Document:

Exhibit

	
			
	 
	 
	Exhibit 10.10

	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [**], HAS BEEN OMITTED BECAUSE ARCHERDX, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO ARCHERDX, INC. IF PUBLICLY DISCLOSED.

SUPPLY AND MANUFACTURING AGREEMENT
(the "Agreement")
	
	
	 

As of December 16, 2014 ("Effective Date") between QIAGEN Inc., a California corporation having its principal office at 19300 Germantown Road, Germantown, MD 20874 ("QIAGEN"), and ArcherDX, Inc., a Delaware corporation ("ArcherDX") having its principal office at Flatiron Park West, Building B, 2477 55th Street, Suite 202, Boulder, CO 80301; QIAGEN and ArcherDX also referred to as "Party" and jointly as "Parties".
WHEREAS QIAGEN is skilled and experienced in the development, manufacture and marketing of superior quality enzymes and buffers.
WHEREAS ArcherDX wishes to purchase from QIAGEN certain products as defined herein and QIAGEN is willing to supply and sell the same to ArcherDX on the terms and conditions hereinafter set forth.
NOW, THEREFORE, in consideration of the mutual covenants contained herein, and for other good and valuable consideration, the Parties hereby agree as follows:
		
	1.
	DEFINITIONS

Whenever used in this Agreement with an initial capital letter, the terms defined in this Section 1 shall have the meanings specified.
1.1    "Affiliate" shall mean any corporation, firm, partnership or other entity which directly or indirectly controls or is controlled by or is under common control with a Party to this Agreement. For purposes of this definition, "control" shall mean ownership, directly or through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body of a corporation or other entity.
1.2    "Agreement" shall mean this Supply and Manufacturing Agreement.
1.3    "Calendar Year" shall mean a period from January 1st until December 31st of each year.
1.4    "Forecast" shall have the meaning set forth in Section 2.4.
1.5    "Party" or "Parties" has the meaning set forth in the first paragraph of this Agreement.

	
			
	 
	 
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1.6        "Product" shall mean any Product listed in Annex 1.6. Products are molecular biological reagents that are intended for general laboratory applications and may be used to collect, prepare, or examine specimens from the human body. The Products are not intended for any specific diagnostic purpose. It is the sole responsibility of ArcherDX to determine the appropriate use of the Products in any specific application. It is also the sole responsibility of ArcherDX to comply with any regulatory requirements applicable to regulated diagnostic products that incorporate the Products.
1.7    "Specifications" shall mean the specifications described in Annex 1.7.
1.8    "Term" shall have the meaning set forth in Section 6.1.
1.9    "Third Party" means any entity other than QIAGEN, ArcherDX and their respective Affiliates.
1.10    "Price" shall mean the applicable price of the Product set forth in Annex 1.6 to this Agreement.
1.11    "GMP" shall mean current good manufacturing practice and standards as provided for (and as amended from time to time) in the Current Good Manufacturing Practice Regulations of the U.S. Code of Federal Regulations Title 21 (21 CFR §§ 820) and the most recent approved U.S., European, or other applicable laws, regulations or respective guidance documents subsequently established by a governmental or regulatory authority, and any arrangements, additions or clarifications agreed from time to time between the Parties.
1.12    "Escrow" shall mean the secure storage of QIAGEN SOPs, formulations, know-how, processes, batch records and other documents and materials required to manufacture the Products.
1.13    "Specified Agreements" shall mean the supply agreements by and between Enzymatics and Ignyta, and by and between Enzymatics and Loxo Oncology,
		
	2.
	TERMS OF SUPPLY

2.1    Supply. QIAGEN commits itself to supply and ArcherDX commits itself to buy the Products based on the terms of this Agreement.
2.2    Limited Use. The Products shall be solely used as components in ArcherDX kits for resale to end-users and ArcherDX shall not re-sell as stand-alone items or components for OEM partners.
2.3    Customs and Export Control Regulations. ArcherDX shall comply with all applicable customs and export control regulations In particular, without limitation, ArcherDX shall refrain from any transactions in relation to the goods delivered by QIAGEN which would violate 

	
			
	 
	 
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any sanctions, embargoes or foreign trade restrictions issued by European Community or the Unites States of America or any applicable national export law (A breach of this obligation by ArcherDX shall be considered a material breach of this Agreement.
2.4    Forecast. ArcherDX shall provide QIAGEN within 30 days from execution of this Agreement with a 12-months monthly rolling written forecast (the "Forecast"), setting out ArcherDX's quarterly requirements of the Product. The Forecast for the immediately following quarter shall constitute a binding purchase obligation.
2.5    Orders. ArcherDX will order the Product by providing QIAGEN with written purchase orders which shall contain the purchase order number, the Product Specifications, name and quantity (which shall not deviate from the forecasted quantities) and total purchase price of the Product in US dollars. Product specifications can be included in the purchase order or attached as separate documents. ArcherDX shall solely be responsible for the planning and maintenance of its inventory. ArcherDX will not place more than one order per month unless agreed to in writing by QIAGEN for every purchase order in excess of the permitted order. Contact for order placement is _________________________.
2.6    Supply Obligation. QIAGEN shall use commercially reasonable efforts to manufacture and deliver those quantities of the Product duly forecasted by ArcherDX and to fill ArcherDX's orders in excess thereof.  
2.7    Delivery. QIAGEN shall deliver Product which is duly forecasted and ordered by ArcherDX within thirty (30) working days of receipt of the complete purchase order from ArcherDX. QIAGEN shall use commercially reasonable efforts to deliver Product which is not duly forecasted and ordered by ArcherDX within sixty (60) working days of receipt of the complete purchase order from ArcherDX. Delivery will be made EXW QIAGEN's facility in Beverly, Massachusetts (Incoterms 2010).
2.8    Shortages. In the event that any shipment of Product is short in quantity with respect to the order, ArcherDX shall notify QIAGEN in writing within a period of thirty (30) days from shipment. QIAGEN shall make commercially reasonable efforts to make up the shortage within 90 days.
2.9    Terms and Conditions. The supply of the Product hereunder shall be exclusively subject to the terms and conditions of this Agreement. Any other terms and conditions referred to by either Party shall have no effect and are hereby expressly excluded.
2.10    Transport Packaging. All Product delivered pursuant to this Agreement shall be packed for shipment in QIAGEN's standard containers.
2.11    Certificate of Analysis. QIAGEN shall send an electronic copy of a Certificate of Analysis with each lot of Product delivered. No special testing shall be required for the Product. An example of the Certificate of Analysis is enclosed in Annex 2.11.

	
			
	 
	 
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2.12    Entry Inspection. In the event that the delivered Product fails to comply with the Specifications at the time of its receipt by ArcherDX or in the event that any delivered quantity of Product falls short of the ordered quantity, ArcherDX shall notify QIAGEN in writing within a period of 14 (fourteen) days from receipt of the respective delivery of Products. QIAGEN shall without undue delay replace nonconforming Products or make up the shortage as the case may be, at the expense of QIAGEN, or, at QIAGEN's option, refund the price of such Products or give ArcherDX a credit equal to the price of such Products provided that ArcherDX has already paid for such Product. If so directed by QIAGEN, ArcherDX shall at QIAGEN's expense return nonconforming Products to QIAGEN's manufacturing facilities, using such carrier and such delivery dates and terms as QIAGEN may reasonably specify. In the event of a dispute between the parties regarding conformance to the Specifications, ArcherDX shall submit the Product to an independent third party laboratory (the "Laboratory") to be mutually agreed upon by the Parties for testing. The Laboratory shall render its determination as arbitral expert and the determination of the Laboratory shall be final and binding on the Parties. The Party against which the Laboratory rules shall bear the costs of the Laboratory
2.13    Technology Transfer for Specified Agreements. In the event that QIAGEN is unable to supply the Product in accordance with any purchase order, or otherwise in accordance with the terms of this Agreement, within sixty (60) days after the firm delivery date for such purchase order, or a technology transfer provision of a Specified Agreement is invoked, then upon ArcherDX's written request QIAGEN shall (i) grant to ArcherDX, and hereby grants to ArcherDX, a worldwide, royalty-free (except royalty-bearing licenses from third parties in effect and disclosed to ArcherDX in advance of such license grant) non-exclusive right and license, with the right to grant sublicenses solely for the purpose of complying with technology transfer obligations under the Specified Agreements, under all relevant, QIAGEN intellectual property to make, have made, use, import and export Products; and (ii) provide, or release from Escrow, to ArcherDX or its designee (which may include another manufacturer or a party to a Specified Agreement) with all assistance and materials, including but not limited to SOPs, formulations, know-how, processes, batch records and other documents and materials as ArcherDX may reasonably request, to enable ArcherDX or a Third Party to manufacture the Products provided that QIAGEN shall not be obliged to expense more than 160 hours of working time for such assistance. Each of ArcherDX and any third party that ArcherDX designates to manufacture the Products must also agree in writing with QIAGEN to observe the terms of this Agreement relating to confidentiality of Products and QIAGEN's proprietary rights and information transferred pursuant to this Section 2.13, in particular, the identification and protection of QIAGEN trade secrets. ArcherDX or its designee may continue to exercise the licensed rights provided in this Section 2.13 only until the technology transfer obligations under a Specified Agreement are terminated and/or QIAGEN notifies ArcherDX that it is again able to supply ArcherDX's Products requirements and has successfully delivered Products from two consecutive purchase orders after such notification in full conformity with this Agreement, whichever condition is applicable. If a technology transfer provision is invoked in a Specified Agreement, and at the request of the Third Party which invoked the technology transfer provision, QIAGEN shall use commercially reasonable efforts to enter into an agreement to supply Product, 

	
			
	 
	 
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on essentially equal terms as, to the other party in the Specified Agreement, as in this Agreement. If a technology transfer provision is invoked in a Specified Agreement, and QIAGEN has not failed to supply the Product in accordance with any purchase order, or otherwise in accordance with the terms of this Agreement, within sixty (60) days after the firm delivery date for such purchase order, then ArcherDX will fully reimburse and compensate QIAGEN for all related costs related to the technology transfer.
2.14    Technology Transfer. In the event that QIAGEN is unable to supply the Product in accordance with any purchase order, or otherwise in accordance with the terms of this Agreement, within sixty (60) days after the firm delivery date for such purchase order, then upon ArcherDX's written request QIAGEN shall (i) grant to ArcherDX, and hereby grants to ArcherDX, a worldwide, royalty-free (except royalty-bearing licenses from third parties in effect and disclosed to ArcherDX in advance of such license grant) non-exclusive right and license, with the right to grant sublicenses solely for the purpose of complying with technology transfer obligations under the Third Party agreements, under all relevant, QIAGEN intellectual property to make, have made, use, import and export Products; and (ii) provide, or release from Escrow, to ArcherDX or its designee (which may include another manufacturer or a Third Party to a ArcherDX agreement) with all assistance and materials, including but not limited to SOPs, formulations, know-how, processes, batch records and other documents and materials as ArcherDX may reasonably request, to enable ArcherDX or a Third Party to manufacture the Products, provided that QIAGEN shall not be obliged to expense more than 160 hours of working time for such assistance. Notwithstanding the foregoing, ArcherDX shall use commercially reasonable efforts not to accept technology transfer obligations in future Third Party Agreements. Each of ArcherDX and any Third Party that ArcherDX designates to manufacture the Products must also agree in writing with QIAGEN to observe the terms of this Agreement relating to confidentiality of Products and QIAGEN's proprietary rights and information transferred pursuant to this Section 2.14, in particular, the identification and protection of QIAGEN trade secrets. ArcherDX or its designee may continue to exercise the licensed rights provided in this Section 2.14 only until QIAGEN notifies ArcherDX that it is again able to supply ArcherDX's Products requirements and has successfully delivered Products from two consecutive purchase orders after such notification in full conformity with this Agreement. If a technology transfer provision is invoked in an agreement by ArcherDX, and at the request of the Third Party which invoked the technology transfer provision, QIAGEN shall use commercially reasonable efforts to enter into an agreement to supply Product, on essentially equal terms as, to the other party in the Third Party agreement, as in this Agreement.
2.15    Technology Transfer due to Termination In the event that QIAGEN terminates prematurely the Agreement for any reason except for conduct by ArcherDX described in Section 6.2, QIAGEN shall (i) irrevocably grant to ArcherDX, and hereby grants to ArcherDX, a worldwide, royalty-free (except royalty-bearing licenses from third parties in effect and disclosed to ArcherDX in advance of such license grant) right and license, with the right to grant sublicenses, under all of QIAGEN intellectual property to make, have made, use, import and export Products; and (ii) provide, or release from Escrow, to ArcherDX or its designee (which may include another manufacturer) with all assistance and materials, including but not limited to SOPs, formulations, know-how, 

	
			
	 
	 
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processes, batch records and other documents and materials as ArcherDX may reasonably request, to enable ArcherDX or a third party to manufacture the Products, at no cost to ArcherDX or such third party provided that QIAGEN shall not be obliged to expense more than 160 hours of working time for such assistance. In the event of a termination of the Agreement by QIAGEN after the initial term of the Agreement, QIAGEN shall provide a license pursuant to (i) above and documentation transfer pursuant (ii) above against reimbursement of the related cost.
		
	3.
	QUALITY

3.1    Changes to the Specifications and Processes. QIAGEN shall provide ArcherDX with at least sixty (60) days' written notice of any material change to the manufacturing equipment or manufacturing process of the Products, or any material improvement in the Products.
3.2    Certifications. QIAGEN carries valid ISO9001 and ISO13485 certificates and QIAGEN maintains a quality management system aligned to the goals of both certifications, the scope of which is the manufacture of molecular diagnostic products according to customer specification. QIAGEN provides upon request of ArcherDX copies of ISO9001 and ISO13485 certificates as well as each update thereof. QIAGEN can provide their Quality Manual upon request.
3.3    Changes. QIAGEN reserves the right to make improvements to the manufacturing process of the Products. QIAGEN will notify ArcherDX in writing in advance of any performance-relevant improvements.
3.4    Right of Inspection. Upon reasonable prior notice, and at mutually agreed upon times, with thirty (30) days advance notice, and except 'for cause' audits, QIAGEN shall, from time to time during the term of this Agreement, allow representatives of ArcherDX to tour and inspect all facilities for manufacturing of the Products, instrumentation, complaint handling, distribution, storage, shipment or other handling of Products by QIAGEN and all agents and subcontractors retained by QIAGEN for the purposes of this Agreement. As a condition of provision of access to facilities, quality documentation, all information obtained by ArcherDX as a result of such access shall be Confidential Information under this Agreement, regardless of whether or not such information is reduced to writing, unless such information falls into any of the categories set forth in (a) through (d) of the definition of "Confidential Information."
		
	4.
	PRICE AND PAYMENT

4.1    Price. The Products sold to ArcherDX under this Agreement are specified in Annex 1.6 attached hereto. QIAGEN will in each calendar year grant a constant discount on all purchases of ArcherDX of the Product.
4.2    Additional Charges. All Prices are exclusive of VAT and other taxes imposed by any government authority, all of which costs and taxes shall be borne by ArcherDX. In the event QIAGEN is required to prepay any such tax or fee, ArcherDX will reimburse QIAGEN promptly upon receipt by ArcherDX of documentation reasonably acceptable to ArcherDX supporting 

	
			
	 
	 
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QIAGEN's prepayment. When applicable, any such charges shall be stated as separate line items on QIAGEN' invoice(s).
4.3    Price Adjustments. The Price set forth in Annex 1.6 shall be firm until the end of the calendar year 2015. Thereafter, the Price will be adjusted once annually proportionally to the change of QIAGEN's list price for the Product (in relation to the list price of the respective previous year, but such increases shall not [**], as required by increase in costs to QIAGEN for supplying Product. [**]
4.4    Invoicing and Payment. Payment for each invoice shall be made by ArcherDX in US dollars within thirty (30) days from the date of such invoice or delivery of the respective order, whichever is later. Any invoices which remain unpaid more than thirty (30) days beyond the scheduled payment due date may be subjected to an interest charge at a rate of one point two-five (1.25) % per month, calculated from the scheduled payment due date forward.
		
	5.
	CONFIDENTIALITY

5.1    Confidentiality Obligation. During the term of this Agreement and for five (5) years thereafter, each Party (each a "Receiving Party") shall keep all confidential information received from the other Party ("Disclosing Party") strictly confidential. Confidential information means any information explicitly marked "confidential" and/or any information that must reasonably be considered to be confidential information of the Disclosing Party by the Receiving Party ("Confidential Information"). Each Party agrees not to disclose any such information to any Third Party, except to their respective Affiliates and as permitted hereunder, without first obtaining the Disclosing Party's written consent. Each Party further agrees to ensure that any such information shall not be used by its Affiliates, directors, officers, employees or agents, except on same terms of confidentiality as stated herein.
5.2    Exceptions. The above obligation of confidentiality shall not apply to that part of such information which the Receiving Party is able to demonstrate
5.2.1    was fully in its possession prior to receipt from the Disclosing Party or has been independently developed as shown by respective documents; or
5.2.2    was in the public domain at the time of receipt from the Disclosing Party; or
5.2.3    became part of the public domain through no fault of the Receiving Party; or
5.2.4    was lawfully received from a Third Party having a right of further disclosure; or

	
			
	 
	 
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5.2.5    is required to be disclosed by law, provided that the Party who is required to make the disclosure shall consult and cooperate with the Disclosing Party as soon as reasonably possible to prevent or limit such disclosure to the maximum extent permitted by law.
5.3    Publicity. Neither Party may publicly disclose the terms of this Agreement without the prior written consent of the other Party; provided, however, that either Party may make such a disclosure to the extent required by law or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which such Party has its securities listed or traded, or to prospective purchasers of stock or assets of such Party, or to such Party's financial or legal advisors, who, in any case, have entered into confidentiality obligations comparable in scope to the obligations set forth in this Agreement. In the event that such disclosure is made as aforesaid, the disclosing Party shall provide the other Party with notice beforehand and to coordinate with the other Party to the maximum extent possible with respect to the wording and timing of any such disclosure.
5.4    Public Announcement. Except as may otherwise be expressly set forth herein, neither Party shall make or issue any press release, statement or other public announcement regarding the contents, existence or formation of this Agreement and shall not otherwise use the name, trademark(s), service mark(s) or logo(s) of the other Party in any advertisements or commercial promotions, without the prior written consent of the other Party.
		
	6.
	TERM; TERMINATION

6.1    Term. The initial term of this Agreement shall be for the term of ten (10) years (the "Initial Term") commencing on the Effective date. At the expiration of the Initial Term, this Agreement will automatically renew for successive one (1) year periods (each a "Renewal Term" and collectively with the Initial Term the "Term") unless a party provides the other parties with notice of its intent not to renew this Agreement at least ninety (90) days prior to the expiration of the then current term.
6.2    Termination.
6.2.1    Termination for Breach. In the event that either Party defaults or breaches any material term of this Agreement on its part to be performed or observed, the other Party shall have the right to terminate this Agreement by giving thirty (30) days' written notice to the defaulting Party; provided, however, that in the case of a default or breach capable of being cured, if the said defaulting Party shall cure the said default or breach within ninety (90) days after the said notice shall have been given, then the said notice shall not be effective.
6.2.2    Termination for IP infringements. In the event that the supply of QIAGEN the Product hereunder should directly or indirectly result in the infringement of Third Party intellectual property rights, the affected Party shall be entitled to terminate the supply of the relevant Product on thirty (30) business days' notice unless the other Party remedies the infringement to the 

	
			
	 
	 
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reasonable satisfaction of the terminating party (by canceling the relevant customer contract, licensing the Third Party intellectual property rights or otherwise) within such period.
6.2.3    Termination for Bankruptcy. In the event that either Party files for protection under bankruptcy laws, makes an assignment for the benefit of creditors, appoints or suffers appointment of a receiver or trustee over its property, files a petition under any bankruptcy or insolvency act or has any such petition filed against it which is not discharged within sixty (60) days of the filing thereof, then the other Party may terminate this Agreement effective immediately upon written notice to such Party.
6.3    Effect of Termination. Upon expiration or termination of this Agreement for any reason (a) each Party shall, except as otherwise provided in this Agreement, return or destroy all Confidential Information of the other Party; provided, that each Party may retain one copy for archival purposes only; (b) ArcherDX shall return to QIAGEN all documentation of every kind related to the Product and cease all use of such documentation; (c) except for a termination for failure of ArcherDX to pay amounts due under this Agreement, ArcherDX's orders for the Product received by QIAGEN prior to the effective date of termination shall be fulfilled in accordance with the terms and conditions of this Agreement; and (d) ArcherDX shall pay all amounts due to QIAGEN in accordance with this Agreement for all conforming Product delivered through the date of such termination, including any Price reconciliation payments required pursuant to Section 5.
6.4    Surviving Provisions. Termination of this Agreement for any reason shall be without prejudice to rights which expressly survive termination in accordance with the terms of this Agreement, including without limitation, the rights and obligations of the Parties provided in Section 5 and Sections 6.3 and 6.4, which shall survive such termination.
		
	7.
	WARRANTIES AND LIABILITY.

7.1    Non-Conformities. QIAGEN hereby warrants that at the time of receipt by ArcherDX, the Product shall conform to the Specifications. In case of non-conformity of the Products with the Specifications, ArcherDX shall only be entitled to require replacement of the non-conforming goods or full delivery (as the case may be). Otherwise no other liability for any defects than complete delivery shall be applicable.
7.2    Limitation of Liability of QIAGEN.
7.2.1    QIAGEN shall only be liable for direct damages and reimbursement of expenses in the amount of the typical and foreseeable losses resulting from grossly negligent violations of QIAGEN's essential contractual obligations or fundamental obligations and for damages caused by QIAGEN's employees as a result of gross negligence or intention without violating essential contractual provisions or fundamental obligations.
7.2.2    The limitation period for claims of the ArcherDX resulting from non-conformities of the Products shall be one (1) year following delivery of the goods. This limitation 

	
			
	 
	 
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period shall also apply for claims based on damages resulting from defects of the Products. Should the ArcherDX be in default of acceptance, then the limitation period shall start to run upon the transfer of risk. Claims of the ArcherDX other than claims based on defects, in particular, claims on the basis of accessory obligations shall be time-barred two years after delivery of the products (or transfer of risk, as the case may be).
The liability of QIAGEN and its employees and agents for any damages shall be limited to the value of ArcherDX's respective order. This limitation of liability shall not apply in cases where the damage was caused by or relates to intentional misconduct or gross negligence, fraudulently non-disclosed defects, or for personal injury and death.
7.2.3    No warranty claims or damage claims or reimbursement of expenses shall be allowed in the event of inappropriate handling and processing of QIAGEN's products.
7.2.4    QIAGEN MAKES NO REPRESENTATION OR WARRANTY THAT THE PRODUCT AND ITS INTENDED USE BY ARCHERDX AND/OR ITS END-CUSTOMERS DOES NOT INFRINGE ON ANY VALID PATENT OR OTHER PROPRIETARY RIGHT OF ANY THIRD PARTY AND ANY LIABILITY OF QIAGEN REGARDING SUCH USE IS HEREBY EXCLUDED. QIAGEN DOES NOT WARRANT MERCHANTABILITY OR FITNESS OF THE PRODUCTS FOR THE USE INTENDED BY ArcherDX.
7.3    Indemnification by the Parties. ArcherDX and QIAGEN shall indemnify, defend and hold harmless the other Party and its officers, directors, employees, agents and representatives (collectively the "Indemnitees") from and against any and all liabilities, claims, demands, actions, suits, losses, damages, costs and expenses (including reasonable attorneys' fees) ("Losses") in connection with any third party claims arising out of (i) any breach by the other Party of any of its obligations and,(ii) any third-party claims, including but not limited to any claims for infringement of intellectual property rights; provided that both Parties shall not be required to indemnify the other Parties' Indemnitees to the extent such Losses arise from the other Parties' Indemnitee gross negligence, fraud, or willful or deliberate misconduct.
		
	8.
	MISCELLANEOUS

8.1    Notices. All notices shall be in writing addressed as follows, or to such other address as may be designated from time to time:
If to QIAGEN:
QIAGEN Legal Department
19300 Germantown Road
Germantown, MD 20874

	
			
	 
	 
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If to ArcherDX:
ArcherDX, Inc.
2477 55th Street at Flatirons West
Suite 202
Boulder, CO 80301
Attention: Jason Myers
With a copy to:
8.2    Governing Law and Dispute Resolution. This Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts, without regard to the application of principles of conflicts of law. The United Nations Convention of Contracts for the International Sale of Goods shall have no application to this Agreement and is hereby excluded. If either Party shall institute a legal action against the other arising out of this 
Agreement, then the prevailing Party in such action shall be entitled, to the fullest extent permitted by applicable law, to recover from the other Party its actual attorneys' fees and all other expenses incurred in connection with such action or proceeding, in addition to all other recoverable court costs. In case that such Party does not prevail in all aspects of the submitted claim, such fees and costs shall be allocated between the Parties on a pro rata basis commensurate with the partial success of the claim as determined by the court.
8.3    Waiver of Jury Trial. THE PARTIES AGREE AND ACKNOWLEDGE THAT THEY HEREBY WAIVE THEIR RESPECTIVE RIGHTS TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION ARISING OUT OF OR RELATED TO THIS AGREEMENT. The scope of this waiver is intended to be all-encompassing of any and all disputes, including, without limitation, contract claims, tort claims, and all other common law and statutory claims. This waiver is irrevocable, and shall apply to any subsequent amendments, renewals, or modifications to this Agreement or any Exhibit to this Agreement.
8.4    Amendment; Waiver. This Agreement may be amended, modified, superseded or canceled, and any of the terms may be waived, only by a written instrument executed by each Party or, in the case of waiver, by the Party or Parties waiving compliance. The delay or failure of any Party at any time or times to require performance of any provisions shall in no manner affect the rights at a later time to enforce the same. No waiver by any Party of any condition or of the breach of any term contained in this Agreement, whether by conduct, or otherwise, in any one or more 

	
			
	 
	 
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instances, shall be deemed to be, or considered as, a further or continuing waiver of any such condition or of the breach of such term or any other term of this Agreement.
8.5    Independent Contractors; No Agency or Partnership. The relationship between QIAGEN and ArcherDX is that of independent contractors. Nothing contained in this Agreement shall give either Party the right to bind the other, or be deemed to constitute the Parties as agents for the other or as partners with each other or any Third Party.
8.6    Assignment and Successors. This Agreement may not be assigned by either Party without the written consent of the other which shall not be unreasonably withheld, except that each Party may assign this Agreement and the rights, obligations and interests of such Party, in whole or in part, to any of its Affiliates. Notwithstanding the foregoing, either Party may transfer or assign its rights and obligations under this Agreement (a "Divisional Sale"), without the consent of the other Party, to a successor to all or substantially all of its business or assets relating to this Agreement whether by sale, merger, operation of law or otherwise. Notwithstanding anything herein to the contrary, without the prior written consent of QIAGEN which may be granted or withheld in QIAGEN's sole discretion, in the event of (a) a Divisional Sale by ArcherDx, (b) a Change in Control of ArcherDx, or (c) an assignment of this Agreement by ArcherDx to other than an Affiliate of ArcherDx, the Products supplied hereunder shall not be combined, included or packaged for sale with any product other than the ArcherDx products sold prior to the consummation of any such transaction, or modifications, improvements, enhancements, new versions or updates, or new uses or applications of such ArcherDX products ("ArcherDx Legacy Products"); which ArcherDx Legacy Products, for the avoidance of doubt, shall not include the products of the acquiror, successor or surviving company in any such transaction.
For purposes hereof, a "Change in Control of ArcherDx" means:
		
	(a)
	the acquisition of ArcherDx by another entity by means of (i) a transaction or series of related transactions (including any reorganization, merger or consolidation) that results in the transfer of fifty percent (50%) or more of the combined voting power of the then outstanding voting securities of ArcherDx, or (ii) a sale, license, assignment or transfer of all or substantially all of the assets of ArcherDx, in each case, unless, following any such transaction or series of related transactions in clauses (i) or (ii), all or substantially all of the individuals and entities who were the owners of the outstanding voting securities of ArcherDx immediately prior thereto beneficially own, directly or indirectly, more than fifty percent (50%) of the combined voting power of the then outstanding voting securities of the company resulting from such transaction(s) (including a company which as a result of such transaction owns ArcherDx or all or substantially all of ArcherDx assets either directly or through one or more subsidiaries); or

		
	(b)
	the acquisition by any person or other entity, including any person or group as defined in Paragraphs 3(a)(9) and 13(d), 14(d) and Rule 13d-5 of the Securities 

	
			
	 
	 
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Exchange Act of 1934, as amended, of more than fifty percent (50%) of the combined voting power of the then outstanding voting securities of ArcherDx.
8.7    Force Majeure. Neither QIAGEN nor ArcherDX shall be liable for failure of or delay in performing obligations set forth in this Agreement, and neither shall be deemed in breach of its obligations, if such failure or delay is due to natural disasters or any causes beyond the reasonable control of QIAGEN or ArcherDX including any civil commotion, strike or other industrial dispute.. In the event of such force majeure, the Party affected thereby shall (a) promptly notify the other Party in writing and (b) use reasonable efforts to cure or overcome the same and resume performance of its obligations hereunder. If such failure shall continue for a period of more than three (3) calendar months, the other Party may terminate this Agreement upon written notice to the Party affected.
8.8    Integration; Severability. This Agreement is the sole agreement with respect to the subject matter hereof and supersedes all other agreements between the Parties with respect to same. Should any provision of this Agreement be or become invalid, ineffective or unenforceable as a whole or in part, the validity, effectiveness and enforceability of the remaining provisions shall not be affected thereby. Any such invalid, ineffective or unenforceable provision shall, to the extent permitted by law, be deemed replaced by such valid, effective and enforceable provision as comes closest to the economic intent and purpose of such invalid, ineffective or unenforceable provision. The aforesaid shall apply mutatis mutandis to any gap in this Agreement.
[Signature page follows]

	
		
	
	Certificate of Analysis (Product Number) Rev (Number)

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the date first written above by their respective duly authorized officers.
	
		
	QIAGEN, INC.

	 
	 

	 
	 

	 
	 

	By:
	/s/ Peer M. Schatz

	Name: Peer M. Schatz

	Title: President & CEO

	 
	 

	ARCHERDX, INC.

	 
	 

	 
	 

	 
	 

	By:
	/s/ Christian LaPointe

	Name: Christian LaPointe

	Title: President 

[Signature Page to Supply and Manufacturing Agreement]Exhibit

Exhibit 10.11
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [**], HAS BEEN OMITTED BECAUSE ARCHERDX, INC. HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO ARCHERDX, INC. IF PUBLICLY DISCLOSED.

CONFIDENTIAL

IVD COLLABORATION AGREEMENT
This IVD Collaboration Agreement (this “Agreement”) is effective as of the date of last signature below (the “Effective Date”) between Illumina, Inc., a Delaware corporation, having a place of business at 5200 Illumina Way, San Diego, CA  92122 (“Illumina”) and ArcherDx, a Delaware corporation, having a place of business at 2477 55th St.# 202 Boulder, CO 80301 (“ArcherDx”). Illumina and ArcherDx may each be referred to individually as a “Party” and collectively as the “Parties.”
RECITALS
A.    Illumina develops, manufactures, and sells (among other things) instruments and consumables for analysis of nucleic acids;
B.    ArcherDx develops, manufactures, and sells (among other things) consumables for use in the analysis of nucleic acids on Illumina’s instruments; and
C.    Illumina and ArcherDx desire to establish a framework for potential collaborations with respect to the development and commercialization of sequencing-based Companion Diagnostics (as defined below) in support of one or more Clients’ (as defined below) drug development program(s);
NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, the foregoing recitals, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1.    DEFINITIONS
The following capitalized terms will have the following meanings:
1.1    “Affiliate” means, with respect to a Party or other Person, any Person which at the time in question directly or indirectly Controls, is Controlled by, or is under common Control with, such Party or other Person. For the purposes of this definition, “Control” means the possession, directly or indirectly, of: (a) a majority of such Person’s outstanding voting securities or the voting power of such securities; or (b) the power to direct or cause the direction of the management or policies of a Person, whether through the ownership of securities, by agreement with respect to the voting of voting interests, by other agreement conferring control over management or policy decisions, by virtue of the power to control the composition of the board of directors or other governing body, or otherwise. The terms “Controlling” and “Controlled” have correlative meanings. Notwithstanding the foregoing, Helix Holdings I, LLC, and its subsidiaries and members, and GRAIL, Inc., and its subsidiaries and shareholders, are not Affiliates of Illumina for purposes of this Agreement. For clarity, Illumina Cambridge is an Affiliate of Illumina.
1.2    “CDA” means the Confidentiality Agreement entered into by and between the Parties on May 6, 2015, as amended on August 31, 2015 and May 16, 2016, and as may be amended in the future.

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1.3    “Change of Control” means the occurrence of any of the following, directly or indirectly, in one transaction or in a series of transactions: (a) any direct or indirect acquisition of ArcherDx (or any Affiliate of ArcherDx that Controls ArcherDx) by means of merger, consolidation, exchange or contribution of securities, or other means; (b) any other consolidation or merger of ArcherDx (or any Affiliate of ArcherDx that Controls ArcherDx) with or into any other Person; (c) the sale, transfer, assignment, or other disposition of securities of ArcherDx (or any Affiliate of ArcherDx that Controls ArcherDx) representing a majority of the voting power of ArcherDx’s outstanding voting securities or a majority of the voting power of the outstanding voting securities of any Affiliate of ArcherDx that Controls ArcherDx; (d) any other transaction(s) in which the holders of the outstanding securities of ArcherDx immediately before such transaction do not, immediately after such transaction(s), retain Control of ArcherDx, or any other transaction(s) in which the holders of the outstanding securities of any Affiliate that Controls ArcherDx immediately before such transaction do not, immediately after such transaction(s), retain Control of such Affiliate; or (e) the direct or indirect sale, transfer, assignment, or other disposition of all or substantially all of the business or assets of ArcherDx to which this Agreement relates.
1.4    “Client” means a pharmaceutical company, biotechnology company, or other Person that desires to have a Companion Diagnostic developed and commercialized in support of a drug development program.
1.5    “Companion Diagnostic” means an assay that provides information that is essential for the safe and effective use of a corresponding drug (a “Therapeutic), including to: (a) predict or determine patient prognosis or response to a Therapeutic; (b) select or choose between appropriate Therapeutic options; (c) predict or determine the safety and/or toxicity of a given Therapeutic; (d) determine the appropriate dosage with respect to a Therapeutic; and/or (e) provide advice on methods, processes and techniques concerning the use and administration of one or more Therapeutic(s).
1.6    “Competitor of Illumina” means any Person that sells, or has announced its intention to 
sell, a nucleic acid sequencing instrument.
1.7    “Effective Date” has the meaning set forth in the Preamble.
1.8    “Intellectual Property Rights” means all rights in patents, copyrights, trade secrets, know-how, trademarks, service marks, trade dress rights, and other industrial or intellectual property rights of any kind under the laws of any jurisdiction, whether registered or not, and including all applications or rights to apply therefor and registrations thereto.
1.9    “IPA” means an Individual Project Agreement between Illumina, ArcherDx, and, potentially, a Client specifying the terms and conditions of a Project.
1.10    “IVD Kit” means an in vitro diagnostic product for use as a Companion Diagnostic that requires regulatory approval and is sold in a kit form for the purpose of allowing Third Parties to perform an assay, wherein such IVD Kit has been collaboratively developed by the Parties pursuant to this Agreement and one or more IPAs and has successfully received commercial clearance, approval, or registration by one or more regulatory agencies.
1.11    “Joint Steering Committee” has the meaning set forth in Section 2.1.
1.12    “Party” and “Parties” have the meanings set forth in the Preamble.

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1.13    “Person” means an individual or firm, trust, corporation, partnership, joint venture (whether entity-based or by contract), limited liability company, association, unincorporated organization, or other legal or governmental entity.
1.14    “Project” means a particular collaboration between the Parties with respect to the 
potential development and commercialization of a specific Companion Diagnostic in support of a Client’s drug development program.
1.15    “Services” means the services to be provided by the Parties pursuant to an IPA, which may include without limitation assay development, design and execution of clinical trials, co-development of diagnostic products, manufacture of IVD Kits, and commercial distribution of IVD Kits
1.16    “Term” has the meaning set forth in Section 8.1.
1.17    “Third Party” means any Person other than: (a) ArcherDx; or (b) Illumina or any of its Affiliates.
2.    JOINT STEERING COMMITTEE
2.1    Formation and Function. Within 30 days following the Effective Date, the Parties will establish a joint steering committee (the “Joint Steering Committee”) pursuant to this Section 2. For clarity, the Joint Steering Committee under this Agreement may be composed of the same individuals, and may also function as, the Joint Steering Committee under the Co-Marketing and Distribution Agreement entered into by the Parties concurrently with this Agreement.
2.2    Composition. The Joint Steering Committee will be composed of six individuals, with each Party designating three representatives. The Joint Steering Committee will be co-chaired by one co­ 
chairperson designated by each of the Parties. Each member of the Joint Steering Committee will serve in such capacities, on such terms and conditions, and for such duration as may be determined by the Party appointing him or her. Each Party may designate an alternate member or co-chairperson to serve temporarily in the absence of a permanent member or co-chairperson designated by such Party. Each Party may from time to time change its co-chairperson or its representative members on the Joint Steering Committee.
2.3    Meetings. The Joint Steering Committee will meet at least once every calendar quarter. 
The location of such meetings will alternate between locations designated by Illumina and locations designated by ArcherDx. Attendance at meetings may be in person, by telephone, by video conference, or other means. The Joint Steering Committee will keep minutes of its meetings, which minutes are 
both Parties’ Confidential Information under the CDA whether or not marked as “confidential” or otherwise.
2.4    Responsibility; Actions. The Joint Steering Committee will be responsible for: (a) reviewing potential Projects; (b) approving the scope of Project work plans; (c) receiving and reviewing Project updates; (d) ensuring the performance of Services by the Parties in compliance with any agreed budgets and timelines, including confirming completion of milestones and delivery of deliverables pursuant to a Project work plan; (e) ensuring each Party’s compliance with the intent of this Agreement and any IPAs, and attempting to resolve any issues or disputes with respect to the foregoing; and (f) coordinating communication with potential Clients to ensure that the Parties present a unified approach. At the first meeting of the Joint Steering Committee, and thereafter as appropriate, the Joint Steering Committee will generate a list of potential Clients, and will identify which Party will take the lead in initiating contact 

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with each potential Client concerning potential Projects and which potential Clients will be contacted jointly by both Parties, taking into consideration each Party’s prior dealings with each potential Client. Except as expressly provided in this Agreement, or, with respect to any individual Project, the IPA for that Project: (a) the Joint Steering Committee’s role will be limited to coordination and providing a forum for discussion with regard to matters in connection herewith; and (b) Joint Steering Committee will have no decision-making authority.
2.5    Technical Subcommittee. The Joint Steering Committee may also establish a group of technical experts with equal representation from both Parties to facilitate the Parties’ interactions and collaboration for opportunities identified in this Agreement and for the development of new technologies in general. The formation of such group will be mutually agreed upon by the Parties.
2.6    Project Manager. Each Party will designate a Project Manager for each Project. Each 
Party’s Project Manager will be responsible for day-to-day operations of the Project and will report to the Joint Steering Committee in accordance with the applicable IPA.
2.7    Limitations. The Joint Steering Committee does not have the right or authority to, and may not: (a) bind either Party; (b) assume, create or incur any liability or any obligation of any kind, express or implied, against, or in the name of or on behalf of, either Party; (c) waive any right on behalf of either Party; or (d) amend this Agreement.
3.    IVD COLLABORATION
3.1    Selection of Projects. A Party may, in its sole discretion, propose one or more potential Projects to the other Party by submitting each such Project for review by the Joint Steering Committee. The Joint Steering Committee will evaluate each potential Project and may elect, from time to time, to undertake a Project (contingent upon each Party’s internal approval process and the Parties entering into one or more IPAs with respect to such Project).
3.2    Project Submission; Conduct of a Project; Terms of IPAs. The participation of each Party in a particular Project will be contingent upon a number of factors including the Client’s approval and the Party’s ability to meet the technical and commercialization requirements for the Project. In the event that the Joint Steering Committee selects a potential Project to be undertaken by the Parties under this Agreement and the applicable contingencies are satisfied, the Parties will negotiate in good faith the terms of an IPA for the particular Project, and enter into an IPA if the Parties are able to reach agreement on such terms. Attached as Exhibit A hereto is a non-binding outline of certain potential terms and considerations contemplated by the Parties as of the Effective Date, which is intended to facilitate the negotiation of each IPA. The Parties hereby acknowledge that, notwithstanding any anticipated or possible IPA terms set forth in Exhibit A, each Project and each IPA may have a diverse set of terms and conditions, and the Parties agree to negotiate such terms in good faith and on a case-by­ 
case basis. The terms agreed upon by the Parties in each IPA will control and govern with respect to the Project covered by such IPA in the event any different or conflicting terms are contained within this Agreement. For clarity, the execution of this Agreement alone will not obligate either Party to enter into any IPA and nothing herein will obligate either Party to perform any Services hereunder except as set forth in a duly executed IPA.
3.3    Client Presentation.  Promptly following the Effective Date, the Parties will commence jointly developing a non-confidential (as to potential Clients) presentation for potential Clients. The Parties will use commercially reasonable efforts to complete such presentation within 60 days following the Effective Date, but each Party will retain sole discretion as to inclusion or exclusion of any content.

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3.4    Training. Each Party will reasonably train the applicable members of its respective sales, business development, and/or service staff regarding the principal terms of this Agreement and the potential for collaboration between the Parties within 90 days following the Effective Date. Additionally, each Party will reasonably train the other Party on such Party’s service offerings and relevant product portfolio, including a high-level overview of such Party’s technical capabilities. Such training will be updated or extended as the Parties may mutually agree.
3.5    Non-exclusivity. Unless expressly agreed by the Parties in an IPA for a particular Project, the Parties’ relationship is non-exclusive. As such, nothing in this Agreement will prevent either Party from entering into a similar agreement, collaboration or relationship with any Third Party.  In addition, neither Party will have any obligation to: (a) propose any potential Project to the Joint Steering Committee or to the other Party; (b) to accept a Project proposed to the Joint Steering Committee; (c) to enter into an IPA with respect to any potential Project; (d) to introduce potential Clients to the other Party; or (e) to otherwise work with the other Party on a potential Project.
4.    INTELLECTUAL PROPERTY
4.1    Intellectual Property relating to Projects. The IPA for each Project will govern each Party’s rights, obligations, representations, and warranties with respect to Intellectual Property relating to such Project. The Intellectual Property of each Party that is used in a Project, whether patentable or not, will remain the property of that Party, unless otherwise agreed by the Parties in the IPA relating to such Project.
4.2    Intellectual Property under this Agreement. The Parties do not anticipate any Intellectual Property Rights being invented, created, or otherwise generated under this Agreement.  However, to the extent any Intellectual Property Right is invented, created, or otherwise generated under this Agreement (“New IP”), such New IP will be owned by the generating Party or Parties, solely or jointly, in accordance with applicable U.S. intellectual property laws. For purposes of clarification, New IP does not include:  (a) Intellectual Property Rights of either Party which existed prior to the Effective Date, or which is generated outside of this Agreement after the Effective Date; or (b) any Intellectual Property generated under an IPA (which will be governed by the terms of that IPA as set forth in Section 4.1 above). In the event any jointly-owned New IP arises under this Agreement, the Parties will negotiate in good faith an agreement governing their respective rights and responsibilities with respect to such jointly-owned New IP.
4.3    No Rights Granted. Neither Party grants (either expressly or by implication) the other Party any rights in, to, or under its Intellectual Property Rights. Any such rights will be granted, if at all, only with respect to a particular Project in the IPA for that Project.
5.    CONFIDENTIAL INFORMATION
5.1    CDA. The exchange of information between the Parties under this Agreement will be governed by the CDA. Notwithstanding anything to the contrary in the CDA, all Affiliates (as that term is defined in this Agreement) will be treated as Illumina’s “Affiliates” under the CDA.
5.2    Agreement; Publicity. The existence and terms of this Agreement are both Parties’ Confidential Information under the CDA.

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6.    REPRESENTATIONS AND WARRANTIES
6.1    General Warranties. Each Party represents and warrants that:
(a)    Such Party is duly organized, validly existing, and in good standing under the laws of jurisdiction of domicile, and has all requisite power and authority to carry on its business as such business is now being conducted;
(b)    This Agreement has been duly authorized, executed, and delivered by such Party and constitutes the legal, valid, and binding obligation of such Party, enforceable against such Party in accordance with its terms, except as enforceability may be limited by law relating to bankruptcy, receivership, or similar laws affecting creditors’ rights generally or by equitable principles relating to enforceability; and
(c)    Such Party has all necessary rights, powers, and authority to enter into this 
Agreement and to carry out its obligations under this Agreement.
6.2    WARRANTY DISCLAIMER. THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT ARE THE PARTIES’ EXCLUSIVE WARRANTIES WITH RESPECT TO THIS AGREEMENT, AND ALL OTHER EXPRESS OR IMPLIED WARRANTIES (INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY, NON­ 
INFRINGEMENT OF THIRD PARTY RIGHTS AND FITNESS FOR A PARTICULAR PURPOSE) ARE HEREBY EXPRESSLY DISCLAIMED.
7.    LIMITATIONS ON LIABILITIES
7.1    TO THE FULLEST EXTENT PERMITTED BY LAW, IN NO EVENT WILL ILLUMINA OR ITS AFFILIATES BE LIABLE TO ARCHERDX, NOR WILL ARCHERDX BE LIABLE TO ILLUMINA OR ITS AFFILIATES, FOR COSTS OF PROCUREMENT OF SUBSTITUTE PRODUCTS OR SERVICES, LOST PROFITS, DATA OR BUSINESS, OR FOR ANY INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY, CONSEQUENTIAL, OR PUNITIVE DAMAGES OF ANY KIND UNDER OR ARISING OUT OF THIS AGREEMENT, HOWEVER ARISING OR CAUSED AND ON ANY THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, MISREPRESENTATION, BREACH OF STATUTORY DUTY, OR OTHERWISE).
7.2    TO THE FULLEST EXTENT PERMITTED BY LAW, EACH PARTY’S CUMULATIVE LIABILITY UNDER OR ARISING OUT OF THIS AGREEMENT, INCLUDING ANY CAUSE OF ACTION IN CONTRACT, NEGLIGENCE, OR TORT (INCLUDING STRICT LIABILITY), WILL NOT EXCEED $500,000.
7.3    THE LIMITATIONS OF LIABILITY IN THIS SECTION 7 APPLY EVEN IF A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LIABILITY, AND NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. FOR CLARITY, THE LIMITATIONS OF LIABILITY IN THIS SECTION 7 DO NOT APPLY TO ANY DAMAGES ARISING UNDER OR ARISING OUT OF ANY IPA.

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8.    TERM AND TERMINATION
8.1    Term. The initial term of this Agreement will commence on the Effective Date and, unless earlier terminated as provided below, will terminate five years from the Effective Date. The period from the Effective Date to the expiration or termination of the Agreement is the “Term” of this Agreement.
8.2    Early Termination. In addition to and without limiting any other rights of termination expressly provided in this Agreement or under law, this Agreement may be terminated as follows:
(a)    Breach of Provision.  If a Party materially breaches this Agreement and fails to cure 
such breach within 60 days after receiving written notice of such breach from the other Party, the other Party may terminate this Agreement with immediate effect by providing written notice of termination to the breaching Party.
(b)    Bankruptcy and Insolvency. A Party may terminate this Agreement, effective immediately upon written notice, if the other Party becomes the subject of a voluntary or involuntary petition in bankruptcy, for winding up of that Party, or any proceeding relating to insolvency, receivership, administrative receivership, administration liquidation, or similar proceeding that is not dismissed or set aside within 60 days.
(c)    Termination for Change of Control involving a Competitor of Illumina. ArcherDx will notify Illumina in writing within three days of entering into any definitive agreement with any Third Party concerning a Change of Control, and will provide Illumina with the name of all parties to the
transaction(s).  ArcherDx will again provide notice to Illumina within three days of the completion of such Change of Control.  Such notices are ArcherDx’s Confidential Information under the CDA whether or not marked as “confidential” or otherwise. If a Change of Control involves a Competitor of Illumina, Illumina may terminate this Agreement by written notice to ArcherDx within the 90 day period 
commencing on the date Illumina receives notice from ArcherDx that the Change of Control has completed, or if ArcherDx fails to timely provide such notice, within 90 days of otherwise receiving written notice that a Change of Control has completed. Upon a Change of Control ArcherDX may terminate this Agreement by written notice to Illumina within the 90 day period commencing on the date Illumina receives notice from ArcherDx that the Change of Control has completed.
(d)    No IPAs.  Either Party may terminate this Agreement, effective immediately upon written notice to the other Party, at any time after the third anniversary of the Effective Date if there are no active IPAs then in place between the Parties.
8.3    Effect of Termination; Survival.
(a)    Unless otherwise provided in an IPA, termination of this Agreement will not affect, or cause termination of, any IPA in effect as of the effective date of termination of this Agreement; provided, however, in addition to any termination rights set forth in an IPA, in the event of termination pursuant to Section 8.2, the terminating Party may also terminate any IPA between the Parties.
(b)    The following provisions will survive any termination or expiration of this Agreement: Sections 1, 5-7 (inclusive), 8.3, 8.4, and 9. Termination or expiration of this Agreement will not relieve either Party of any liability or obligation that accrued under this Agreement prior to the effective date of such termination or expiration, nor preclude either Party from pursuing all rights and remedies it may have under this Agreement, at law, or in equity with respect to any breach of this Agreement.

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8.4    NO DAMAGES FOR TERMINATION OR EXPIRATION. NEITHER PARTY WILL BE LIABLE TO THE OTHER PARTY FOR ANY DAMAGES OF ANY KIND (INCLUDING DAMAGES ON ACCOUNT OF PRESENT OR PROSPECTIVE PROFITS, OR ON ACCOUNT OF EXPENDITURES, INVESTMENTS, OR COMMITMENTS MADE IN CONNECTION WITH THIS AGREEMENT, OR IN CONNECTION WITH THE DEVELOPMENT OR MAINTENANCE OF THE BUSINESS OR GOODWILL OF THE OTHER PARTY) BY REASON OF EXPIRATION OF THIS AGREEMENT OR PROPER EXERCISE OF ITS RIGHT TO TERMINATE THIS AGREEMENT IN ACCORDANCE WITH THIS AGREEMENT, AND EACH PARTY HEREBY WAIVES ANY RIGHT IT MAY HAVE TO RECEIVE ANY SUCH DAMAGES.
9.    GENERAL
9.1    Governing Law; Jurisdiction. This Agreement and any dispute or claim arising out of, in connection with, or related to this Agreement or its subject matter or formation will be governed and construed in accordance with the laws of the State of Delaware, without regard to provisions on the conflicts of laws. Any legal process to resolve any dispute under this Agreement, including arbitration or court proceedings, will take place in San Diego, California. The Parties agree that the United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement.
9.2    Arbitration.
(a)    All disputes, controversies or claims arising out of, or relating to, this Agreement 
(other than claims for injunctive relief, specific performance, or any other equitable relief, which may be resolved in any court having jurisdiction) will be settled by arbitration. The arbitration will be conducted by three arbitrators and administered by JAMS pursuant to its Comprehensive Arbitration Rules and Procedures and in accordance with the Expedited Procedures in those Rules. Each Party will bear its expenses of the arbitration, and each Party will be responsible for one half of the arbitrators’ fees.
(b)    The arbitrators will issue a written decision providing the reasons for their decision. 
The decision of the arbitrators will be an award under California law. The award will be final and binding on the Parties and judgment upon the award may be entered in and enforced by any court having jurisdiction.
(c)    The contents and results of any arbitration under this Agreement are both Parties’ Confidential Information.
9.3    Injunctive Relief; Cumulative Remedies. Each Party acknowledges that its breach of Section 4 or 5 may cause irreparable injury to the other Party for which monetary damages would not be an adequate remedy, and the other Party will therefore be entitled to seek injunctive relief (including specific performance) with respect to any breach or threatened breach without posting a bond or other security as a condition for obtaining any such relief. All rights and remedies provided to each Party in this Agreement are cumulative and in addition to any other rights and remedies available to each Party under this Agreement, at law, or in equity.
9.4    Rights of Third Parties. Except with respect to the rights granted to Illumina’s Affiliates, there are no Third Party beneficiaries to this Agreement and no term of this Agreement is enforceable under the Contracts (Rights of Third Parties) Act 1999 by a Person who is not a Party to this Agreement. The Parties may rescind or terminate this Agreement or vary any of its terms in accordance with their rights under this Agreement and by law, without the consent of any Third Party.

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9.5    Severability; No Waiver. If any term or provision of this Agreement is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability will not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction. Upon a determination that any term or provision is invalid, illegal, or unenforceable, the Parties will negotiate in good faith to modify this Agreement to effect the original intent of the Parties as closely as possible in order that the transactions contemplated by this Agreement be consummated as originally contemplated by the Parties to the greatest extent possible. The failure or delay of either Party to exercise any right or remedy provided in this Agreement or to require any performance of any term of this Agreement may not be construed as a waiver, and no single or partial exercise of any right or remedy provided in this Agreement, or the waiver by either Party of any breach of this Agreement, will prevent a subsequent exercise or enforcement of, or be deemed a waiver of any subsequent breach of, the same or any other term of this Agreement. No waiver of any right, condition, or breach of this Agreement will be effective unless in writing and signed by the Party who has the right to waive the right, condition, or breach.
9.6    Assignment. Neither Party may assign or otherwise transfer, or delegate any of its obligations under, this Agreement or any rights or obligations under this Agreement without the prior written consent of the other Party; provided that:
(a)    either Party (the “Assigning Party”) may, without the other Party’s prior written 
consent (but in the case of ArcherDx, subject to, and contingent upon compliance with, Section 8.2 and Illumina’s rights thereunder) assign this Agreement in its entirety: (i) in connection with a consolidation or reorganization of such Assigning Party; (iii) to an acquirer or successor of all or substantially all of (A) the business or assets of such Assigning Party to which this Agreement relates or (B) the securities of such Assigning Party, in each case in this clause (iii) whether by merger, sale, assignment, or operation of law; and
(b)    Illumina may, without ArcherDx’s prior written consent, assign or delegate any or all of its rights and obligations under this Agreement to one or more of its Affiliates; provided, however, that Illumina will remain responsible for the activities of such Affiliate(s) under this Agreement.
Any purported assignment or other transfer of this Agreement (in whole or in part) not expressly permitted in this Section 9.6 will be null and void. Subject to the remainder of this Section 9.6, this Agreement will be binding upon and inure to the benefit of each of the Parties and their successors and assigns.
9.7    Notices.  All notices required or permitted under this Agreement will be in writing, in English, and will be deemed received only when: (a) delivered personally; or (b) one day after deposit with a commercial express courier specifying next day delivery or, for international courier packages, two days after deposit with a commercial express courier specifying two-day delivery, with written verification of receipt.  All notices will be sent to the following or any other address designated by a Party using the procedures set forth in this Section:

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	If to Illumina:
Illumina, Inc. 
5200 Illumina Way 
San Diego, CA 92122 
Attn: General Counsel
With a copy not constituting notice to: 
Legalnotices@illumina.com
	If to ArcherDx:
ArcherDX, Inc. 
2477 55th St. # 202 
Boulder, CO 80301 
Attn: CEO
With a copy not constituting notice to: 
Legal@archerdx.com

9.8    Entire Agreement: Amendment. This Agreement (together with the CDA and any IPAs entered into under this Agreement) represents the entire agreement between the Parties regarding the subject matter hereof and supersedes all prior discussions, communications, agreements, and understandings of any kind and nature between the Parties. The Parties acknowledge and agree that by entering into this Agreement, they do not rely on any statement, representation, assurance or warranty of any Person than as expressly set forth in this Agreement. Each Party agrees that it will have no right or remedy (other than for breach of contract) in respect of any statement, representation, assurance or warranty (whether made negligently or innocently) other than as expressly set forth in this Agreement. Nothing in this Section 9.8 will exclude or limit any liability for fraud. No amendment to this Agreement will be effective unless in writing and signed by both Parties.
9.9    Relationship of the Parties. The Parties are independent contractors under this Agreement and nothing in this Agreement may be construed as creating a partnership, joint venture or agency relationship between the Parties, or as granting either Party the authority to bind or contract any obligation in the name of the other Party or to make any statements, representations, warranties or commitments on behalf of the other Party.
9.10    Headings; Interpretation; Miscellaneous.  Sections, titles and headings in this Agreement 
are for convenience only and are not intended to affect the meaning or interpretation hereof. Whenever required by the context, the singular term includes the plural, the plural term includes the singular, and the gender of any pronoun includes all genders. As used in this Agreement except as the context may otherwise require, the words “include,” “includes,” “including,” and “such as” are deemed to be followed by “without limitation” or “but not limited to,” whether or not they are in fact followed by such words or words of like import, and “will” and “shall” are used synonymously. As used in this Agreement except as the context may otherwise require the term “consent” means in the consenting Party’s sole and absolute discretion. Except as expressly stated, any reference to “days” will be to calendar days, and “business day” means all days other than Saturdays, Sundays, or a national or local holiday recognized in the United States, any reference to “calendar month” will be to the month and not a 30 day period, and any reference to “calendar quarter” will mean the first three calendar months of the year, the fourth through sixth calendar months of the year, the seventh through ninth calendar months of the year, and the last three calendar months of the year.  Time is of the essence in performing under this Agreement. Whenever the last day for the exercise of any right or the discharge of any obligation of this Agreement falls on, or any notice is deemed to be given on, a Saturday, Sunday, or national holiday, the Party having such right or obligation will have until 5:00 pm PST on the next succeeding business day to exercise such right or to discharge such obligation or the Party giving notice will be deemed to have given notice on the next succeeding business day. No usage of trade, course of performance, or other regular practice between the Parties may be used to interpret or alter the terms or conditions of this Agreement.  Unless otherwise expressly provided in this Agreement, any agreement, instrument, or statute defined or referred to means such agreement, instrument, or statute as from time to time amended, modified, or supplemented, including (in the case of agreements or instruments) by waiver or consent and (in the case of statutes) by 

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succession of comparable successor statutes and references to all attachments thereto and instruments incorporated therein. The Parties have participated jointly in the negotiation and drafting of this Agreement. If an ambiguity or question of intent or interpretation arises, this Agreement will be construed as if drafted jointly by the Parties and no presumption or burden of proof will arise favoring or disfavoring any Party because of the authorship of any provision of this Agreement.
9.11    Counterparts.  This Agreement may be executed in one or more counterparts, each of which will be deemed to be an original, and all of which will constitute one and the same instrument.
9.12    Costs and Expenses.  Except to the extent expressly provided in this Agreement or an IPA, 
or as may otherwise be agreed in advance in writing by the Parties, each Party will be solely responsible for the costs and expenses it incurs in performing its obligations under this Agreement.
9.13    Further Assurances. Each Party will execute and deliver such further documents and take such further actions as the other Party may reasonably request to evidence and implement the provisions and intent of this Agreement.
[SIGNATURE PAGE FOLLOWS DIRECTLY]

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SIGNATURE PAGE TO
IVD COLLABORATION AGREEMENT
IN WITNESS WHEREOF, the Parties have executed this Agreement effective as of the Effective Date.
	
					
	ILLUMINA
	ArcherDx
	 

	 
	 
	 
	 
	 

	Illumina, Inc.
	 
	ArcherDx, Inc.

	a Delaware corporation
	 
	a Delaware corporation

	 
	 
	 
	 
	 

	 
	 
	 
	 
	 

	By:
	/s/ Charles M. Moehle
	 
	By:
	/s/ Jason Myers

	 
	 
	 
	 
	 

	Name:
	Charles M. Moehle
	 
	Name:
	Jason Myers

	 
	 
	 
	 
	 

	Title:
	VP Business Development & Licensing
	 
	Title:
	CEO

	 
	 
	 
	 
	 

	Date:
	May 16, 2016
	 
	Date:
	May 16, 2016

CONFIDENTIAL

EXHIBIT A
The following terms are non-binding and are intended only as a general outline of potential terms and considerations for discussion in connection with any particular IPA.
	
		
	General Scope of IPAs
	•    ArcherDx has the opportunity to develop a CDx for a pharmaceutical or biotechnology partner and, under a specific IPA, receives support from Illumina.
•    Development of the IVD Test would be carried out as described by a mutually agreed Development Plan incorporated into the IPA as an Exhibit.
•    Unless otherwise specified in the Agreement, ArcherDx would be responsible for and take the lead on development, regulatory submissions, and commercialization of the IVD Test.
•    Illumina would provide reasonable levels of support, related to MiSeqDx instruments and sequencing consumable, for ArcherDx development activities and regulatory submissions.
•    Illumina would sell MiSeqDx instruments and consumables to ArcherDx for product development. These products may be labelled IUO or IVD depending on their configuration and regulatory status in each jurisdiction.
•    For commercialization after regulatory approval of IVD Tests, Illumina would sell MiSeqDx instruments and consumables directly to IVD Test end-users and provide primary instrument maintenance and instrument and consumables support.
•    To allow for appropriate product planning, Illumina would provide at least 6 months’ notice to ArcherDx of voluntary changes in sequencing consumables.
•    This is a mutually non-exclusive relationship.

	Territory
	Worldwide except where prohibited or penalized by applicable law

	Term
	5 years

	Joint Responsibilities to be included in an IPA
	•    Parties would agree on composition and performance specifications of the IVD Test. Parties would agree on responsibility for technical development activities, and, if Illumina resources are required, the estimated hours needed to complete technical development.
•    Parties would agree on on-instrument IVD Test execution software requirements and the estimated timing to complete the module for development and clinical studies.
•    Parties would discuss and agree upon regulatory strategy and regulatory aspects each will provide, and estimated resources needed to complete regulatory filing and approval.
•    Support estimates would be incorporated into the Development Plan. Initial Illumina resource assumptions (for purposes of Compensation milestones below) are [**] total for a PMA submission.  Amendments to the Development Plan, including changed resource requirements, would be by mutual agreement.

CONFIDENTIAL

	
		
	ArcherDx Responsibilities (IPA)
	Development
•    ArcherDx would, at its sole cost, develop the JVD Test. Sequencing instruments and consumables required for development would be purchased from Illumina under Terms and Conditions specified in the IPA.
•    ArcherDx would, at its sole cost, perform any and all testing and studies necessary in order to commercialize the IVD Test such as analytical or pre-clinical studies, stability studies, and clinical studies.
•    ArcherDx would, at its sole cost, file regulatory submissions for the IVD Test.
Commercialization
•    ArcherDx would manufacture and sell the IVD Test in Territory.
•    ArcherDx would provide all product support for the IVD Test components it manufactures.
•    ArcherDx would direct the end-users of its IVD Test to purchase Illumina’s MiSeqDx instruments and IVD sequencing consumables.
•    If ArcherDx wishes to implement reagent rental, it may purchase sequencing instruments from Illumina and loan them to its IVD Test end-users. ArcherDx may not resell these instruments nor loan an individual instrument to more than one IVD Test end-user at a time.

	Illumina Responsibilities (IPA)
	Development
•    Illumina, at its sole cost (subject to agreed-upon milestone and overage costs), would provide the development, software and regulatory support as mutually agreed. If ArcherDx has working prototypes for library prep methods and secondary analysis software tools, it is anticipated that the majority of Illumina support would be in the areas of assay-specific MiSeqDx software module development and regulatory support including allowing the necessary access to Illumina instrument software to ArcherDX software developers.
•    Illumina would sell MiSeqDx consumables to ArcherDx at a [**] discount to then-current list prices for development work.
•    Illumina would enable ArcherDx to reference Illumina’s design history files and other documents in order to support regulatory submissions.
•    Illumina will not be required to obtain any new (as of the Effective Date) regulatory clearances/approvals for the MiSeqDx and its consumables unless expressly specified and accounted for in the applicable Development Plan.
Commercialization
•    Illumina would sell the MiSeqDx (or successor) instruments to IVD Test end-users. Illumina would take primary responsibility for instrument maintenance and support.
•    Illumina would sell lVD sequencing consumables to IVD Test end users, and provide primary support, pursuant to its standard practices.

CONFIDENTIAL

	
		
	Compensation (to be included in IPA)
	Milestones* for each IVD Test:
•    [**]
•    [**]
•    [**]
o    [**]
•    [**]
•    [**]
•    [**]
•    [**]
*Note: These milestones are proposed for first IPA under Collaboration Agreement. Certain subsequent IPA milestones may decrease depending on: use of same Illumina component as prior IPAs; level of customization required for software module from one IPA to another; chosen regulatory path (PMA vs. 510k).

	Alternate Structure
	Illumina may also implement an IPA with ArcherDx for development of a CDx test and, in such a scenario, Illumina will pay ArcherDx for development, clinical and validation services performed in such scenario.

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