NIMH Center for Collaborative Genetic Studies

Updated 12-MAY-2022

Distribution Agreement

WHEREAS, the National Institute of Mental Health ("NIMH"), pursuant to its public

health mission to identify and characterize the genetic basis of Alzheimer disease,

schizophrenia, bipolar disorder, autism spectrum disorders, and other mental disorders,

supports research projects in which there is collection by scientific investigators

("Submitters") of blood and/or other cell samples and clinical data from affected

individuals and their relatives;

WHEREAS, anonymous blood and/or other cell samples collected by Submitters, stripped

of all personal identifiers and thus unlinkable to the individuals from whom they were

obtained, are provided to the NIMH Center for Genetic Studies ("the Center"), as operated

under an NIMH cooperative agreement to Rutgers University for the production of

transformed or reprogrammed cell lines and extraction of DNA (cell lines and DNA

samples are collectively known as "Biomaterials");

WHEREAS, anonymous data on family structure, age, sex, vital status, psychopathology,

diagnosis, and other clinically relevant information ("Clinical Data") collected by

Submitters, stripped of all personal identifiers and thus unlinkable to the individuals from

whom they were obtained, are provided to the Center;

WHEREAS, anonymous data derived from genotyping, mutation analysis, and other

genetic analyses of Biomaterials and Clinical Data ("Genetic Analysis Data") conducted

by Submitters and other scientists, stripped of all personal identifiers and thus unlinkable

to the individuals from whom they were obtained, are provided to the Center;

WHEREAS, the Center maintains as a national resource Biomaterials, Clinical Data, and

Genetic Analysis Data on mental disorders that are distributed for analysis by qualified

scientific investigators conducting research specifically on the genetic bases of those

disorders. The disorders for which Biomaterials, Clinical Data, and Genetic Analysis

Data are currently being distributed by the Center are listed on the NIMH Human

Genetics Initiative World Wide Web site at

https://www.nimhgenetics.org/nimh_human_genetics_initiative/index.php;

WHEREAS, Receiving Institution ("Recipient") desires to use Biomaterials, Clinical Data,

and Genetic Analysis Data at its sole risk and at no expense to NIMH.

WHEREAS, Infinity BiologiX LLC has a sub-award from the NIMH Center

for Genetic Studies and Rutgers University to perform the collection,

processing distribution, and subsequent billing for the Biomaterials;

Updated 12-MAY-2022

NOW THEREFORE, it is mutually agreed as follows:

NIMH, through the Center, agrees to transfer to Recipient Biomaterials and/or Clinical

Data for exclusive use by Recipient's principal investigator ("Principal Investigator")

to conduct research on the genetic basis of

(please list disorder(s) that is/are being researched).

Recipient will submit a signed and dated Distribution Agreement to NIMH for

Biomaterials, Clinical Data, and Genetic Analysis Data that are being requested.

Biomaterials, Genetic Analysis Data, and Clinical Data received from the Center will

be used exclusively by Principal Investigator and individuals working on the project

under the direction and control of the Principal Investigator in connection with a specific

genetic research project ("Research Project") for which Principal Investigator has sole

responsibility, and which is explicitly described on ATTACHMENT PAGES. This

description will specify which Genetic Analysis Data are expected to be produced in

the proposed Research Project.

This Distribution Agreement is not transferable to another Recipient or to another

facility that is not under the control of Recipient. Principal Investigator cannot transfer

the Research Project to a different institution unless NIMH agrees to a new Distribution

Agreement with that institution. Recipient cannot appoint a new Principal Investigator,

conduct the Research Project at a different facility under Recipient's control, or make

other substantive changes, unless NIMH agrees to an appropriate amendment of this

Distribution Agreement.

Recipient agrees to retain control over Biomaterials, Clinical Data and Genetic

Analysis Data received from the Center and further agrees not to provide them, with or

without charge, to any other entity or any individual other than Principal Investigator.

No rights of Recipient under this Distribution Agreement may be assigned or otherwise

conveyed to any party, including a purchaser of Recipient, without the specific written

agreement of NIMH.

NIMH, through the Center, agrees to provide Principal Investigator with Clinical Data

and accompanying documentation, on the disorder specified above.

NIMH, through the Center, agrees to provide Principal Investigator with periodic

updates of Clinical Data on the disorder specified above, including updates of family

structure as determined from laboratory analysis of DNA samples, if available.

NIMH, through the Center, agrees to provide Principal Investigator with periodic

updates of Genetic Analysis Data on the disorder specified above, if available,

including the name and address of the scientists who generated such Genetic Analysis

Data.

Updated 12-MAY-2022

10.

Biomaterials are provided at a cost of $100 per 25 micrograms of lymphoblastoid cell

line DNA, $200 per lymphoblastoid cell line, $250 per fibroblast or olfactory cell line,

and $500 per reprogrammed cell line such as induced pluripotent stem cells (iPSCs).

Bulk orders will be provided at reduced cost. Where available, whole blood DNA is

provided at a cost of $100 per 3 micrograms. Services for reprogramming source cells

(e.g., fibroblasts) to iPSCs or other reprogrammed cell types will be provided at full

cost to the Recipient, ranging from $6,400 to $11,000 per line, depending on source

material and extent of validation; with the use of this service the $500 distribution cost

will be waived. These fees are subject to change following written notification from

NIMH. Recipient agrees to pay any and all fees to the Center via its designated

representative, Infinity BiologiX LLC. If Recipient is awarded a peer-reviewed NIMH

research grant to specifically analyze Biomaterials for the disorder specified above, the

fees for obtaining those Biomaterials (with the exception of reprogramming services)

may be waived subject to NIMH approval of a waiver request. Shipping costs will be

applied to all orders.

11.

Recipients who propose to use Biomaterials in the Research Project described in this

agreement must request those Biomaterials no later than four (4) months from the date

on which Clinical Data and Genetic Analysis Data are made available by the Center. If

Biomaterials are not requested within that time period, the proposed Research Project

will be deemed terminated. At that time, Recipient will notify NIMH and provide

written certification that any and all Clinical Data and Genetic Analysis Data were

destroyed by Recipient, unless Recipient obtains NIMH's agreement to an extension of

the agreement. Any such extension must be in writing and in accordance with the terms

and conditions under which NIMH is distributing data and biomaterials at that time.

12.

Recipient agrees to provide an electronic copy of all raw molecular data (genotyping,

ChIP-Seq, RNA-seq, and other genomic, epigenetic and protective data) and Genetic

Analysis Data derived from Clinical Data and Biomaterials received under the

conditions of this Distribution Agreement. Recipient will submit such genetic data to

an NIH approved data repository no later than the agreed-upon data submission date as

stipulated in the Data/Resource Sharing Plan, or upon publication of research in which

such data were analyzed, whichever comes first. NIH may at any time distribute these

Genetic Data to qualified scientific investigators, subject to any patents or pending

patent applications of Recipient. Recipient will provide Genetic Data, indexed by

NIMH subject ID number and cell-ID number, in the electronic format specified by the

chosen NIH repository and will provide to the Center a linking ID file. When

genotyping has been conducted, DNA marker names and allele sizes in base pairs will

be provided for each individual subject, as indexed by NIMH subject ID number.

Descriptive information about each typed marker, including marker name, allele sizes

in base pairs and corresponding frequencies, relative distances in Megabases and in

Centimorgans, marker heterozygosity, and the source of information used to determine

map location, will also be provided. Recipient also agrees to submit to the Center all

data relevant to the establishment of family structure as determined from laboratory

analysis, at the time such determinations are made.

13.

Principal Investigator will acknowledge the contribution of scientists who generated

Genetic Analysis Data received from the Center, in any and all oral and written

presentations, disclosures, and publications resulting from any and all analyses of

Updated 12-MAY-2022

these Genetic Analysis Data. Principal Investigator will provide to NIMH a list of all

such presentations, disclosures, and publications.

14.

Principal Investigator will acknowledge the contribution of both the NIMH Repository

& Genomics Resource and Submitters in any and all oral and written presentations,

disclosures, and publications resulting from any and all analyses of Biomaterials and

Clinical Data received from the Center. Principal Investigator will provide to NIMH a

list of all such presentations, disclosures, and publications. Principal Investigator will

use the following acknowledgment: "Bio-samples and/or data for this publication were

obtained from NIMH Repository & Genomics Resource, a centralized national

biorepository for genetic studies of psychiatric disorders.” In addition to the above

statement, Principal Investigator will use detailed collection-specific

acknowledgements found at: https://www.nimhgenetics.org/acknowledgements.php,

depending upon which disorder Biomaterials and Clinical Data were received and

analyzed.

15.

When the Research Project is completed, Recipient must notify NIMH and provide

written certification of the destruction of Biomaterials, Clinical Data, and Genetic

Analysis Data received from the Center in accordance with any applicable laws and/or

accepted safety procedures. The Research Project shall be deemed completed for

purposes of this agreement three (3) years after the effective date of this agreement,

unless Recipient obtains NIMH's agreement to an extension of the agreement. Any such

extension must be in writing and in accordance with the terms and conditions under

which NIMH is distributing data and biomaterials at that time.

16.

Recipient agrees that Biomaterials, Clinical Data, and Genetic Analysis Data received

from the Center will not be used, either alone or in conjunction with any other

information, in any effort whatsoever to establish the individual identities of any of the

subjects from whom Biomaterials, Clinical Data, and Genetic Analysis Data were

obtained.

17.

Recipient agrees that Biomaterials, their progeny, and unmodified or modified

derivatives thereof will not be used in any experiments or procedures that are not

disclosed and approved as part of the Research Project, and will not be used in human

experimentation of any kind.

18.

Recipient acknowledges that the Biomaterials may be the subject of a patent application

or covered by patent rights in one or more countries. Except as provided in this

Distribution Agreement, no express or implied licenses to such patent rights are

provided. NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO

THE MERCHANTABILITY OR FITNESS FOR ANY PURPOSE OF THE

BIOMATERIALS, CLINICAL DATA, AND GENETIC ANALYSIS DATA

PROVIDED BY THE CENTER TO RECIPIENT UNDER THIS AGREEMENT, OR

THAT THE BIOMATERIALS, CLINICAL DATA, AND GENETIC ANALYSIS

DATA MAY BE EXPLOITED WITHOUT INFRINGING THE INTELLECTUAL

PROPERTY OR PROPRIETARY RIGHTS OF ANY THIRD PARTIES.

19.

The United States (US) Government and its contractor and subcontractor that operate

the Center are not responsible for the accuracy of Clinical Data and Genetic Analysis

Updated 12-MAY-2022

Data, provided by Submitters and other Recipients, which are distributed by the Center.

20.

Recipient acknowledges that Biomaterials have the potential for carrying viruses, latent

viral genomes, and other infectious agents in an in apparent state. Recipient agrees to

treat Biomaterials received from the Center as if they were not free of contaminations,

and that Biomaterials will be handled by trained persons under laboratory conditions

that afford adequate biohazard containment. By accepting Biomaterials from the

Center, Recipient assumes full responsibility for their safe and appropriate handling.

21.

Recipient agrees not to claim, infer, or imply endorsement by the US Government of

the Research Project, the institution, or personnel conducting the Research Project or

any resulting commercial product(s). To the extent permitted by law, non-US

Government Recipients agree to hold the US Government, its contractor and

subcontractor that operate the Center, Submitters, and other Recipients providing

Genetic Analysis Data to the Center harmless and to indemnify all such parties for all

liabilities, demands, damages, expenses, and losses arising out of Recipient's use for

any purpose of Biomaterials, Clinical Data, and Genetic Analysis Data received from

the Center.

22.

Recipient acknowledges that the conditions for use of Biomaterials, Clinical Data, and

Genetic Analysis Data are approved by the Institutional Review Board (IRB) of the

NIMH contractor and subcontractor that operate the Center in accordance with

Department of Health and Human Services regulations at 45 CFR Part 46. Recipient

agrees to comply fully with all such conditions and to report promptly to NIMH any

proposed changes in the Research Project and any unanticipated problems involving

risks to subjects or others. Recipient remains subject to applicable State or local laws

or regulations and institutional policies which provide additional protections for human

subjects.

The following two paragraphs apply to Recipients that have entered into a previous

Distribution Agreement.

23.

Execution of this Distribution Agreement is contingent upon Recipient's compliance

with all terms and conditions of any existing Distribution Agreement. This excludes

the requirement stated in paragraph 6 of Distribution Agreements executed from

January 1, 1996 through December 31, 1997, in which Recipient agreed to provide

genotyping data one year after laboratory confirmation or upon publication of marker

data, whichever came first.

24.

The requirements set forth in this paragraph supersede the requirements set forth in

paragraph 6 of Distribution Agreements executed from January 1, 1996 through

December 31, 1997. If Recipient executed a Distribution Agreement more than twelve

(12) months from the time of the current request for Biomaterials, Clinical Data, and

Genetic Analysis Data, and has not provided to NIMH Genetic Analysis Data derived

from any Biomaterials previously received from NIMH or its current or previous

contractor(s), Recipient agrees that provision to NIMH, through the Center, of such

Genetic Analysis Data is a condition for execution of the current Distribution

Agreement. If Recipient executed a Distribution Agreement within twelve (12) months

from the time of the current request for Biomaterials, Clinical Data and

Updated 12-MAY-2022

Genetic Analysis Data, Recipient agrees to provide to NIMH, through the Center, any

Genetic Analysis Data derived from such Biomaterials within twelve (12) months from

the time that Biomaterials were previously received, or upon publication of research in

which such data were analyzed, whichever comes first.

25.

NIMH may terminate this Distribution Agreement if Recipient is in default of any of

the terms specified herein and if the deficit has not been remedied within 30 days after

the date of written notice by NIMH of such deficit. Upon termination of this

Distribution Agreement, Recipient agrees to return all unused Biomaterials, Clinical

Data, and Genetic Analysis Data to the Center, or provide NIMH with written

certification of their destruction.

26.

Failure to comply with any of the terms specified herein may result in disqualification

of Recipient from receiving additional Biomaterials, Clinical Data, and Genetic

Analysis Data from NIMH, as provided by the Center.

27.

NIMH reserves the right to distribute, through the Center, any and all Biomaterials,

Clinical Data, and Genetic Analysis Data to others and to use it for its own purposes.

28.

Recipient expressly certifies that the contents of any statements made or reflected in

this Distribution Agreement are truthful and accurate.

29.

This Distribution Agreement shall be construed in accordance with Federal law as

applied by the Federal courts in the District of Columbia.

Updated 12-MAY-2022

NIMH Center for Collaborative Genetic Studies

Distribution Agreement

Please list disorder(s) that is/are being researched

Name and Title, Principal Investigator (PLEASE PRINT)

Mailing Address, Principal Investigator

Telephone Number, Principal Investigator

Fax Number, Principal Investigator

E-Mail, Principal Investigator

Name and Title, Receiving Institution's Authorized Representative

Mailing Address, Receiving Institution's Authorized Representative

Telephone Number, Receiving Institution's Authorized Representative

Fax Number, Receiving Institution's Authorized Representative

E-Mail, Receiving Institution's Authorized Representative

DATED SIGNATURES

Signature, Principal Investigator Date

Signature, Receiving Institution's Authorized Representative Date

Signature, NIMH Center for Genetic Studies' Authorized Representative

Rutgers University

Date

Signature, NIMH's Authorized Representative

Date