AZIENDA OSPEDALIERO UNIVERSITARIA MEYER

AZIENDA OSPEDALIERO UNIVERSITARIA XXXXX

Delibera del Direttore Generale n. 258 del 11-06-2020

Proposta n. 568 del 2020

Oggetto: APPROVAZIONE DELLA REVISIONE DELL’ACCORDO DI MEMBRO SATELLITE PER LA PARTECIPAZIONE DELL’AOU XXXXX AL CHILDREN’S BRAIN TUMOR TISSUE CONSORTIUM (CBTTC) REGISTRY AND REPOSITORY

Dirigente: XXXXXXX XXXXX XXXXXXXX

Struttura Dirigente: AFFARI GENERALI E SVILUPPO

Delibera del Direttore Generale n. 258 firmata digitalmente il 11-06-2020

AZIENDA OSPEDALIERO-UNIVERSITARIA XXXXX

(Art. 33 L.R.T. 24 febbraio 2005 n. 40)

Xxxxx Xxxxxxxxxx, 00 - 00000 XXXXXXX

C.F. P.Iva 02175680483

DELIBERAZIONE DEL DIRETTORE GENERALE

Oggetto	Studio osservazionale
Contenuto	APPROVAZIONE DELLA REVISIONE DELL’ACCORDO DI MEMBRO SATELLITE PER LA PARTECIPAZIONE DELL’AOU XXXXX AL CHILDREN’S BRAIN TUMOR TISSUE CONSORTIUM (CBTTC) REGISTRY AND REPOSITORY

Area Tecnico Xxx.xx	AREA TECNICO AMMINISTRATIVA
Coord. Area Tecnico Xxx.xx	XXXX XXXXX
Struttura	AFFARI GENERALI E SVILUPPO
Direttore della Struttura	XXXXXXX XXXXX XXXXXXXX
Responsabile del procedimento	XXXXXXX XXXXXXXX
Immediatamente Esecutiva	NO

Conti Economici
Spesa	Descrizione Conto	Codice Conto	Anno Bilancio
Spesa prevista	Conto Economico	Codice Conto	Anno Bilancio

Estremi relativi ai principali documenti contenuti nel fascicolo
Allegato	N° di pag.	Oggetto

1	54	Accordo di membro satellite

IL DIRETTORE GENERALE

Dr. Xxxxxxx Xxxxxxxx (D.P.G.R.T. n. 156 del 31 agosto 2015)

Visto il D. Lgs.vo 30/12/1992 n. 502 e sue successive modifiche ed integrazioni e la L. R. Toscana n. 40 del 24/02/2005 e s.m.i. di disciplina del Servizio Sanitario Regionale;

Dato atto:

- che con deliberazione del Direttore Generale n. 133 del 29.12.2015 è stato approvato il nuovo Atto Aziendale dell’A.O.U. Xxxxx, ai sensi dell’art. 6 del Protocollo d’intesa del 22.04.2002 fra Regione Toscana e Università degli Studi di Firenze, Siena e Pisa, con decorrenza dal 1.1.2016;

- che con deliberazione del Direttore Generale n. 134 del 30.12.2015 si è provveduto a definire l’organigramma complessivo dell’A.O.U. Xxxxx e sono stati assunti i primi provvedimenti attuativi relativi al conferimento degli incarichi di direzione delle strutture Dipartimentali e/o a valenza dipartimentale, delle Aree Funzionali Omogenee, dell’Area Servizi dell’Ospedale, dell’Area delle Professioni Sanitarie e dell’Area Tecnico Amministrativa;

- che con deliberazione del Direttore Generale n. 140 del 30.12.2015 sono state assunte determinazioni attuative del nuovo Atto aziendale in merito alla conferma/riassetto delle strutture organizzative complesse e semplici;

- che con deliberazione del Direttore Generale n. 492 del 2.12.2016 si è provveduto ad approvare la sistematizzazione della organizzazione aziendale, dopo un primo percorso attuativo dello Statuto Aziendale;

- che con deliberazione del Direttore Generale n. 543 del 29.12.2016 sono state assunte determinazioni volte al conferimento degli incarichi delle Strutture Complesse dell’Area Tecnico Amministrativa, così come rimodulate a seguito delle azioni di attualizzazione dell’organizzazione aziendale;

- che con successiva deliberazione del Direttore Generale n. 173 del 05.04.2018 si è altresì provveduto ad ulteriori azioni di sistematizzazione dell’organizzazione aziendale ed all’integrazione dell’art. 63 dell’Atto Aziendale “Promozione della salute nella comunità”;

- che con successiva deliberazione del Direttore Generale n. 739 del 31.12.2019 si è provveduto ad approvare ulteriori azioni di sistemazione dell'organizzazione aziendale in ambito amministrativo;

Su proposta del Responsabile della S.O.C. Affari Generali e Sviluppo Dr.ssa Xxxxx Xxxxxxxx Xxxxxxx la quale, con riferimento alla presente procedura, ne attesta la regolarità amministrativa e la legittimità dell’atto;

Richiamato l’impegno di questa Azienda a favorire la ricerca scientifica, inclusa quella nel campo oncologico, promuovendo collaborazioni internazionali e accordi di ricerca;

Ricordato:

- che questa Azienda, con disposizione dirigenziale n. 493 del 27.11.2014, aveva autorizzato la conduzione dello studio osservazionale non-profit denominato “Childhood Brain Tumor Tissue Consortium (CBTTC) Registry and Repository”, prot. n. 09-007316, il cui Responsabile è la Dott.ssa Xxxx Xxxxx Xxxxxxxxxx;

- che il Children’s Hospital of Philadelphia (CHOP), centro coordinatore del consorzio CBTTC, aveva sottoscritto insieme ad altre istituzioni statunitensi un atto costitutivo e un apposito Accordo sulla condivisione della proprietà intellettuale, degli introiti e del materiale del CBTTC, sottoscritto tra i membri principali del CBTTC per la disciplina delle finalità e delle attività del medesimo CBTTC;

- che l’Accordo sopra menzionato include la costituzione e la gestione di un archivio centrale di materiali biologici e di dati fenotipici associati, localizzato presso il CHOP, e a cui sono inviati i materiali biologici nell’ambito dello studio osservazionale di cui trattasi;

Premesso:

- che l’AOU Meyer è stata individuata dal CHOP quale membro satellite per la raccolta del materiale biologico necessario allo studio su citato, ai sensi dell’accordo dei membri principali e dell’atto costitutivo del CBTTC sopra richiamati;

- che l’adesione in qualità di membro satellite di questa Azienda al CBTTC per le finalità dello studio medesimo è stata formalizzata con Delibera del Direttore Generale n. 8 del 08.01.2018 a seguito della firma, in data 18.12.2017, dell’Accordo di Membro Satellite, nella prima versione modificata dello stesso Accordo, e della Lettera di Implementazione per il trasferimento di materiali biologici all’archivio del CBTTC;

Atteso che il CHOP, con comunicazione email del 20.09.2019 inviata alla Dott.ssa Xxxx Xxxxx Xxxxxxxxxx, ha reso noto che sono stati aggiornati, sulla base di una seconda versione, i termini dell’Accordo rivisto sulla condivisione della proprietà intellettuale, degli introiti e del materiale del CBTTC, sottoscritto dai membri principali del CBTTC in data 14.05.2019, e che è cambiata anche la composizione dello stesso consorzio CBTTC;

Vista la richiesta del CHOP di allineare le disposizioni contenute nell’Accordo di membro satellite sottoscritto da questa Azienda con il CHOP alle modifiche apportate nell’Accordo rivisto sulla condivisione della proprietà intellettuale, degli introiti e del materiale del CBTTC e alla composizione dei membri principali del CBTTC;

Preso atto della relazione del 08.06.2020 della Dott.ssa Xxxx Xxxxx Xxxxxxxxxx riguardo alle attività svolte nello studio anche in relazione alle modifiche apportate dal CHOP all’Accordo di membro satellite;

Xxxxxxxxx che è nell’interesse di questa Azienda continuare la collaborazione per ricerca con il CHOP nell’ambito del CBTTC e dare così il proprio apporto alla ricerca oncologica in vista di una maggiore comprensione dei meccanismi di sviluppo dei tumori al cervello in età pediatrica;

Verificato che dall’Accordo di cui sopra non derivano oneri economici a carico dell’AOU Xxxxx;

Ritenuto pertanto di stipulare il nuovo Accordo di membro satellite del CBTTC per la disciplina delle condizioni normative ed operative della prosecuzione della partecipazione di questa Azienda nello studio sopra citato, così come emendato e aggiornato a seguito della seconda versione dell’Accordo rivisto sulla condivisione della proprietà intellettuale, degli introiti e del materiale del CBTTC nella, e a seguito della composizione dei membri principali dello stesso consorzio CBTTC, che allegato N. 1 al presente atto, ne formano parte integrante e sostanziale;

Considerato che il Responsabile del Procedimento, individuato ai sensi della Legge n. 241/1990 nella persona del Xxxx. Xxxxxxx Xxxxxxxx, sottoscrivendo l’atto attesta che lo stesso, a seguito dell’istruttoria effettuata, nella forma e nella sostanza è legittimo;

Acquisito il parere del Coordinatore dell’Area Tecnico Amministrativa, Dr.ssa Xxxxx Xxxx, espresso mediante sottoscrizione nel frontespizio del presente atto;

Vista la sottoscrizione del Direttore Sanitario e del Direttore Amministrativo, per quanto di competenza, ai sensi dell’art. 3 del Decreto Legislativo n. 229/99;

DELIBERA

Per quanto esposto in narrativa che espressamente si richiama,

1. Di approvare il nuovo Accordo di membro satellite del CBTTC da stipulare con il CHOP che, allegato

N. 1 al presente atto, ne forma parte integrante e sostanziale.

2. Di dare atto che il su menzionato Accordo è stato proposto dal CHOP per allineare le disposizioni contenute nell’Accordo di membro satellite già sottoscritto da questa Azienda con il CHOP alle modifiche apportate nell’Accordo rivisto sulla condivisione della proprietà intellettuale, degli introiti e del materiale del CBTTC e alla composizione dei membri principali del CBTTC.

3. Di prendere atto della relazione prodotta dalla Dott.ssa Xxxx Xxxxx Xxxxxxxxxx in relazione alle attività svolte nello studio anche con riguardo alle modifiche apportate dal CHOP all’Accordo di membro satellite.

4. Di trasmettere il presente atto al Collegio Sindacale ai sensi dell’art. 42, comma 2, della L.R.T. n. 40/2005 contemporaneamente all’inoltro all’albo di pubblicità degli atti di questa A.O.U. Xxxxx.

IL DIRETTORE GENERALE

(Dr. Xxxxxxx Xxxxxxxx)

IL DIRETTORE SANITARIO IL DIRETTORE AMMINISTRATIVO

(Dr.ssa Xxxxxxxxx Xxxxxxx) (Dr. Xxxx Xxxxx)

Exhibit A

Children’s Brain Tumor Tissue Consortium Satellite Member Agreement

THIS AMENDED AND RESTATED SATELLITE MEMBER AGREEMENT (“Agreement”) FOR THE CHILDREN’S BRAIN TUMOR TISSUE CONSORTIUM

(“CBTTC”) is entered into on May 14, 2019 (“Effective Date”) by and among:

(a) The Children’s Hospital of Philadelphia located at 00xx Xxxxxx xxx Xxxxx Xxxxxx Xxxxxxxxx, Xxxxxxxxxxxx, XX 00000 (“CHOP”), on behalf of itself, its Affiliates (as defined below), employees, subcontractors and agents;

(b) Xxx & Xxxxxx X. Xxxxx Children’s Hospital of Chicago, 000 Xxxx Xxxxxxx Xxxxxx, Xxxxxxx, Xxxxxxxx 00000-0000, on behalf of itself, its Affiliates, employees, subcontractors and agents (“Xxxxx”);

(c) Seattle Children’s Hospital d/b/a Seattle Children’s Research Institute with a primary location at 0000 Xxxx Xxxxx Xxx XX, Xxxxxxx, XX 00000 on behalf of itself, its Affiliates, employees, subcontractors and agents (“Seattle Children’s”);

(d) University of Pittsburgh - Of the Commonwealth System of Higher Education, located at Office of Research, 000 Xxxxxxxxxx Xxxxx, Xxxxx Xxxxx, Xxxxxxxxxx, XX 00000, on behalf of itself, its employees, subcontractors and agents (“Pittsburgh”);

(e) The Regents of the University of California, on behalf of itself, its Affiliates, employees, subcontractors, agents and its San Xxxxxxxxx Campus, with offices at 0000 Xxxxxxxxxx Xxxxxx, XXX X-x 0, Xxx Xxxxxxxxx, XX 00000-0000 (“San Xxxxxxxxx”);

(f) Xxxxxxx University, with offices at 000 X 00xx Xxxxxx, Xxxx XX000, Xxx 0, Xxx Xxxx, XX 00000;

(g) The Board of Trustees of the Xxxxxx Xxxxxxxx Junior University, with offices at 0000 Xx Xxxxxx Xxxx, Xxxxxxxx 0, Xxxxx 000, Xxxx Xxxx, XX 00000; and

(h) Children’s Research Institute/Children’s National Medical Center with offices at 111Michigan Avenue, NW, Washington, DC 20010 (each of CHOP, Xxxxx, Seattle Children’s, Pittsburgh and San Xxxxxxxxx, a “Core Member” and collectively, “Core CBTTC Members” or “Core Members”); and

(i) The entities executing this Agreement on the last pages of the Agreement and designated as a Satellite Member (each a “Satellite Member” and collectively “Satellite Members”).

Satellite Members together with the Core Members and those Joined Institutions (as defined below) and Joined Satellite Members (as defined below) that have executed or in the

future execute a Joinder Agreement (as defined below) or Satellite Joinder Agreement (as defined below) are referred to herein as “CBTTC Members,” “Members” or “Parties.”

WHEREAS, certain of the Core CBTTC Members, wishing to conduct a multi- institutional cooperative research program dedicated to the study of childhood brain tumors, executed the Children’s Brain Tumor Tissue Consortium Intellectual Property and Revenue and Material Sharing Agreement, effective March 4, 2013 (the “Original Agreement”), which was replaced with an Amended and Restated Intellectual Property and Revenue and Material Sharing Agreement, effective May 4, 2016, (the “Prior Agreement”) and a Second Amended and Restated Intellectual Property and Revenue and Material Sharing Agreement, effective [INSERT DATE], 2017 (the “Core Member Agreement”), as may be amended from time to time, to which this Agreement is attached as Exhibit B; and

WHEREAS, CHOP is the operations and coordinating center for the CBTTC Repository (as defined below) and the CBTTC is governed by the Core Member Agreement, the Constitution (as defined below), and the Protocol (as defined below); and

WHEREAS, pursuant to the Core Member Agreement, the Constitution and the Protocol, the Core Members have agreed to contribute to and manage a central repository of biological materials and associated data to be located at CHOP acting as the Coordinating Center; and

WHEREAS, the Core Member Agreement and the Constitution provide that each Core Member shall identify at least one satellite institution to augment biological sample procurement together with clinical data entry; and

WHEREAS, the Core Members wish to agree upon a standard set of terms that will bind each of the Core Members and each entity that may from time to time be admitted as a Satellite Member; and

WHEREAS, the undersigned Parties designated as Satellite Members wish to participate in the CBTTC as Satellite Members; and

WHEREAS, the Core Member identified below as the Corresponding Core Member (as defined herein) with respect to a Satellite Member has identified such Satellite Member in fulfillment of its responsibilities under Article XI of the Core Member Agreement;

NOW, THEREFORE, the Parties, intending to be legally bound, agree to the following:

I. Definitions:

1. “Affiliates” means, with respect to any person or entity, any other person or entity which controls, is controlled by, or is under common control with, such person or entity, where

‘control’ means the possession, directly or indirectly, of the power to direct or cause the direction of management policies of a person or entity, whether through ownership of securities, by contract or otherwise.

2. “Background Information” means any information, including but not limited to technical know-how and experimental results (i) known and owned by a CBTTC Member as of the earliest date on which the CBTTC Member first signed a CBTTC Agreement (as defined below) or Joinder Agreement (as defined below), or (ii) known and owned as of the date of execution of a Satellite Joinder in the case of a Joined Satellite Member (as those terms are defined below), and/or (iii) which are developed by a CBTTC Member outside of a CBTTC Agreement, Satellite Joinder Agreement or Joinder Agreement without the utilization of (a) Materials, (b) Research Data or (c) Results received from the CBTTC Repository.

3. “Background Intellectual Property” means any Intellectual Property (i) in existence as of the date on which the CBTTC Member first signed a CBTTC Agreement (as defined below) or Joinder Agreement, or (ii) as of the date of execution of a Satellite Joinder Agreement in the case of a Joined Satellite Member (as those terms are defined below), and/or

(iii) Intellectual Property which is developed by a CBTTC Member outside of a CBTTC Agreement, Satellite Joinder Agreement or Joinder Agreement and owned by each CBTTC Member as their separate property.

4. “CBTTC Agreements” means the Original Agreement, Prior Agreement, Core Member Agreement and this Agreement.

5. “CBTTC Member,” “Member,” “Party” has the meaning given to it in the recitals of this Agreement.

6. “CBTTC Repository” means the central repository located at and/or managed by CHOP within which de-identified Materials, Research Data, and Results are stored and accessed by CHOP for dissemination and use pursuant to this Agreement, the Constitution and the Protocol.

7. “Confidential Information” means, subject to Article VIII, all proprietary information disclosed in writing by the disclosing Party and marked confidential, or if initially disclosed other than in written form, information that is summarized in writing, marked confidential, and provided to receiving Party within twenty (20) days of the initial disclosure. For the avoidance of doubt, Confidential Information does not include Material, or Data (as defined below).

8. “Constitution” means the CBTTC constitution that was ratified on October 21, 2012 and as amended from time to time.

9. “Contractor” means a third party that is not a CBTTC Member or External Recipient and who may receive Materials, Research Data, and/or Results solely for the purposes set forth under and subject to this Agreement, the Constitution and the Protocol, as applicable.

10. “Coordinating Center” means CHOP in its capacity as (i) receiving the Materials, Core Analysis Data, Source Data, and Results, (ii) processing Data to generate Research Data,

and (iii) maintaining and disclosing the Materials, Research Data, and Results according to the terms of this Agreement, the Constitution and the Protocol. For purposes of this Agreement, all references to CHOP are references to CHOP in its capacity as the Coordinating Center unless specifically stated otherwise. All references to “Core Members,” “CBTTC Members,” “Parties” and words of similar meaning include CHOP when acting in its capacity as a Core or CBTTC Member.

11. “Core Analysis” or “Core Analyses” means analyses performed on Materials maintained in the CBTTC Repository or on materials owned or otherwise lawfully possessed by a CBTTC Member, as defined in the Protocol including molecular analyses of DNA, RNA and protein in tumor biopsy specimens, cell lines, xenografts, blood samples, saliva, buccal cells and cerebrospinal fluid (as applicable) but only to the extent such analyses do not occur during a Research Study.

12. “Core Analysis Data” means data generated by Core Analyses and submitted to CHOP in accordance with this Agreement, the Protocol and the Constitution. For the avoidance of doubt, “Core Analysis Data” are not “Results” within the meaning of this Agreement, whether produced (i) by a CBTTC Member utilizing Materials provided through the CBTTC Repository, or (ii) by a CBTTC Member using materials owned and/or otherwise lawfully possessed by the CBTTC Member.

13. “Core Members” has the meaning given to it in the recitals.

14. “Corresponding Core Member” with respect to a Satellite Member means the Core Member that identified the Satellite Member in fulfillment of its responsibilities under Article XI of the Core Member Agreement.

15. “Data” means Source Data and Research Data, collectively.

16. “Executive Board” means the committee responsible for oversight of the CBTTC, reviewing and approving participating CBTTC Members, evaluating continued participation of CBTTC Members and other responsibilities as defined by the Constitution.

17. “External Recipient” means a third party, excluding Contractors, that receives Materials, Research Data, and/or Results through a means reviewed and approved by the Scientific Committee.

18. “Foreground Intellectual Property” means Intellectual Property created in the course of the Research Studies.

19. “HIPAA” means collectively the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, as amended and supplemented by the Health Information Technology for Economic and Clinical Health Act of the American Recovery and Reinvestment Act of 2009, Pub. Law No. 111-5 and its implementing regulations, when each is effective and as each is amended from time to time.

20. “HIPAA Authorization” means an authorization valid under 45 C.F.R. § 164.508, or any successor regulation thereto obtained by a CBTTC Member from a subject pursuant to the

Protocol that permits disclosure of PHI by the CBTTC Member to CHOP in its capacity as the Coordinating Center for research activities and the disclosure by CHOP in its capacity as the Coordinating Center of that PHI to other Recipients as contemplated by this Agreement, or, when permitted by the Protocol, waiver of any such authorization requirement by a properly constituted institutional review board (“IRB”) or privacy board in accordance with the requirements of 45 C.F.R. § 164.512, or any successor regulation thereto.

21. “Informed Consent” means the written document approved by the CBTTC Member’s institutional review board and signed by the subject or the subject’s legally authorized representative that represents the legally effective: (a) informed consent of the subject, as prescribed by 45 C.F.R. § 46.116 and/or 21 C.F.R. § 50.25, or any successor regulation thereto; and (b) HIPAA Authorization.

22. “Intellectual Property” or “IP” means any material, composition of matter, method, process, product, biological material or other tangible or intangible property, regardless of whether such property is patentable or not and shall include, without limitation, any foreign or domestic patent right together with any extension, registration, reissue, re-examination or renewal thereof, and any pending application, including any continuation, or divisional thereof for any of the foregoing.

23. “Joinder Agreement” has the definition given to it in the Core Member Agreement.

24. “Joined Institution” means an institution that became, or in the future becomes, a CBTTC Member by executing a Joinder Agreement. For the avoidance of doubt, all references to “CBTTC Member(s)” in this Agreement include current and future Joined Institutions.

25. “Joined Satellite Member” means an institution that became, or in the future becomes, a CBTTC Member by executing a Satellite Joinder Agreement.

26. “Materials” means Original Materials, Progeny and Unmodified Derivatives.

27. “Original Materials” means DNA and/or biologic samples submitted to the CBTTC.

28. “Protected Health Information” or “PHI” shall have the meaning given to that term by HIPAA at 45 C.F.R. § 160.103, or any successor regulation thereto, and is limited to the Protected Health Information collected, received, maintained, or created by a CBTTC Member and disclosed to CHOP pursuant to a HIPAA Authorization and the Protocol.

29. “Progeny” means unmodified descendant from the Original Materials, such as virus from virus, cell from cell, or organism from organism.

30. “Protocol” means the Children’s Brain Tumor Tissue Consortium (CBTTC) Registry and Repository protocol first dated November 23, 2009 and as amended from time to time, and as later divided into the Collection Protocol and the Repository Protocol [IRB Approval March 31, 2015].

31. “Provider” means the CBTTC Member that is providing Materials, Source Data, Results, and/or Core Analysis Data to CHOP in CHOP’s capacity as the Coordinating Center pursuant to this Agreement, and does not include CHOP in CHOP’s capacity as the Coordinating Center for the CBTTC repository.

32. “Provider Scientist” means the scientist who is responsible for providing Materials, Source Data, Results and/or Core Analysis Data pursuant to this Agreement.

33. “Recipient” means the CBTTC Member that is receiving Materials, Research Data and/or Results pursuant to this Agreement to perform Research Studies or Core Analyses. For the avoidance of doubt, CHOP shall not be a Recipient under this Agreement when CHOP is acting in its capacity as the Coordinating Center, including, without limitation, when CHOP receives and/or maintains Materials, Source Data, Results, and/or Core Analysis Data and generates Research Data for possible further distribution to CBTTC Members and External Recipients that request Materials, Research Data, Results, and/or Core Analysis Data for use in connection with a Research Study conducted by or on behalf of that CBTTC Member or External Recipient. CHOP may, however, be a Recipient when it receives Materials, Research Data or Results from the CBTTC Repository to perform Research Studies.

34. “Recipient Scientist” means the scientist who is receiving Materials, Research Data and/or Results pursuant to this Agreement.

35. “Research Data” means (i) de-identified data derived from Source Data processed by CHOP in its capacity as the Coordinating Center, (ii) de-identified data derived from Core Analysis Data that were produced without using Materials from the CBTTC Repository after such data have been processed by CHOP in its capacity as the Coordinating Center, and (iii) de- identified Core Analysis Data produced using Materials from the CBTTC Repository. Research Data will be published or made available to all Recipients and External Recipients by use of shared software platforms as defined per the Protocol, Constitution and this Agreement.

36. “Research Studies” means research and/or experimentation utilizing the Materials, Research Data, and/or Results to be performed by CBTTC Members, a Recipient and/or External Recipients as approved by the Scientific Committee and in accordance with the Constitution, the Protocol and this Agreement.

37. “Results” means all experimental results and raw data arising from the Research Studies performed by a Recipient. For the avoidance of doubt, “Results” do not include Research Data.

38. “Satellite Joinder Agreement” means an agreement through the execution of which an institution becomes a Joined Satellite Member, attached hereto as Attachment A.

39. “Satellite Member” means an institution identified by a CBTTC Member and approved by the Executive Board to participate in the CBTTC pursuant to the terms set forth in the “Children’s Brain Tumor Tissue Consortium Satellite Member Agreement,” attached hereto as Exhibit A and incorporated herein by reference. For the avoidance of doubt, all references to “Satellite Member(s)” include Joined Satellite Members that have, or may in the future, execute a Satellite Joinder Agreement.

40. “Scientific Committee” means the committee responsible for oversight of the CBTTC Collection Protocol and CBTTC Repository, including the assessment and approval of specimen and data requests, associated Request Forms, recommendations and policies regarding analysis and storage of specimens, analysis, storage, publication, and distribution platforms of Source Data, Research Data, Research Studies, and Results, and any required review and approval of proposed posters, abstracts, publications, and other items utilizing CBTTC Repository Materials, and Research Data as defined in the Protocol and Constitution.

41. “Source Data” means all health information data submitted or provided to CHOP in its capacity as the Coordinating Center by the CBTTC Members under this Agreement. Source Data shall include all the data elements identified in the Protocol.

42. “Request Form” means a specimen, data, or other form approved by the Scientific Committee or its designee submitted by a CBTTC Member or External Recipient to CHOP in writing for the obtaining of Materials, Research Data, Results or Core Analysis Data in accordance with the process set forth in the Protocol, the Constitution, and any procedures adopted thereunder as approved by the Scientific Committee.

43. “Tangible Research Materials” means tangible materials which shall include cell lines, antibodies, cDNA, transgenic animals, and the like created through use of Materials.

44. “Unmodified Derivatives” means substances which constitute an unmodified functional subunit or product expressed by or derived from the Original Material. Some examples include: subclones of unmodified cell lines, purified or fractionated subsets of the Original Material, DNA/RNA isolated from Original Material or proteins expressed therefrom.

II. Effect

1. Satellite Members shall be bound by this Agreement as of the date on which the Satellite Member, having been admitted as a CBTTC Member pursuant to the Constitution, executes this Agreement, or by execution of a Satellite Joinder Agreement in the case of Joined Satellite Members.

2. This Agreement shall be read so as not to conflict with the Core Member Agreement. In the event of any conflict between this Agreement and the Core Member Agreement, the Core Member Agreement shall govern.

III. CBTTC Documents.

The Core Members and Satellite Members agree to comply with the terms of this Agreement, the Joinder Agreement, the Protocol and the Constitution, as applicable to them.

IV. Satellite Members

1. The rights of Satellite Members shall be as set forth in the Constitution, where they are referenced as “satellite institutions,” this Agreement and the Protocol.

2. Satellite Members undertake to provide some of their childhood brain tumor samples to the CBTTC but unlike Core Members are not required to provide any specified percentage of such specimens.

3. Satellite Members will not have representation on the Executive Board (as defined in the Constitution) but the Executive Board may appoint Satellite Members’ study personnel to the Scientific Committee (as defined in the Constitution).

V. Transfers of Materials, Source Data, Core Analysis Data, and Results to the CBTTC Repository

1. Transfer of Materials and Source Data to CHOP for Inclusion in the CBTTC Repository.

(a) Provider agrees to comply with the Constitution, the Protocol and this Agreement when providing CHOP with Materials, Results and Source Data for CHOP and CBTTC Members’ use in accordance with Articles VI and VII hereof.

(b) Material and Source Data transferred by Provider to CHOP may include biological samples and health information that include direct identifiers, including a subject’s first name, last name, date of birth, institutional medical record number (“MRN”) and pathology case numbers, all of which constitute PHI. Each Provider represents to CHOP that the Provider has obtained, or will obtain, a valid HIPAA Authorization that authorizes the Provider to disclose any PHI associated with or included in the Materials or Source Data to CHOP for the uses and further processing contemplated by this Agreement. CHOP will use such PHI pursuant to the applicable HIPAA Authorizations for uses including (i) to confirm diagnosis and that information included in the CBTTC is accurate, and (ii) to create and assign a unique re- identification code for specimens and data as specified in the Protocol. No PHI will be transferred to the CBTTC Repository or disclosed to Recipients, and CHOP will not otherwise use or disclose the PHI in the Source Data other than as permitted by the HIPAA Authorization and this Agreement. CHOP will use appropriate safeguards to prevent use or disclosure of the PHI other than as permitted by the HIPAA Authorization and this Agreement, in accordance with applicable requirements under HIPAA.

(c) Provider represents that it has the authority to provide Materials, Source Data, and Results to CHOP as contemplated in this Agreement and that such transfer of Materials, Source Data and Results to CHOP is not subject to the approval requirements of any applicable regulations, or Provider has obtained any such required approval(s), and that such transfer either is exempt from IRB review, or has been approved by the Provider’s IRB or other applicable ethical review body operating under an Office for Human Research Protections (“OHRP”)-approved Federal Wide Assurance (“FWA”) and in accordance with applicable U.S. Department of Health and Human Services (“HHS”) regulations at 45 C.F.R. Part 46. Provider represents further that it has obtained, where applicable, the Informed Consent of the subjects. Provider agrees that any Source Data transferred to CHOP under this Agreement shall be processed by CHOP to generate Research Data. CHOP will assign an arbitrary or random alphanumeric code to the Materials and Research Data prior to incorporating such Materials and

Research Data into the CBTTC Repository or making such Research Data and Materials available to CBTTC Members or more broadly as permitted under this Agreement.

2. Transfer of Core Analysis Data to CHOP.

(a) Each CBTTC Member agrees to transfer to CHOP, for inclusion in the CBTTC Repository, any Core Analysis Data generated through the utilization of Materials that have been provided to the CBTTC Member by CHOP pursuant to this Agreement and all such data shall be considered Research Data hereunder.

(b) Each CBTTC Member may supply CHOP, for inclusion in the CBTTC Repository, with Core Analysis Data produced utilizing materials owned or otherwise lawfully possessed by such CBTTC Member, which CBTTC Member agrees will be subject to the terms and conditions governing the use of Core Analysis Data set forth in the Constitution, the Protocol and this Agreement.

(c) To the extent that any Core Analysis Data supplied to CHOP contains PHI, each Provider represents to CHOP that the Provider has obtained, or will obtain, a valid HIPAA Authorization that authorizes the Provider to disclose any PHI associated with or included in the Core Analysis Data to CHOP for the uses and further processing contemplated by this Agreement. CHOP shall use such PHI in the same manner and to the same extent as the PHI associated with Materials and Source Data, as specified in Article V.1.b above.

(d) In the event a CBTTC Member supplies Core Analysis Data in the manner described in this Article V.2, Provider represents that it has the authority to provide such Core Analysis Data and that such transfer is not subject to any additional applicable approval requirements, or Provider has obtained any such required approval, and represents further that the transfer either is exempt from IRB review, or has been approved by the Provider’s IRB or other applicable ethical review body operating under an OHRP-approved FWA in accordance with HHS regulations at 45 C.F.R. Part 46. Provider represents further that it has obtained, where applicable, the Informed Consent of the subjects. Provider agrees that any Core Analysis Data transferred to CHOP under this Agreement that were generated through the utilization of Materials owned or otherwise lawfully possessed by such CBTTC Member shall be processed by CHOP to generate Research Data in the same manner as the process identified in Article V.1.c above.

VI. CHOP’s Provision of Materials, Research Data and Results

1. CHOP, acting in its capacity as the Coordinating Center, will process Source Data and Core Analysis Data to create Research Data and maintain Materials, Research Data and Results in the CBTTC Repository. CHOP will provide Materials, Research Data and Results to Recipients, Satellite Members and External Recipients in accordance with the Constitution, the Protocol and this Agreement.

2. Each CBTTC Member agrees that Materials, Research Data and Results may be provided by CHOP to other CBTTC Members and Satellite Members for education, teaching and research purposes in accordance with the terms and conditions of Articles VII and X hereof. Notwithstanding the forgoing, each CBTTC Member agrees that Materials, Research Data and

Results may be provided by CHOP to other CBTTC Members and Satellite Members for additional purposes upon the majority vote of the Scientific Committee and in accordance with the terms and conditions of Articles VII and X hereof.

3. Each CBTTC Member agrees that Materials, Research Data and in certain cases Results may be provided by CHOP to External Recipients for education, teaching and research purposes as designated and approved by the Scientific Committee from time to time under terms no less restrictive than those contained herein and in accordance with the terms and conditions of Articles VII and X hereof. Notwithstanding the forgoing, each CBTTC Member agrees that Materials, Research Data and Results may be provided by CHOP to External Recipients for additional purposes upon the majority vote of the Scientific Committee and in accordance with the terms and conditions of Articles VII and X hereof.

4. CBTTC Members agree that CHOP may provide Materials and Research Data to Contractors providing services to the CBTTC.

VII. Use of Materials, Research Data and Results by CBTTC Members

Notwithstanding any other provisions in this Agreement, each CBTTC Member agrees as follows:

1. Any and all Materials obtained pursuant to this Agreement will not be used in human subjects, clinical trials, or for therapy, transplantation or diagnostic purposes involving human subjects.

2. The Materials, Research Data and Results obtained pursuant to this Agreement will be used solely in accordance with this Agreement, the Constitution, the Protocol, all applicable federal, state and local laws and regulations, and the Specimen and Data Request Form approved by the Scientific Committee (as applicable).

3. Each Recipient shall maintain the Materials, Research Data and Results obtained from the CBTTC Repository for its own education, teaching and research purposes, or for such broader purposes as approved by the Scientific Committee pursuant to Article VI.2 above, in accordance with this Agreement, the Constitution and Protocol. Notwithstanding the foregoing, the maintenance of Results shall be subject to those additional requirements set forth in Article X below.

4. Each Recipient shall use the Materials, Research Data and Results obtained from the CBTTC Repository solely in its own facilities and under the direction of the Recipient Scientist or others working under his or her direct supervision, unless the Scientific Committee has provided written permission for use outside of the CBTTC Member’s organization and/or other than under the direction of the Recipient Scientist.

and/or Research Data following completion of the contracted services unless otherwise approved in advance by the Scientific Committee. Each Recipient shall hold any of its agents, including Contractors, to the standards, restrictions and conditions stated in this Agreement with respect to the use of Materials and/or Research Data.

6. Each Recipient shall ensure proper storage of Materials, Results, and Research Data and shall ensure that all persons handling Materials, Results, Core Analysis Data, and Research Data are appropriately trained.

7. Each Recipient’s acquisition and use of Materials, Core Analysis Data, Results and Research Data is not in violation of either state or federal laws and regulations.

8. Each Recipient shall not use the Materials, Results and Research Data either alone or in conjunction with any other information, in any effort whatsoever, to establish the individual identities of any subjects from whom the Materials, Results, and Research Data were derived, except in accordance with an IRB-approved protocol and/or the Constitution.

9. Each Recipient shall use appropriate safeguards to prevent the use or disclosure of the Materials, Results, and Research Data, other than as provided for in the Protocol, Constitution, or this Agreement.

10. Each Recipient shall notify CHOP promptly of any uses or disclosures of the Materials, Results, and Research Data in violation of the Agreement of which the CBTTC Member becomes aware.

11. Recipient shall hold any agent of the Recipient (including subcontractors) to the standards, restrictions and conditions stated herein with respect to the Materials, Results and Research Data.

12. Except as expressly provided herein, no option, license or conveyance of rights, express or implied, is granted by one Party to the other Party in connection with any Materials, Data, or Results provided under the Agreement, except the right to use the Materials, Results and Research Data strictly in accordance with the terms of the Agreement and, if applicable, a Specimen and Data Request Form.

VIII. Confidentiality

The Parties agree to retain in confidence and use only for the purposes of this Agreement any Confidential Information supplied pursuant to this Agreement. Confidential Information will not include information that:

1. is in receiving Party’s possession prior to receipt from disclosing Party as evidenced by competent documentation;

2. is in the public domain at the time of receipt from disclosing Party;

3. becomes part of the public domain through no fault of the receiving Party;

4. is lawfully received from a third party not prohibited from disclosing it;

5. is independently developed by receiving Party without reference to disclosing Party’s information, as evidenced by receiving Party’s written records; or

6. is required by law or regulation, or to be disclosed in a judicial or administrative proceeding after legal remedies for maintaining information in confidence shall have been exhausted, but only to the minimum extent required by such law, regulation or proceeding; notice of any such proceeding to be given to disclosing Party promptly upon receiving Party’s first notice or information about such proceeding. The obligations of the receiving Party with respect to Confidential Information shall continue for a period ending three (3) years from the date of initial disclosure pursuant to this Agreement.

For the avoidance of doubt, CHOP and any CBTTC Member will not be in violation of this Article VIII by using and/or providing Materials, Data and/or Results in conformance with the terms of this Agreement.

IX. Liability, No Warranties and Indemnification

1. Any Materials, Research Data and Results delivered pursuant to this Agreement are provided in an “AS IS” condition, and are understood to be experimental in nature and may have hazardous properties. THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, EXCEPT FOR THOSE EXPLICITLY SET FORTH HEREIN. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIALS, RESEARCH DATA, CORE ANALYSIS DATA, RESULTS, OR FOREGROUND IP WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS.

2. The Parties acknowledge that the Materials are biomedical in nature and contain certain properties that are inherently hazardous. Furthermore, the Parties acknowledge that the storage, use, transport, and disposal of such Materials are strictly regulated.

3. To the extent allowable by applicable laws, Recipient agrees to indemnify, defend and hold harmless Provider, CHOP and the other Parties from and against any and all liability, losses, damages, claims, demands and/or fees (including reasonable attorney’s fees) costs, penalties and/or judgments but only in proportion to and to the extent arising from Recipient’s, or Recipient’s Contractors’, use, storage or disposal of Materials, Research Data Core Analyis Data, or Results, or from Recipient’s use of Foreground Intellectual Property, and for any such liability arising from the negligence or misconduct of Recipient or Recipient’s Contractors related to such use, storage or disposal, except insofar as such liability, losses, damages, claims, demands and/or fees (including attorney’s fees) costs, penalties and/or judgments arise from the Provider’s or another Recipient’s breach of this Agreement, or any negligence or intentional or willful misconduct by Provider or another Recipient.

with all and any instructions or advice which may be given by the Provider supplying the Materials or by CHOP in its role as Coordinating Center and in accordance with all applicable federal, state and local laws and regulations, including, but not limited to, animal welfare laws and regulations and National Institutes of Health regulations and guidelines.

5. The Recipient shall use the Materials and any materials treated with the Materials under appropriate containment conditions.

6. Recipient assumes all risk and responsibility in connection with its respective receipt, handling, storage, disposal, transfer and use of the Materials including, without limitation, taking all appropriate safety and handling precautions to minimize health or environmental risk. Recipient agrees that any activity undertaken with the Materialswill be in compliance with all applicable federal, state and local laws and regulations, including, but not limited to Public Health Service and National Institutes of Health regulations and guidelines and regulations involving the use of animals, human samples or recombinant DNA.

X. Results and Intellectual Property

1. All Materials and Source Data shall remain the property of the Provider and any Materials, Results, and Research Data will be used by the Recipient solely in accordance with the Protocol, the Constitution and the terms of this Agreement. CHOP shall administer all Materials and Data in accordance with the terms and conditions set forth by the CBTTC Scientific Committee. Any Materials, Source Data and/or Core Analysis Data generated from materials other than Materials received from the CBTTC Repository that are retained by the Provider may be utilized at the Provider’s sole discretion.

2. It is recognized and understood that the existing Background Intellectual Property and Background Information of CBTTC Members are their separate property, respectively, and are not affected by this Agreement and none of the Parties shall have any claims to or rights in such existing inventions and technologies of the other Party.

3. Results developed solely by one CBTTC Member shall be solely owned by such CBTTC Member. Jointly generated Results will be jointly-owned by those CBTTC Members involved in generating the jointly-generated Results.

4. Each CBTTC Member will disclose to the other CBTTC Members a summary of all Results generated under this Agreement and will disclose all Results to CHOP for inclusion in the CBTTC Repository. The Results shall be considered Confidential Information and shall be maintained in accordance with Article VIII of this Agreement by each Party until they are published, and if the disclosing CBTTC Member determines no publications will result, it shall notify the other CBTTC Members accordingly. Subject to the foregoing, CHOP may distribute Results to CBTTC Members for use by such CBTTC Member(s) in their internal education, teaching and non-commercial research purposes as approved by the Scientific Committee. CHOP may disclose Results from the CBTTC Repository to an External Recipient for its own educational, teaching and non-commercial research purposes only after receiving (i) the written approval of the Provider, and (ii) the approval of the Scientific Committee for disclosure of the Results to a specific External Recipient.

5. Inventorship of Foreground Intellectual Property will be determined in accordance with applicable U.S. Patent laws and regulations and ownership shall follow therefrom.

6. Foreground Intellectual Property made in the course of the Research Studies solely by employees of a CBTTC Member shall be owned by such CBTTC Member and shall be governed in accordance with that CBTTC Member’s policies and procedures. Foreground Intellectual Property made jointly by employees of two or more CBTTC Members will be jointly owned by those CBTTC Members involved in making such Foreground Intellectual Property, and ownership in any patents or patent applications included in the Foreground IP shall follow inventorship as determined in accordance with Article X.5. CBTTC Members jointly owning the Foreground Intellectual Property shall enter into an inter-institutional agreement that outlines each Member’s rights and responsibilities with respect to the jointly owned Foreground Intellectual Property.

7. Each CBTTC Member will report to the CBTTC, in writing, all Foreground Intellectual Property made during the Research Studies promptly and no later than three (3) months from the time the invention is disclosed to the CBTTC Member’s office of technology transfer by its investigator. The invention reports will be treated as Confidential Information in accordance with Article VIII of this Agreement.

8. Each CBTTC Member-owner of Results and Foreground Intellectual Property hereby grants to the other CBTTC Members a non-exclusive, royalty-free, non-transferable, perpetual license to use the Results and Foreground Intellectual Property solely for such CBTTC Member’s educational, teaching and research purposes.

9. Revenues accruing to a CBTTC Member from licensing or otherwise commercializing Foreground Intellectual Property shall be distributed in accordance with the Member(s) institutional policy, provided, however, that 20% of gross revenues realized from licensing or otherwise commercializing Tangible Research Materials and 10% of gross revenues realized from licensing or otherwise commercializing other Foreground Intellectual Property shall be distributed to CHOP solely for the support and maintenance of the CBTTC, provided that any unreimbursed expenses related to Intellectual Property protection shall be recovered from revenue before any sharing of such revenue occurs. Nothing in this Section X.9 shall be construed to require the sharing of any revenues generated from the licensing or commercialization of Core Analysis Data by a CBTTC Member. CBTTC Members shall have the right to audit CBTTC’s use of revenues under terms reasonable and customary in the industry.

XI. Use of Names

No Party shall use the name, insignia or logo of another Party for any purpose, except as required by law, without the prior written consent of the other Party, provided however that each Party may use the name of another Party in its routine listings of sponsored projects, as required xx xxxxx applications, and as required by peer-reviewed journals for publication; and provided further that CHOP, in its capacity as Coordinating Center, may use the names of the Satellite Members when listing Satellite Members publicly.

XII. Termination

1. Any Party may at any time terminate its participation in this Agreement without cause upon written notice to the other Parties at least sixty (60) days prior to the date upon which termination is to take effect. Termination or expiration of this Agreement shall not affect any rights or obligations which have accrued prior thereto and each Party shall maintain, store and use following termination of such Party’s participation any Materials, Research Data and/or Results received from the CBTTC Repository hereunder solely in accordance with the terms of this Agreement, the Constitution, the Protocol and any approved Specimen and Data Request Form pursuant to which such Materials, Research Data and/or Results were received.

2. If a Party breaches a material term of this Agreement, the Protocol or Constitution, then the other Parties may exercise their right of termination by giving the Party in breach a written description of the event or occurrence constituting the breach. The Party in breach will have the opportunity to cure such breach within thirty (30) days of receipt of such notice. Upon the expiration of the thirty (30) day period, the breaching Party’s participation in this Agreement shall automatically terminate unless the breaching Party has removed the condition of termination. Notwithstanding the foregoing, following termination of the breaching Party’s participation, such Party shall maintain, store and use any Materials, Research Data and/or Results received from the CBTTC Repository hereunder solely in accordance with the terms of this Agreement, the Constitution, the Protocol and any approved Specimen and Data Request Form pursuant to which such Materials, Research Data and/or Results were received.

3. Articles VII, VIII (for the three (3) year period set forth therein), IX and X shall survive termination of this Agreement for any reason.

XIII. Notices

Notices, invoices, communications, and payments hereunder shall be deemed made if given by overnight courier or by registered or certified envelope, post prepaid, and addressed to the Party to receive such notice, invoice or communication at the address as provided in the recitals for Core Members and in the signature page below for Satellite Members, or such other address as may hereafter be designated by notice in writing. Notice given pursuant to this Article shall be effective as of the day of receipt of notice.

XIV. General Provisions

1. Non-Assignability: The rights and obligations of the Parties under this Agreement shall not be assignable without written permission of the other Parties.

2. Severability: If any provision hereof is held unenforceable or void, the remaining provisions shall be enforced in accordance with their terms.

3. Entire Agreement: This Agreement contains the entire and only agreement between the Parties respecting the subject matter hereof and supersedes or cancels all previous negotiations, agreements, commitments and writings between the Parties on the subject of this Agreement. Should processing of this Agreement require issuance of a purchase order or other contractual document, all terms and conditions of said document are hereby deleted in entirety.

This Agreement may not be amended in any manner except by an instrument in writing signed by the duly authorized representatives of each of the Parties hereto, except that Joined Satellite Members and Joined Institutions, may be added as Parties through execution of a Satellite Joinder Agreement or Joinder Agreement, respectively.

4. Export Control Regulations: CBTTC Members agree that they shall comply with all applicable export control regulations of the United States of America. Notwithstanding any other provision of this Agreement, the Parties hereto understand and agree that they are subject to, and agree to abide by, any and all applicable U.S. laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities. The Parties’ obligations hereunder are contingent on their ability to comply with applicable United States export and embargo laws and regulations. It is the expectation of the Parties that the work done pursuant to this Agreement will constitute fundamental research and be exempt from export control licensing requirements under the applicable export control laws and regulations. The CBTTC Members do not wish to take receipt of export-controlled information except as may be knowingly and expressly agreed to in writing signed by an authorized representative of the CBTTC Member and for which that Member has made specific arrangements. The Parties agree that they will not provide or make accessible to any other CBTTC Member any export-controlled materials (including, without limitation, equipment, information and/or data) without first informing such CBTTC Member of the export-controlled nature of the materials and obtaining from such CBTTC Member its prior written consent to accept such materials as well as any specific instructions regarding the mechanism pursuant to which such materials should be passed to that CBTTC Member. CBTTC Members agree to comply with any and all applicable U.S. export control laws and regulations, as well any and all embargoes and/or other restrictions imposed by the Treasury Department’s Office of Foreign Asset Controls.

5. Waiver: No Party waives its right to enforce any and all provisions of the Agreement at any time during the term. A Party’s failure to enforce any provision shall not prejudice such Party from later enforcing or exercising the same or any other provision of the Agreement.

6. Binding Agreement on Successors: This Agreement shall be binding upon each Party’s successors and assigns.

7. Headings: Headings are for convenience of reference only, and not for interpreting the provisions of the Agreement.

8. Counterparts: This Agreement may be executed in counterparts, and by any Party on separate counterpart, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

REMAINDER OF XXXX INTENTIONALLY LEFT BLANK

Satellite Member: Beijing Genomics Institute at Shenzhen

Authorized Officer: Xxx Xx

Title: Executive Director of CNAB, Director of BGI-Research Signature:

Date:

Address: China Xxxxxxxx XxxxXxxx, Xxxxxx Xxxx, Xxxxxx Xxxxxx, Xxxxxx Xxxxxxxx, Xxxxxxxxx, Xxxxx

Corresponding Core Member: The Children’s Hospital of Philadelphia

Satellite Member: Beijing Tian Tan Hospital

Authorized Officer: Xxxxxx Xx Title: Doctor of Neurosurgery

Signature: Date:

Address: Xx. 0 Xxxx Xxx Xx Xx Xxxxxxxxx Xxxxxxxx, Xxxxxxx, Xxxxx

Corresponding Core Member: The Children’s Hospital of Philadelphia

Satellite Member: Hackensack University Medical Center Authorized Officer: Xxxxxx Xxxxxxxx, RN

Title: VP of Research and Regulatory Affairs Signature: Date:

Address: 00 Xxxxxxxx Xxxxxx, Xxxxxxxx Xxxxxxxx Xxxxxxxxxx, XX 00000

Corresponding Core Member: The Children’s Hospital of Philadelphia

Satellite Member: University Hospital of Meyer

Authorized Officer: Dr. Xxxxxxx Xxxxxxxx Title: Managing Director

Signature: Date: Address: Xxxxx Xxxxxxxxxx 00, Xxxxxxx (Xxxxx)

Corresponding Core Member: The Children’s Hospital of Philadelphia

Satellite Member: Dayton Children’s Hospital

Authorized Officer: Xxxx Xxxx, M.D.

Title: Vice President for Academic Affairs & Community Health

Signature: Date: Address: 1 Children’s Plz, Dayton, OH 45404-1873

Corresponding Core Member: The Children’s Hospital of Philadelphia

EXHIBIT A

Satellite Joinder Agreement

This Satellite Joinder Agreement is made pursuant to the Children’s Brain Tumor Tissue Consortium (“CBTTC”) Second Amended and Restated Intellectual Property and Revenue and Material Sharing Agreement dated May 14, 2019, as amended from time to time (“Agreement”) and the Children’s Brain Tumor Tissue Consortium Amended Satellite Member Agreement dated May 14, 2019, as amended from time to time (the “Satellite Agreement”) and establishes that the below-identified, undersigned institution (the “Joined Satellite Member”) is a party to the Satellite Agreement, with all of the associated rights and obligations under each of the Agreement and the Satellite Agreement. [Insert Institution Name] is the Corresponding Core Member for the Joined Satellite Member.

By execution of this Satellite Joinder Agreement, the Joined Satellite Member hereby: (i) represents and warrants that it meets all eligibility requirements for participation in the Satellite Agreement, including but not limited to, the approval of the Executive Board through a majority vote; (ii) joins in, accepts and agrees to be bound by all of the terms and conditions of the Satellite Agreement; and (iii) makes all of the representations and warranties required of Parties to the Satellite Agreement.

Any capitalized terms used in this Satellite Joinder Agreement and not defined herein shall have the same meanings given to them in the Agreement or Satellite Agreement, as applicable.

The Effective Date of this Satellite Joinder Agreement is the date on which the Joined Satellite Member executes the Satellite Joinder Agreement as indicated by its Authorized Institutional Official/Signatory below.

The Joined Satellite Member must keep this Satellite Joinder Agreement and a copy of the Agreement and Satellite Agreement on file and provide a copy of the signed Satellite Joinder Agreement to The Children’s Hospital of Philadelphia on behalf of CBTTC at the address set forth for notices in the Satellite Agreement.

Institution Legal Name:

Notices. All written notices and other communications required under the Satellite Agreement from any other Party to the Joined Satellite Member may be made in hard copy or electronic form and shall be delivered to the following address(es):

For notice:

NAME:

TITLE:

INSTITUTION:

TOWN, STATE, ZIP:

Email address:

With a copy to: (Add as many as apply) NAME:

TITLE:

INSTITUTION: TOWN, STATE, ZIP:

Email address:

Point of Contact.

NAME: TITLE:

INSTITUTION: TOWN, STATE, ZIP:

Email address:

Agreed by the Authorized Institutional Official/Signatory of the Joined Satellite Member on behalf of itself, its Affiliates, employees, subcontractors and agents

(Authorized Institutional Official/Signatory)

Read & Acknowledged by the Corresponding Core Member: [Insert Institution Name]

(Authorized Institutional Official/Signatory)

Whereas, each CBTTC Member (as defined below) will transfer Materials, Source Data Core Analysis Data, and Results (all as defined below) to CHOP and CHOP will then distribute Materials, Research Data, and Results to the CBTTC Members or External Recipients (as defined below) for use in research projects as described in this Agreement; and

Whereas, each CBTTC Member also will transfer to CHOP Core Analysis Data generated using Materials provided by CHOP pursuant to this Agreement, and may transfer to CHOP Core Analysis Data generated using other material owned and/or otherwise lawfully possessed by the CBTTC Member; and

Whereas, the CBTTC Members desire to make available Research Data, Core Analysis Data, and Results to CBTTC Members, Satellite Members (as defined below) and, in certain cases, External Recipients (as defined below) through the CBTTC Repository, as well as through other means reviewed and approved by the Scientific Committee, including but not limited to distribution through the CAVATICA or a similar platform; and

Whereas, certain of the Core Members previously entered into an Intellectual Property and Revenue and Material Sharing Agreement effective March 4, 2013 (the “Original Agreement”) and the Core Members entered into an Amended and Restated Intellectual Property and Revenue and Material Sharing Agreement effective May 4, 2016 (the “Prior Agreement”); and

Whereas, the Core Members approved a First Amendment to the Amended and Restated Intellectual Property and Revenue and Material Sharing Agreement, effective September 15, 2016 (the “First Amendment to the Amended and Restated Agreement”), by which the Core Members agreed to permit new CBTTC Members to join the CBTTC, provided that such Members execute a Joinder Agreement (as defined below), obligating the new CBTTC Member to all the terms and conditions set forth in the Prior Agreement and any amendments thereto; and

Whereas, the CBTTC Members wish to amend and restate the Prior Agreement to add reference to Core Analysis Data, provide for the dissemination of Research Data, Core Analysis Data, and, in certain cases, Results, to External Recipients and the public and amend various other provisions as set forth below;

Now, therefore, the CBTTC Members, intending to be legally bound, agree to amend, restate and replace the Prior Agreement with the terms of this Agreement, which shall consist of the following:

I. Definitions:

1. “Affiliates” means, with respect to any person or entity, any other person or entity which controls, is controlled by, or is under common control with, such person or entity, where ‘control’ means the possession, directly or indirectly, of the power to direct or cause the direction of management policies of a person or entity, whether through ownership of securities, by contract or otherwise.

2. “Background Information” means any information, including but not limited to technical know-how and experimental results (i) known and owned by a CBTTC Member as of

the earliest date on which the CBTTC Member signed a CBTTC Agreement (as defined below) or Joinder Agreement (as defined below), and/or (ii) which are developed by a CBTTC Member outside of this Agreement without the utilization of (a) Materials, (b) Research Data or (c) Results received from the CBTTC Repository.

3. “Background Intellectual Property” means any Intellectual Property in existence as of (i) the earliest date on which the CBTTC Member signed a CBTTC Agreement (as defined below) or Joinder Agreement (as defined below), and/or (ii) which is developed by a CBTTC Member outside of this Agreement and owned by each CBTTC Member as their separate property.

4. “CBTTC Agreements” means the Original Agreement, Prior Agreement and this Agreement.

5. “CBTTC Member,” “Member,” “Party” and all plural forms thereof mean for purposes of this Agreement both Core Members and Joined Institutions who become Members pursuant to the execution of a Joinder Agreement.

7. “Confidential Information” means, subject to Article V, all proprietary information disclosed in writing by the disclosing Party and marked confidential, or if initially disclosed other than in written form, information that is summarized in writing, marked confidential, and provided to receiving Party within twenty (20) days of the initial disclosure. For the avoidance of doubt, Confidential Information does not include Material Core Analysis Data, or Data (as defined below).

8. “Constitution” means the CBTTC constitution that was ratified on October 21, 2012 and as amended from time to time.

10. “Coordinating Center” means CHOP in its capacity as (i) receiving the Materials, Core Analysis Data, Source Data, and Results, (ii) processing Data to generate Research Data, and (iii) maintaining and disclosing the Materials, Research Data, and Results according to the terms of this Agreement, the Constitution and the Protocol. For purposes of this Agreement, all references to CHOP are references to CHOP in its capacity as the Coordinating Center unless specifically stated otherwise. All references to “Core Members,” “CBTTC Members,” “Parties” and words of similar meaning include CHOP when acting in its capacity as a Core or CBTTC Member.

11. “Core Analysis” or “Core Analyses” means analyses performed on Materials maintained in the CBTTC Repository or on materials owned or otherwise lawfully possessed by a CBTTC Member, including molecular analyses of DNA, RNA and protein in tumor biopsy specimens, cell lines, xenografts, blood samples, saliva, buccal cells and cerebrospinal fluid (as applicable) but only to the extent such analyses do not occur during a Research Study.

13. “Core Members” has the meaning given to it in the recitals.

14. “Data” means Source Data and Research Data, collectively.

15. “Executive Board” means the committee responsible for oversight of the CBTTC, reviewing and approving participating CBTTC Members, evaluating continued participation of CBTTC Members and other responsibilities as defined by the Constitution.

16. “External Recipient” means a third party, excluding Contractors, that receives Materials, Research Data, and/or Results through a means reviewed and approved by the Scientific Committee.

17. “Foreground Intellectual Property” means Intellectual Property created in the course of the Research Studies.

18. “HIPAA” means collectively the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, as amended and supplemented by the Health Information Technology for Economic and Clinical Health Act of the American Recovery and Reinvestment Act of 2009, Pub. Law No. 111-5 and its implementing regulations, when each is effective and as each is amended from time to time.

19. “HIPAA Authorization” means an authorization valid under 45 C.F.R. § 164.508, or any successor regulation thereto, obtained by a CBTTC Member from a subject pursuant to the Protocol that permits disclosure of PHI by the CBTTC Member to CHOP in its capacity as the Coordinating Center for research activities and the disclosure by CHOP in its capacity as the Coordinating Center of that PHI to other Recipients as contemplated by this Agreement, or, when permitted by the Protocol, waiver of any such authorization requirement by a properly constituted institutional review board (“IRB”) or privacy board in accordance with the requirements of 45 C.F.R. § 164.512, or any successor regulation thereto.

20. “Informed Consent” means the written document approved by the CBTTC Member’s institutional review board and signed by the subject or the subject’s legally authorized representative that represents the legally effective: (a) informed consent of the subject, as prescribed by 45 C.F.R. § 46.116 and/or 21 C.F.R. § 50.25, or any successor regulation thereto; and (b) HIPAA Authorization.

21. “Intellectual Property” or “IP” means any material, composition of matter, method, process, product, biological material or other tangible or intangible property, regardless of whether such property is patentable or not and shall include, without limitation, any foreign or domestic patent right together with any extension, registration, reissue, re-examination or renewal thereof, and any pending application, including any continuation, or divisional thereof for any of the foregoing.

22. “Joinder Agreement” means (i) for CBTTC Members that joined the Prior Agreement the agreement attached to the First Amendment to the Amended and Restated Agreement through the execution of which an institution became a Joined Institution, and (ii) for Institutions added after the effective date of this Agreement the Joinder Agreement attached hereto as Attachment A.

23. “Joined Institution” means an institution that became, or in the future becomes, a CBTTC Member by executing a Joinder Agreement. For the avoidance of doubt, all references to “CBTTC Member(s)” in this Agreement include current and future Joined Institutions.

24. “Joined Satellite Member” means an institution that became, or in the future becomes, a CBTTC Member by executing a Satellite Joinder Agreement.

25. “Materials” means Original Materials, Progeny and Unmodified Derivatives.

26. “Original Materials” means DNA and/or biologic samples submitted to the CBTTC.

27. “Protected Health Information” or “PHI” shall have the meaning given to that term by HIPAA at 45 C.F.R. § 160.103, or any successor regulation thereto, and is limited to the Protected Health Information collected, received, maintained, or created by a CBTTC Member and disclosed to CHOP pursuant to a HIPAA Authorization and the Protocol.

28. “Progeny” means unmodified descendant from the Original Materials, such as virus from virus, cell from cell, or organism from organism.

29. “Protocol” means the Children’s Brain Tumor Tissue Consortium (CBTTC) Registry and Repository protocol first dated November 23, 2009 and as amended from time to time, and as later divided into the Collection Protocol and the Repository Protocol [IRB Approval March 31, 2015].

30. “Provider” means the CBTTC Member that is providing Materials, Source Data, Results, and/or Core Analysis Data to CHOP in CHOP’s capacity as the Coordinating Center pursuant to this Agreement, and does not include CHOP in CHOP’s capacity as the Coordinating Center for the CBTTC repository.

31. “Provider Scientist” means the scientist who is responsible for providing Materials, Source Data, Results and/or Core Analysis Data pursuant to this Agreement.

32. “Recipient” means the CBTTC Member that is receiving Materials, Research Data, and/or Results through a means reviewed and approved by the Scientific Committee. For

the avoidance of doubt, CHOP shall not be a Recipient under this Agreement when CHOP is acting in its capacity as the Coordinating Center, including, without limitation, when CHOP receives and/or maintains Materials, Source Data, Results, and/or Core Analysis Data and generates Research Data for possible further distribution to CBTTC Members and External Recipients that request Materials, Research Data, and/or Results, for use in connection with a Research Study conducted by or on behalf of that CBTTC Member or External Recipient. CHOP may, however, be a Recipient when it receives Materials, Research Data or Results from the CBTTC Repository to perform Research Studies.

33. “Recipient Scientist” means the scientist who is receiving Materials, Research Data, and/or Results pursuant to this Agreement.

34. “Research Data” means (i) de-identified data derived from Source Data processed by CHOP in its capacity as the Coordinating Center, (ii) de-identified data derived from Core Analysis Data that were produced without using Materials from the CBTTC Repository after such data have been processed by CHOP in its capacity as the Coordinating Center, and (iii) de- identified Core Analysis Data produced using Materials from the CBTTC Repository. Research Data will be published or made available to all Recipients and External Recipients by use of shared software platforms as defined per the Protocol, Constitution and this Agreement.

35. “Research Studies” means research and/or experimentation utilizing the Materials, Research Data, and/or Results to be performed by CBTTC Members, a Recipient and/or External Recipients as approved by the Scientific Committee and in accordance with the Constitution, the Protocol and this Agreement.

36. “Results” means all experimental results and raw data arising from the Research Studies performed by a Recipient. For the avoidance of doubt, “Results” do not include Research Data or Core Analysis Data.

37. “Satellite Joinder Agreement” means an agreement through the execution of which an institution becomes a Joined Satellite Member.

38. “Satellite Member” means an institution identified by a CBTTC Member and approved by the Executive Board to participate in the CBTTC pursuant to the terms set forth in the “Children’s Brain Tumor Tissue Consortium Satellite Member Agreement,” attached hereto as Exhibit A and incorporated herein by reference. For the avoidance of doubt, all references to “Satellite Member(s)” includes Joined Satellite Members that have, or may in the future, execute a Satellite Joinder Agreement.

39. “Scientific Committee” means the committee responsible for oversight of the CBTTC Collection Protocol and CBTTC Repository, including the assessment and approval of specimen and data requests, associated Request Forms, recommendations and policies regarding analysis and storage of specimens, analysis, storage, publication, and distribution platforms of Source Data, Core Analysis Data, Research Data, Research Studies, and Results, and any required review and approval of proposed posters, abstracts, publications, and other items utilizing CBTTC Repository Materials, Core Analysis Data, and Research Data as defined in the Protocol and Constitution.

40. “Source Data” means all health information data submitted or provided to CHOP in its capacity as the Coordinating Center by the CBTTC Members under this Agreement. Source Data shall include all the data elements identified in the Protocol.

41. “Request Form” means a specimen, data, or other form approved by the Scientific Committee or its designee submitted by a CBTTC Member or External Recipient to CHOP in writing for the obtaining of Materials, Research Data, or Results in accordance with the process set forth in the Protocol, the Constitution, and any procedures adopted thereunder as approved by the Scientific Committee.

42. “Tangible Research Materials” means tangible materials which shall include cell lines, antibodies, cDNA, transgenic animals, and the like created through use of Materials.

43. “Unmodified Derivatives” means substances which constitute an unmodified functional subunit or product expressed by or derived from the Original Material. Some examples include: subclones of unmodified cell lines, purified or fractionated subsets of the Original Material, DNA/RNA isolated from Original Material or proteins expressed therefrom.

II. Transfers of Materials, Source Data, Results and Core Analysis Data to the CBTTC Repository

1. Transfer of Materials, Source Data to CHOP for Inclusion in the CBTTC Repository.

transfer either is exempt from IRB review, or has been approved by the Provider’s IRB or other applicable ethical review body operating under an Office for Human Research Protections (“OHRP”)-approved Federal Wide Assurance (“FWA”) and in accordance with applicable U.S. Department of Health and Human Services (“HHS”) regulations at 45 C.F.R. Part 46. Provider represents further that it has obtained, where applicable, the Informed Consent of the subjects.

Provider agrees that any Source Data transferred to CHOP under this Agreement shall be processed by CHOP to generate Research Data. CHOP will assign an arbitrary or random alphanumeric code to the Materials, and Research Data prior to incorporating such Materials, and Research Data into the CBTTC Repository or making such Research Data and Materials available to CBTTC Members or more broadly as permitted under, the Protocol, the Constitution, and this Agreement.

2. Transfer of Core Analysis Data to CHOP.

(d) In the event a CBTTC Member supplies Core Analysis Data in the manner described in this Article II.2, Provider represents that it has the authority to provide such Core Analysis Data and that such transfer is not subject to any additional applicable approval requirements, or Provider has obtained any such required approval, and represents further that the transfer either is exempt from IRB review, or has been approved by the Provider’s IRB or other applicable ethical review body operating under an OHRP-approved FWA in accordance with HHS regulations at 45 C.F.R. Part 46. Provider represents further that it has obtained, where applicable, the Informed Consent of the subjects. Provider agrees that any Core Analysis Data transferred to CHOP under this Agreement that were generated through the utilization of Materials owned or otherwise lawfully possessed by such CBTTC Member shall be processed by CHOP to generate Research Data in the same manner as the process identified in Article II.1.c above.

III. CHOP’s Provision of Materials, Research Data and Results

1. CHOP, acting in its capacity as the Coordinating Center, will process Source Data and Core Analysis Data to create Research Data and maintain Materials, Research Data and Results in the CBTTC Repository. CHOP will provide Materials, Research Data, and Results to Recipients, Satellite Members and External Recipients in accordance with the Constitution, the Protocol and this Agreement.

2. Each CBTTC Member agrees that Materials, Research Data and Results may be provided by CHOP to other CBTTC Members and Satellite Members, for education, teaching and research purposes in accordance with the terms and conditions of Articles IV and VII hereof. Notwithstanding the forgoing, each CBTTC Member agrees that Materials, Research Data and Results may be provided by CHOP to other CBTTC Members, and Satellite Members for additional purposes upon the majority vote of the Scientific Committee and in accordance with the terms and conditions of Articles IV and VII hereof.

3. Each CBTTC Member agrees that Materials, Research Data and in certain cases Results may be provided by CHOP to External Recipients for education, teaching and research purposes as designated and approved by a majority vote of the Scientific Committee from time to time under terms no less restrictive than those contained herein and in accordance with the terms and conditions of Articles IV and VII hereof or as set forth in the Protocol and Constitution. Notwithstanding the forgoing, each CBTTC Member agrees that Materials, Research Data and Results may be provided by CHOP to External Recipients for additional purposes upon the majority vote of the Scientific Committee and in accordance with the terms and conditions of Articles IV and VII hereof, the Protocol and Constitution.

4. CBTTC Members agree that CHOP may provide Materials and Research Data to Contractors providing services to the CBTTC.

IV. Use of Materials, Research Data and Results by CBTTC Members

Notwithstanding any other provisions in this Agreement, each CBTTC Member agrees as follows:

1. Any and all Materials obtained pursuant to this Agreement will not be used in human subjects, clinical trials, or for therapy, transplantation or diagnostic purposes involving human subjects.

2. The Materials, Research Data and Results obtained pursuant to this Agreement will be used solely in accordance with this Agreement, the Constitution, the Protocol, all applicable federal, state and local laws and regulations, and the Request Form approved by the Scientific Committee (as applicable).

3. Each Recipient shall maintain the Materials, Research Data and Results obtained from the CBTTC Repository for its own education, teaching and research purposes, or for such broader purposes as approved by the Scientific Committee pursuant to Article III.2 above, in accordance with this Agreement, the Constitution and Protocol. Notwithstanding the foregoing,

the maintenance of Results shall be subject to those additional requirements set forth in Article VII below.

5. Each Recipient is permitted to deliver Materials and Research Data to Contractors to perform Core Analyses to produce Core Analysis Data or to perform research activities as approved by the Scientific Committee. Contractors must be approved in advance by the Scientific Committee and may only use Materials and Research Data for the purposes outlined in the research proposal approved by the Scientific Committee, and may not retain any Materials and/or Research Data following completion of the contracted services unless otherwise approved in advance by the Scientific Committee. Each Recipient shall hold any of its agents, including Contractors, to the standards, restrictions and conditions stated in this Agreement with respect to the use of Materials and/or Research Data.

6. Each Recipient shall ensure proper storage of Materials, Results and Research Data and shall ensure that all persons handling Materials, Results, and Research Data are appropriately trained.

7. Each Recipient’s acquisition and use of Materials, Results, and Research Data is not in violation of either state or federal laws and regulations.

8. Each Recipient shall not use the Materials, Results, and Research Data either alone or in conjunction with any other information, in any effort whatsoever, to establish the individual identities of any subjects from whom the Materials, Results, and Research Data were derived, except in accordance with an IRB-approved protocol, the Protocol, and/or the Constitution.

10. Each Recipient shall notify CHOP promptly of any uses or disclosures of the Materials, Results, and Research Data in violation of the Agreement of which the CBTTC Member becomes aware.

11. Recipient shall hold any agent of the Recipient (including subcontractors) to the standards, restrictions and conditions stated herein with respect to the Materials, Results, and Research Data.

Research Data strictly in accordance with the terms of the Agreement and, if applicable, a Request Form.

V. Confidentiality

1. The Parties agree to retain in confidence and use only for the purposes of this Agreement any Confidential Information supplied pursuant to this Agreement. Confidential Information will not include information that:

(a) is in receiving Party’s possession prior to receipt from disclosing Party as evidenced by competent documentation;

(b) is in the public domain at the time of receipt from disclosing Party;

(d) is lawfully received from a third party not prohibited from disclosing it;

(e) is independently developed by receiving Party without reference to disclosing Party’s information, as evidenced by receiving Party’s written records; or

(f) is required by law or regulation, or to be disclosed in a judicial or administrative proceeding after legal remedies for maintaining information in confidence shall have been exhausted, but only to the minimum extent required by such law, regulation or proceeding; notice of any such proceeding to be given to disclosing Party promptly upon receiving Party’s first notice or information about such proceeding. The obligations of the receiving Party with respect to Confidential Information shall continue for a period ending three

(3) years from the date of initial disclosure pursuant to this Agreement.

For the avoidance of doubt, CHOP and any CBTTC Member will not be in violation of this Article V by using and/or providing Materials, Data and/or Results in conformance with the terms of this Agreement.

VI. Liability, No Warranties and Indemnification

1. Any Materials, Research Data and Results delivered pursuant to this Agreement are provided in an “AS IS” condition, and are understood to be experimental in nature and may have hazardous properties. THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, EXCEPT FOR THOSE EXPLICITLY SET FORTH HEREIN. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIALS, RESEARCH DATA, CORE ANALYSIS DATA, RESULTS OR FOREGROUND IP WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK OR OTHER PROPRIETARY RIGHTS.

2. The Parties acknowledge that the Materials are biomedical in nature and contain certain properties that are inherently hazardous. Furthermore, the Parties acknowledge that the storage, use, transport and disposal of such Materials are strictly regulated.

3. To the extent allowable by applicable laws, Recipient agrees to indemnify, defend and hold harmless Provider, CHOP and the other Parties from and against any and all liability, losses, damages, claims, demands and/or fees (including reasonable attorney’s fees) costs, penalties and/or judgments but only in proportion to and to the extent arising from Recipient’s, or Recipient’s Contractors’, use, storage or disposal of Materials, Research Data or Results, or from Recipient’s use of Foreground Intellectual Property, and for any such liability arising from the negligence or misconduct of Recipient or Recipient’s Contractors related to such use, storage or disposal, except insofar as such liability, losses, damages, claims, demands and/or fees (including attorney’s fees) costs, penalties and/or judgments arise from the Provider’s or another Recipient’s breach of this Agreement, or any negligence or intentional or willful misconduct by Provider or another Recipient.

4. Recipient represents that the researchers employed by it are qualified to perform the Research Studies and shall be responsible for the proper and safe transport, handling, storage, disposal and use of the Materials, Results, Core Analysis Data and Research Data in accordance with all and any instructions or advice which may be given by the Provider supplying the Materials or by CHOP in its role as Coordinating Center and in accordance with all applicable federal, state and local laws and regulations, including, but not limited to, animal welfare laws and regulations and National Institutes of Health regulations and guidelines.

5. The Recipient shall use the Materials and any materials treated with the Materials under appropriate containment conditions.

6. Recipient assumes all risk and responsibility in connection with its respective receipt, handling, storage, disposal, transfer and use of the Materials including, without limitation, taking all appropriate safety and handling precautions to minimize health or environmental risk. Recipient agrees that any activity undertaken with the Materials will be in compliance with all applicable federal, state and local laws and regulations, including, but not limited to Public Health Service and National Institutes of Health regulations and guidelines and regulations involving the use of animals, human samples or recombinant DNA.

VII. Results and Intellectual Property

2. It is recognized and understood that the existing Background Intellectual Property and Background Information of CBTTC Members are their separate property, respectively, and are not affected by this Agreement, and none of the Parties shall have any claims to or rights in such existing inventions and technologies of the other Party.

4. Each CBTTC Member will disclose to the other CBTTC Members and Satellite Members a summary of all Results generated under this Agreement and will disclose all Results to CHOP for inclusion in the CBTTC Repository. The Results shall be considered Confidential Information and shall be maintained in accordance with Article V of this Agreement by each Party until they are published, and if the disclosing CBTTC Member determines no publications will result, it shall notify the other CBTTC Members accordingly. Subject to the foregoing, CHOP may distribute Results to CBTTC Members and Satellite Members for use by such CBTTC Member(s) and Satellite Member(s) in their internal education, teaching and non- commercial research purposes as approved by the Scientific Committee. CHOP may disclose Results from the CBTTC Repository to an External Recipient for its own educational, teaching and non-commercial research purposes only after receiving (i) the written approval of the Provider, and (ii) the approval of the Scientific Committee for disclosure of the Results to a specific External Recipient.

5. Inventorship of Foreground Intellectual Property will be determined in accordance with applicable U.S. Patent laws and regulations and ownership shall follow therefrom.

6. Foreground Intellectual Property made in the course of the Research Studies solely by employees of a CBTTC Member shall be owned by such CBTTC Member and shall be governed in accordance with that CBTTC Member’s policies and procedures. Foreground Intellectual Property made jointly by employees of two or more CBTTC Members will be jointly owned by those CBTTC Members involved in making such Foreground Intellectual Property, and ownership in any patents or patent applications included in the Foreground IP shall follow inventorship as determined in accordance with Article VII.5. CBTTC Members jointly owning the Foreground Intellectual Property shall enter into an inter-institutional agreement that outlines each Member’s rights and responsibilities with respect to the jointly owned Foreground Intellectual Property.

licensing or otherwise commercializing Tangible Research Materials and 10% of gross revenues realized from licensing or otherwise commercializing other Foreground Intellectual Property shall be distributed to CHOP solely for the support and maintenance of the CBTTC, provided that any unreimbursed expenses related to Intellectual Property protection shall be recovered from revenue before any sharing of such revenue occurs. Nothing in this Section VII.9 shall be construed to require the sharing of any revenues generated from the licensing or commercialization of Core Analysis Data by a CBTTC Member. CBTTC Members shall have the right to audit CBTTC’s use of revenues under terms reasonable and customary in the industry.

VIII. Use of Names

1. No Party shall use the name, insignia or logo of another Party for any purpose, except as required by law, without the prior written consent of the other Party, provided however that each Party may use the name of another Party in its routine listings of sponsored projects, as required xx xxxxx applications, and as required by peer-reviewed journals for publication.

IX. Termination

1. Any Party may at any time terminate its participation in this Agreement without cause upon written notice to the other Parties at least sixty (60) days prior to the date upon which termination is to take effect. Termination or expiration of this Agreement shall not affect any rights or obligations which have accrued prior thereto and each Party shall maintain, store and use following termination of such Party’s participation any Materials, Research Data and/or Results received from the CBTTC Repository hereunder solely in accordance with the terms of this Agreement, the Constitution, the Protocol and any approved Request Form pursuant to which such Materials, Research Data and/or Results were received.

2. If a Party breaches a material term of this Agreement, the Protocol or Constitution, then the other Parties may exercise their right of termination by giving the Party in breach a written description of the event or occurrence constituting the breach. The Party in breach will have the opportunity to cure such breach within thirty (30) days of receipt of such notice. Upon the expiration of the thirty (30) day period, the breaching Party’s participation in this Agreement shall automatically terminate unless the breaching Party has removed the condition of termination. Notwithstanding the foregoing, following termination of the breaching Party’s participation, such Party shall maintain, store and use any Materials, Research Data and/or Results received from the CBTTC Repository hereunder solely in accordance with the terms of this Agreement, the Constitution, the Protocol and any approved Request Form pursuant to which such Materials, Research Data and/or Results were received.

3. Articles IV, V (for the three (3) year period set forth therein), VI and VII shall survive termination of this Agreement for any reason.

X. Notices

1. Notices, invoices, communications and payments hereunder shall be deemed made if given by overnight courier or by registered or certified envelope, post prepaid and addressed to the Party to receive such notice, invoice or communication at the address given

below or such other address as may hereafter be designated by notice in writing. Notice given pursuant to this Article shall be effective as of the day of receipt of notice.

XI. Addition of New Members and Satellite Members

1. Additional parties may be added to this Agreement as CBTTC Members upon (i) approval of the new parties’ membership by the Executive Board, and (ii) execution by such new party of a Joinder Agreement.

2. CBTTC Members may add Satellite Members to the CBTTC in accordance with the Constitution. The Parties agree that the form attached hereto as Exhibit A, the “AMENDED AND RESTATED SATELLITE MEMBER AGREEMENT,” shall be executed by an institution identified by a CBTTC Member and approved by the Executive Board, as provided in the Constitution. Additional Satellite Members may be added at a later time through execution of a Satellite Joinder Agreement. Satellite Members have the rights and obligations set forth in the CBTTC Satellite Member Agreement.

XII. General Provisions

1. Non-Assignability. The rights and obligations of the Parties under this Agreement shall not be assignable without written permission of the other Parties.

2. Severability. If any provision hereof is held unenforceable or void, the remaining provisions shall be enforced in accordance with their terms.

3. Entire Agreement. This Agreement contains the entire and only agreement between the Parties respecting the subject matter hereof and supersedes or cancels all previous negotiations, agreements, commitments and writings between the Parties on the subject of this Agreement. Should processing of this Agreement require issuance of a purchase order or other contractual document, all terms and conditions of said document are hereby deleted in entirety. This Agreement may not be amended in any manner except by an instrument in writing signed by the duly authorized representatives of each of the Parties hereto, except that new CBTTC Members may be added as Parties through execution of a Joinder Agreement.

4. Export Control Regulations. CBTTC Members agree that they shall comply with all applicable export control regulations of the United States of America. Notwithstanding any other provision of this Agreement, the Parties hereto understand and agree that they are subject to, and agree to abide by, any and all applicable U.S. laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities. The Parties’ obligations hereunder are contingent on their ability to comply with applicable United States export and embargo laws and regulations. It is the expectation of the Parties that the work done pursuant to this Agreement will constitute fundamental research and be exempt from export control licensing requirements under the applicable export control laws and regulations. The CBTTC Members do not wish to take receipt of export-controlled information except as may be knowingly and expressly agreed to in writing signed by an authorized representative of the CBTTC Member and for which that Member has made specific arrangements. The Parties agree that they will not provide or make accessible to any other CBTTC Member any export-controlled materials (including, without limitation, equipment, information and/or data) without first

informing such CBTTC Member of the export-controlled nature of the materials and obtaining from such CBTTC Member its prior written consent to accept such materials as well as any specific instructions regarding the mechanism pursuant to which such materials should be passed to that CBTTC Member. CBTTC Members agree to comply with any and all applicable U.S. export control laws and regulations, as well any and all embargoes and/or other restrictions imposed by the Treasury Department’s Office of Foreign Asset Controls.

5. Waiver. No Party waives its right to enforce any and all provisions of the Agreement at any time during the term. A Party’s failure to enforce any provision shall not prejudice such Party from later enforcing or exercising the same or any other provision of the Agreement.

6. Binding Agreement on Successors. This Agreement shall be binding upon each Party’s successors and assigns.

7. Headings. Headings are for convenience of reference only, and not for interpreting the provisions of the Agreement.

8. Counterparts. This Agreement may be executed in counterparts, and by any Party on separate counterpart, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

REMAINDER OF XXXX INTENTIONALLY LEFT BLANK

Attachment A

Joinder Agreement

This Joinder Agreement is made pursuant to the Children’s Brain Tumor Tissue Consortium (“CBTTC”) Second Amended and Restated Intellectual Property and Revenue and Material Sharing Agreement dated May 14, 2019, as amended from time to time (“Agreement”) and the Children’s Brain Tumor Tissue Consortium Amended and Restated Satellite Member Agreement dated May 14, 2019 as amended from time to time (the “Satellite Agreement”) and establishes that the below-identified, undersigned institution (the “Joined Institution”) is a party to the Agreement and is added as a Core Member to the Satellite Agreement, with all of the associated rights and obligations under each of the Agreement and the Satellite Agreement.

By execution of this Joinder Agreement, the Joined Institution hereby: (i) represents and warrants that it meets all eligibility requirements for participation in the Agreement and participation as a Core Member in the Satellite Agreement, including but not limited to, the approval of the Executive Board through a majority vote of such committee; (ii) joins in, accepts and agrees to be bound by all of the terms and conditions of the Agreement and all of the terms and conditions of the Satellite Agreement that are applicable to Core Members; and (iii) makes all of the representations and warranties required of Parties to the Agreement and Core Members of the Satellite Agreement.

Any capitalized terms used in this Joinder Agreement and not defined herein shall have the same meanings given to them in the Agreement or Satellite Agreement, as applicable.

The Effective Date of this Joinder Agreement is the date on which the Joined Institution executes the Joinder Agreement as indicated by its Authorized Institutional Official/Signatory below.

The Joined Institution must keep this Joinder Agreement and a copy of the Agreement and Satellite Agreement on file and provide a copy of the signed Joinder Agreement to The Children’s Hospital of Philadelphia on behalf of CBTTC at the address set forth for notices in the Agreement.

Institution Legal Name:

Notices. All written notices and other communications required under the Agreement and Satellite Agreement from any other Party to the Joined Institution may be made in hard copy or electronic form and shall be delivered to the following address(es):

For notice:

NAME:

TITLE: INSTITUTION:

TOWN, STATE, ZIP:

Email address:

With a copy to: (Add as many as apply) NAME:

TITLE: INSTITUTION: TOWN, STATE, ZIP:

Email address:

Point of Contact.

NAME: TITLE:

INSTITUTION: TOWN, STATE, ZIP:

Email address:

Agreed by the Authorized Institutional Official/Signatory of the Joined Institution on behalf of itself, its Affiliates, employees, subcontractors and agents

(Authorized Institutional Official/Signatory)

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AZIENDA OSPEDALIERO UNIVERSITARIA MEYER

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