LEGAL

USE OF SITE TERMS AND CONDITIONS

Effective as of May 25, 2018

These Use of Site Terms and Conditions together with our Privacy Notice govern your use or viewing of this website (the “Site”) and your relationship with the owner of the Site, Roche Sequencing Systems, Inc. (the “Site Owner” or “Roche”). You may contact Roche at 9115 Hague Road, PO Box 50414, Indianapolis, IN 46250.  You may find more information about how to contact our data protection officer in our Privacy Notice. By using this Site, you agree to be bound by these Terms and Conditions.

1. Terms of Use. When using our site, you represent that you understand and will comply with the following Terms of Use. 

A. Availability of the Site: Access to the Site is permitted at the Site Owner’s discretion. The Site Owner reserves the right to withdraw, amend, or restrict, the service we provide on this Site without notice. 

B. Unauthorized Uses: The Site Owner, in its sole discretion, may determine which uses of this Site are improper and/or unauthorized. The Site Owner may take any appropriate action in response to unauthorized uses of this Site, including but not limited to blocking any user of this Site. You agree not to use this Site to:

(1) make fraudulent statements or other misrepresentations; 

(2) use this Site in violation of any legal duty to a third party; 

(3) post, transmit or otherwise make available any material that contains software viruses or any other computer code, files, or programs designed to interrupt, destroy or limit the functionality of any computer software or hardware or telecommunications equipment; 

(4) intentionally or unintentionally violate any national or international statute, law, decree, rule and/or regulation; 

(5) “stalk” or harass another person; or

(6) collect or store personal data about others.

2. Not Health Advice
By using this Site you acknowledge that the material provided is for informational purposes only. Nothing on this website should be construed as or deemed to be advice or counsel regarding any health or medical condition, or the diagnosis or treatment of any health or medical condition. Users should not rely on the materials on this Site in deciding on a treatment plan, drug usage, or any other medical advice. Users are strongly urged to consult with a physician in connection with any and all treatment options.

3. DISCLAIMER OF WARRANTIES
THE INFORMATION, PRODUCTS, AND SERVICES PROVIDED ON THE SITE ARE “AS IS, WHERE IS” WITH NO EXPRESS OR IMPLIED WARRANTY OR GUARANTEE OF ANY KIND REGARDING THE ACCURACY, CONTENT, COMPLETENESS, RELIABILITY, OPERABILITY, OR LEGALITY OF THE CONTENT OF THIS SITE. IN ADDITION, THE SITE OWNER AND ITS AFFILIATES FULLY DISCLAIM ANY REPRESENTATIONS OR WARRANTIES ABOUT THE SATISFACTION OF ANY GOVERNMENT REGULATIONS REQUIRING DISCLOSURE OF INFORMATION ON MEDICAL DEVICE, PRESCRIPTION DRUG, OR HEALTH PRODUCTS. ANY WARRANTY THAT IS PROVIDED IN CONNECTION WITH ANY ROCHE PRODUCTS DESCRIBED ON THE SITE SHALL BE LIMITED TO THE WARRANTIES PROVIDED IN THE DOCUMENTS OF SALE OF SUCH PRODUCT, AND ANY LIMITATIONS INCLUDED THEREIN.

4. LIABILITY
YOUR USE OF THIS SITE, ANY WEBSITE LINKED THROUGH THIS SITE, AND ANY MATERIAL AVAILABLE ON THIS SITE IS ENTIRELY AT YOUR OWN RISK. IN NO EVENT SHALL THE SITE OWNER OR ITS AGENTS, AFFILIATES, PARTNERS, OR LICENSORS (COLLECTIVELY, “AFFILIATES”) BE LIABLE FOR ANY DIRECT, SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, OR ANY DAMAGES WHATSOEVER, RESULTING FROM LOSS RELATED TO THE USE OF THE SITE OR THE CONTENT CONTAINED HEREIN REGARDLESS OF THE TYPE OF CLAIM OR THE NATURE OF THE CAUSE OF ACTION, EVEN IF THE SITE OWNER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE OR LOSS. NONE OF THE SITE OWNER OR AFFILIATES SHALL BE RESPONSIBLE FOR LOST PROFITS, REVENUES, OR DATA, OR FINANCIAL LOSSES ASSOCIATED WITH THE USE OF THIS SITE OR THE MATERIALS CONTAINED HEREIN. IN THE EVENT ANY EXCLUSION OR LIMITATION OF LIABILITY IS LIMITED BY LAW, SUCH LIABILITY IS LIMITED TO THE FULLEST EXTENT PERMITTED BY LAW. 

ANY DISCLAIMER OF LIABILITY THAT IS PROVIDED IN CONNECTION WITH ANY ROCHE PRODUCTS DESCRIBED ON THIS SITE SHALL BE LIMITED TO THE WARRANTIES PROVIDED IN THE DOCUMENTS OF SALE OF SUCH PRODUCT, AND ANY LIMITATIONS INCLUDED THEREIN. YOU ARE RESPONSIBLE FOR THE CORRECT HANDLING OF ANY ROCHE PRODUCTS AND MUST FOLLOW THE INSTRUCTIONS OF THE PACKAGE INSERT AND WARNINGS ON THE LABEL. ROCHE SHALL NOT ASSUME ANY LIABILITY FOR DAMAGES RESULTING FROM WRONG HANDLING OF SUCH PRODUCTS.

5. INDEMNITY
YOU AGREE TO INDEMNIFY AND HOLD HARMLESS THE SITE OWNER, ITS AFFILIATES, AND THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYERS AND AGENTS, FROM ANY LIABILITY, DAMAGES, LOSSES, PENALTIES AND COSTS OF ANY KIND (INCLUDING REASONABLE ATTORNEYS’ FEES) MADE DUE TO OR ARISING OUT OF YOUR USE OF THE SITE OR OTHER ONLINE SERVICES PROVIDED BY THE SITE OWNER; YOUR VIOLATION OF THESE TERMS AND CONDITIONS OR THE PRIVACY NOTICE; OR YOUR VIOLATION OF ANY LAW OR THE RIGHTS OF A THIRD PARTY.

6. Third Party Content
Any link contained on this Site which provides access to third party resources or content is provided for convenience only. The Site Owner does not express any opinion on or endorsement of the content of any such third party links and expressly disclaims any liability for the quality, content, nature, or reliability of any such third party resources and the information, products and services found thereon. 

7. Copyright and Trademark
The Site Owner owns the copyright in all material and information contained on this Site unless otherwise indicated. This Site and all materials and information herein are for informational purposes only and are subject to all applicable U.S. and international copyright laws. Any reproduction, retransmission or other use is strictly prohibited. You may print one copy and may download extracts of any page(s) from the Site for your personal reference. You must not modify the paper or digital copies of any materials you have printed or downloaded in any way, and you must not use any illustrations, photographs, video or audio sequences, or any graphics separately from any accompanying text. You must always acknowledge the Site Owner’s status (and that of any identified contributors) as the author of material on this Site. You must not use any part of the materials on the Site for commercial purposes without the Site Owner’s written permission.

The Site Owner is licensed to use all intellectual property in the content of this Site and reserves the right to pursue any intellectual property infringement in the courts of the country where the Site Owner suffers damage. No license is granted to you to use any trademark of the Site Owner or their Affiliates. You shall not assert any claim or ownership to any such trademarks.

8. No Offers or Solicitations; Forward Looking Statements
The information provided on this Site does not constitute an offer of or solicitation for the purchase or disposal of, trading, or any transaction in any Roche securities. Investors must not rely on this information for investment decisions. 

This Site may contain forward-looking information. Such information is subject to a variety of significant uncertainties, including scientific, business, economic and financial factors, and therefore actual results may differ significantly from those presented.

9. Privacy Notice
Where allowed by law, by using the Site you also agree to our Privacy Notice, which can be viewed here .

10. Miscellaneous

A. Applicable Law: The courts of Indiana will have exclusive jurisdiction over any claim arising from, or related to, a visit to the Site, although we retain the right to bring proceedings against you for breach of these conditions in your country of residence or any other relevant country. These Terms and Conditions are governed by Indiana law.

B. Void Where Prohibited: Although this Site and its content may be accessible worldwide, not all products or services discussed on this Site are available to all persons or in all geographic locations or jurisdictions. Any offer for any product or service herein or access to information made on this Site is void where prohibited by law. Accessing the Site from territories where its contents are illegal or unlawful is prohibited. 

C. Minors: The use of this Site is not intended for children under the age of 16. Moreover, all minors should seek their parent’s or guardian’s permission prior to use of this website. 

D. Changes to these Terms and Conditions: The Site Owner reserves the right to change these Terms and Conditions at any time by publishing the amended Terms and Conditions on the Site. You should visit this page from time to time to review updates to the Terms and Conditions that are binding on you. Certain Terms and Conditions may be superseded by expressly designated legal notices or terms located on particular web pages visited by you or correspondence sent to you. 

E. Severability: If any of these Terms and Conditions should be determined to be illegal, invalid or otherwise unenforceable, then to the extent that Term or Condition is illegal, invalid or unenforceable, it shall be severed and deleted. The remaining Terms and Conditions shall survive, remain in full force and effect, and continue to be binding and enforceable. No waiver by Roche of breach of an obligation arising under these Terms and Conditions shall constitute a waiver of any other breach.

F. Contact Information: Please contact us with any questions or concerns regarding these Terms and Conditions, or any notices or complaints: 9115 Hague Road, PO Box 50414, Indianapolis, IN 46250.

 

ADDITIONAL PRODUCT PURCHASE TERMS AND CONDITIONS

October 10, 2018

These Additional Product Purchase Terms and Conditions together with the Use of Site Terms and Conditions (collectively, the “Terms and Conditions”) and our Privacy Notice  govern your use or viewing of the Site and your purchase and use of products (together, “Roche System”) and your relationship with Roche. By using the Roche System, you (“Customer”) agree to be bound by these Terms and Conditions.

Shipping and Delivery

Orders received Monday through Thursday by 4:00 pm EST will be fulfilled same day for receipt the next business day. Therefore, any orders received after 4:00 pm EST will be fulfilled the following day. Orders received on Friday will be fulfilled the following Monday.

Customer should ask its customer service representative for more information.  Please note, however, not all products can be shipped by air.  Not all products may be available for next-day delivery.

Customer may notice that, on occasion, certain products are shipped at temperatures that differ from the recommended storage temperature on the label (e.g., a product shipped at room temperature has a recommended storage temperature of -15 to - 20°C).  Roche has determined that these products, unopened, are stable for a reasonable time frame when shipped under these conditions.  We guarantee stability through the control date on the label when products are shipped under these conditions and stored upon receipt at the recommended temperature.

Customer may designate delivery address for orders shipped by Roche; provided, however, orders will be shipped only to actual business locations used solely for business purposes.  Roche reserves the right to request additional information from Customer as necessary to confirm that the delivery address supplied by Customer is a business location. Roche may, in its sole discretion, refuse to ship orders to a location specified by Customer. Roche will select the method of delivery.  Title passes to the Customer upon delivery to Customer’s designated facility. Customer is responsible for all freight, shipping, and handling charges which will be added to the invoice provided by Roche.  Where applicable, a $34.00 processing fee will be added to the prices quoted.  Taxes imposed on the sale of any product listed herein will be added to the prices quoted and will be the Customer’s sole responsibility.

Payment

Payment terms are NET 30 from the date of invoice.  Roche will invoice for the products upon shipment. Prices are subject to change without notice.  All orders are subject to final acceptance by Roche at the prices in effect at the time of shipment.  

Claims for Shortages

Roche uses great care in selection, checking, rechecking, and packing to minimize the possibility of error.  If any shipping discrepancies are discovered, claims must be made to the place of shipment within 10 days to be considered.  Please check all packing material thoroughly upon receipt of shipment.

Returning Product

There is a 15% restocking fee for returned product. No product may be returned without authorization from Roche.  Authorization (and the assigned return authorization number) is necessary to ensure correct return of material and issuance of credit or exchange of material. Requests for permission to return products must be made within 10 days of receipt.  Returned products must be clearly marked with sender's name, address, and return authorization number, and carefully packed and shipped prepaid.  Products must be returned in the same condition as received and within 15 days of original shipment by Roche.

No Resale

Products are intended solely for internal use by Customer and may not in any circumstances be resold by Customer.

Customer Provided Information

Customer accepts full responsibility for the security of its data, libraries and any other information submitted by Customer in connection with its use of the Roche System.  Roche is not obliged to, but it may in its sole discretion, review or edit the data, libraries and any other information submitted by Customer or accessed by Customer through Roche Systems for either accuracy or Customer’s intended purpose.  Customer is at all times responsible to ensure the accuracy of data, libraries and any other information submitted by Customer.  Roche assumes no liability for such review or edits and may remove or restrict content which, in Roche’s sole discretion, may be illegal, may subject Roche or its affiliates to liability, or which otherwise violates these Terms and Conditions.  Roche may cooperate in the investigation of any suspected or alleged crime, civil wrong or infringement.

Customer authorizes and grants Roche a limited, non- exclusive, royalty-free, perpetual, world-wide license to: (1) reproduce, transmit, disclose, display and use Customer’s data, libraries, and information for the purpose of enabling Customer to use the Roche System; (2) process Customer requests and transactions, including without limitation development manufacturing and sale of products or services to Customer and third parties (3) monitor the Roche System for indications of unauthorized use; and (4) maintain and improve the Roche System.

Customer’s use of the Roche System does not constitute an order.  To place an order, design submissions must be transmitted to a Roche web store or otherwise communicated to Roche through an ordering channel acceptable to Roche.  Additional terms and conditions shall apply to any sale, manufacturing, and ordering of products based on designs and configurations that have been made using the Roche System.

Warranty

The sole and exclusive warranty for products shall be the written warranty included in the product labeling, regardless of medium in which it is provided. The sole and exclusive remedy for breach of warranty is to refund, replace, or repair the affected product, at Roche's sole discretion. THE LIMITED WARRANTY SET FORTH IN THIS SECTION WILL BE IN LIEU OF, AND ROCHE EXPRESSLY DISCLAIMS, ANY OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES WHETHER ARISING FROM WARRANTY OR OTHERWISE.

Rights to Products

Roche's products are developed, designed, and labeled for sale for a variety of uses, including "For Life Sciences Research" or “Research Use Only.”  Customer acknowledges that product is intended exclusively for use as labeled. Product labeled as "For Life Sciences Research" or “Research Use Only” are intended exclusively for research use only and not for any in vitro diagnostic or in vivo use.   Customer acknowledges that use of product for diagnostic purposes or in studies to demonstrate the safety and effectiveness of product for human applications(s) is not allowed under federal regulations.  Customer agrees not to use products in violation of any legal duty to any third party or to intentionally or unintentionally violate any national or international statute, law, decree, rule and/or regulation.

Subject to the terms and conditions on this Site, Customer is granted only a non-exclusive, non-transferable, personal, non-sublicensable right under Roche Sequencing Solutions, Inc.’s Core IP (defined below) to use product for Research Use Only in next-generation-sequencing only (the “Field”). Without limitation, Field expressly excludes any other use or application product such as, among other things the following non-exhaustive list of exclusions (a) incorporation of product into any of Customer’s products or kits other than those specified above; (b) any use or application of product for any steps within the sequencing workflow other than pre-sequencing sample preparation; (c) diagnostic or forensic purposes, including but not limited to pre-natal testing; (d) therapeutic purposes (including any attempt to cure, mitigate, treat or prevent disease); (e) point-of-care-applications; or (f) in vivo use. “Research Use Only” means use for internal research, specifically excluding any use that (i) is not in accordance with product’s specifications, user manual, package insert, and any other similar documentation for product in effect on the date that product ships from Roche, (ii) utilizes (or requires grants of rights or a license to) Application Specific IP (defined below), (iii) is the disassembling, reverse-engineering, separation, extraction, or isolation of components of product or other unauthorized analysis of product, or (iv) is a clinical, forensic, diagnostic, or other non-research use of product.

Customer agrees that the first sentence of the above paragraph is designed to and does alter the effect of the exhaustion of patent rights that would otherwise result if the sale was made without restriction. Except as expressly stated in this section, no right or license under any Roche intellectual property rights is or are granted, expressly, by implication, or by estoppel, to Customer. “Application Specific IP” means the intellectual property owned by or controlled by Roche that pertain to or cover aspects or features of product (and use thereof) only with regard to specific field(s) or specific application(s) or specific assays. Application Specific IP excludes all Core IP. “Core IP” means the intellectual property owned, controlled or sub-licensable by Roche Sequencing Solutions, Inc. (specifically excluding Roche’s Affiliates), as of the date product ships: (A) that covers or claims product as a composition of matter in a stand-alone product and (B) methods of use claims are licensed only to the extent that such method of use claims are directed at generic use of product for sample preparation for next-generation sequencing reactions. Customer agrees that (i) Customer’s use of product in any manner or for any purpose other than Research Use is a breach of these terms and conditions; (ii) actual knowledge by Roche, or Roche’s Affiliates, that Customer is using product in any manner or for any purpose other than Research Use does not (a) waive or otherwise limit any rights that Roche, or Roche’s Affiliates, may have as a result of such use of product, including without limitation, any rights or remedies available under these terms and conditions, at law and/or in equity, or (b) grant Customer a license to any intellectual property owned or controlled by Roche or Roche’s Affiliates whether by implication, estoppel, or otherwise with respect to such use of product; and (iii) any trade usage, course of performance, or course of dealing between Roche and Customer, will not be used to interpret these terms and conditions, including without limitation, the scope of the Research Use rights for product conferred under this Section.  Federal regulations may require Roche to obtain written confirmation from Customer that product is not being used for human diagnostic or therapeutic purposes.

Customer is solely responsible for determining whether Customer has all intellectual property rights that are necessary for Customer’s intended uses of product, including without limitation, any rights from third parties or rights from Customer, or Customer’s affiliates, to Application Specific IP. Customer makes no guarantee or warranty that Customer’s specific intended uses will not infringe the intellectual property rights of a third party or Application Specific IP of Roche or Roche’s affiliates.

Intellectual Property

Customer agrees not to translate, reverse engineer, reverse compile, disassemble, make derivative works from, or in any way attempt to gain access to the underlying features of the Roche System, or to disable, improperly access or modify the products in any way or to cause any others to do any of the foregoing.  Customer acknowledges and agrees that Roche retains intellectual property rights in the Roche products and agrees not to act in any manner that may infringe on these rights.  Furthermore, Roche makes no representation or warranty regarding non-infringement. 

Reagents Regulatory Classification

Roche’s products are developed, designed, and labeled for sale for a variety of uses, including "For Research Use Only".   The Roche System is intended exclusively for use as labeled.  Products labeled as "For Research Use Only" are intended exclusively for in vitro and non-human in vivo use where not prohibited by regulatory agencies and explicitly stated on the label.  Use of these products for diagnostic purposes or in studies to demonstrate the safety and effectiveness of the product for human applications(s) is not allowed under regulations.  Regulations may require Roche to obtain written confirmation from Customer that Roche products are not being used for human diagnostic or therapeutic purposes.  It is Customer’s responsibility to ensure compliance with all state and federal laws and regulations.

NimbleDesign, RealTimeReady, SeqCap, HEAT-Seq

1.         For avoidance of doubt, NimbleDesign, RealTimeReady tools and the process for ordering services or products directed to peptide arrays (“Design System”) are Sites.

 2.        Through Customer’s use of Design System, Customer may provide one or more targets, which may include specific nucleic acid or peptide sequences (“Targets”), which may result in one or more designs of one or more peptide or nucleic acid sequences related to Targets, including designs designated by Roche IRN or configuration numbers (“Designs”), which may result in product made according to the specifications of Designs (“Design Product”). 

3.         Roche agrees that no right, title and interest to patents or patent applications claiming Targets already held by Customer that pre-existed Customer’s use of Design System are transferred by these Terms and Conditions, except that a limited non-exclusive license to make, use and sell Design and Design Product under these Terms and Conditions is hereby granted to Roche.  Customer agrees that all right, title and interest to Designs are and are hereby assigned to Roche and that Roche has no obligation to disclose details of Designs to Customer.  Design Products are for research use only and will not be used for diagnostic, prognostic or therapeutic uses.  For clarity, Design Products that are peptide arrays will not be provided to Customer.

4.         In the event that Roche has expressly accepted a project order, for a period of two (2) years from Roche’s receipt of Targets, Roche agrees: (a) to treat Targets with the same confidential treatment as it would treat its own confidential information of a similar nature, but with at least reasonable care; and (b) not to disclose the Confidential Information to any third party, other than Affiliates, without Customer’s consent.  Roche shall be relieved of the foregoing with respect to Target(s) which:

  1. was known to Roche or its Affiliates prior to Roche’s receipt of the Target from Customer; or
  2. at the time of disclosure by Customer to Roche, was generally available to the public, or which after disclosure by Customer to Roche becomes generally available to the public including but not limited to Customer’s publications, through no fault or omission attributable to Roche or its Affiliate; or
  3. is hereafter made available to Roche or its Affiliates for use or disclosure by Roche or its Affiliate from any third party having a right to do so without any obligation back to Customer; or
  4. was developed independently by Roche or its Affiliates without access to or use of Targets as disclosed by Customer to Roche; or
  5. is the subject of disclosure required by applicable law or regulation; or
  6. is inherently disclosed in, or capable of being determined by, the observation, use, lease, sale, distribution, design, or operation of any commercially available product or service, including associated documentation.

5.         Only as expressly stated in a project order that has been expressly accepted by Roche, Customer may send certain materials to Roche (“Materials”).   Customer shall ensure that Roche will not be provided with any Personal Data associated with Materials.  Customer represents and warrants that: (a) it has the rights to provide the Materials to Roche; (b) it has obtained all necessary permissions; and (c) it has in good faith ascertained whether informed consent is required by any other applicable legal authority, and if necessary, obtained informed consent.  Customer is responsible for ensuring safe packaging, transport, and delivery of Materials (including, without limitation, biological specimens) to Roche and in compliance with Customer’s applicable federal, state and local shipping regulations.  Without limiting the foregoing, Materials shall be shipped to Roche in accordance with the shipping guidance (including, packaging and labeling requirements for biological specimens) requirements specified by Roche to Customer.

6.         Customer hereby acknowledges and agrees that Roche and its Affiliates have had, currently has and is free to: (a) use Design System with any third party and that such use has the potential for overlap or identity with Design and/or Design Products; (b) possess or independently develop information and designs that are similar to or the same as Design and (c) develop, make, have made, use, sell, offer to sell, have sold, have distributed, import and export products related to the foregoing (a) and (b) in any field worldwide.  Nothing in these Terms and Conditions shall prohibit Roche’s use of publically available information to develop, make, have made, use, sell, offer to sell, have sold, have distributed, import and export products related to the foregoing (a) through (c).

7.         In the event Customer agrees that Roche may sell Design Product as catalog item and/or off-the-shelf item, Customer hereby acknowledges and agrees that Roche and its Affiliates: 

a.      May make, have made, use, sell, offer for sale, have distributed, import and export Design Products worldwide and in any field and no royalty, payments or other consideration shall be due to Customer.

b.      May use, publish, display publicly, and/or transmit electronically Design, along with any information contained therein, including Targets, in any present or future media, including without limitation, any publications, displays, websites (including www.mylabonline.com) or other print, video, broadcast or promotion media, for any educational, commercial or promotional purposes.

c.       May use both: (a) Customer’s name in a factual manner as the party to whom Design Product was provided or as the author of a publication or similar in which Design Product was used or described, and/or (b) the names or trade names used by Customer to refer to Design Product in any of Customer publications or other disclosures, in Roche’s research, development, marketing, promotion and advertising of Design Products, including but not limited to brochures, catalogs, websites, case studies, press release, sales presentations, posters, emails, videos and promotions. 

8.         Customer warrants that: (a) Targets, oligonucleotides, peptides and collections of oligonucleotides or peptides which hybridize to Targets are not covered by any third party’s rights (including without limitation intellectual property rights), (b) no dispute with any third party regarding infringement or a possible infringement exists and (c) Customer has the right to provide Targets to Roche.

Entire Agreement

The Terms and Conditions constitute the entire agreement between Roche and Customer, and supersede any previous communications, representations or agreements between the parties, whether oral or written, regarding transactions using the Roche System. Customer's additional or different terms and conditions will not apply.

 

Research Use Only. Not for use in diagnostic procedures.