Document:

htgm-ex1030_714.htm

EXHIBIT 10.30

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

Statement of Work No. Two

 

THIS STATEMENT OF WORK NO. TWO (“SOW”) is effective as of June 2, 2017 (the “SOW Effective Date”) by and between HTG Molecular Diagnostics, Inc. (“HTG”) and QIAGEN Manchester Limited (“QIAGEN”). This SOW is made a part of, and shall be governed by, the terms and conditions of the Master Assay Development, Commercialization and Manufacturing Agreement (the “MSA”) executed between the Parties dated as of November 16, 2016. In the event of a conflict between the terms and conditions of this SOW and those of the MSA, this SOW shall govern.

	
1.
	
Sponsor Project Agreement and Supplement Agreement. This SOW covers the performance by each Party of its respective activities in support of the Development of the PDP Assay that is the subject of the Sponsor Project Agreement, identified as the Initiation Agreement, dated June 2, 2017 (“Effective Date of Sponsor Project Agreement”), between QIAGEN and the pharmaceutical company referenced therein (“PHARMA”). Concurrently with the execution of this SOW, PHARMA, QIAGEN and HTG are entering into a Supplement Agreement (the “Supplement Agreement”).

	
2.
	
Definitions. The terms in this SOW with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth in this SOW, or if not defined in this SOW, shall have the meaning set forth in the MSA, or if not defined in this SOW or the MSA, shall have the meaning set forth in the Supplement Agreement, or if not defined in this SOW, the MSA or the Supplement Agreement, shall have the meaning set forth in the Sponsor Project Agreement, in the form delivered by QIAGEN to HTG on August 24, 2017.
	
 

	
3.
	
Term. This SOW shall commence as of the SOW Effective Date and shall expire on the date on which the last of the following occurs: (i) completion of all Development activities specified in this SOW, or (ii) receipt by HTG of payment of all amounts due to HTG (including any profit sharing) under this SOW; unless this SOW is earlier terminated in accordance with its terms or the terms of the MSA.

	
4.
	
Development Work

	
 
	
4.1.
	
Development Objectives. Development activities under this SOW, generally, are directed to the following objectives (collectively, the “Project”), all or part of which may occur in series or in parallel as circumstances may dictate:

	
 
	
4.1.1.
	
Project initiation;

HTG/QIAGEN CONFIDENTIALPage 1 of 6

 

	
 
	
4.1.2.
	
Design of an assay for NGS detection of mRNA expression of a mutually approved number of genes in conformance with applicable FDA regulations for use in [...***...] PHARMA’s clinical studies (the “Clinical Trial Assay” or “CTA”).

	
 
	
4.1.3.
	
Development of the CTA.

	
 
	
4.1.4.
	
Engage and qualify one or more mutually approved [...***...] clinical testing site(s) for performance of PHARMA’s clinical studies involving the retrospective testing of a mutually approved number and type of biological samples with the CTA (“Retrospective Testing”).

	
 
	
4.1.5.
	
Conduct, or cause to be conducted, the Retrospective Testing.

	
 
	
4.2.
	
Development Activities. In furtherance of the foregoing Development objectives, the Parties confirm that they have exchanged details of their respective Development activities for mutual review and approval prior to the full execution of this SOW (“Work Plan”). Each Party shall use commercially reasonable efforts to complete its respective Development activities in the Work Plan in a time- and cost-efficient manner and otherwise in conformance with this SOW and Section 3 of the MSA.

	
 
	
4.3.
	
As provided in the Section 3.7 of the MSA, each Party’s Project Lead shall keep the other Party, and (if applicable) PHARMA, updated and consult with such other Party on a reasonably regular basis with respect to all the Development work being conducted by such Party. Without limiting the generality of the foregoing, the responsible Party shall, to the extent reasonably feasible:

	
 
	
4.3.1.
	
 Invite a reasonable number of representatives of the other Party to attend any formal design reviews (“FDR”) that occur as part of the responsible Party’s Development activities under this SOW.

	
 
	
4.3.2.
	
Make final or near-final “Deliverables” (as provided in Section 5) available to the other Party for review; provided that such other Party’s review shall not delay the corresponding Development milestone or other obligation of the responsible Party related to such Deliverable.

	
 
	
4.3.3.
	
Subject to the responsible Party’s independent professional judgment in accordance with the applicable provisions of this SOW (as provided in Section 3.4 of the MSA), the responsible Party agrees to consider, in good faith, comments or requests timely received from the non‐responsible Party regarding Deliverables or FDR-related topics.

	
 
	
4.4.
	
In the event of a Project Delay or if PHARMA rejects any deliverable based upon quality issues attributed to HTG’s Development work under this SOW, Section 3.9 of the MSA shall apply.

HTG/QIAGEN CONFIDENTIALPage 2 of 6

 

	
 
	
4.5.
	
QIAGEN Materials. Except to the extent HTG expressly has agreed to provide Samples (as defined in the MSA) for all or part of its Development activities, QIAGEN shall timely deliver, or cause PHARMA to timely deliver, to HTG all Samples and other QIAGEN Materials (as defined in the MSA) necessary for HTG to perform its Development activities hereunder. Samples (as defined in the MSA), and all reagents, data and information relating to the Samples or the use of the Samples, delivered to HTG by or on behalf of PHARMA pursuant to this Section 4.5 shall be deemed QIAGEN Materials (as defined in the MSA) for purposes of this SOW.

	
5.
	
Milestones, Deliverables and Related Matters. Development activities for this SOW are directed to achieve certain milestones and, for each milestone, the delivery to PHARMA of one or more Deliverables. The applicable milestones, Deliverables, Party responsible for completion of each Deliverable, target (or, as applicable, due) dates, and expected PHARMA milestone payments are set forth in the Work Plan. Upon completion of each Deliverable for which HTG is responsible, HTG shall deliver such Deliverable to QIAGEN. Upon receipt from HTG or upon completion by QIAGEN, as applicable, QIAGEN shall deliver all Deliverables to PHARMA and promptly notify HTG when such Deliverable has been accepted (or, as applicable, rejected) by PHARMA. QIAGEN shall also invoice, and receive applicable payment(s) from, PHARMA in accordance with the terms and conditions of the Sponsor Project Agreement. QIAGEN shall promptly notify HTG in writing of any payments received from PHARMA pursuant to the Sponsor Project Agreement.

	
6.
	
Compensation Arrangement

	
 
	
6.1.
	
Allowable Project Costs. For purposes of this SOW, allowable Project Costs for the respective Parties shall include direct employee costs, materials and other direct expenses, capital purchases, and subcontractor expenses, as follows:

	
 
	
6.1.1.
	
Direct employee costs shall be tracked on a daily basis by project calculated using the daily Wage Rate (defined below) applicable to each employee performing Development activities under this SOW. The Steering Committee shall, at an appropriate time, determine a mutually acceptable process for daily time tracking.

	
 
	
6.1.1.1.
	
For purposes of this subsection, the “Wage Rate” shall be an average salary for similarly-situated employees performing specified skills-based functions plus a Payroll Burden Rate, and will not be the actual wage paid each specific individual who performs Development work. For purposes of this subsection, the “Payroll Burden Rate” will include the expense for payroll taxes, vacation, accrued bonus, group insurance (representing workers’ compensation insurance, health insurance and life and disability insurance), stock compensation and payroll service fees representative of the employee mix performing the applicable Development activities. 

HTG/QIAGEN CONFIDENTIALPage 3 of 6

 

	
 
	
6.1.1.2.
	
Wage Rates will be recalculated every six months in June and December of each calendar year, and utilized for the immediately following six‐month period. Upon request, each Party shall provide the other Party reasonable documentary support for its Wage Rate calculations.

	
 
	
6.1.2.
	
Material and other direct costs are all directly incurred expenses associated with Development activities. These expenses are expected to include materials used internally or provided by a Party to subcontractors (including a Party’s product inventory and supplies purchased from a third party), direct travel required for the Development activities, and any other mutually approved direct expenses. Amounts invoiced to a Party by any third‐party subcontractor shall not be a direct cost under this subsection.

	
 
	
6.1.3.
	
Capital purchases shall be the acquisition cost of any capital asset that is to be used solely for Development activities. Any such capital purchases by either Party must be approved in writing by the non-purchasing Party prior to purchase. Upon completion of the Development activities in this SOW, any remaining value attributable to the purchased capital asset (as determined in accordance with US GAAP) shall be credited back to the Net Profit share (see below). HTG shall specifically itemize any approved capital purchases in invoices to QIAGEN.

	
 
	
6.1.4.
	
Subcontractor expense shall be the actual cost invoiced to a Party by any permitted third-party subcontractor that performs Development activities. Materials provided to a permitted subcontractor, such as assay kits, for use by such subcontractor to perform Development activities are subject to Section 6.1.2 (and not this subsection) and will be billed at cost.

	
 
	
6.2.
	
Project Costs Acknowledgment or Overage.

	
 
	
6.2.1.
	
The Parties have exchanged their estimated Project Costs for mutual review and approval prior to the full execution of this SOW. Such approved estimated Project Costs shall not be modified unless the Parties confer in good faith to determine the desirability of such modification, and no modification, change or amendment to approved estimated Project Costs will be effective until revised estimated Project Costs are received and approved by both Parties.  

	
 
	
6.2.2.
	
In the event actual Project Costs are expected to exceed the estimated Project Costs by [...***...]% or more, the Party expecting to incur such cost overages shall notify the other Party as soon as possible, and, where possible, prior to incurring the overages and, in HTG’s case, prior to invoicing QIAGEN. The Steering Committee shall meet promptly following receipt by the applicable Party of the overage notice to discuss the circumstances. Where overages are identified, the Parties shall work in good faith to agree to a reasonable reimbursement solution based upon the facts and circumstances that have led to the overage, and agreement should be made in writing within one month of 

HTG/QIAGEN CONFIDENTIALPage 4 of 6

 

the overage being identified. No amounts in excess of [...***...]% of the original estimated Project Costs should be included in Development Net Profit calculations without mutual agreement of the Parties. 

	
 
	
6.3.
	
HTG Development Fee: QIAGEN shall pay HTG for the Development work performed by HTG on a monthly, fee-for-service basis (the “HTG Development Fee”). The HTG Development Fee shall be the amount of allowable HTG Project Costs actually incurred in the applicable period plus [...***...]% of such allowable HTG Project Costs as a management and administration fee (which fee shall, for purposes of Section 6.5 below, be deemed HTG Project Costs).

	
 
	
6.3.1.
	
Invoices for the HTG Development Fee will be submitted by HTG to QIAGEN on a monthly basis containing the applicable purchase order number provided by QIAGEN, and will be due within [...***...] days from the date of receipt of invoice by QIAGEN. Payment of such invoices will occur regardless of whether QIAGEN has collected payments from or invoiced PHARMA. In no event will QIAGEN be obligated to make any pre‐payments to HTG for services or Deliverables.

	
 
	
6.4.
	
QIAGEN Project Costs: QIAGEN shall retain for itself (subject to Net Profit accounting) allowable QIAGEN Project Costs for Development work performed in the period corresponding to each PHARMA payment plus [...***...]% of such allowable QIAGEN Project Costs as a program management and administration fee (which fee shall, for purposes of Section 6.5 below, be deemed QIAGEN Project Costs). 

	
 
	
6.5.
	
Profit Sharing. Except to the extent otherwise provided in this subsection, Net Profit shall be determined as provided in Section 5.2.4 of the MSA. Within [...***...] business days after the end of each calendar quarter, QIAGEN will prepare and deliver to HTG an initial calculation of Net Profit for the then‐ended calendar quarter (“Applicable Period”), including all amounts paid by PHARMA to QIAGEN under the Sponsor Project Period during the Applicable Period. The support for the Net Profit calculation will include documentary evidence of allowable Project Costs for HTG and QIAGEN for the Applicable Period, including, for example, timesheets and copies of invoices received from third parties and subcontractors. No later than [...***...] business days after HTG’s receipt of the initial Net Profit calculation, the Parties shall meet as provided in the MSA and approve the Net Profit amount for the Applicable Period. The Parties shall each receive 50% of the mutually approved Net Profit amount. HTG will issue an invoice to QIAGEN containing the relevant purchase order number provided by QIAGEN for HTG’s Net Profit amount. QIAGEN shall pay HTG’s Net Profit amount within [...***...] days of receiving the applicable invoice. Upon completion of this SOW, being [...***...] days after acceptance of the final deliverable by PHARMA; a true-up calculation of each party’s total costs should be performed in comparison to the total amounts paid by PHARMA to determine the overall Net Profit. A comparison of the amounts paid to HTG for each quarter’s Net Profit will be made and a final invoice issued by either HTG to 

HTG/QIAGEN CONFIDENTIALPage 5 of 6

 

QIAGEN or QIAGEN to HTG, as applicable, to ensure an overall 50% share of the total Net Profit amount. The invoice will be paid by the relevant party within [...***...] days of receipt.

	
7.
	
Subsequent Statements of Work. The terms and conditions of one or more statements of work related to further Development activities or the manufacturing or commercialization of the subject PDP Assay shall be negotiated by the Parties as provided in the MSA. 

	
8.
	
Intellectual Property. Intellectual Property Rights (as defined in the MSA) among HTG, QIAGEN and PHARMA with respect to the Development activities shall be set forth in the Supplement Agreement.

	
9.
	
Confidentiality. Certain rights and obligations among HTG, QIAGEN and PHARMA concerning confidential and proprietary information related to the Development activities shall be set forth in the Supplement Agreement.

	
10.
	
SOW Suspension and Termination. This SOW may be suspended or terminated as specified in the MSA, as it may be amended from time to time; provided that notwithstanding anything in Section 13.3.2 of the MSA to the contrary, in the event of a Change of Control, neither Party shall have the right to terminate this SOW or the MSA to the extent it relates to this SOW.

	
11.
	
Supplement Agreement.  HTG and QIAGEN shall execute this SOW concurrently with the execution of the Supplement Agreement by PHARMA, QIAGEN and HTG, and if this SOW is not so executed concurrently with the Supplement Agreement, this SOW and the Supplement Agreement shall each be null and void and of no force or effect.

IN WITNESS WHEREOF, HTG and QIAGEN each has caused this SOW to be executed by its respective duly authorized representative effective as of the SOW Effective Date.

 

HTG MOLECULAR DIAGNOSTICSQIAGEN MANCHESTER LIMITED

 

 

By:/s/ Timothy B. JohnsonBy:/s/ Douglas Liu

 

Name:Timothy B. JohnsonName:Douglas Liu

 

Title:President, Chief Executive OfficerTitle:SVP Global Operations

 

 

HTG/QIAGEN CONFIDENTIALPage 6 of 6htgm-ex1031_817.htm

EXHIBIT 10.31

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

 

SUPPLEMENT AGREEMENT

THIS SUPPLEMENT AGREEMENT (this “Supplement Agreement”) is effective  June 2, 2017 (the “Effective Date”) and is made and entered into by and between  HTG Molecular Diagnostics, Inc., having a place of business at 3430 E. Global Loop, Tucson, AZ 85706, U.S.A. (“HTG”), QIAGEN Manchester Limited, having a place of business at Skelton House, Lloyd Street North, Manchester, M15 6SH, England (“QIAGEN”), and Bristol-Myers Squibb Company, having a place of business at Route 206 & Province Line Road, Princeton, NJ 08543-4000, U.S.A. (“BMS”). QIAGEN, HTG and BMS are collectively referred to as the “Parties,” and each individually as a “Party.”

WHEREAS, HTG and QIAGEN entered into a Master Assay Development, Commercialization and Manufacturing Agreement dated as of November 16, 2016 (the “Master HTG/QIAGEN Agreement”);

WHEREAS, QIAGEN and BMS entered into an Initiation Agreement having an effective date of June 2, 2017 and amended on July 17, 2017 and August 7, 2017 (collectively, and including any amendments subsequent to the date this Supplement Agreement is last signed by a Party hereto to which HTG consents, the “Initiation Agreement”) so that work could commence on the Project (as that term is defined in the Initiation Agreement) while QIAGEN and BMS [...***...] for the [...***...] of diagnostic products based on Project [...***...] (the “[...***...]”);

WHEREAS, the Initiation Agreement allows QIAGEN to engage HTG to perform certain work for which QIAGEN is responsible under the Initiation Agreement in furtherance of the Project, subject to the approval of BMS; 

WHEREAS, HTG and BMS entered into a Collaboration Agreement having an effective date of May 11, 2016 (the “HTG/BMS Collaboration Agreement”);

WHEREAS, QIAGEN wants to engage HTG to perform certain of the work that is part of the Project and, HTG is willing to perform the work designated to HTG in the Project Plan (as that term is defined in the Initiation Agreement) in the form provided to HTG by QIAGEN on October 10, 2017 (the “Work”), and BMS is willing to allow QIAGEN to engage HTG to perform the Work;

WHEREAS, under the HTG/BMS Collaboration Agreement, HTG and BMS have identified [...***...] of the genes that are expected to be the genes of the Project [...***...] (as that term is defined in the Initiation Agreement) for the Project and have obtained or generated [...***...] probes [...***...];

WHEREAS, QIAGEN and HTG will enter into a statement of work under the Master HTG/QIAGEN Agreement to establish certain rights and obligations of QIAGEN and HTG with 

 

 

regard to performance of the Work (as it may be amended from time-to-time, the “Statement of Work No. 2”);

WHEREAS, BMS agrees that generation and identification of [...***...] probes [...***...] that are referred to above and that are expected to be part of the Project [...***...] is part of the Work to be performed under the Statement of Work No. 2 and will not be conducted under the HTG/BMS Collaboration Agreement; and

WHEREAS, the Parties want to clarify the rights of BMS, QIAGEN and HTG with respect to intellectual property generated by HTG under the Statement of Work No. 2.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises and covenants contained herein, and intending to be legally bound, QIAGEN, HTG and BMS agree as follows: 

1.DEFINITIONS

1.1  Defined Terms. The terms in this Supplement Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth herein, or if not defined herein, as set forth in the Initiation Agreement.

1.2 Certain Definitions.  The following terms shall have the following definitions for the purposes of this Supplement Agreement:

“Control” means, with respect to any Know-How, Patent or other intellectual property right, possession by a Party (including its Affiliates), as of the effective date of the Initiation Agreement or at any time thereafter, of the right (whether by ownership, license or otherwise) to grant to another Party access, ownership, a license, sublicense and/or other right to or under such Know‐How, Patent or other intellectual property right as provided for herein without any conflict with any other obligation or violating the terms of any agreement or other arrangement with any Third Party and without misappropriating the proprietary or trade secret information of a Third Party.

“Confidential Information” means, with respect to a Party, all information, data and materials received by or made available to such Party from or by or on behalf of another Party pursuant to or in connection with the Initiation Agreement, this Supplement Agreement, or the Statement of Work No. 2, including any such information that is communicated by one Party to another Party in oral, written, visual, graphic, electronic or other form, and regardless as to whether any of the foregoing is marked “confidential” or “proprietary”.  The terms of this Agreement are deemed to be the Confidential Information of each Party.

“HTG Technology” means HTG’s proprietary sample processing and molecular profiling platform technology consisting of proprietary instrumentation, consumables (including reagents and probes) and software analytics for analyzing biological samples to identify gene expression and activity using nuclease protection chemistry, including the HTG EdgeSeq technology. For the avoidance of doubt, HTG Technology does not include any Third Party commercially available component of such platform technology, including any such reagent or probe.

“HTG Technology Improvements” means any modification, advancement, improvement or the like of or to HTG Technology that is conceived, generated, discovered or made by employees, 

 

 

agents, consultants and/or contractors of QIAGEN or HTG (solely or jointly) in connection with performance of the Project or other activities carried out by HTG and/or QIAGEN in connection with the Initiation Agreement, the Statement of Work No. 2 or this Supplement Agreement, in each case only to the extent separable from: (i) [...***...], Project [...***...] Results (as the foregoing terms are defined in the Initiation Agreement, and where applicable, as modified by this Supplement Agreement), and (ii) data or information of any kind generated as a result of any use of HTG Technology in the Project. 

“QIAGEN IVD” means an IVD being developed by QIAGEN pursuant to the Initiation Agreement and/or the Statement of Work No. 2 or by HTG pursuant to the Statement of Work No. 2.  For the avoidance of doubt, the PDP Assay referred to in the Statement of Work No. 2 is a QIAGEN IVD.

“Permitted Third Party” means (i) in the case of BMS (a) any Third Party who works for or on behalf of or provides services to, for or on behalf of BMS or any Affiliate of BMS, (b) any Third Party collaborator of BMS or any Affiliate of BMS, and (c) any Third Party developing or commercializing a therapeutic agent or therapeutic product after such agent or product has been acquired or licensed from BMS or any Affiliate of BMS, and (ii) in the case of QIAGEN or HTG, (a) any Third Party who works for or on behalf of or provides services to, for or on behalf of QIAGEN (or any Affiliate of QIAGEN) or HTG (or any Affiliate of HTG), respectively, (b) any Third Party collaborator of QIAGEN (or any Affiliate of QIAGEN) or HTG (or any Affiliate of HTG), respectively, and (c) any Third Party developing or commercializing an IVD after such agent or product has been acquired or licensed from QIAGEN (or any Affiliate of QIAGEN) or HTG (or any Affiliate of HTG), respectively.

 “Resulting Patents” means all Patents Controlled by QIAGEN, HTG and/or BMS having a filing priority on or after the effective date of the Initiation Agreement, to the extent claiming the Results of the Project. 

“Third Party” means any Person other than QIAGEN, HTG or BMS or their respective Affiliates.

1.3Modification of Certain Terms in the Initiation Agreement.  

(a)The terms “[...***...]”, “BMS IP”, “BMS Know-How”, “BMS Materials”, “Correlation Data”, “Gene Expression Data”, “Project [...***...]”, and “Results” in the Initiation Agreement are hereby modified as follows for the purposes of this Supplement Agreement:

(i)  any reference to “QIAGEN and/or BMS” shall be replaced with a reference to “QIAGEN, HTG and/or BMS”;

(ii)  any reference to “QIAGEN” alone in Sections 1.4 through 1.7, 1.13, 1.15, 1.32, and 1.34 shall be replaced with a reference to “QIAGEN and/or HTG”; and

(iii)  any reference to “in connection with this Agreement” shall be replaced with a reference to “in connection with the Initiation Agreement, this Supplement Agreement or the Statement of Work No. 2”.

 

 

(b)Section 1.2 of the Initiation Agreement shall be replaced by the following for the purposes of this Supplement Agreement:

1.2“Analytical Performance Data” means any and all data supporting the non-clinical performance of a QIAGEN IVD, including but not limited to [...***...] and [...***...], that are generated by QIAGEN, HTG and/or BMS (solely or jointly) and/or any of their respective employees, agents, consultants and/or contractors arising from or in connection with the performance of the Project by QIAGEN, HTG and/or BMS (solely or jointly) or other activities carried out by QIAGEN, HTG and/or BMS in connection with the Initiation Agreement, this Supplement Agreement or the Statement of Work No. 2.  All Analytical Performance Data shall be jointly owned by QIAGEN and HTG and shall be Confidential Information of QIAGEN and HTG. [...***...].

(c)Section 1.17 of the Initiation Agreement shall be replaced by the following for the purposes of this Supplement Agreement:

 “GeneReader Platform Algorithm” means an algorithm that is generated solely or jointly by QIAGEN and/or HTG ([...***...]) or solely or jointly by any of their respective  employees, agents, consultants and/or contractors (but not jointly with any employees, agents, consultants and/or contractors of BMS) arising from or in connection with the performance of the Project by QIAGEN and/or HTG or other activities carried out by QIAGEN and/or HTG in connection with the Initiation Agreement, this Supplement Agreement or the Statement of Work No. 2, that is generated for the [...***...] or any [...***...] platform [...***...], and that [...***...] to generate a Project [...***...] or a Project [...***...] Result.  For clarification, the GeneReader Platform Algorithm shall not include any subsystem algorithms that are non-specific to a [...***...] and [...***...].

 (d)Section 1.21 of the Initiation Agreement shall be replaced by the following for the purposes of this Supplement Agreement:

“QIAGEN Classifiers” means those Classifiers that are discovered or generated solely or jointly by QIAGEN and/or HTG ([...***...]) or solely or jointly by any of their respective employees, agents, consultants and/or contractors (but not jointly with any employees, agents, consultants and/or contractors of BMS) arising from or in connection with the performance of the Project by QIAGEN and/or HTG or other activities carried out by QIAGEN and/or HTG in connection with the Initiation Agreement, this Supplement Agreement or the Statement of Work No. 2 and that are discovered or generated using [...***...] and/or [...***...] but not using [...***...] or any [...***...].

(e)Section 8.1 of the Initiation Agreement shall be replaced by the following for the purposes of this Supplement Agreement:

“Nondisclosure and Restriction on Use.  During the Term, and for a period of [...***...] years thereafter, each Party (the "Receiving Party") will maintain all Confidential Information of 

 

 

another Party (the "Providing Party") as confidential and will not disclose any such Confidential Information to any Third Party or use any Confidential Information for any purpose except (a) as expressly authorized by the Initiation Agreement or this Supplement Agreement, or (b) to its Affiliate(s), employees, agents, consultants, sub-contractors and other representatives, who have a need to know such Confidential Information for purposes of the Initiation Agreement or this Supplement Agreement and who are bound by written obligations no less restrictive than those set forth herein to keep such information confidential and restricting the use of such information (collectively, “Permitted Recipients”). The Receiving Party may use such Confidential Information of the other Party only to the extent required to perform the Work (in the case of HTG) or to perform the Project (in the case of QIAGEN and BMS) and to fulfill its obligations or to exercise its rights under the Initiation Agreement or this Supplement Agreement or Statement of Work No. 2.  Each Party will use at least the same standard of care as it uses to protect proprietary or confidential information of its own to ensure that its Permitted Recipients do not disclose or make any unauthorized use of such Confidential Information of another Party.   Notwithstanding the foregoing or anything to the contrary in this Agreement or otherwise, each of QIAGEN and HTG shall not disclose the Project Plan, the Statement of Work No. 2, any Confidential Information of BMS, any of the terms and conditions of the Initiation Agreement or this Supplement Agreement (including any schedule or exhibit to the Initiation Agreement or this Supplement Agreement), any [...***...] or any information, material or intellectual property arising under or related to the Initiation Agreement, this Supplement Agreement or the Statement of Work No. 2, including but not limited to any activities of QIAGEN or HTG under the Initiation Agreement, this Supplement Agreement or the Statement of Work No. 2, to any employee, agent, consultant, sub-contractor or other representative of QIAGEN or HTG or any Affiliates of QIAGEN or HTG involved in the [...***...], without the prior written approval of BMS.  For clarification, the foregoing sentence shall not prohibit QIAGEN or HTG from sharing any of the foregoing, as necessary for the performance of the Work in the case of HTG or for the performance of the Project in the case of QIAGEN and subject to the restrictions on confidentiality and use in the Initiation Agreement and this Supplement Agreement, with employees, consultants, or sub-contractors of QIAGEN or HTG or any Affiliates of QIAGEN or HTG [...***...].  BMS shall not disclose the Project Plan, any Confidential Information of QIAGEN or HTG, any of the terms and conditions of the Initiation Agreement or this Supplement Agreement (including any schedule or exhibit to the Initiation Agreement or this Supplement Agreement), any QIAGEN IP, any QIAGEN Materials, any HTG Technology, any HTG Technology Improvements or any Patents or any information, material or intellectual property arising under or related to the Initiation Agreement or this Supplement Agreement (including any schedule or exhibit to the Initiation Agreement or this Supplement Agreement), with employees, consultants, or sub-contractor or other representative of BMS or any of its Affiliates [...***...], without the prior written approval of QIAGEN and/or HTG, as applicable. For clarification, the foregoing sentence shall not prohibit BMS from sharing any of the foregoing, as necessary for the performance of the Project and subject to the restrictions on confidentiality and use in the Initiation Agreement and this Supplement Agreement, with employees, consultants, or sub-contractors of BMS or any of its Affiliates working on the [...***...].

 

 

(f)    QIAGEN and BMS hereby amend Section 9.9 of the Initiation Agreement to add the following at the end of Section 9.9:

“For the avoidance of doubt, based on the Project [...***...] Results, QIAGEN may disclose to Third Parties the generic intended use of the Project [...***...] that is supported by the Project [...***...] Results (for example, but not limited to, a [...***...]), but shall not disclose the Project [...***...] Results to any Third Party and shall not associate BMS, any Sample, or any Drug or  disclose the identity of BMS or any Drug in connection with the Project [...***...] or any disclosure of any such generic intended use; provided, however, QIAGEN may disclose Project [...***...] Results in regulatory filings submitted to regulatory authorities, including the FDA, as necessary to obtain approval of a [...***...].  However, QIAGEN, as the case may be, shall notify  BMS before the first disclosure to any Third Party of any such generic [...***...], and any materials that disclose such generic [...***...] shall be provided to BMS for review and comment at least [...***...] days prior to such materials being provided to a Third Party for the first time, and QIAGEN shall consider any comments provided by BMS in good faith  In addition, if substantive changes are made to any such materials previously reviewed by BMS, the modified materials shall be provided to BMS for review and comment and be subject to the preceding sentence.”

(g)  Section 9.9 of the Initiation Agreement shall be replaced by the following for the purposes of this Supplement Agreement:

“Ownership of Project [...***...] Results.  [...***...].  For the avoidance of doubt, based on the Project [...***...] Results, [...***...] and HTG may disclose to Third Parties the generic intended use of the Project [...***...] that is supported by the Project [...***...] Results (for example, but not limited to, [...***...]), but shall not disclose the Project [...***...] Results to any Third Party and shall not associate BMS, any Sample, or any Drug or  disclose the identity of BMS or any Drug in connection with the Project [...***...] or any disclosure of any such generic intended use; provided, however, [...***...] and HTG may disclose Project [...***...] Results in regulatory filings submitted to regulatory authorities, including the FDA, as necessary to obtain approval of a [...***...].  However, [...***...] and/or HTG, [...***...], shall notify BMS before the first disclosure to any Third Party of any such generic [...***...], and any materials that disclose such generic [...***...] shall be provided to BMS for review and comment at least [...***...] days prior to such materials being provided to a Third Party for the first time, and [...***...] and/or HTG, [...***...], shall consider any comments provided by BMS in good faith.  In addition, if substantive changes are made to any such materials previously reviewed by BMS, the modified materials shall be provided to BMS for review and comment and be subject to the preceding sentence.”

 

 

(h)The terms “QIAGEN IP”, “QIAGEN Know-How” and “QIAGEN Material” in the Initiation Agreement are hereby modified as follows for the purposes of this Supplement Agreement:

(i)  any reference to “in connection with this Agreement” shall be replaced with a reference to “in connection with the Initiation Agreement, this Supplement Agreement or the Statement of Work No. 2”. 

 

2.REPRESENTATIONS AND WARRANTIES. 

2.1HTG represents and warrants that: (i) it has the corporate power and authority and the legal right to enter into this Supplement Agreement and perform its obligations hereunder; (ii) it has reviewed the Initiation Agreement in full, and (iii) to the extent not otherwise provided for under this Supplement Agreement, it shall provide such technical assistance as is reasonably necessary, for QIAGEN and BMS to exercise their rights and to fulfill their obligations under the Initiation Agreement, the Statement of Work No. 2 and/or this Supplement Agreement. 

 

2.2QIAGEN represents and warrants that (i) it has the corporate power and authority and the legal right to enter into this Supplement Agreement and perform its obligations hereunder, and (ii) to the extent not otherwise provided for under this Supplement Agreement or the Master HTG/QIAGEN Agreement, it shall provide such technical assistance as is reasonably necessary for HTG to exercise its rights and to fulfill its obligations under this Supplement Agreement and the Statement of Work. No. 2.

2.3BMS represents and warrants that it has the corporate power and authority and the legal right to enter into this Supplement Agreement and perform its obligations hereunder.

 

3.ASSIGNMENTS AND LICENSES.

3.1Notwithstanding anything to the contrary in the Statement of Work No. 2 or the Master HTG/QIAGEN Agreement, the Parties acknowledge and agree that (a) all [...***...] and Project [...***...] Results (as those terms are defined in the Initiation Agreement, and where applicable, as modified by this Supplement Agreement) are solely owned by BMS and are Confidential Information of BMS, (b) all GeneReader Platform Algorithms (as that term is defined in the Initiation Agreement as modified by this Supplement Agreement) are solely owned by QIAGEN except to the extent generated for any platform other than the GeneReader Platform, in which case, such algorithm will be  jointly owned by QIAGEN and HTG, (c) all Analytical Performance Data and QIAGEN Classifiers (as those terms are defined in the Initiation Agreement and where applicable, as modified by this Supplement Agreement) shall be jointly owned by QIAGEN and HTG, (d) all HTG Technology Improvements shall be solely owned by HTG, (e) the Project [...***...] shall be jointly owned by the Parties, and, notwithstanding anything in the HTG/BMS Collaboration Agreement to the contrary, HTG shall be subject to the same Project [...***...] disclosure limitations imposed upon QIAGEN in Section 9.7 of the Initiation Agreement, and (f) 

 

 

all other Results (as that term is defined in the Initiation Agreement, as modified by this Supplement Agreement) are jointly owned by QIAGEN, HTG and BMS.  Subject to QIAGEN’s assignment being of the same scope and nature pursuant to the Initiation Agreement, as it may be amended from time-to-time after the Effective Date of this Supplement Agreement, HTG hereby assigns (i) HTG’s entire right, title and interest in and to all [...***...] and Project [...***...] Results (as those terms are defined in the Initiation Agreement, and where applicable, as modified by this Supplement Agreement) to BMS.  BMS and QIAGEN each hereby assigns its entire right, title and interest in and to HTG Technology Improvements to HTG.  Subject to any applicable use or disclosure obligations, and subject to Sections 3.1(a) through (e) of this Supplement Agreement, (i) HTG hereby assigns its entire, right title and interest in any Results (as that term is defined in this Supplement Agreement) that are jointly owned by HTG and QIAGEN pursuant to this Supplement Agreement and that are QIAGEN Property (as that term is defined in the Master HTG/QIAGEN) to QIAGEN; and (ii) QIAGEN hereby assigns its entire, right title and interest in any Results (as that term is defined in this Supplement Agreement) that are jointly owned by HTG and QIAGEN pursuant to this Supplement Agreement and that are HTG Property (as that term is defined in the Master HTG/QIAGEN) to HTG.  For clarity, the assignments made in the preceding sentence shall be subordinate to and shall have no effect upon the ownership provisions in Sections 

3.1(a) through (e) of this Supplement Agreement.  The Results falling within clause (f) above shall be deemed to be Confidential Information of each Party and shall be used and disclosed by the Parties solely for the purposes of, and solely to the extent expressly permitted under the Initiation Agreement and this Supplement Agreement.  Accordingly, QIAGEN, HTG and BMS shall be considered the Receiving Party with respect to such Results and QIAGEN, HTG and BMS shall be subject to all of the restrictions and obligations of this Supplement Agreement with respect to the disclosure and use of such Results to the same extent as applicable to Confidential Information disclosed to such Party by another Party.  HTG shall, and does hereby, assign, and shall cause its Affiliates to so assign, to BMS and/or QIAGEN, as applicable, without additional compensation, such right, title and interest in and to any Results as is necessary to fully effect the ownership of Results as set forth in this Section 3.1 and in Section 3.2, and agrees to execute all instruments as may be reasonably requested to effect same.  QIAGEN and/or BMS, as applicable, shall, and do hereby, assign, and shall cause their Affiliates to so assign, to HTG, [...***...], such right, title and interest in and to any Results as is necessary to fully effect the ownership of Results as set forth in this Section 3.1 and in Section 3.2, and agree to execute all instruments as may be reasonably requested to effect same.  Except as otherwise expressly provided in this Section 3.1 (with applicable reference to the Initiation Agreement), each Party that is a joint owner of a particular right granted in this Section 3.1 (“Joint Right(s)”) may, subject to any dominant intellectual property rights, exercise all right, title and interest in such Joint Right(s) for any purpose without any obligation or accounting to the other Party(ies) jointly owning such Joint Right(s). 

3.2Ownership of Resulting Patents. Inventorship of inventions made in connection with performance of the Project or other activities carried out by HTG, QIAGEN and/or BMS in connection with the Initiation Agreement, the Statement of Work No. 2 or this Supplement Agreement  and Patents covering such inventions (i.e., the Resulting Patents) shall be determined in accordance with U.S. patent laws for determining inventorship. Ownership of Resulting Patents will be based on inventorship as follows: HTG will own Resulting Patents only covering inventions invented solely by employees, agents, consultants and/or contractors of HTG; QIAGEN will own Resulting Patents only covering inventions invented solely by employees, agents, 

 

 

consultants and/or contractors of QIAGEN; BMS will own [...***...]; HTG and QIAGEN will jointly own Resulting Patents covering inventions invented jointly by employees, agents, consultants and/or contractors of HTG and QIAGEN; HTG and [...***...]; QIAGEN and BMS will [...***...], QIAGEN, and BMS (all such jointly owned Resulting Patents are hereinafter collectively called the “Joint Patent Rights”). The applicable Parties jointly owning particular Joint Patent Rights shall confer with and cooperate with one another with respect to the preparation, filing, prosecution, maintenance and enforcement of such Joint Patent Rights. Each Party that is a joint owner of particular Joint Patent Rights may, subject to any dominant intellectual property rights, exercise all right, title and interest in, including practice and license, such Joint Patent Rights for any purpose without any obligation or accounting to the other Party(ies) jointly owning such Joint Patent Rights. For purposes of, and notwithstanding anything to the contrary in, this Section 3.2, no Party, its employees, agents, consultants and/or contractors shall be considered a contractor of another Party. HTG shall have the sole right but not the obligation to prepare, file, prosecute, maintain and enforce any Resulting Patents that are solely owned by HTG at its own expense. QIAGEN shall have the sole right but not the obligation to prepare, file, prosecute, maintain and enforce any Resulting Patents that are solely owned by QIAGEN at its own expense. BMS shall have the sole right but not the obligation to prepare, file, prosecute, maintain and enforce any Resulting Patents that are solely owned by BMS at its own expense.  Notwithstanding anything in this Supplement Agreement to the contrary, (i) HTG hereby assigns all of its right, title and interest in any Resulting Patents to the extent claiming QIAGEN Property (as defined in the Master HTG/QIAGEN Agreement) to QIAGEN, and (ii) QIAGEN hereby assigns all of its right, title and interest in any Resulting Patents to the extent claiming HTG Property (as defined in the Master HTG/QIAGEN Agreement) to HTG.

3.3Licenses to BMS.  HTG hereby grants to BMS a nonexclusive, royalty-free, sublicenseable only to a Designated Contractor (defined below), license to use HTG Technology, HTG Technology Improvements, and Resulting Patents solely owned by HTG only for purposes of completion of HTG’s obligations and activities under the Statement of Work No. 2 in the event of a Project Delay as provided in Section 3.7 (“Project Delay License”).  Any Project Delay License shall expire upon the earlier of (i) HTG fully resuming its obligations and activities under Statement of Work No. 2, or (ii) expiration or earlier termination of Statement of Work No. 2.  HTG also hereby grants to BMS a non-exclusive, irrevocable, worldwide, royalty-free and fully-paid up license to use and practice under the Resulting Patents owned solely by HTG and, to the extent of its right, title and interest, under the Resulting Patents owned jointly by HTG and QIAGEN for any purpose, [...***...].  QIAGEN hereby grants to BMS a [...***...] license, to use and practice under the [...***...] and to the extent of its right, title and interest, under [...***...] for any 

 

 

purpose, [...***...].  The foregoing license from QIAGEN to BMS supersedes the license granted by QIAGEN to BMS in Section 9.13 of the Initiation Agreement.

3.4License to HTG.  BMS hereby grants to HTG a non-exclusive, world-wide, royalty-free license to use [...***...] for carrying out the Work.

3.5No Other License.  Except as expressly provided in this Supplement Agreement or the Statement of Work No. 2, or, with respect to the subject matter thereof, the HTG/BMS Collaboration Agreement or any other agreement between HTG and BMS that is unrelated to the Project, no other right or license is granted, expressly or impliedly, to HTG under any of BMS’s intellectual property rights, or to BMS under any of HTG’s intellectual property rights, and no other right or license is to be inferred from any provision of this Supplement Agreement or by the conduct of the Project by the Parties.

3.6Licenses to HTG from QIAGEN.  QIAGEN hereby grants to HTG (a) all of the same licenses granted to QIAGEN by BMS pursuant to the Initiation Agreement other than the license granted in Section 9.13 of the Initiation Agreement, subject to the same limitations of each respective license that are imposed upon QIAGEN in the Initiation Agreement, and (b) the sublicense QIAGEN is permitted to grant HTG under clause (a) of Section 3.8 of this Supplement Agreement with the limitations set forth in clause (a) of Section 3.8 of this Supplement Agreement with respect to sublicenses granted by HTG.  

3.7If there is a Project Delay (as that term is defined in the Master HTG/QIAGEN Agreement) during the term of the Statement of Work No. 2, HTG and QIAGEN shall use best efforts to resolve such Project Delay pursuant to the terms of the Master HTG/QIAGEN Agreement.  If HTG and QIAGEN are unable to so resolve such Project Delay, then, [...***...], HTG shall as quickly as commercially reasonably possible transfer to a [...***...] contractor, who is not a HTG competitor (as mutually determined by BMS and HTG) and has agreed to appropriate obligations of confidentiality and limited use consistent with the Master HTG/QIAGEN Agreement (“Designated Contractor”), all information (including feasibility, verification and process validation information and data), know-how, materials, and other information relating to the HTG Technology that is necessary for the completion of HTG’s obligations and activities under the Statement of Work No. 2 (“Transferred Materials”).  HTG shall promptly notify BMS in writing of any Project Delay or anticipated Project Delay.  HTG shall make available to the Designated Contractor via face to face meetings, telephone or email, on a mutually convenient timetable, reasonable technical assistance with respect to HTG’s obligations and activities and the use of the Transferred Materials and HTG shall provide reasonable technical assistance to the Designated Contractor to enable the Designated Contractor to fulfill HTG’s obligations and activities under the Statement of Work No. 2 (“Transition Assistance”). The Designated Contractor’s use of the Transferred Materials shall be subject to the confidentiality and limited use terms of the Statement of Work No. 2 or the Master HTG/QIAGEN Agreement.  The technology transfer rights granted to BMS hereunder shall be effective only during the period of time commencing with [...***...] and continuing through and until such time as HTG fully resumes its obligations and activities under the Statement of Work 

 

 

No. 2, following which neither BMS nor the Designated Contractor shall exercise any rights to perform or have performed such obligations or activities on behalf of HTG and shall return or destroy all Transferred Materials without undue delay; provided, however, HTG shall only be entitled to resume its performance of its obligations and activities under the Statement of Work No. 2 upon the expiration or termination of BMS’ agreement with the applicable Designated Contractor unless HTG is willing to pay any early termination payments that may be owed to such Designated Contractor.

3.8License to QIAGEN from BMS.  BMS hereby grants to QIAGEN a [...***...] license, to use and practice under the [...***...] and to the extent of its right, title and interest, under [...***...] for any purpose, with (a) the right to [...***...], with the further right of [...***...], including in connection with the [...***...], and (b)  the right to grant [...***...], including in connection with the [...***...].  The foregoing license from BMS to QIAGEN supersedes the license granted by BMS to QIAGEN in Section 9.13 of the Initiation Agreement.

 

4.CONFIDENTIALITY.  

4.1HTG, QIAGEN and BMS acknowledge and agree that the terms and conditions of Sections 8.1 (as modified above in this Supplement Agreement), 8.2 and 8.3 of the Initiation Agreement shall be binding upon HTG, BMS and QIAGEN with respect to Confidential Information (as defined in this Supplement Agreement) of another Party, to the same extent that such terms and conditions are binding upon a Receiving Party of Confidential Information. 

4.2HTG further acknowledges and agrees that the obligations and restrictions under Section 9.5(b) of the Initiation Agreement with respect to Results, including their disclosure and use, shall be binding upon HTG to the same extent that such obligations and restrictions are binding upon QIAGEN.

4.2HTG shall not disclose any GeneReader Platform Algorithm or any portion of any GeneReader Platform Algorithm or any QIAGEN Classifier [...***...] without the prior written consent of QIAGEN [...***...].  If any GeneReader Platform Algorithm or any portion of any GeneReader Platform Algorithm or any QIAGEN Classifier is disclosed by HTG to [...***...], such GeneReader Platform Algorithm or such portion of such GeneReader Platform Algorithm or such QIAGEN Classifier shall be Confidential Information of HTG and QIAGEN.  However, in the event that HTG discloses any GeneReader Platform Algorithm or any portion of any GeneReader Platform Algorithm or any QIAGEN Classifier to [...***...], such GeneReader Platform Algorithm or such portion of such GeneReader Platform Algorithm or such QIAGEN Classifier shall not be Confidential Information under this Supplement Agreement or the Initiation Agreement and [...***...] 

 

 

Platform Algorithm or such QIAGEN Classifier solely for its and/or any Affiliate’s internal research and development purposes.

 

5.PRECEDENCE.

The rights of BMS under and the terms and conditions of the Initiation Agreement and this Supplement Agreement shall prevail over any conflicting or inconsistent terms or conditions in the Statement of Work No. 2 or the Master HTG/QIAGEN Agreement, and shall govern where there are no corresponding terms or conditions in the Statement of Work No. 2 or the Master HTG/QIAGEN Agreement. For the avoidance of doubt, the carve-out of HTG Technology Improvements as set forth in Section 3.1(d) of this Supplement Agreement shall not be a breach by QIAGEN of the Initiation Agreement.  

 

6.MISCELLANEOUS

6.1Term; Survival.  This Supplement Agreement shall be effective as of the Effective Date and expire or terminate upon expiration or termination of the Initiation Agreement.  The following Articles and Sections of this Supplement Agreement, all definitions relating thereto and any other provisions of this Supplement Agreement that by their nature are intended to survive expiration or termination of this Supplement Agreement shall survive any expiration or termination of this Supplement Agreement for any reason:  Articles 1, 2, 4 and 5 and Sections 3.1 through 3.6, 3.8, 6.2, 6.4 through 6.16, and this Section 6.1.  

6.2Governing Law.  This Supplement Agreement shall be governed and construed in accordance with the internal laws of the State of Delaware, USA, excluding any choice of law rules that may direct the application of the laws.

6.3Force Majeure. The Parties shall be excused from the performance of their obligations under this Agreement (other than the payment of monies owed to another Party) to the extent that such performance is prevented by force majeure and the non-performing Party promptly provides notice of the prevention to each other Party.  Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition.  For purposes of this Supplement Agreement, force majeure shall mean acts of God, strikes or other concerted acts of workers, civil disturbances, fires, earthquakes, acts of terrorism, floods, explosions, riots, war, rebellion, sabotage or failure or default of public utilities or common carriers or similar conditions beyond the control of the parties. 

6.4No Waiver; Modifications.  It is agreed that no waiver by a Party hereto of any breach or default of any of the covenants or agreements herein set forth shall be deemed a waiver as to any subsequent and/or similar breach or default.  No amendment, modification, release or discharge shall be binding upon the parties unless in writing and duly executed by authorized representatives of all parties. 

6.5No Strict Construction.  This Supplement Agreement has been prepared jointly and shall not be strictly construed against any Party.  No presumption as to construction of this Supplement Agreement shall apply against any Party with respect to any ambiguity in the wording of any 

 

 

provision(s) of this Supplement Agreement irrespective of which Party may be deemed to have authored the ambiguous provision(s).

6.6Independent Contractor.  The parties are independent contractors of each other, and the relationship between the parties shall not constitute a partnership, joint venture or agency. No Party shall be the agent of another Party or have any authority to act for, or on behalf of, another Party in any matter.  

6.7Assignment.  No Party may assign or transfer this Supplement Agreement or any rights or obligations hereunder without the prior written consent of each other Party, except that a Party may make such an assignment without each other Party’s consent to (i) an entity that acquires all or majority of the shares or assets of such Party (or the business or assets to which this Agreement pertains) whether by merger, consolidation, reorganization, acquisition, sale, license or otherwise, and (ii) an Affiliate if the assigning Party remains liable and responsible for the performance and observance of all of the Affiliate’s duties and obligations hereunder.  This Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties.  Any assignment or attempted assignment by any Party in violation of the terms of this Section 6.7 shall be null and void and of no legal effect. 

6.8Headings.  The captions to the several Sections and Articles hereof are not a part of this Supplement Agreement, but are included merely for convenience of reference only and shall not affect its meaning or interpretation. 

6.9Counterparts.  This Supplement Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument.  This Supplement Agreement may be executed by facsimile or electronic (e.g., .pdf) signatures and such signatures shall be deemed to bind each Party hereto as if they were original signatures. 

6.10Severability. If any provision of this Supplement Agreement is held to be illegal, invalid or unenforceable under any present or future law, and if the rights or obligations of a Party under this Supplement Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Supplement Agreement shall be construed and enforced as if such illegal, invalid or unenforceable provision had never comprised a part hereof, (c) the remaining provisions of this Supplement Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision or by its severance herefrom and (d) the Parties covenant and agree to renegotiate such illegal, invalid or unenforceable provision in good faith in order to provide a reasonably acceptable alternative to such illegal, invalid or unenforceable provision, it being the intent of the Parties that the basic purposes of this Supplement Agreement are to be effectuated. 

6.11No Benefit to Third Parties.  The representations, warranties and agreements set forth in this Supplement Agreement are for the sole benefit of the parties and their successors and permitted assigns, and they shall not be construed as conferring any rights on any other parties. 

6.12Statement of Work No. 2.  HTG and QIAGEN shall execute the Statement of Work No. 2 concurrently with the execution of this Supplement Agreement by BMS, QIAGEN and HTG, and if the Statement of Work No. 2 is not so executed concurrently with this Supplement Agreement, this Supplement Agreement and the Statement of Work No. 2 shall each be null and 

 

 

void and of no force or effect. HTG and QIAGEN may not amend or modify the Statement of Work No. 2, including any exhibit or attachment thereto or the Work to be performed by HTG under Statement of Work No. 2, without the prior written consent of BMS, which consent shall not be unreasonably withheld or delayed.

6.13Construction.  Except as otherwise explicitly specified to the contrary, (a) references to a Section, Article or Exhibit means a Section or Article of, or Exhibit to, this Supplement Agreement and all subsections thereof, unless another agreement is specified; (b) references to a particular statute or regulation include all rules and regulations promulgated thereunder and any successor statute, rules or regulations then in effect, in each case including the then-current amendments thereto; (c) words in the singular or plural form include the plural and singular form, respectively; (d) the terms “including,” “include(s),” “such as,” and “for example” used in this Supplement Agreement mean including the generality of any description preceding such term and will be deemed to be followed by “without limitation”; and (e) the words “hereof,” “herein,” “hereunder,” “hereby” and derivative or similar words refer to this Supplement Agreement.  No presumption as to construction of this Supplement Agreement shall apply against any Party with respect to any ambiguity in the wording of any provision(s) of this Supplement Agreement irrespective of which Party may be deemed to have authored the ambiguous provision(s).

6.14Further Assurance. Each of QIAGEN, BMS and HTG agree to duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things as a Party may reasonably request in order to perfect any license, assignment or other transfer of any properties or rights expressly granted or permitted under, or pursuant, to this Supplement Agreement.

6.15Entire Agreement.  QIAGEN, HTG and BMS agree that this Supplement Agreement sets forth the complete, final and exclusive agreement between QIAGEN, HTG and BMS collectively concerning the subject matter hereof and supersedes all prior agreements and understandings by and between QIAGEN, HTG and BMS collectively with respect to such subject matter. For the avoidance of doubt, other than as expressly provided herein, this Supplement Agreement does not supersede the Initiation Agreement, the Statement of Work No. 2, the HTG/BMS Collaboration Agreement or the Master HTG/QIAGEN Agreement. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between QIAGEN, HTG and BMS collectively with respect to such subject matter other than as are expressly set forth in this Supplement Agreement. 

 

6.16 Master Development and Commercialization Agreement.  

 

(a) In the event that [...***...] or any other agreement encompassing the development and commercialization of the QIAGEN IVD [...***...], (i) such other agreement shall contain provisions for the [...***...] arising under such agreement that are equivalent to those applying to [...***...] under the 

 

 

Initiation Agreement and this Supplement Agreement and (ii) in the case of  the [...***...], permit (x) one or more projects utilizing the [...***...], (y) [...***...], and (z) [...***...].  

 

(b)In addition, upon the mutual agreement of the parties to this Supplement Agreement and subject to Section 6.16(c), HTG shall either enter into a supplement agreement to the [...***...] or such other agreement encompassing the development and commercialization of the QIAGEN IVD that is the subject of the [...***...] (the “Additional Supplement Agreement”) or be a party to the [...***...] or such other agreement, and the Additional Supplement Agreement or the [...***...] or such other agreement to which HTG is a party shall contain provisions for the ownership, use and confidentiality of, and license grants for, intellectual property arising under such agreement that are equivalent to those applying to Results, including [...***...], Analytical Performance Data, GeneReader Platform Algorithms, Project [...***...], Project [...***...] Results and [...***...] and [...***...] under this Supplement Agreement.  

 

(c)For clarity, no agreement to terms in any of the aforementioned agreements shall be binding unless and until each party to such agreement has reviewed, approved (in its sole discretion), and executed a definitive written agreement, and no party shall have any liability to another other if such definitive agreement is not reached.

6.17Dispute Resolution.  Each Party hereby agrees that it will first attempt in good faith to resolve any dispute arising out of or relating to this Agreement.  If after discussing the matter in good faith and attempting to find a mutually satisfactory resolution to the issue, the Parties involved in such dispute (the “Involved Parties”) are unable to resolve such dispute within [...***...] days of the date an Involved Party brought such dispute to the attention of the other Involved Party(ies), such dispute shall be immediately referred to a [...***...] of BMS if it is an Involved Party, the CEO of QIAGEN if it is an Involved Party and the CEO of HTG if it is an Involved Party (or their respective designees) for resolution within [...***...] days.  If, after such efforts, the Involved Parties are unable to resolve such dispute, the Parties shall be free to seek any remedy available at law or in equity. This Section 6.17 shall not prohibit a Party from seeking injunctive relief from a court of competent jurisdiction in the event of a breach or prospective breach of this Supplement Agreement by any other Party which would cause irreparable harm to the first Party or otherwise justifies that Party seeking a provisional remedy. 

 

6.18Financial Transparency Laws.  HTG acknowledges that BMS is subject to Applicable Laws related to the collection and reporting of any payments or transfers of value to certain healthcare providers and teaching hospitals (collectively, “Financial Transparency Laws”), which include, without limitation, relevant provisions of the Affordable Care Act of 2010 and its 

 

 

implementing regulations for the United States along with similar laws and regulations in other countries.  HTG shall reasonably cooperate with BMS in its compliance with Financial Transparency Laws and promptly provide any information requested BMS in connection with this Supplement Agreement in a mutually agreed upon format that is necessary or reasonably useful for BMS to comply with its obligations under the Financial Transparency Laws.  BMS shall have the right to allocate payments or other transfers of value in connection with this Supplement Agreement in any required reporting under Financial Transparency Laws in accordance with its normal business practices.

 

 

 

[Signature page follows]

 

 

          IN WITNESS WHEREOF, QIAGEN, BMS and HTG, intending to be legally bound hereby, have caused this Supplement Agreement to be executed by their duly authorized representatives effective as of the Effective Date.

		
	
QIAGEN Manchester Limited
	
HTG Molecular Diagnostics, Inc.

	
By: /s/ Douglas Liu
	
By: /s/ Timothy B. Johnson

	
Name: Douglas Liu
	
Name: Timothy B. Johnson

	
Title: SVP Global Operations
	
Title: President and Chief Executive Officer

	
 

Bristol-Myers Squibb Company

By: /s/ Steven Averbuch

	
Name: Steven Averbuch, M.D.

	
Title: Head of Precision Medicine

	
 

 

 

 

AMENDMENT No. 1 TO SUPPLEMENT AGREEMENT

This is the first amendment (“Amendment 1”) dated November 01, 2017 (“Amendment 1 Effective Date”) to the Supplement Agreement dated June 2, 2017 (the “Supplement Agreement”) by and between QIAGEN Manchester Ltd., (“QIAGEN”), HTG Molecular Diagnostics, Inc., (“HTG”) and Bristol-Myers Squibb Company (“BMS”).

Whereas, BMS, QIAGEN and HTG agree to amend the Supplement Agreement as follows:

	
 
	
1.
	
To replace the date in the fifth paragraph on page one of the Supplement Agreement with the date of October 30, 2017. With this amendment, the entire paragraph will read as follows:

WHEREAS, QIAGEN wants to engage HTG to perform certain of the work that is part of the Project
and, HTG is willing to perform the work designated to HTG in the Project Plan (as that term is defined in the Initiation Agreement) in the form provided to HTG by QIAGEN on October 30, 2017 (the “Work”), and BMS is willing to allow QIAGEN to engage HTG to perform the Work;

IN WITNESS WHEREOF, BMS, QIAGEN and HTG have caused this Amendment 1 to be signed by their duly authorized representatives, effective as of the day and year first indicated above.

Bristol-Myers Squibb Company

By: /s/ Steven Averbuch, M.D.Date: November 2, 2017

Name: Steven Averbuch, M.D.

Title: Vice President, Head of Precision Medicine

QIAGEN Manchester Limited

By: /s/ Roland SackersDate: November 1, 2017

Name:  Roland Sackers

 

Title: CFO

HTG Molecular Diagnostics, Inc.

By: /s/ Timothy B. JohnsonDate: November 8, 2017

Name: Timothy B. Johnson

Title: President and Chief Executive Officer

 

 

 

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