Document:

ex10-1.htm

Exhibit 10.1

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN

FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

AMENDMENT

 

TO

 

MARKETING AUTHORIZATION HOLDER AGREEMENT

 

(“Amendment”)

 

This Amendment (“Amendment”) is made this 1st day of April, 2016, by and between Oxford Immunotec Limited, a company organized and existing under the laws of UK, address at 94C Milton Park, Abingdon, Oxfordshire OX14 4RY United Kingdom (hereinafter referred to as "MANUFACTURER", and RIKEN GENESIS CO., LTD., a company organized and existing under the laws of Japan, address at 1-5-1 Taito, Taito-ku, Tokyo 110-8560, Japan (hereinafter referred to as “MAH”).

 

 Recitals:

 

WHEREAS, MANUFACTURER and MAH are parties to the Marketing Authorization Holder Agreement dated July 29, 2011, as amended September 1, 2013 (“Agreement”);

WHEREAS, as of April 1st, 2016 (“Effective Date”), the parties agreed to modify the Agreement to adjust the commission defined in the Agreement; and

WHEREAS, MANUFACTURER and MAH now wish to memorialize the amounts to be paid by MANUFACTURER to MAH under the Agreement. 

NOW, THEREFORE, IN CONSIDERATION OF THE FOREGOING, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged and agreed, MANUFACTURER and MAH agree to amend the Agreement as follows:

 

	
1.
	
This Amendment shall have effect as of the Effective Date. 

	
2.
	
Appendix A of the Agreement shall be replaced by as attached hereto. 

	
3.
	
For the avoidance of doubt, MANUFACTURER acknowledges and agrees that the delivery of PRODUCTS shall be made at the DISTRIBUTOR’s premises directed by DISTRIBUTOR and the risk of loss or damages to PRODUCTS under the Agreement shall pass from MANUFACTURER to DISTRIBUTOR at the time of completion of delivery.

	
4.
	
Except for the terms and conductions set forth above, all terms of the Agreement shall remain in full force and effect.

 

 

 

 

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN

FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

IN WITNESS WHEREOF, the parties have executed this Amendment as of the date first above written.

 

 

	RIKEN GENESIS CO., LTD. 	 	Oxford Immunotec Limited	 
	 	 	 	 	 	 
	 	
 
	
 
	
 
	
 
	
 

	By:	
/s/ Yusuke Tsukahara
	
 
	
By:
	
/s/ Peter Wrighton-Smith
	
 

	Name:	Yusuke Tsukahara	
 
	
Name:
	Peter Wrighton-Smith	
 

	Title:	CEO	
 
	
Title:
	CEO	
 

 

 

 

 

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN

FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

APPENDIX A (Effective as of April 1st, 2016)

 

DMAH Service Package for In-Vitro Diagnostics 

 

	 	
•
	
We (MAH) support marketing in Japan for the PRODUCTS placed on the market by the foreign manufacturer. 

 

	 	
•
	
We must act as the foreign manufacturer's contact point for all Japanese Authorities. 

 

	 	
•
	
We oversee the GQP and will be in charge of monitoring the shipping and receiving methods of the foreign manufacturer. 

 

	 	
•
	
We are responsible for notifying the PMDA of any manufacturing or in-process control changes. 

 

	 	
•
	
We communicate with your DISTRIBUTOR and create the Import Procedure for your DISTRIBUTOR. 

 

	 	
•
	
We communicate with your packaging manufacturer to develop the Quality Agreement and assist in preparation of the Manufacturing Standard (Seihinhvojunsho) for labeling and warehousing as applicable. 

 

	 	
•
	
We are responsible for establishing and ensuring the release criteria and Quality Standard (Hinshitsuhyojunsyo) for each PRODUCT. 

 

	 	
•
	
We prepare and submit the Import Submission for each PRODUCT family for customs clearance. 

 

	 	
•
	
We register JAN code to MEDIS for each item of the PRODUCTS. 

 

	 	
•
	
We are responsible for handling all necessary communication between foreign manufacturer and MHLW in the case of a PRODUCT recall. 

 

	 	
•
	
We protect the confidentiality of your documentation. The Japanese Authorities are the only entities to whom we will show the documents, and only upon their request. 

 

	 	
•
	
We obtain your PAL certificates and other documentation for each PRODUCT from the Japanese Authorities and forward them to you. We will ensure that all certificates and approvals will be issued in your (MANUFACTURER’s) name.

 

	 	
•
	
We have right to conduct audits of your facilities. The MAH must be able to show their audit records of the foreign manufacturer which has no location in Japan to Japanese Authorities upon request. If your company faces a serious or many reportable events, this will be expected. 

  

 

 

 

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN

FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

  

 

Fee Structure 

 

	 	
•
	
One time initiation fee of [***] upon signing of this Agreement. This includes the fee for review of IVD documentation, labeling, and developing the required Quality Standard (Hinshitsuhyojunsyo) and Import Submission, Quality Agreement, JAN Code registration. An additional one-time [***] fee per a PRODUCT family is required for an additional PRODUCT family. This also includes the review of IVD documentation, labeling, and developing the required Quality Standard (Hinshitsuhyojunsyo) and Import Submission.

 

	 	
•
	
DMAH Retainer and Handling Fee: 

 

We charge a monthly commission per commercial invoice at custom clearance for PRODUCTS listed in APPENDIX B on the proviso that PRODUCTS are directly delivered from MANUFACTURER to DISTRIBUTOR. The applicable rate of the commission shall be one of the following:

 

	
I.
	
If the total invoiced amount for the preceding fiscal year starting from April 1 and ending on March 31 (the “Preceding Year”) cleared through customs exceeds [***], MAH will charge [***] commission applied to each commercial invoice for a PRODUCT listed in APPENDIX B, invoiced monthly.

	
II.
	
If the total invoiced amount for the Preceding Year cleared through customs exceeds [***] (but does not exceed [***]), MAH will charge [***] commission applied to each commercial invoice for a PRODUCT listed in APPENDIX B, invoiced monthly.

	
III.
	
If the total invoiced amount for the Preceding Year cleared through customs does not exceed [***], MAH will charge [***] commission applied to each commercial invoice for a PRODUCT listed in APPENDIX B, invoiced monthly.

  

	
•
	
To set-up Import Procedure for shipping process, [***] is charged per DISTRIBUTOR, if any. This includes necessary communication with the DISTRIBUTOR including explanation of new import procedure. 

 

	
•
	
If necessary, vigilance/reportable event reporting will be charged on an hourly rate basis of [***]. 

 

	
•
	
If an on-site audit of your facilities is required, fees will be charged at the rate of [***] per person per day, with a fee cap of [***] (2 persons for 2 days). In addition, Manufacturer will reimburse MAH for reasonable out-of-pocket travel expenses of the auditing team, at cost (without mark-up), with all air travel in economy class and accommodations at standard business (not luxury) hotels. MAH will endeavour to use audit personnel who are geographically proximate to the facility to be audited. In the event the on-site audit cannot be completed by two persons in two days (or by one person in four days), the parties agree to discuss appropriate adjustments to the fee cap.

 

	
•
	
Travel expenses where applicable are charged at cost. 

 

	
•
	
Manufacturer is responsible for payment of all fees related to the Product registration charged by the PMDA or Registration Certification Body. 

 

 

 

 

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN

FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

  

 

	
•
	
The amount of fees for custom clearances including consumption taxes to be paid at customs clearance which must be paid to MAH before customs clearance can occur. We will invoice the amount of fees to your DISTRIBUTOR as a substantial importer and not release PRODUCT to your DISTRIBUTOR until paid. 

 

	
•
	
If RIKEN GENESIS is assuming the DMAH role for any Product from the MANUFACTURER's existing MAH/DMAH, RIKEN GENESIS must gather the following information and perform the additional actions itemized below. Our assistance with the following activities will be billed at a fee of [***] per hour, plus travel time and travel expenses, which are invoiced at cost: 

 

	 	
o
	
Obtain the GQP and GVP, including quality control records, release judgment records and adverse event/field corrective action records, complaint data, et al. 

 

	 	
o
	
Succeed original copy of the Pre-Market Approval/Certification (PMA/PMC) and copy of the application of the Pre-Market Approval/Certification (PMA/PMC) 

 

	 	
o
	
Succeed copy of package insert, instruction for use/operation manual and labeling 

 

	 	
o
	
Prepare and submit DMAH Change Notification

  

Notes: 

  

	
•
	
In Japan, class I IVDs are not required to go through the Pre-market Approval or Pre-market Certification process. Instead, registration is executed by the Pre-market Submission process with no assessment by the PMDA or a registered Certification Body as is required with a Premarket Approval or Pre-market Certification. 

 

	
•
	
While the Foreign Special Approval System under the PAL is not applicable for PRODUCTS that fall under the Pre-market Submission process, you can select MAH as your MAH rather than as your DMAH. 

 

	
•
	
Manufacturer must appoint a licensed Packaging Manufacturer, Distribution Company and if necessary a Logistics Firm licensed for your specific PRODUCTS.

 

	
•
	
In the case of a transfer of existing registered PRODUCTS from your existing MAH or DMAH, MANUFACTURER is responsible for providing all of the documents, e.g., pre-market approval application, package insert, Quality Standard (Hinshitsuhyojunsyo) etc., needed to transfer from the existing MAH or DMAH. Any fee and/or costs for re-registration of the PRODUCTS transferred from the existing MAH or DMAH will be charged separately.ex10-2.htm

Exhibit 10.2

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

FIRST AMENDMENT TO SUPPLY AGREEEMENT

 

This First Amendment to Supply Agreement (the “Amendment”) is made and entered into effective as of December 31, 2015 (the “Amendment Effective Date”), by and between Oxford Immunotec Limited, having a place of business at 94C Innovation Drive, Milton Park, Abingdon, Oxfordshire OX14 4RZ (the “Buyer”) and MicroCoat Biotechnologie GmbH with an address of Am Neuland 3, 82347, Bernried am Starnberger See, Germany (the “Supplier”).

 

WHEREAS, the Parties entered into a Supply Agreement effective as of the 17th of December 2010 (the “Agreement”); 

 

WHEREAS, the Parties desire that Supplier continue to manufacture for Buyer certain antibody-coated membrane plates for use in in vitro diagnostic assays leveraging the Buyer’s T-SPOT® technology platform;

 

WHEREAS, the Parties desire to memorialize the extension of the term of the Agreement, to memorialize certain pricing terms, and to make certain other modifications as set forth herein;

 

NOW THEREFORE, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged and agreed, Buyer and Supplier hereby agrees as follows:

 

	 	
I.
	
New Section 2.8 is hereby added to the Agreement as follows:

	 	 	 
	 	 	2.8          Buyer’s Affiliates. Notwithstanding any provision to the contrary in this Agreement, the Parties agree that any of Buyer’s Affiliates may place purchase orders directly with Supplier under and pursuant to the terms and conditions of this Agreement, and Supplier agrees to ship and invoice against such purchase orders directly to the Buyer’s Affiliate placing the purchase order in accordance with the terms and conditions of this Agreement. For purposes of this Section 2.8, all rights and obligations of Buyer specified in this Agreement with respect to Products and Supplier shall be deemed to be assigned and assumed by the Buyer’s Affiliate for the particular purchase order placed by it. At Buyer’s discretion it may either include its Affiliates’ estimated requirements in a single aggregate forecast or require that each of its Affiliates submit its own individual forecast. 

 

 

 

 

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

	 	
II.
	
The second sentence of Section 4.3 is hereby amended and restated in its entirety as follows:

	 	 	 
	 	 	Supplier shall perform quality control inspection and testing of the test plates in order to confirm their compliance with the Specifications and the adequacy of their use in in vitro diagnostic assays leveraging the Buyer’s T-SPOT® technology platform. 

  

	 	
III.
	
Section 7.1 is hereby amended and restated in its entirety as follows:

	 	 	 
	 	 	Delivery to Buyer’s facility in the United Kingdom shall take place CIP (Incoterms 2010) Buyer’s premises in Abingdon, Oxfordshire, United Kingdom. Delivery to Buyer’s Affiliates shall take place Ex Works (Incoterms 2010) at Supplier’s premises in Bernried am Starnberger See, Germany. Risk of loss shall pass from the Supplier to the Buyer upon such delivery. 

  

	 	
IV.
	
Section 8.1 is hereby amended by the addition of the following language:

	 	 	 
	 	 	Pricing for the calendar years 2015 and 2016 shall be as follows:

  

	
Calendar Year
	
Price Per Product (€)*

	
2015
	
[***] 

	
2016
	
[***]

 

* The currency for purchase orders submitted by Buyer shall be in EURO (€) at the price indicated above. 

 

Subject to exceeding certain aggregate annual volume thresholds described below, Buyer and its Affiliates will be entitled to rebates paid in the form of a credit against future purchases from Supplier based on the total amount paid for a given calendar year as follows:

 

	
Calendar Year
	
Aggregate Annual Volume Threshold
	
Rebate Rates
	
Date Issued

	
2015
	
[***] plates
	
[***]%
	
January 2016

	
2016
	
[***] plates
	
[***]% for [***]; 

[***]% for [***]
	
January 2017

 

 

 

 

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

	 	
V.
	
Section 8.2 is hereby amended and restated in its entirety as follows:

 

All prices are stated exclusive of VAT or other sales taxes. All prices are stated CIP (Incoterms 2010) Buyer’s facility, Abingdon, Oxfordshire, United Kingdom (for orders placed by Buyer) or Ex Works (Incoterms 2010) at Supplier’s facility, Bernried am Starnberger See, Germany (for orders placed by Buyer’s Affiliates).

 

	 	
VI.
	
Section 17.1 is hereby amended as follows:

	 	 	 
	 	 	
Buyer’s address for purpose of notice is hereby amended and restated as follows:

 

Oxford Immunotec Limited

94C Innovation Drive

Milton Park

Abingdon, Oxfordshire OX14 4RZ

United Kingdom

Attention: Chief Operating Officer

Telephone: +44 (0) 1235 442780

Facsimile: +44 (0) 1235 442781

 

Buyer’s address for day-to-day contact concerning the purchase and supply of Products under the Agreement is hereby amended and restated as follows:

 

Oxford Immunotec Limited

94C Innovation Drive

Milton Park

Abingdon, Oxfordshire OX14 4RZ

United Kingdom

Attention: Jemma Parsons

Telephone: +44 (0) 1235 442780

Facsimile: +44 (0) 1235 442781

  

	 	
VII.
	
The following modifications are hereby made to Schedule 1 of the Agreement:

	 	 	 
	 	 	The following preamble paragraph is added to Schedule 1:

  

	 	
-
	
There are two versions of the Product: [***]. For the avoidance of doubt, this Schedule 1 applies to both versions of the Product.

 

 

 

 

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

 

Section 3.2.2.3 (Reporting Requirements) is hereby amended and restated in its entirety as follows:

 

	 	
-
	
A Certificate of Analysis (CofA) in the form attached hereto as Appendix I or as otherwise reasonably requested by Oxford Immunotec shall be produced containing [***].

 

The first bullet under Section 3.4.1 (Protocol) is hereby amended and restated in its entirety as follows:

 

	 	
-
	
[***]

 

Table 1 under Section 3.4.1 (Protocol) is hereby deleted.

 

The first bullet under Section 3.5 (Oxford Immunotec Kit QC Test) is hereby amended and restated in its entirety as follows:

 

	 	
-
	
[***]

 

	 	
VIII.
	
Section 15 is hereby amended as follows:

	 	 	 
	 	 	The first sentence of Section 15 is hereby amended and restated in its entirety as follows:

  

The Agreement, as amended, shall become effective as of the Effective Date hereof and shall continue in effect, unless earlier terminated, through December 31, 2016.

 

	 	
IX.
	
All capitalized terms used but not defined in this Amendment shall have the meanings given them in the Agreement.

 

	 	
X.
	
In all other aspects, the Agreement shall continue in full force and effect.

 

[Signature Page Follows]

 

 

 

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

   

 

IN WITNESS THEREOF, the parties hereto have executed this Amendment effective as of the day and year first written above.

   

	OXFORD IMMUNOTEC LIMITED	 	 	MICROCOAT BIOTECHNOLOGIE GMBH 	 
	 	 	 	 	 
	
 
	
 
	
 
	
 
	
 

	BY:  /s/Peter Edwardson	
 
	
 
	
/s/ Bernd Buchberger
	
 

	(Signature) 	 	 	(Signature)	 
	 	 	 	 	 
	P. Edwardson	
 
	
 
	
Bernd Buchberger 
	
 

	(Print Name) 	 	 	(Print Name) 	 
	 	 	 	 	 
	
COO 
	
 
	
 
	
General Manager
	
 

	(Title)	 	 	(Title)	 
	 	 	 	 	 
	DATE: 5 Apr 2016	 	 	DATE: 30 Mar. 2016 	 

 

 

 

 

 

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

  

Certificate of Analysis

 

[***]

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