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Product Restriction Agreements


Certain products purchased from Zalgen Labs require that the Purchaser/User agree to specific terms and conditions concerning the use of these products.

Each time the Purchaser/User purchases restricted products on the ZalgenLabs.com website, the Purchaser/User will be promoted to acknowledge acceptance and agreement to the appropriate restriction(s) listed below for that particular product. Failure to accept these restrictions will limit the Purchaser/User from purchasing the restricted products.

Some products also require that the Purchaser/User agree to the restricted terms and conditions in writing prior to the initial purchase.

I. PURCHASE OF Diagnostic test kits and materials labeled For Research Use Only.

  • Products sold by Zalgen Labs LLC labeled Research Use Only (RUO) are referred to as “RUO Version Products”.
  • RUO Version Products are “For Research Use Only”. RUO Version Products are not US Food and Drug Administration (“FDA”) cleared or approved for diagnostic, prognostic, or any other clinical use. They are not authorized for emergency use.
  • RUO Version Products do not bear a CE mark. RUO Version Products are not to be used to compare to an IVD that bears a CE mark. If the Purchaser/User intends to compare it to a test with the CE mark, Zalgen must be notified in writing for review and approval, and to obtain the appropriate labeled product that conforms to the requirements of the European Union IVD Directive (“IVDD”).
  • RUO Version Products have no intended investigational use and the testing performed is not to be used to provide data addressing or demonstrating safety or effectiveness.
  • RUO Version Products are not to be used to report patient results for diagnostic, prognostic, or any clinical purposes, or to make treatment decisions, except as permitted by applicable law.
  • RUO Version Products are not to be used in an independent clinical study. If the Purchaser/User wishes to conduct an independent clinical study, Zalgen shall be notified in writing for review and approval, and to obtain the appropriately labeled product.
  • The Purchaser/User understands RUO Version Products are subject to change at any time.
  • By purchasing RUO Version Products, the Purchaser/User verifies the intention to use these products for Research Use Only, except as otherwise expressly permitted by applicable law.


  • Products sold by Zalgen Labs LLC labeled Investigational Use Only (IUO) are referred to as “IUO Version Products”.
  • IUO Version Products are specifically for use in designated clinical studies. Prior to purchase of IUO Version Products from Zalgen, the clinical investigators and all others directly responsible for use of the IUO Version Products in a specific clinical study (the “Clinical Study”), hereby designated as the “Investigators”, must provide a copy of the clinical protocol to Zalgen.
  • The Investigators certify that they have all governmental approvals to conduct the Clinical Study including use of the IUO Version Products.
  • IUO Version Products are “For Investigational Use Only”. IUO Version Products are not cleared or approved by the US Food and Drug Administration (“FDA”) for diagnostic, prognostic, or any other clinical use. IUO Version Products are not authorized for emergency use. IUO Version Products are not CE Marked.
  • The performance characteristics of the IUO Version Products have not been established.
  • IUO Version Products are IVD product being provided for product testing that is not subject to the FDA 21 CFR part 812 prior to full commercial marketing for testing of specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful.
  • Testing using IUO Version Products must be performed and used to generate clinical data and assess safety or effectiveness as specified in the Clinical Study.
  • IUO Version Products are not to be used to report patient results for diagnostic, prognostic, or any clinical purposes, or to make treatment decisions, except as permitted by applicable law other than as specified in the Clinical Study.
  • The Investigators understand IUO Version Products are subject to change at any time.


  • Purchaser/User must have in place a written License and Material Transfer Agreement (“LMTA”) with Zalgen Labs specifying restrictions to the use of Viral Antigens, Viral Antibodies, and certain other products prior to purchasing those restricted products from Zalgen.
  • See example below of a LMTA template.
  • Each Purchaser/User wishing to establish a LMTA to obtain such limited products are to proceed as follows:
    • Contact Zalgen at admin@zalgenlabs.com with a request to prepare a LMTA, providing basic information including list of Zalgen product(s) of interest and information highlighted in yellow in the template below.
    • Zalgen will prepare and return a draft LMTA for further discussion. Conference calls will be scheduled as appropriate.
    • Following completion and execution of the LMTA by both parties, the Purchaser/User will have access to purchasing the designated products.




This License and Material Transfer Agreement (the “Agreement”) is between Zalgen Labs, L.L.C., a Maryland limited liability corporation with a principal place of business located at 7495 New Horizon Way, Suite 120, Frederick, Maryland 21703 USA, (“Zalgen”), and [Name of Recipient] a Company organized under the laws of the State of __________with an address at _____________________________ (“Recipient”), in response to a request to purchase certain research materials controlled by Zalgen (hereinafter, “Zalgen Material”).




  1. Zalgen is engaged in the research, development, production, and commercial distribution of diagnostic platforms, vaccines, immunotherapeutic agents, and materials for the response to and the identification and treatment of human viral infectious diseases, including tropical diseases such as Ebola, Lassa and other lethal hemorrhagic viral diseases.


  1. Zalgen is the owner and/or exclusive licensee of the Zalgen Material identified herein. For any Zalgen Materials in licensed by Zalgen, Zalgen has the rights necessary to grant the rights provided hereunder.


  1. Recipient is engaged in (insert description of Recipient’s business).


  1. Recipient wishes to acquire a license to use certain Zalgen Material identified in Appendix A to this Agreement (the “Licensed Zalgen Material”) for purposes of investigating the Licensed Zalgen Material solely for Recipient’s internal research purposes.


  1. Zalgen desires to grant Recipient a license to use the Licensed Zalgen Material and to provide the Licensed Zalgen Material solely for the performance of research internal to Recipient as set forth in the research program outlined in Appendix B to this Agreement and for no other purpose.


In accordance with the mutual covenants and conditions herein set forth, Zalgen and Recipient hereby agree as follows:




  1. Definitions:


  1. Effective Date: The Effective Date of this Agreement shall be the date of the last party to sign the Agreement at the places indicated at the end hereof.


  1. Licensed Zalgen Material: The Zalgen Material identified and listed in Appendix A to this Agreement including but not limited to materials delivered by Zalgen to Recipient pursuant to the provisions of this Agreement and any modified or unmodified Progeny, Derivatives and/or Modifications thereof (as those terms are defined in this Agreement) created by Recipient or Recipient Scientist.


  1. Progeny: Unmodified direct descendants from the Licensed Zalgen Materials.


  1. Unmodified Derivatives: Substances created by the Recipient that constitute an unmodified functional subunit or product expressed by the Licensed Zalgen Material. Some examples include: subclones of unmodified cell lines, purified or fractionated subsets of the Licensed Zalgen Material, proteins expressed by DNA/RNA supplied by Zalgen, or monoclonal antibodies secreted by a hybridoma cell line.


  1. Modifications: Substances created by the Recipient which contain and/or incorporate the Licensed Zalgen Material, Progeny, or Unmodified Derivatives.


  1. Commercial Purposes: The sale, lease, license, or other transfer of the Licensed Zalgen Material to any organization, including Recipient, to perform contract research, to screen compound libraries, to produce or manufacture products for general sale, or to conduct research activities that result in any sale, lease, license, or transfer of the Licensed Zalgen Material to outside parties. However, industrially sponsored academic research will not be considered a use of the Licensed Zalgen Material for Commercial Purposes per se, unless any of the above conditions of this definition are met.


  1. Research: The research program described in Appendix A.


  1. License Grant:


  1. Zalgen hereby grants to Recipient a nontransferable nonexclusive, revocable right and license to use the Licensed Zalgen Material solely for the Recipient’s performance of internal research as set forth in the research program outlined in Appendix B to this Agreement.


  1. Only the rights and licenses specifically set forth in Section 2.A are granted under this Agreement as of the Effective Date hereof, and, in particular, under this Agreement, no rights are granted to Recipient to sell Licensed Zalgen Material to third parties.


  1. Ownership and Limitations on Use:


  1. Ownership: The Recipient understands and agrees that it may not make, manufacture, derive, or otherwise create materials through the use of the Licensed Zalgen Material that are not Progeny, Unmodified Derivatives, or Modifications (i.e., do not contain the Licensed Zalgen Material identified in Appendix A, Progeny, Unmodified Derivatives, or Modifications). If the Recipient makes, manufactures, derives, or otherwise creates such Modifications, materials, or other substances, all such Modifications, materials, and other substances shall be owned by Zalgen and Recipient will have no rights in or to such substances.


  1. Limitations on Use: The Recipient agrees that the Licensed Zalgen Material:


1)         is to be used solely for internal research purposes;


2)         will not be used in human subjects, in clinical trials or for diagnostic purposes involving human subjects;


3)         is to be used only at the Recipient organization; and


4)         is to be used only for the Research as described in Appendix B and will not be used for any other research or purpose without the prior written consent of Zalgen; and


  1. Confidentiality and Reservation of Rights:


  1. Duty of Confidentiality: All Licensed Zalgen Material and any information relating thereto (the “Confidential Information”) that is disclosed by Zalgen to Recipient is confidential. Recipient will use reasonable best efforts consistent with standards in the industry to prevent the disclosure of Confidential Information to third parties for a period of ten (10) years from receipt, except for any Confidential Information that is expressly marked as a trade secret. As such, a trade secret will be maintained in confidence for so long as it is considered confidential and its trade secret status remains, provided that if it is no longer confidential, its entry into the public domain was through no fault of the Recipient. Recipient will not use Confidential Information for any purpose other than the Research. Recipient’s obligations of confidentiality and non-use will not apply to Confidential Information that:


1)         is already in the Recipient’s possession at the time of disclosure by Zalgen under this Agreement, as evidenced by the Recipient’s written records;


2)         is or later becomes part of the public domain through no fault of the Recipient;


3)         is received by the Recipient from a third party having no obligations of confidentiality to Zalgen; or


4)         is independently developed by the Recipient without reference to information disclosed by Zalgen to Recipient under this Agreement, as evidenced by the Recipient’s written records.


  1. Disclosure Pursuant to Court Order: In the event that Recipient receives a subpoena, a notice to produce, or information submissions or filings required by government agencies demanding Confidential Information, the Recipient will, to the extent possible and permissible under applicable law, promptly notify Zalgen in writing of such a demand to disclose. Such notice will include, without limitation, identification of the information to be so disclosed and a copy of the order. Zalgen may seek an appropriate protective order and/or waive the Recipient’s obligations of nondisclosure under this Agreement. If requested by Zalgen, the Recipient will reasonably cooperate with Zalgen, at Zalgen’s expense, in seeking an appropriate protective order. If the Recipient is nonetheless compelled to disclose the Confidential Information, the Recipient will disclose only that portion of the Confidential Information which the Recipient, in its good faith judgment, is legally required to disclose. Upon Zalgen’s request and at Zalgen’s expense, the Recipient will use reasonable efforts to obtain assurances that confidential treatment will be accorded to such Confidential Information to the extent such treatment is available. The act of such disclosure will not operate to render Confidential Information non-confidential, unless the making of such required disclosure renders the Confidential Information public record.


  1. Requests from Third Parties: The Recipient agrees that any request for the Licensed Zalgen Material from anyone other than the Recipient will be referred to Zalgen.


  1. No Implied Licenses: The Recipient acknowledges that the Licensed Zalgen Material is or may be the subject of a patent application. Except as provided in this Agreement, no express or implied licenses or other rights are provided to the Recipient under any patents, patent applications, trade secrets or other proprietary rights of Zalgen, including any proprietary rights of Zalgen relating to any altered forms of the Licensed Zalgen Material. No express or implied licenses or other rights are provided to use the Licensed Zalgen Material, or any related patents controlled by Zalgen for Commercial Purposes or for any purposes other than the Research.


  1. Retention and Reservation of Rights: Other than the rights granted by Zalgen to Recipient herein to use the Licensed Zalgen Material for the Research, Zalgen retains and reserves all other rights to the Licensed Zalgen Material. Should the Recipient desire to use or license the Licensed Zalgen Material for Commercial Purposes, the Recipient agrees, in contemplation and in advance of such use, to negotiate in good faith with Zalgen to establish the terms of a commercial license. Recipient understands and agrees that Zalgen has no obligation to grant a commercial license or any other type of a license to the Recipient, and that Zalgen may grant exclusive or non-exclusive commercial licenses to others or sell or assign all or part of the rights in the Licensed Zalgen Material to any third party or parties, subject to any pre-existing rights held by others and obligations to the United States Federal Government. Nothing contained in this Agreement obligates or may be construed to obligate in any way Zalgen to proceed with any negotiation or transaction or to establish any business relationship, whether expressly contemplated by this Agreement or otherwise, with Recipient or any other third party.


  1. Disclaimer of Warranties; Indemnification:




  1. Assumption of Liability and Indemnification by Recipient:


1)         Except to the extent prohibited by law caused by the gross negligence or willful misconduct of Zalgen, the Recipient assumes all liability for any and all damages which may arise from its use, storage, or disposal of the Licensed Zalgen Material. Zalgen will not be liable to the Recipient for any loss, claim or demand made by the Recipient or any other party, due to or arising from the use, storage, or disposal of the Licensed Zalgen Material by the Recipient.


2)         Recipient will defend, indemnify and hold harmless Zalgen, its administrators, officers, directors, employees, licensors, and insurers (individually, an “Indemnified Party”, and collectively, the “Indemnified Parties”), at the expense of Recipient, from and against any and all liability, loss, injury, damage, action, court or administrative order, claim or expense suffered or incurred by the Indemnified Parties, including, without limitation, reasonable attorney’s fees and expenses, court costs and other legal expenses, (individually, a “Liability”, and collectively, the “Liabilities”) that results from or arises out of: (a) any act or failure to act of Recipient (b) the development, use, manufacture, promotion, sale or other disposition of any Licensed Zalgen Material by Recipient, or any of its Affiliates, or any of its agents, or any other third parties under Recipient’s control; (c) any material breach by Recipient of this Agreement; or (d) the enforcement by an Indemnified Party of this Section.



  1. Miscellaneous:


  1. Research Results: The Recipient agrees and acknowledges that no manuscript, abstract, presentation, or other publication disclosing Research results that includes Confidential Information that has been expressly marked as a trade secret may be submitted to a third party or otherwise disclosed to a third party without Zalgen’s prior written approval. The Recipient agrees that appropriate acknowledgement of the source of the materials upon which any such manuscript, abstract, presentation, or other publication disclosing Research results is based will be included in any publication that results from the Research.


  1. Regulatory Compliance: The Recipient agrees to use the Licensed Zalgen Material in compliance with all applicable statutes and regulations, including U.S. Public Health Service and U.S. National Institutes of Health regulations and guidelines, such as those relating to research involving the use of animals or recombinant DNA, for example.


  1. Export Regulations: Recipient further agrees that it will not export any Licensed Zalgen Material received under this Agreement to any countries for which the United States government requires an export license or other supporting documentation at the time of export or transfer.


  1. Term and Termination: This Agreement will terminate on the earliest of the following dates: (a) five (5) years from the Effective Date, or (b) on completion of the Research, or (c) on thirty (30) days’ written notice by either party to the other. Upon any expiration or termination of this Agreement, the Recipient will discontinue its use of the Licensed Zalgen Material and will, upon direction of Zalgen, return or destroy any remaining Licensed Zalgen Material and Confidential Information and certify in writing of its destruction.


  1. Assignment: This Agreement is not assignable, whether by operation of law or otherwise, without the prior written consent of Zalgen. Any purported assignment that does not comply with this Section 6.E. is null and void. This Agreement is binding upon and will inure to the benefit of and be enforceable by the parties, their successors, and their permitted assignees, if any.


  1. Survival: Sections 3, 4, 5, 6.A, 6.D, 6.F, 6.H, 6.I., 6.J, 6.K, and 6.L will survive any expiration or termination of this Agreement.


  1. Authority to Enter into Agreement: Each of the parties represents that it has full and unrestricted power and authority to enter into this Agreement and to adhere to the obligations. Each of the parties represents that to the best of its knowledge, the terms of this Agreement do not conflict with, violate, or constitute a breach or default under any other agreement to which it may be a party.


  1. Inadvertent Disclosure: In the event that Confidential Information, including Licensed Zalgen Material, is inadvertently or accidentally disclosed, the Recipient will notify Zalgen as promptly as possible and will take all necessary precautions to avoid further dissemination of the Confidential Information and/or Licensed Zalgen Material disclosed, as well as precautions to prevent any additional disclosure thereof.


  1. Entire Agreement: This Agreement embodies the entire agreement and understanding between the parties hereto and supersedes all prior agreements and understandings relating to the subject matter. This Agreement may not be changed, modified, or extended except by written amendment executed by an authorized representative of each party.


  1. Governing Law: This Agreement, and all matters arising out of or relating to this Agreement, will be interpreted, construed, and enforced in accordance with the laws of the State of Maryland, without giving effect to its conflicts of law principles.


  1. Severability/Unenforceability: If any provision of this Agreement is held to be illegal, invalid, or unenforceable, then such illegality, invalidity or unenforceability will attach only to such provision and will not in any manner affect or render illegal, invalid, or unenforceable any other provision of this Agreement, and this Agreement will be carried out as if any such illegal, invalid, or unenforceable provision were not contained herein.


  1. Injunctive Relief: The Recipient acknowledges that money damages would be both incalculable and an insufficient remedy for any breach of this Agreement and that any such breach would cause Zalgen irreparable harm. Accordingly, the Recipient agrees that in the event of any breach or threatened breach of this Agreement, Zalgen will be entitled, without the requirement of posting a bond or other security, to equitable relief, including injunctive relief and specific performance, in addition to any other remedies at law or in equity it may have.


  1. Multiple Counterparts: This Agreement may be executed in several counterparts, each of which, when executed and delivered, will be deemed to be an original, and all of which together will constitute and be deemed to be one and the same instrument. Transmission by facsimile, email, or other form of electronic transmission of an executed counterpart of this Agreement will be deemed to constitute due and sufficient delivery of such counterpart.


  1. Notices: All notices, requests, and other communications hereunder will be in writing and will be personally delivered or by registered or certified mail, return receipt requested, postage prepaid, in each case to the respective address specified above, or such other address as may be specified in writing to the other party, and will be deemed to have been given upon receipt.


  1. Waivers: It is agreed that no waiver by either party of any provision, or of any breach or default of any of the covenants or agreements set forth herein, will be deemed a waiver as to any subsequent and/or similar breach or default, nor will any delay or omission on the part of either party to exercise or avail itself of any right, power or privilege that it has or may have hereunder operate as a waiver of any right, power or privilege by such party.


Remainder of this page intentionally left blank. Signature page to follow.





By: ____________________________


Name: _________________________


Title: __________________________


Date: __________________________






By: ___________________________________


Name: ________________________________


Title: _________________________________


Date: _________________________________









The materials which are the subject of this Agreement are as follows:




Description of the research to be conducted with the Licensed Zalgen Materials:

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