TBDA Cooperation & Sharing Agreement

2012-01-19

COOPERATION & SHARING AGREEMENT

TB Drug Accelerator Program

THIS COOPERATION & SHARING AGREEMENT (this Agreement) is hereby entered into effective as of     , 2011 by and among the founding members of the TBDA listed in Annex A (each a Party and a Founding TBDA Member and collectively the Parties and the Founding TBDA Members).

WHEREAS, each Party is a participant in the TB Drug Accelerator Program (TBDA) – a program that is largely funded by the Bill & Melinda Gates Foundation (the Foundation) to support their collective work aimed at identifying and generating lead drug compounds to fit into the global tuberculosis drug pipeline. Each Party becomes a Founding TBDA Member upon their signature of this Agreement.

WHEREAS, each of the Parties acknowledge that the primary goals of the TBDA are to accelerate the discovery of lead TB drug compounds that can be developed into new TB therapies through the development and use of innovative technologies and consistent, collaborative laboratory practices (the TBDA Goals).

WHEREAS, the Parties include public and private entities, including agencies of sovereign nations, whose compliance with specific terms of this Agreement may be conditioned by legal limitations.

WHEREAS, the TBDA is not a separate legal entity and this Agreement and its Annexes do not themselves create an obligation on TBDA Members to contribute resources or undertake research projects, but this Agreement and its Annexes do create a collaborative framework through which TBDA Members may better carry out research projects they are undertaking individually and under agreements with other TBDA Members.

WHEREAS, the TBDA Members intend to work in collaboration, united by a robust system for the exchange of Data and Materials, and supported, as appropriate, by the Foundation’s Global Health Program staff.

WHEREAS, the agreements needed to establish the TBDA as a working collaborative network will be based on this Agreement and the Annexes hereto.

WHEREAS, each of the Parties agrees to conduct TBDA Projects under this Agreement in a manner that is consistent with and in furtherance of the Global Access Objectives.

Now, therefore, the Parties agree to the following terms and conditions:

  1. Defined Terms. Annex B contains a set of defined terms that have the same definition as used within this Agreement and the documents described in Sections 4-6 below, unless otherwise specifically stated in the particular document.
  2. Cooperative Activities. The Parties agree to use good faith efforts to conduct various activities under the TBDA in a collaborative fashion with other TBDA Members with the aim of

accelerating the achievement of the TBDA’s Goals through the building of efficiencies, avoiding redundancies and cross-analyzing research results. The scope, timing and level of such cooperative activities, and the budgetary implications, are to be agreed upon by the organizations conducting the activities. Such activities may include (but are not limited to) cross screening of compounds, target finding (e.g., mutant generation), and assistance in conducting protocols/SOPs. Specific cooperative activities may be identified and suggested by any TBDA Member, the Foundation or the Scientific Advisory Panel. This agreement does not prohibit TBDA Members from collaborating with non-TBDA Members in projects related to tuberculosis

  • Scientific Advisory Panel. A Scientific Advisory Panel (SAP) will be established to provide guidance to the TBDA Members in the performance of TBDA Projects and to the TBDA as a whole in order to identify priorities, potential cooperative activities and possible additional organizations to be included in the TBDA, and to assist in moderating disagreements within cooperative activities, assessing ongoing work and shaping the overall direction of the TBDA. The TBDA Council will agree on the membership of the SAP and on a SAP charter agreement that will describe more specifically the role of the SAP as well as the requirements for membership on the SAP.
  • Guiding Principles for Sharing. In furtherance of the primary goals of the TBDA, and taking into consideration and balancing the respective business, legal and academic needs and incentives, the Parties have prepared the Data & Materials Sharing Guiding Principles as set out in Annex C. Each Party hereby agrees that they will comply with the Guiding Principles regarding its sharing of Data and Materials with the other TBDA Members and the broader scientific community.
  • Confidentiality. Each Party hereby agrees that Confidential Information exchanged between TBDA Members shall be exchanged in accordance with the terms of the Master TBDA Confidential Disclosure Agreement set out in Annex D.
  • Material Transfers. Each Party hereby agrees that Materials which are transferred between TBDA Members shall be transferred in accordance with the terms of the Master TBDA Material Transfer Agreement set out in Annex E.
  • Incorporation by Reference; Modification. All Annexes and Exhibits referenced above are hereby incorporated into and made a part of this Agreement. This Agreement may only be modified or supplemented in a writing expressly stated for such purpose and signed by the Parties.
  • Counterparts. This Agreement may be signed in counterpart, each of which will be considered an original, and all of which collectively will be deemed the same document.
  • Affiliates. Each TBDA Member shall have the right to extend the rights and licenses granted to it hereunder to those entities which can be defined as such TBDA Member’s Affiliates, provided that such TBDA Member shall remain responsible and liable for all obligations of its Affiliates under this Agreement.
  1. TBDA Membership.
    1. All Founding TBDA Members are TBDA Members upon their signature of this Agreement.1 Additional entities may become TBDA Members if (i) they provide evidence to the

1 The Parties acknowledge that Abbott announced on October 19, 2011 that it intends to separate into two publicly traded companies: (1) a diversified medical products company, that will retain the name Abbott Laboratories, and (2) a research-

TBDA Council of a commitment to make a material contribution to the TBDA Goals, (ii) the TBDA Council agrees by consensus to their admission (which shall not be unreasonably withheld) and (iii) they sign this Agreement. For the purposes of this paragraph, a “commitment to make a material

contribution to the TBDA Goals” can be demonstrated through a written agreement between the proposed new member and another TBDA Member or the Foundation. Such an agreement with an existing TBDA Member or the Foundation may be in the form of a sponsorship agreement whereby an existing TBDA Member and/or the Foundation sponsors an applicant for TBDA membership and whereby that applicant commits to specific activities in furtherance of the TBDA Goals.

  • A TBDA Member may withdraw from this Agreement upon written notice to the Foundation which will then promptly send that written notice to the TBDA Council. The withdrawal of a TBDA Member will be effective 60 days following the receipt of such notice.
  • In the event a TBDA Member is unable or unwilling to continue to make a material contribution to the TBDA Goals, it may be invited by the TBDA Council to withdraw their membership in the TBDA in accordance with sub-paragraph (b). Such an invitation may be made on the basis of a simple majority of the TBDA Council members. If the TBDA Member concerned does not withdraw its membership in the TBDA, its membership in the TBDA may be terminated by a 2/3 majority vote of the TBDA Council.
  • Withdrawal under sub-paragraph (b) or termination under sub-paragraph (c) does not affect any rights or obligations established (including license rights granted to and by the withdrawing or terminated TBDA Member) with respect to TBDA Inventions, Data, Materials, Confidential Information, or obligations to achieve the Global Access Objectives established prior to the effective date of the withdrawal.
  • The TBDA Council may establish committees or other subsidiary bodies to better carry out its work and may establish rules and procedures to implement all responsibility given to it under this Agreement and its Annexes.
  1. Term. This Agreement shall remain in force as long as there are at least two TBDA Members.
  1. Compliance with Laws. In conducting its activities under this Agreement and the Annexes hereto, each TBDA Member agrees to comply with all applicable laws and regulations, including but not limited to the antitrust and/or competition laws of governing jurisdictions.
  1. No Conflict. Agreements entered into or obligations assumed by TBDA Members prior to signature of this Agreement (or that will be entered into or assumed thereafter) do not and will not prohibit or prevent the TBDA Member from performing its obligations under this Agreement and the Annexes hereto.

based pharmaceutical company that will be named later (“Pharmaco”). Notwithstanding any provision of this Agreement and/or the Annexes hereto to the contrary, the Parties hereby consent to the transfer or assignment of Abbott’s rights and obligations under this Agreement to Pharmaco or a subsidiary of Abbott or Pharmaco in connection with or in anticipation of the separation, and notwithstanding anything to the contrary in this Agreement, such transfer or assignment shall not violate, constitute a breach of, result in any additional obligations or loss of rights under, or give rise to any right to terminate or cancel this Agreement. Following such transfer or assignment, the person to whom such rights and obligations are transferred or assigned shall have all rights and all obligations of Abbott under this Agreement, and shall be deemed to be a founding TBDA Member, and Abbott shall have no further obligations under this Agreement.

  1. Publicity. TBDA Members agree that they may publicize the fact of the existence of the TBDA, their membership and descriptions of the TBDA in a manner consistent with this Agreement. No party, may, however directly or indirectly cause or permit the use of any Party’s name, trade name, logo or trademarks without such Party’s prior written consent. The TBDA Council may establish additional terms and conditions to enable broader and more accurate public discussion about the TBDA.
  1. Project Manager. TBDA Members agree that a project manager will be appointed by the Foundation (the TBDA Project Manager). The TBDA Project Manager will have the responsibility of supporting the work of the TBDA Members (as they require and agree to accept), the TBDA Council, and generally to support the work of the TBDA as requested by TBDA Members, the TBDA Council, or the Foundation.

17.  Non-Debarment Certification. Each TBDA Member certifies that as of the date of its receipt of Materials hereunder that neither it and or any of its employees or principals performing any acts in connection with the handling or use of the Materials is debarred, suspended, or proposed for debarment by the U. S. Food and Drug Administration (“FDA”) or any agency of the U.S. Federal Government or any foreign and applicable equivalent of the FDA (“Applicable Governmental Authority”). Further, each TBDA Member shall provide immediate written notice to the Provider of any materials in the event that such TBDA Member or any of its employees or principals is debarred, suspended, or proposed for debarment by the FDA or an Applicable Governmental Authority.

SIGNATORY

to the

TBDA COOPERATION & SHARING AGREEMENT

IN WITNESS WHEREOF, the undersigned Party hereby executes the TBDA Cooperation & Sharing Agreement.

By:                                                                   Name:          Title:  Date Signed: 

[Separate Signature Pages to be Completed by Each TBDA Member]

ANNEX A

Founding TBDA Members

ANNEX B DEFINITIONS

Affiliate means any business entity controlled by, controlling or under common control of a TBDA Member. Such control shall include beneficial ownership of more than fifty percent (50%) of the voting interest in an entity, or such other relationship as, in fact, constitutes actual control.

Assays means any assays performed in the conduct of any TBDA activities including, but not limited to, MIC determination, MBC determination, kill kinetics, Wayne model, synergy screening, microbiological spectrum, frequency of resistance, cross-resistance, biochemical test, or in vivo test.

Compound Structure Data means the precise chemical structure of the compound, including full stereochemical representation.

Compound Related Data means data and information specific for the compound, including but not limited to activity in biological assays and predicted and/or measured physiochemical and biological properties.

Confidential Information has the meaning as provided in the Master TBDA Confidential Disclosure Agreement.

Confirmed Hit means an Identified Hit in which the compound’s anti-tubercular activity, purity, and structure have been validated.

Data means (a) recorded information generated in the performance of a TBDA Project, including (but not limited to) the interpretation and analysis of results, and associated opinions, from the performance of any assays conducted in furtherance of TBDA-related activities as well as (b) recorded information used in the performance of a TBDA Project that is deemed by the TBDA Member, in its sole discretion, to be useful to other TBDA Members in the performance of TBDA Projects; provided,

however, the term Data shall not include “Compound Structure Data.”

Global Access Objectives means (i) the prompt dissemination of new scientific information within the TBDA and with the broader scientific community and (ii) facilitating the accessibility of future TB drug therapies to people most in need within developing countries.

Guiding Principles means the Data & Materials Sharing Guiding Principles as described in Section 4 (and contained in Annex C) of the TBDA Cooperation & Sharing Agreement

Identified Hit means a compound that has been screened within one or more assays of the TBDA and for which anti-tubercular activity has been identified at a single point in the assay(s); cut-off and prioritization criteria may vary.

Identified Pathways means the biochemical or metabolic pathways by which a chemical entity affects anti-tubercular activity.

Identified Target means the biochemical target (e.g. enzyme, protein, macromolecule, etc.) by which a validated chemical hit manifests its anti-tubercular activity.

Lead Series means a chemical series that meets the following criteria: (a) Series demonstrates discrete, reasonable SAR, (b) Series passes holistic analyses of series properties, including chemical and metabolic stability, reactivity, toxicity, selectivity, etc., (c) Series risks have been explored and defined (gentox, in vitro and in vivo metabolism, drug-drug interactions, etc.), and (d) the series is deemed

“chemically tractable/drugable” and judged likely to afford a preclinical drug candidate.

Materials – means physical materials for use in any TBDA Project, including but not limited to, compounds, bacterial strains (e.g., resistant mutants, knockdown strains, over-expression strains), DNA, plasmids, Progeny, or other reagents. For purposes of this definition Progeny means unmodified descendants from the original Materials (as described in the specific TBDA MTA document being used to transfer the Materials).

Non-Progressible Hit means a Confirmed Hit which (i) a TBDA Member has determined, in its sole discretion, to be unencumbered by internal or external obligations, and (ii) the TBDA Member has deemed to have failed a set of medicinal chemistry drugability filters, including but not limited to (a) cytotoxicity data obtained against mammalian cells (selectivity index), (b) preliminary evidence of series structure-activity relationship (SAR), and (c) evaluation of structure (toxicophores, reactive groups, etc.), and associated physiochemical properties (e.g., molecular weight, ClogP, polar surface area).

Progressible Hit means a Confirmed Hit which (i) a TBDA Member has, in its sole discretion, determined to be unencumbered by internal or external obligations, and (ii) the TBDA Member has deemed to have passed a set of medicinal chemistry drugability filters, including but not limited to (a) cytotoxicity data obtained against mammalian cells (selectivity index), (b) preliminary evidence of series structure-activity relationship (SAR), and (c) evaluation of structure (toxicophores, reactive groups, etc.), and associated physiochemical properties (e.g., molecular weight, ClogP, polar surface area).

Protocol/SOPs means a detailed written description of an experimental procedure which will enable other researchers to accurately replicate assays and methods within their laboratories.

Publish or Publishing means the act of communicating to the public, whether through publications, presentations, posters or otherwise, and whether by text or images via written, verbal or electronic means (with such means being referred to collectively as Publications).

TBDA means a network of TBDA Members largely funded by the Bill & Melinda Gates Foundation, to support the implementation of the scientific strategic plan of the TB Drug Accelerator Program.

TBDA Council means the council, the members of which will consist of one representative of each of the TBDA Members and the Foundation, established as a coordinating body for the purposes ascribed to it under this Agreement. In the event that a TBDA Member has been awarded more than one grant by the Foundation, each principal investigator for all such grants may participate in the meetings of the TBDA Council, but only one representative of a given TBDA Member may participate in decision-making by the TBDA Council.

TBDA Invention means any invention or discovery of any new and useful process, machine, manufacture or composition of matter or any new and useful improvement thereof, conceived and

reduced to practice by TBDA Members pursuant to the activities of the TBDA (that are not deemed encumbered by a TBDA Member).

TBDA Master CDA means the Master TBDA Confidential Disclosure Agreement as described in Section 5 of the Agreement (and contained in Annex D).

TBDA Member means an institution that has agreed in writing to this TBDA Data & Materials Sharing Agreement.

TBDA Master MTA or Master MTA means the Master TBDA Materials Transfer Agreement as described in Section 6 of the Agreement (and contained in Annex E).

TBDA MTA means all of the agreement terms, including the provisions of the TBDA Master MTA, governing the individual transfer of Materials from one TBDA Member to another TBDA Member.

TBDA Projects means the TBDA-related data and material sharing activities and collaborative research project established and conducted by TBDA Members and specifically excludes projects that TBDA Members are pursuing on their own or with third parties who are not TBDA members.

ANNEX C

DATA & MATERIALS SHARING GUIDING PRINCIPLES

TB Drug Accelerator Program

1.     DATA SHARING PRINCIPLES

a.     Definitions

Capitalized terms not otherwise defined in these Guiding Principles shall have the definitions as provided to them in Annex B to the TBDA Cooperation & Sharing Agreement.

b.     Inventions

  1. Ownership of TBDA Inventions is outside the scope of these Guiding Principles and should be addressed by the TBDA Members concerned under separate contractual arrangements and under the appropriate laws governing inventorship and ownership of inventions.
    1. To the extent not prohibited by law, regulation or third-party obligation (which obligation exists prior to the organization becoming a TBDA Member), each TBDA Member agrees to grant to the other TBDA Members a fully paid-up, worldwide, non-exclusive, royalty free license to make and use all TBDA Inventions for purposes of education and research within the activities of the TBDA in support of generating new lead drug compounds solely for development into TB therapeutics. To the extent such grants by a TBDA Member are prohibited by law, regulation, or pre-existing third-party obligation, the relevant TBDA Member will in good faith seriously consider requests from TBDA Members for a license to such TBDA Inventions for such purposes and explore ways to enable such use on similar terms. The grant of the right to make and use provided under this paragraph does not waive any obligations under the TBDA Master CDA, the TBDA Master MTA, or other contractual arrangement between the TBDA Members.

c.     Management of Data

  1. The ownership of Data is outside the scope of these Guiding Principles and should be addressed by the TBDA Members under a separate contractual arrangement.
    1. The Foundation and TBDA Council, in consultation with the TBDA Members, will identify a data repository or database, its functionality (including levels of confidentiality, and levels of disclosure) and the types and timing of Data to be deposited and timeline for public disclosure, all of which will be constructed and operated in a manner that is consistent with the terms of these Guiding Principles.
    1. In the event a data repository or database is constructed or identified for use within the TBDA, no organization (including the Foundation) shall assert against any TBDA Member or the Foundation any database rights, copyrights, moral rights or other rights in the Data incorporated into such repository or database to the extent it is being utilized to support the primary objectives of the TBDA. For the purpose of clarity, nothing in this section affects ownership of such rights or the ability to assert those rights if used outside the identified range of parties and uses.

d.     Confidentiality of Information

Subject to the provisions contained in these Guiding Principles, Confidential Information (as defined in the TBDA Master CDA), including but not limited to Data, that is shared between TBDA Members will be held in confidence according to the terms of a Master TBDA CDA.

e.     Treatment of Data

  1. The TBDA Council will work with the Foundation to:
    1. Determine the process by which Data will be physically or electronically transferred among the TBDA Members.
    1. Establish data standards for each TBDA Project to the extent helpful to facilitate the sharing and comparison of Data and information resulting from the work in support of generating new lead drug compounds for development into TB therapeutics, and shall take into account applicable laws and regulations.
  1. The following specific types of Data generated by a TBDA Member in the performance of a TBDA Project and specifically related to tuberculosis will be treated in the manner described below and all Data and information that is shared or made available will be in the form of robust, reproducible datasets which would meet commonly accepted scientific standards:
    1. All such Data relating to Assays and Protocols/SOPs shall be readily shared amongst other TBDA Members upon request. In addition, this Data should be made available to the broader scientific community within a prescribed time (determined by the Foundation in consultation with the TBDA Council), ideally as soon as possible but minimally within 18 months of Data generation.
    1. All such Data associated with Identified Targets shall be readily shared amongst other TBDA Members upon request. In addition, this Data should be made available to the broader scientific community within a time prescribed by the TBDA Council, ideally as soon as possible but minimally within 18 months of Data generation.
    1. All such Data associated with Identified Pathways shall be readily shared amongst other TBDA Members upon request. In addition, this Data should be made available to the broader scientific community within a time prescribed by the TBDA Council, ideally as soon as possible but minimally within 18 months of Data generation.
    1. Such Data associated with Identified Hits before they become Confirmed Hits (other than Compound Structure Data) shall be shared amongst other TBDA Members at the mutual discretion of the TBDA Member who generated the Data and the TBDA Member who provided the compound upon which the Data was generated; provided, however, information relating to the performance characteristics of the primary screen (number of compounds screened or percentage of such compounds active in the screen, number or percentage active at different cut-offs, etc) shall be shared with all the TBDA Members as promptly as possible.
    1. Such Data associated with Confirmed Hits (other than Compound Structure Data) shall be shared amongst other TBDA Members at the mutual discretion of the TBDA Member who generated the Data and the TBDA Member who provided the compound upon which the Data was generated; however, Data relating to the performance characteristics of the assay or assays employed (retest positive rate, etc) shall be shared with all the TBDA Members as promptly as possible..
    1. Subject to Sections 1-5 above, all such Data relating to Progressible Hits will be shared with the other TBDA Members as promptly as possible but no later than the disclosure of the related Compound Structure Data (as described in Section 1.e.iv below). All such Data that represents cumulative learnings from activities by a single TBDA Member (e.g., analysis and synthesis of information derived from Data relating to Progressible Hits) will

be shared with the other TBDA Members as promptly as possible, subject to a reasonable (but as brief as possible) delay to allow for the filing of a patent application should patent protection be desired at this stage. Such Data will thereafter be made available to the broader scientific community within 36 months following its being made available to other TBDA Members.

  • For the purposes of clarity, Data that is shared with other TBDA Members in accordance with this Section 1e.ii. is considered Confidential Information unless or until it falls within the scope of Section 5 of the Master CDA or is otherwise allowed to be shared with non-TBDA members under the terms of the Agreement or its Annexes. But in the event of a conflict between the terms of these Guiding Principles and the Master CDA or the Master MTA, the provisions of these Guiding Principles will control.
    • Any other Data generated by a TBDA Member in the performance of a TBDA Project, and any Data used by a TBDA Member in the performance of a TBDA Project, will be shared by such TBDA Member if, in its sole discretion, it determines such Data to be useful to other TBDA Members in the performance of TBDA Projects.
  1. At the time a Confirmed Hit becomes a Progressible Hit, all related Compound Structure Data shall be made available to the other TBDA Members. The TBDA Members agree to maintain the Compound Structure Data on each Progressible Hit in confidence from non-TBDA Members in accordance with the terms of the Master CDA, until it is made available to the broader scientific community (which shall occur within 36 months of becoming a Progressible Hit or such longer period of time that is reasonably required if the Progressible Hit is the subject of an active TB drug discovery program and additional time is required to pursue patent protection pertaining to that program). Exceptions to these timelines may be made, with Foundation approval (not to be unreasonably withheld), for a small subset of compounds should any of the Progressible Hits become the subject of an alternative and active internal lead optimization research program for a therapeutic indication other than TB.
  • In general, at the time that a Confirmed Hit becomes a Non-Progressible Hit, associated Compound Structure Data may be optionally kept private by a TBDA Member except when the compounds:
  • have been publically disclosed (whereupon it shall be made available to other TBDA Members within 6 months of becoming a Non-Progressible Hit and to the broader scientific community within 36 months of becoming a Non-Progressible Hit); or
  • have been entered into mode of action studies in tuberculosis or other research activities (other than HTS cross-screening) in tuberculosis by the TBDA Member (whereupon it shall be made available to other TBDA members within 6 months of entering mode of action studies or

other research activities, and to the broader scientific community within 36 months of entering such studies).

2.     MATERIALS SHARING PRINCIPLES

  1. Each TBDA Member acknowledges that it is strongly encouraged to share Materials among other TBDA Members, but is under no obligation to do so. The TBDA Members also acknowledge that their ability to share Materials may be limited for various reasons, including the availability of the Materials. The TBDA Master MTA shall define the terms, including the authorized use, of the transfer of Materials for use within a TBDA Project.
    1. Ownership of Materials is outside the scope of these Guiding Principles and should be addressed by the TBDA Members under the relevant Material Transfer Record Form attached to the TBDA Master MTA, along with any need for confidentiality of information concerning the Materials.
    1. Consistent with the strong encouragement of sharing, TBDA Members shall use good faith efforts to treat Materials that are generated from or used within their work on generating lead TB compounds in the following manner:
      1. TB strains shall be made available to other TBDA Member upon request.
      1. Confirmed Hits shall be made available to other TBDA Members upon request on a “blinded” basis and Progressible Hits shall be made available to other TBDA Members with chemical structure revealed (both according to agreements between the two parties and in accordance with the principles outlined within this document).
      1. Other biological reagents and tools, including plasmids, etc., shall be made available to other TBDA Members upon request.
      1. In general the recipient shall bear the costs associated with preparing and shipping the materials.
    1. The TBDA Members will, on a semi-annual basis, provide a list of relevant Materials that are potentially available for use by the TBDA Members. The TBDA Council will, in consultation with the Foundation, establish the mechanism for creating and updating a consolidated list of such Materials.

3.     PUBLICATION RIGHTS

Subject to the provisions of Sections 1 and 2 above, Data will be Published according to the following principles:

  1. With respect to all Data generated by a TBDA Member (Recipient) in conducting activities using Materials that it received from another TBDA Member (Provider), the individual TBDA Member(s) of the Provider may Publish on that Data accompanied by the appropriate attributions (co-authorship or acknowledgement as appropriate, in accordance with authorship guidelines referenced below where Publication is in written form) of the

relevant TBDA Member (Recipient) that contributed to the generation of the Data. The individual TBDA Member(s) of the Recipient that generated the Data may also Publish on such Data. The Party desiring to publish on Data shall furnish the Provider or Recipient, as the case may be, with a copy of any proposed Publication for review and comment at least forty-five (45) days prior to submission for publication and shall reasonably consider any comments provided and requested amendments to the text to protect Confidential Information, in particular through its removal. However, nothing herein shall be interpreted to require the publishing Party to delete or alter the Data and conclusions of the study in any publication. If during the review period, the Provider notifies the publishing Party that it desires to establish a patent filing strategy, to accommodate filing patent applications on disclosed inventions, publishing Party will defer publication or other disclosure for a period, not to exceed an additional forty-five (45) days, sufficient to permit the Provider or its designee to have filed or to file any desired patent applications. At the end of the review period, the publishing Party will have the right to proceed with the publication.

  • With respect to all Data generated jointly through cooperative activities among multiple TBDA Members, all associated TBDA Members will have the joint right to Publish on such Data, subject to Section 3.a., above. In this case, the TBDA Member that intends to Publish shall furnish the other applicable TBDA Members (including the TBDA Member (Provider)), with a copy of any proposed Publication for review and comment at least forty-five (45) days prior to submission for publication and shall reasonably consider any comments provided and any requests for a short delay in publication to accommodate filing patent applications on disclosed inventions. Such a short delay may be extended for an additional forty-five (45) day period by the TBDA Member concerned where necessary to have adequate time to file patent applications on disclosed inventions. Moreover, the Member that intends to Publish shall ensure that the Publication of the Data is accompanied by the appropriate attributions (co-authorship or acknowledgement as appropriate, in accordance with the authorship guidelines referenced below) for each of the applicable TBDA Member.
    • Authorship guidelines will be in accordance with those of the International Committee of Medical Journal Editors, or other generally recognized standards.
    • Any dispute relating to Publications will be referred to the TBDA Council for resolution, with input from the SAP as requested by the TBDA Council.

4.     NON-TBDA MEMBERS

  1. Involvement in TBDA Activities. The Parties agree that broad involvement in the activities of the TBDA will be beneficial in building and sustaining a robust environment of

collaborative research aimed at furthering the TBDA’s primary objectives. In the event an organization outside the TBDA wishes to conduct TBDA related activities in conjunction with a TBDA Member and/or utilize Materials (e.g., compounds) or other resources (e.g., Foundation funded reagents or screens), the TBDA Council will establish a process whereby the anticipated work and Materials (including without limitation third party compounds to be screened) will be confidentially evaluated to assess whether there would be any redundancy relative to the ongoing work within the TBDA.

  • Sharing of TBDA Related Data & Materials. Where Materials that are generated or identified through the activities of a TBDA Project are shared with a third party organization (i.e., outside the TBDA Members), such sharing can only be undertaken with the permission of the TBDA Member that is the provider of such Materials. Moreover, such third party will be required to acknowledge, in writing, the Foundation’s funding, where appropriate, with respect to such Materials and agree to adhere to the Global Access Objectives with respect to its use of the Material and any improvement, modification or invention resulting from their use.

5.     CLARIFICATION ON RIGHTS OF TBDA MEMBERS TO USE DATA, MATERIALS OR INVENTIONS

For the purposes of clarity, nothing in this Agreement provides any rights in or licenses in favor of a TBDA Member to use Data, Materials or Inventions owned by another TBDA Member except to the extent expressly provided for in this Agreement and for the purpose of carrying out TBDA Projects.

6.     UNIQUENESS OF IDENTIFIERS

For bookkeeping purposes in order to ensure that Data and Materials generated or provided may be associated with the TBDA Member and investigator, all TBDA Members will comply with an identification naming convention that will be used across the TBDA which will be established by the TBDA Council in consultation with the Foundation. Unique identifiers will be used to identify (consistent with applicable privacy laws and regulations) all TBDA Members, investigators within the TBDA Members, Material, documents, and Data, as well as transfers of Materials, documents and Data between TBDA Members.

ANNEX D

MASTER TBDA CONFIDENTIAL DISCLOSURE AGREEMENT

WHEREAS, the TBDA Members anticipate that any exchange of information and data (including, without limitation, information concerning Materials) between TBDA Members will be in accordance with the terms of this Master CDA.

WHEREAS, each TBDA Member is interested in examining and evaluating other TBDA

Member’s Confidential Information solely for the purpose of carrying out research activities within its own TBDA Project (the “Purpose”).

Now, therefore, the TBDA Members agree, by virtue of their agreement to the Cooperation and Sharing Agreement, to the following terms and conditions with respect to the transfer of Confidential Information between TBDA Members:

DEFINITIONS

Confidential Information means, subject to Section 5, all information provided at any TBDA-Related Communication with respect to any aspect of a TBDA Project, including Data. Confidential Information in a documentary or written form should be marked as confidential to be considered Confidential Information. A written record is not required, however, for information to be considered as Confidential Information where the information was provided orally and indicated as being confidential.

TBDA-Related Communication means any meeting, discussion or activity (whether in person, electronically, by phone or otherwise) among or on behalf of multiple TBDA Members.

Capitalized terms not otherwise defined in this Master CDA shall have the definitions as provided to them in Annex B to the TBDA Cooperation & Sharing Agreement.

TERMS AND CONDITIONS OF THIS AGREEMENT

  1. The terms and conditions of this Master CDA include the provisions set forth below, as well as the provisions of the Guiding Principles which are hereby incorporated by reference and made a part of this Master CDA. In the event that there are any conflicts between the provisions set forth below and those set forth in the Guiding Principles, the provisions of the Guiding Principles shall control.
  • Each TBDA Member (as a Disclosing Party) may, at its own discretion, disclose certain Confidential Information owned or rightfully possessed by it to other TBDA Members (each as the Receiving Party).
  • The TBDA Members shall ensure that all participants under their control in a TBDA-Related Communication will have executed an agreement prior to their receipt of Confidential Information obligating them to refrain from disclosure or use of Confidential Information in any manner inconsistent with this Master CDA.
  • Each TBDA Member, as a Receiving Party, agrees that it will:
    • use the Confidential Information received from a Disclosing Party solely for the Purpose;
  • treat the Confidential Information with reasonable care to avoid disclosure of the Confidential Information to any third party, person, firm or corporation other than as expressly stated herein; and
  • be liable for use of the Disclosing Party’s Confidential Information outside the scope of the Purpose as well as for any unauthorized disclosure directly resulting from its failure to exercise such reasonable care (Founding TBDA Member NIAID, as an agency of the U.S. Government, assumes liability only to the extent provided under the Federal Tort Claims Act, 28 U.S.C. Ch. 171).
  • Notwithstanding anything to the contrary in this Master CDA, the Receiving Party shall have no obligation with respect to the Confidential Information received from a Disclosing Party to the extent such information is:
  • already known by the Receiving Party or its Affiliates at the time of disclosure, as can be demonstrated by competent proof;
  • publicly known, or subsequently becomes publicly known, without the wrongful act or breach of this Master CDA by the Receiving Party;
  • rightfully received by the Receiving Party or its Affiliates from a third party having the lawful right to make such a disclosure, where said disclosure is rightfully made without any obligation of confidence to the Disclosing Party;
  • approved for release or disclosure by written authorization of the Disclosing Party;
  • independently developed by or for the employees or agents of the Receiving Party or its Affiliates without the use or knowledge of the Confidential Information provided by the Disclosing Party as can be demonstrated by competent proof; or
  • required to be disclosed pursuant to any competent judicial or government request, requirement or order, provided that the Receiving Party so disclosing takes reasonable steps to provide the Disclosing Party with sufficient prior notice in order to allow the Disclosing Party to contest such request, requirement or order, and provided further that such Confidential Information is disclosed only subject to reasonably available restrictions on further disclosure and use, and otherwise remains subject to the obligations of confidentiality and restricted use set forth in this Master CDA.
  • Each Receiving Party shall be entitled to disclose the Disclosing Party’s Confidential Information to its employees and the employees of its Affiliates, as well as its agents and consultants who are bound by confidentiality and restricted use obligations no less strict than those set out herein. However, each Receiving Party shall only disclose the Disclosing Party’s Confidential Information to those of its employees, agents, consultants and Affiliates who reasonably need to know such Confidential Information in order to further the Purpose and/or to make decisions or render advice in connection with the Purpose and who shall be informed of the existence of this Master CDA and shall agree in writing or via employment policy to be bound by the terms hereof or be otherwise bound by law not to disclose such Confidential Information. Each Receiving Party shall be responsible for

ensuring that its employees, agents and consultants, and those of its of its Affiliates who receive Confidential Information comply with the terms of this Master CDA.

  • Notwithstanding the provisions of Paragraphs 4 and 6 above, the transfer, disclosure, use, dissemination, and publication of specific types of Data (as that term is defined in the TBDA Cooperation & Sharing Agreement and as applied in the Guiding Principles) will be governed by the provisions of the Guiding Principles.
  • Subject to exemptions and limitations elsewhere in this Master CDA, the obligations of Paragraph 4 shall remain in effect for each subject disclosure of Confidential Information for a period of five (5) years from date of the termination of the appertaining TBDA Projects for which Confidential Information has been transferred or Five (5) years from termination of the Agreement, whichever is shorter.
  • Unless otherwise expressly agreed upon by the Disclosing Party and the Receiving Party, no rights additional to those enumerated in Paragraph 4(a) in the Confidential Information are provided to any TBDA Member under any patent applications, patents, or other proprietary rights of the Disclosing Party. Except as allowed under Paragraph 5 above, no TBDA Member shall be entitled to use the Confidential Information provided by the Disclosing Party for commercial purposes without separate written agreement to that effect. Nothing contained in this Master CDA shall be construed as an obligation to enter into any further agreement relating to any of the Confidential Information or as a grant of a license to the Receiving Party to use the Disclosing Party’s Confidential Information other than for the Purpose.
  1. The Receiving Party agrees to discontinue its use of the Confidential Information and destroy or return to the Disclosing Party all written Confidential Information (whether received in written form or reduced to a written form following receipt) upon request by the Disclosing Party; provided, however, one (1) copy of such Confidential Information may be retained by the Receiving Party to preserve an archival record of the same to monitor ongoing legal and/or regulatory obligations.
  1. Any dispute or controversy arising in connection with this Master CDA shall first be referred to the respective senior management of the Disclosing and Receiving Parties, or their successors, for attempted resolution in good faith negotiations within thirty (30) days of notice of such dispute. If such senior management are not able to resolve the dispute within the thirty (30)-day period, or any agreed upon extensions, the Disclosing and Receiving Parties shall be free to resolve the dispute through any dispute resolution mechanism they may individually or collectively choose. The Parties agree that should this Master CDA be breached, the non-breaching party shall be entitled to seek, and a court of competent jurisdiction may grant, specific performance and injunctive or other equitable relief as a remedy for any breath of this Master CDA. Such remedy shall be in addition to all other remedies, including money damages, available to a non-breaching party at law or in equity.
  1. Upon request of either the Disclosing Party or the Receiving Party, the transfer of Confidential Information may be documented through a Confidential Information Transfer Record Form (in the form as contained in Attachment A) to be completed by the Disclosing and the Receiving Party. For purposes of clarification, the use of a Confidential Information Transfer Record Form is not required in order to categorize any information or data as confidential.
  2. Except as certain provisions may survive as set forth in Paragraph 14 below, this Master CDA will terminate (including but not limited to termination as regards Confidential Information transferred

under any and all subject Confidential Information Transfer Record Forms not previously terminated) upon the termination of the TBDA Project of either the Disclosing Party or the Receiving Party or if the Receiving Party is in breach of any of the conditions of this Master CDA.

  1. The Definitions and Paragraphs 1, 4, 5, 7-11, 13, and 18herein shall survive any termination or expiration of this Master CDA.
  1. If any provision of this Master CDA is found to be unenforceable, such provision will be limited or deleted to the minimum extent necessary so that the remaining terms remain in full force and effect.
  1. No waiver of any term, provision or condition of this Master CDA, whether by conduct or otherwise, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of the same term, provision or condition, or of any other term, provision or condition of this Master CDA.
  1. The Disclosing Party understands and acknowledges, that prior to the Effective Date of this Master CDA, the Receiving Party and/or its Affiliates may have performed or engaged in. or otherwise arranged for the conducting of research, development and commercialization activities relating to the subject matter of the Disclosing Party’s Confidential Information. Accordingly, the Disclosing Party acknowledges and agrees that nothing in this Master CDA will be construed by implication or otherwise as preventing the Receiving Party and/or its Affiliates, during the term of this Master CDA or thereafter, from (i) either internally or with a third party, engaging in research, development and commercialization activities relating to the subject matter of the Disclosing Party’s Confidential Information, and (ii) evaluating such programs and capabilities of third parties relating to the subject matter of the Disclosing Party’s Confidential Information, provided, that in each case of (i) and (ii), the Receiving Party does not use the Disclosing Party’s Confidential Information in connection therewith.

ATTACHMENT A

CONFIDENTIAL INFORMATION TRANSFER RECORD FORM

DISCLOSING PARTY (Institution/Company name):

DISCLOSING PARTY SCIENTIST:

RECEIVING PARTY (Institution/Company name):

RECEIVING PARTY SCIENTIST:

Description of the Confidential Information:  Exhibit I (attached)

The ORIGINAL CONFIDENTIAL INFORMATION described in Exhibit I (attached) is / are supplied by the DISCLOSING PARTY to the RECEIVING PARTY subject to the terms and conditions of the MASTER CDA.

The DISCLOSING PARTY hereby gives its authorization for the RECEIVING PARTY to further transfer the Confidential Information to other TBDA Members in accordance with the terms of the Master CDA. The DISCLOSING PARTY gives such authorization by initialing here:                                                                                                                                                        

Description of the intended and authorized use of the Confidential Information:                                   

(Use additional pages if required)

The following are the terms and conditions of the allocation of ownership/licensing of Confidential Information and TBDA Inventions and other inventions that arise from use of the Confidential Information. This Disclosing and Receiving Party recognize that these terms and conditions must take into account and be consistent with the objectives and intentions of the Guiding Principles and the Global Access Objectives:

(Use additional pages if required)

[Optional clause] Any dispute or controversy arising in connection with the transfer of Confidential Information documented herewith which is not resolved by the designated officers of this Disclosing Party and the Receiving Party in accordance with the Master CDA shall be finally settled in accordance with the following terms:

EXHIBIT I

ORIGINAL CONFIDENTIAL INFORMATION

List the type of Confidential Information to be transferred and, if applicable, identify the software (and version) used to compile or organize the information.

ANNEX E

MASTER TBDA MATERIAL TRANSFER AGREEMENT

WHEREAS, consistent with the TBDA Cooperation & Sharing Agreement, the terms of this Material Transfer Agreement (Master MTA) shall govern the transfer of Materials from and between the TBDA Members in connection with activities carried out under a TBDA Project. The TBDA Members recognize that Attachment A contains additional standard MTA provisions for use with this Master MTA for use when transferring Material that is created or used within activities of the TBDA but is to be transferred to organizations that are not TBDA Members.

Now, therefore, the TBDA Members agree to the following terms and conditions with respect to the transfer of Materials between TBDA Members.

DEFINITIONS: All capitalized terms not otherwise defined in this Master MTA shall have the definitions provided in Annex B to the TBDA Cooperation & Sharing Agreement.

Provider means the entity that is providing the Materials and / or having the Materials provided by another entity on its behalf, including the principal investigator and / or co-principal investigator or his/her designee employed by such entity who will be physically supplying the Materials.

Recipient means the entity that is receiving the Materials, including the principal investigator or, where applicable, co-principal investigator or his/her designee employed by such entity who will be physically receiving the Materials.

TERMS AND CONDITIONS OF THIS AGREEMENT:

  1. The terms and conditions of this Master MTA include the provisions of the Guiding Principles, which are hereby incorporated by reference and made a part of this Master MTA. In the event that there are any conflicts between the provisions set forth below and those set forth in the Guiding Principles, the provisions of the Guiding Principles shall control. Moreover, Materials and information provided to the Recipient are considered to be the Confidential Information of the Provider under the terms of the Master CDA.
  2. Transfer of any Materials by TBDA Members under this Master MTA shall be documented through the completion of the Material Transfer Record Forms (in the form as contained in Attachment B), a copy of which will be provided by the Provider to the Foundation for each Material transfer.
  3. The Recipient agrees that Materials (a) will not be used in human subjects, in clinical trials, or for diagnostic purposes involving human subjects unless such use is expressly approved by the Provider in writing; (b) will not be used for commercial purposes; (c) will only be used by individuals who are legally obligated, in the manner and to the extent required in the applicable Material Transfer Record Forms, to assign their respective right in any and all TBDA Inventions (and any patent rights or other rights arising therefrom); and (d) will not be given to or made available to other TBDA Members or third parties.
  • The Provider may Publish on Data generated by Recipient when using Materials it received from Provider. Such Publication shall be accompanied by the appropriate attributions (co-authorship or acknowledgement as appropriate) of the Recipient as having contributed to the generation of the Data. The Recipient may also publish on such Data, accompanied by the appropriate attribution (co-authorship or acknowledgement as appropriate) of the Provider. The Party desiring to publish on Data shall furnish the Provider or Recipient, as the case may be, with a copy of any proposed Publication for review and comment at least forty-five (45) days prior to submission for publication and shall reasonably consider any comments provided and requested amendments to the text to protect Confidential Information, in particular through its removal. However, nothing herein shall be interpreted to require the publishing Party to delete or alter the Data and conclusions of the study in any publication. If during the review period, the Provider notifies the publishing Party that it desires to establish a patent filing strategy, to accommodate filing patent applications on disclosed inventions, publishing Party will defer publication or other disclosure for a period, not to exceed an additional forty-five (45) days, sufficient to permit the Provider or its designee to have filed or to file any desired patent applications. At the end of the review period, the publishing Party will have the right to proceed with the publication. The Recipient agrees to promptly provide a report to the Provider of the results for research in which the Materials were utilized.
  • (a) It is understood and agreed that the attachments to this Master MTA, and the TBDA Cooperation & Sharing Agreement, set forth certain other provisions regarding confidentiality, the sharing of Data, TBDA Inventions, Publications, the scientific and charitable goals of the TBDA Projects, and other related issues and appertaining activities under this Master MTA.

(b) The use and allocation of ownership or licensing, if any, of the Materials, research results, and TBDA Inventions arising through the use of the Materials is addressed in the applicable Material Transfer Record Forms. Such ownership or licensing provisions shall survive termination of the Master MTA.

  • Any Materials transferred pursuant to this Master MTA are understood to be experimental in nature and may have hazardous properties. THE PROVIDER MAKES NO REPRESENTATIONS NOR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIALS WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER THIRD PARTY PROPRIETARY RIGHTS, OR THAT THE MATERIALS WILL NOT POSE A HEALTH OR SAFETY RISK.
  • The Materials are supplied without cost to TBDA Members but, unless provided otherwise, the Recipient shall reimburse the Provider for any reasonable shipping and related costs that may be incurred when preparing and sending the Materials to the Recipient. The Recipient and recipient scientist shall use the Materials in accordance with good laboratory practice and the highest standards of skill and care and shall ensure compliance with any applicable laws and regulations governing the transportation, keeping or use of the Materials.
  • Except to the extent prohibited by applicable law, the Recipient assumes all liability for claims for damages that may arise from its use, storage, and/or disposal of the Materials for any activities related to the Material.2 The Provider will not be liable to the Recipient for any loss, claim, or demand

2 Founding TBDA Member NIAID, as an agency of the U.S. Government, assumes liability only to the extent provided under the Federal Tort Claims Act, 28 U.S.C. Ch. 171.

made by the Recipient, or made against the Recipient by any other party, due to or arising from the use, storage, and/or disposal of the Materials by the Recipient, except to the extent permitted by applicable law when such loss, claim, or demand is caused by the gross negligence and/or willful misconduct of the Provider. All Materials will be shipped EXW3 Provider’s place of business for activities carried out pursuant to this Agreement (unless Provider and Recipient mutually agree to a different Incoterm shipping classification).

  • The Provider certifies that, if applicable to the Material being supplied under this Master MTA, it has obtained all informed consent(s) and / or other necessary approval(s) and / or authorization(s) in the collection of the Materials necessary to provide the Materials for use in accordance with the respective Material Transfer Record Form. The Recipient agrees to handle, store, and use the Materials in a safe manner and in compliance with all applicable statutes and regulations, including applicable governmental regulations and guidelines as well as the requirements of national drug regulatory authorities and other relevant regulatory agencies. The Recipient certifies that it has obtained any Institutional Review Board and / or Ethics Committee and / or other approvals that may be required for the use of Materials received under this Master MTA as outlined in the respective Material Transfer Record Form.
  • This Master MTA will terminate as regards Materials transferred under a subject Material Transfer Record Form on the earliest of the following dates: (a) on completion of the Recipient’s use of the Materials for the TBDA Projects; or (b) on termination of the appertaining TBDA Projects for which Materials were transferred. Upon such termination Recipient will immediately discontinue its use of the Materials and will, upon direction of the Provider, return or destroy any remaining Materials. Termination of the Provider’s TBDA Project shall not affect the Provider’s rights hereunder.
  • Except as certain provisions may survive as set forth in Paragraph 12 below, this Master MTA will terminate in its entirety (including but not limited to termination as regards Materials transferred under any and all subject Material Transfer Record Forms not previously terminated) upon the termination of the TBDA Project of either the Provider or the Recipient or if the Recipient is in breach of any of the conditions of this Master MTA.
  • The Definitions and Sections 1 and 4-15 herein, the TBDA Cooperation & Sharing Agreement, and the rights of any Provider set forth herein shall survive any termination or expiration of this Master MTA, including but not limited to subject termination as regards Materials transferred under a subject Material Transfer Record Form.
  • Any dispute or controversy arising in connection with this Master MTA shall first be referred to the Parties’ senior management, on behalf of the Recipient and the Provider, or their successors, for attempted resolution in good faith negotiations within thirty (30) days of notice of such dispute. If such senior management are not able to resolve the dispute within the thirty (30)-day period, or any agreed upon extensions, the Disclosing Party and the Receiving Party shall be free to resolve the dispute through any dispute resolution mechanism they may individually or collectively choose.

3 EXW is an Incoterm abbreviation for “EX Works.” Ex works means that the Provider delivers when he places the goods at the disposal of the Recipient at the Provider’s premises or another named place (i.e. works, factory, warehouse, etc.) not cleared for export and not loaded on any collecting vehicle. This term thus represents the minimum obligation for the Provider, and the Recipient has to bear all costs and risks involved in taking the goods from the Provider’s premises.

  1. If any provision of the Agreement is found to be unenforceable, such provision will be limited or deleted to the minimum extent necessary so that the remaining terms remain in full force and effect.
  2. No waiver of any term, provision or condition of this Master MTA, whether by conduct or otherwise, in any one or more instances, shall be deemed to be or construed as a further or continuing waiver of the same term, provision or condition, or of any other term, provision or condition of this Master MTA.

ATTACHMENT A

[This attachment includes additional provisions that must be included in a Material Transfer Agreement when transferring Materials that are created within activities of the TBDA to Recipients that are not TBDA Members.]

  1. The Recipient acknowledges that it has read, understands and agrees to be bound by the terms of the TBDA Master MTA.
  2. The Recipient will adhere to the following global access objectives: (i) the broad and prompt dissemination of research information generated through use of the Materials to the scientific community and (ii) the generation of lead drug compounds for development into TB therapeutics through use of the Materials and any improvements, modifications, or inventiosn that may arise through such use will be made accessible to the people most in need in the developing world.
  3. The Provider will require any person or entity to whom or which it provides the Materials (if allowed to do so) and any improvements, modifications or inventions that have arisen through the its use of the Materials to include the global access objectives stated above in paragraph 2 in connection with agreements through which it provides the Materials or permission or licenses to use such improvements, modifications or inventions.

ATTACHMENT B MATERIAL TRANSFER RECORD FORM

PROVIDER (Institution/Company name):

PROVIDER Contact:

RECIPIENT (Institution/Company name):

RECIPIENT Contact:

Description of the MATERIAL:  Exhibit I (attached)

The ORIGINAL MATERIAL(S) described in Exhibit I (attached) is / are supplied by the PROVIDER to the RECIPIENT subject to the terms and conditions of the TBDA Master MTA.

Transfers by the Recipient to non-TBDA Members are specifically prohibited. Further transfers of MATERIAL by the RECIPIENT to other TBDA Members may be made only by PROVIDER.

Description of the intended and authorized use of the MATERIALS:                                                     

(Use additional pages if required)

Describe any special handling or storage instructions for the MATERIALS:                                   

(Use additional pages if required)

The following are the terms and conditions of the use, transfer, allocation of ownership/licensing of Materials and TBDA Inventions, research results, and other inventions that arise from use of the Materials. This Provider and the Recipient recognize that these terms and conditions must take into account and be consistent with the objectives and intentions of the Guiding Principles and the Global Access Objectives:

(Use additional pages if required)

By signing, the RECIPIENT accepts all terms and conditions expressly stated in this Material Transfer Record and/or Exhibit I.

Duplicate originals of this form shall be fully completed and executed with: (i) the Recipient being notified by the Provider of the upcoming transfer via a copy of the completed subject Material Transfer Record Form (supplied electronically via facsimile transmission, attachment as an image file to e-mail, or the like) within seventy-two (72) hours of the Provider’s completion and execution of this Material Transfer Record Form and (ii) a copy being supplied electronically (via facsimile transmission, attachment to e-mail as an image file, or the like) to   and / or facsimile number

                             or to such other e-mail address and/ or facsimile number as may be provided by the Foundation in the future) by the Provider within seventy-two (72) hours of its completion and execution of this Material Transfer Record Form.

EXHIBIT I ORIGINAL MATERIAL(S)

Describe the Material being transferred under this Material Transfer Record as well as the unique barcode identifier or other unique identifier.