by Great Basin, unless Great Basin provides BioHelix with a valid tax exemption certificate authorized by the appropriate taxing authority.
(b) All payments by Great Basin specified hereunder are expressed as net amounts and shall be made free and clear of, and without reduction for, any withholding taxes. Any such taxes, which are otherwise imposed on payments to BioHelix shall be the sole responsibility of Great Basin. Great Basin shall provide BioHelix with official receipts issued by the appropriate taxing authority or such other evidence as is reasonably requested by BioHelix to establish that such taxes have been paid. If BioHelix uses a foreign tax credit received by BioHelix as a result of the payment of withholding taxes by Great Basin and thereby reduces the amount of U.S. income tax that BioHelix otherwise would have paid, BioHelix shall refund to Great Basin the amount of such reduction with respect to such foreign tax credit.
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foreign currency to US Dollars shall be made at the conversion rate existing in the United States (as reported in the New York Times or the Wall Street Journal) on the last working day of each royalty period.
Approximately six (6) months prior to the anticipated first commercial sale of an Assay Product, Great Basin shall provide in writing to BioHelix a rolling forecast by Quarter of quantities, if any, of Great Basin’s anticipated requirements of Product for each Quarter during the twelve (12) month period commencing on the date of such forecast. Such forecast shall not create a binding obligation on the part of either BioHelix or Great Basin, but shall be used for planning purposes only. Such Quarterly rolling forecasts shall be updated by Great Basin at least thirty (30) days prior to the end of each Quarter, and shall provide Great Basin’s forecasted orders for the subsequent four Quarters.
In the event BioHelix is unable to supply Great Basin with a Product: (i) in accordance with Great Basin’s firm orders issued in accordance with Article 3; (ii) as a result of an uncured material breach by BioHelix of any covenant, representation or warranty contained in this Agreement; (iii) as a result of the bankruptcy or insolvency of BioHelix; or (iv) as a result of an event of force majeure, BioHelix shall notify Great Basin in writing within thirty (30) days of BioHelix’s knowledge of such inability. BioHelix shall have the opportunity to cure such failure to supply within a one (1) month period (the “Cure Period”), whether by improving its manufacturing capabilities, having the Product manufactured on BioHelix’s behalf by another party (which meets with all manufacturing and quality requirements specified in this Agreement), or otherwise. If BioHelix’s failure to supply has not been resolved within the Cure Period, then Great Basin shall have the option to (1) terminate this Agreement immediately on written notice to BioHelix or (2) manufacture, or have manufactured, the Product, immediately on written notice to BioHelix.
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ARTICLE 4
REPRESENTATIONS AND WARRANTIES
ARTICLE 5
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5.4 Wind-down. Upon expiration or termination of this Agreement for any reason, Great Basin shall have the option to issue a final order of Products to BioHelix, not to exceed Great Basin’s most recent 12-month forecast, and BioHelix shall manufacture and supply such Products to Great Basin according to the terms and conditions of this Agreement.
ARTICLE 6
ARTICLE 7
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complaint, suit, proceeding or cause of action (collectively and individually referred to as a “Claim”) brought against Great Basin Indemnities by a third party resulting from a defect in the Product’s design or manufacture by BioHelix (and not resulting from any alteration of the Product by Great Basin), and BioHelix shall pay resulting damages or settlement amounts finally awarded against Great Basin Indemnities (including reasonable attorneys’ fees, legal expenses and court costs) to the extent attributable to such Claim but no more in total than the maximum limit of liability insurance that BioHelix possesses for product liability at that time. Great Basin shall (i) promptly notify BioHelix of each Claim, (ii) provide BioHelix with sole control over the defense and/or settlement thereof, and (iii) at BioHelix’s request and expense, provide full information and reasonable assistance to BioHelix with respect to such Claims.
ARTICLE 8
8.1 Governing Law. THIS AGREEMENT SHALL BE GOVERNED BY, AND CONSTRUED AND INTERPRETED IN ACCORDANCE WITH, THE LAWS OF THE UNITED STATES AND THE STATE OF MASSACHUSETTS WITHOUT REFERENCE TO CONFLICT OF LAWS PRINCIPLES AND EXCLUDING THE 1980 U.N. CONVENTION ON CONTRACTS FOR THE INTERNATIONAL SALE OF GOODS.
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that BioHelix enters into discussions with any party regarding a change of control (i.e, merger, acquisition, or sale of substantially all of the assets relating to the Product), BioHelix shall provide Great Basin with written notification within 30 days of the initiation of such discussions and the successor of BioHelix shall assume all of BioHelix’s rights, duties, covenants and obligations of this Agreement.
If to BioHelix:
BioHelix Corporation
00 Xxxxx Xxxx
Xxxxxxx, Xxxxxxxxxxxxx 00000
Attention: Huimin Kong, CEO
Fax: (000)-000-0000
If to Great Basin:
Great Basin Scientific Inc.
000 Xxxxx Xxxx Xxxxxx
Xxxxx 000
Xxxx Xxxx Xxxx, XX 00000
Attn: Xxxxxxx Xxxxxxxx
FAX: 000 000-0000
8.6 Limitation of Liability.
(a) General. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY OR INCIDENTAL DAMAGES (INCLUDING LOST OR ANTICIPATED REVENUES OR PROFITS RELATING TO THE SAME), ARISING FROM OR RELATING TO THIS AGREEMENT OR THE SUBJECT MATTER HEREOF, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE OR STRICT LIABILITY) OR OTHERWISE, AND EVEN IF SUCH PARTY IS ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME. THE LIMITATIONS IN THIS SECTION 10.6 SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY PROVIDED HEREIN.
(b) Upon Termination. In the event of termination of this Agreement by either party in accordance with any of the provisions hereof, neither party shall be liable to the other, because of such termination, for compensation, reimbursement or damages on account of the loss of prospective profits or anticipated sales or on account of expenditures, inventory, investments, leases or commitments in connection with the business or goodwill of BioHelix or Great Basin. Termination shall not, however, relieve either party of obligations incurred prior to the termination.
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8.7 Headings. Headings included herein are for convenience only, do not form a part of this Agreement and shall not be used in any way to construe or interpret this Agreement.
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confirmation or any other document issued by either party affecting the sale of Product. No agreement or understanding varying or extending this Agreement shall be binding upon either party hereto, unless set forth in a writing which specifically refers to the Agreement signed by duly authorized officers or representatives of the respective parties, and the provisions hereof not specifically amended thereby shall remain in full force and effect.
GREAT BASIN CORPORATION | BIOHELIX CORPORATION | |||||||
By: | /s/ Xxxx Xxxxxx |
By: | /s/ Huimin Kong | |||||
Name: | Xxxx Xxxxxx | Name: | Huimin Kong | |||||
Title: | President and CEO | Title: | CEO and President |
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EXHIBIT A
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EXHIBIT B
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EXHIBIT C
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EXHIBIT D
TERMS AND CONDITIONS OF LICENSE
1. | Definitions |
Capitalized terms in these Terms and Conditions of License (herein called “License”) not defined herein shall have the meaning ascribed to them in the License and Supply Agreement (herein called “Agreement”), which definitions shall be incorporated herein by reference. In addition, the following additional capitalized terms used in this License shall have the following meanings.
“Know-how” means confidential and/or proprietary technical information, techniques, processes, methods, data, assays, substances and materials, and other information in a person’s or entity’s possession that is not generally available to the public.
“Licensee” means Great Basin.
“Licensor” means BioHelix.
2. | Grant |
Effective on the Date of Grant, Licensor hereby grants, subject to the terms and conditions set forth in this License, to Licensee, and Licensee hereby accepts, a perpetual (except as set forth below in this License), non-exclusive, non-transferable (except as set forth below in this License), license under BioHelix Intellectual Property Rights to manufacture, have manufactured, use, import, offer to sell, and sell Products in the specified Field. No right to sublicense pursuant to this License is granted.
3. | Royalties and Payments |
3.1 ******
3.2 ******
3.3 All payments set forth hereunder shall be made by Licensee in US dollars.
4. | Intellectual Property Rights and Obligations |
4.1 Licensor at its sole discretion shall have the right to abandon or cease to prosecute or maintain any issued patent or patent application constituting BioHelix Intellectual Property Rights; provided, however, that Licensor shall give Licensee written notice of such decision and Licensee shall have the right, exercisable within sixty (60) days after receipt of such written notice from Licensor, and exercised by providing written notice to Licensor, to take over the rights to prosecute and maintain any issued patent or patent application constituting BioHelix Intellectual Property Rights, and to assume responsibility for payment of all costs, fees and expenses related thereto.
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4.2 Except as set forth in Section 4.1 of this License, Licensee shall have no responsibility or obligation for any costs, fees and expenses incurred in connection with the prosecution and maintenance of any patents and patent applications under BioHelix Intellectual Property Rights.
5. | Confidentiality |
5.1 The parties shall abide by the Confidentiality provision (Section 6.1) of the Agreement, which shall be incorporated herein by reference.
6. | Assignment |
The rights and obligations of a party under this License with respect to assignments shall be governed by Section 8.4 of the Agreement, which shall be incorporated herein by reference.
7. | Term and Termination |
The term of this License shall commence on the Date of Grant and expire upon the expiration of the last to expire of the Licensed Patents. Licensor may terminate the licenses and rights granted hereunder in the event Licensee at any time fails to pay royalties when due and payable hereunder; provided Licensor has first given Licensee written notice of such failure and a period of at least thirty (30) days thereafter to make such payment and Licensee has not made such payment within said thirty (30) day period. Licensee may terminate this License on sixty (60) days prior written notice to Licensor. In the event of any such termination, all obligations of the parties arising on or before the date of termination shall remain in effect including without limitation any obligations to pay royalties.
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First Amendment to the License and Supply Agreement
This First Amendment to the License and Supply Agreement (this “Amendment”) is entered into on this 25th day of June, 2010, by and between Great Basin Scientific Corporation, a Nevada corporation (“Great Basin”), and BioHelix Corporation, a Massachusetts corporation (“BioHelix”). This Amendment amends that certain License and Supply Agreement dated January 9, 2009, by and between Great Basin and BioHelix (the “Original Agreement”) and shall become effective upon satisfaction of the condition provided in Section 4 below.
1. Section 1.6 (Field(s)) of the Original Agreement is hereby amended by deleting it entirely and replacing it with the following:
1.6 “Field(s)” means human diagnostic testing using the amplification method disclosed and defined in the BioHelix Intellectual Property Rights in combination with Great Basin’s solid surface chip based detection methods for the detection of any pathogen identified in writing by Great Basin and delivered to BioHelix during the term of this Agreement (each a “Target Pathogen”). By way of example, the Field may include screening for the presence, identity, subtype and antibiotic resistance profile of any Target Pathogen identified by Great Basin. The number of Target Pathogen that may be selected by Great Basin during the term of this Agreement shall be subject to the terms and conditions set forth in Sections 2.1 and 2.1b.
2. Section 2.1 (License Grant) of the Original Agreement is hereby amended by deleting it entirely and replacing it with the following:
2.1 License Grant. In consideration of the payment of Royalties as specified in Section 2.2, BioHelix hereby grants to Great Basin, and Great Basin accepts from BioHelix an irrevocable, non-exclusive license under BioHelix Intellectual Property Rights in the Field and in the Territory to practice the Method and to develop, make, have made, use, offer for sale, sell, have sold, export and import the Product as part of Assay Products, during the Term of this Agreement. Unless the Option (as defined in Section 2.1b below) is timely exercised, the number of Target Pathogens subject to this Agreement shall be limited to three (3) Target Pathogens, one of which shall be Staphylococcal species identification and associated drug resistance markers, including the mecA gene.
3. Section 2.1b (Option Grant) of the Original Agreement is hereby amended by deleting it entirely and replacing it with the following:
2.1b Option Grant. ******
4. In consideration of the amendment and extension of the Option provided herein, a non-refundable Option Extension Fee of ****** is due by July 9, 2010 from Great Basin to BioHelix. This Amendment will become effective upon receiving the ****** Option Extension Fee from Great Basin. The ****** Option Extension Fee is creditable to the licensing fee and/or Royalties.
IN WITNESS WHEREOF, the parties hereto have caused their duly authorized representatives to execute this First Amendment to the License and Supply Agreement.
GREAT BASIN CORPORATION | BIOHELIX CORPORATION | |||||||
By: | /s/ Xxxxxx Xxxxxxx | By: | /s/ Huimin Kong | |||||
Name: | Xxxxxx Xxxxxxx | Name: | Huimin Kong | |||||
Title: | Chief Technology Officer | Title: | CEO and President |
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Second Amendment to the License and Supply Agreement
This Second Amendment to the License and Supply Agreement (this “Second Amendment”) is entered into on this 18th day of January, 2011, by and between Great Basin Scientific Corporation, a Nevada corporation (“Great Basin”), and BioHelix Corporation, a Massachusetts corporation (“BioHelix”). This Second Amendment amends that certain License and Supply Agreement dated January 9, 2009, as amended by the First Amendment to the License and Supply Agreement dated June 25, 2010, by and between Great Basin and BioHelix (as amended, the “Agreement”) and shall become effective upon satisfaction of the condition provided in Section 2 below.
1. Section 2.1b (Option Grant) of the Original Agreement is hereby amended by deleting it entirely and replacing it with the following:
2.1b Option Grant. ******
2. ******
GREAT BASIN CORPORATION | BIOHELIX CORPORATION | |||||||
By: | /s/ Xxxxxx Xxxxxxx | By: | /s/ Huimin Kong | |||||
Name: | Xxxxxx Xxxxxxx | Name: | Huimin Kong | |||||
Title: | Chief Technology Officer | Title: | President and CEO |
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