ADMA Biologics, Inc. Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Confidential Portions denoted by [***] Testing Services Agreement

 

 

 

THIS TESTING SERVICES AGREEMENT (“the Agreement”) is made effective as of the date last signed below (the “Effective Date”) by and between [***]), with a principal office located at [***] and ADMA Biologics, Inc. with a principal office located at 65 Commerce Way, Hackensack, NJ 07601 (“Client”) for [***] (the “Project”).  [***] and Client shall each herein be referred to as a “Party” and together as the “Parties.”

[***] provides laboratory testing and related services (“[***]”) to pharmaceutical, bio-technology, and other companies involved in pharmaceutical and medical research and product development.  Client wishes to engage [***] to perform Services, including services which are exclusive to Client, as described in Exhibit A (collectively, the “Services”), and both parties wish to set forth their respective rights, duties, and obligations in connection therewith.

1.1           Provision of Services.  [***] shall provide Services in accordance with this Agreement, inclusive of the [***] attached hereto as Exhibit A and the Estimated [***] Budget attached hereto as Exhibit B, and all applicable laws and regulations.

1.1.1           Project Manager.  [***] will assign a Project Manager to interact on a regular basis with Client, coordinating and monitoring the Services provided by [***] for the Project.  Client is responsible for ensuring that all updated versions of the Project [***] or any Project [***] amendments are sent to the [***] Project Manager.

1.2           Affiliates.  “Affiliate” shall mean any entity that directly or indirectly controls, is controlled by or is under common control with a Party through the ownership of a majority of the outstanding voting securities or by contract.  For purposes of this provision, the term “control” shall mean the power to either direct or cause the direction of the management of the entity or, in [***] case, the management of the Services performed under this Agreement.  Notwithstanding anything in this Agreement to the contrary, [***] shall have the right to provide Services hereunder through its Affiliates without prior approval of Client.  [***] agrees to notify Client in writing [***] of its decision to provide any services to Client through an Affiliate.  [***] shall remain fully responsible to Client for the performance of such Services.

1.3           Storage Limitations.  If requested by Client and agreed by [***], [***] will [***] at the conditions [***] agreed to between the parties for the time period defined by Client in the Project [***].  [***] cannot guarantee that [***] will remain stable and suitable for testing or that stability data will be available during or after that storage time period.  [***] guarantees that any and all [***] will be maintained under industry standard [***].  Client should review the [***] with [***] Scientific Affairs department prior to [***].  If the [***] is unknown, the Client must define the [***], [***] duration, and testing interval of the [***].  Should [***] determine that any [***] were not [***] as set forth in the Project [***], [***] shall provide prompt notification of such to Client and shall promptly undertake all remediation actions as reasonably requested by Client.

 

[***]

 

 

1.4.1           Cancellation.  If a Project is cancelled by Client after [***] has been authorized to initiate start-up Services, Client agrees to reimburse [***] for (i) the project management, data management and logistics set-up fees specified in the Budget, (ii) any applicable fees for Services rendered in accordance with the Budget, including any collection kits that have been prepared or distributed, and (iii) the purchase of any specialized testing reagents and/or supplies.

1.4.2           Revision.  If the Project is revised after Project materials have been approved, including but not limited to (i) requisition forms, (ii) investigator manuals, and (iii)  [***]/transport supplies, Client agrees to pay [***] for Services rendered and costs incurred in the revision or replacement of previously-approved Project materials and supplies, and any costs associated with database changes resulting from Project revision.

1.4.3           Delay.  If Client delays the initiation or conduct of a Project protocol to the extent that [***]/transport supplies and/or specialized testing reagents expire, Client agrees to pay [***] for costs incurred to replace expired supplies and/or specialized testing reagents.

2.1           Billing and Payment Terms.  [***] will bill Client for Services once per month.  Charges will be billed at the rates agreed to in Exhibit B, subject to any adjustments permitted in this Agreement.  It is a material term of this Agreement that Client shall pay all undisputed amounts [***] of the date of an invoice for Services.  In addition to any other remedies provided for under this Agreement, [***] reserves the right to charge a late fee of up to [***] on any undisputed amounts outstanding for [***] from Client's receipt of an invoice for Services.

2.2.           Upon written notice to Client of non-payment hereunder and failure of Client to cure such non-payment [***] from receipt of such notice, [***], at its sole option, may suspend further performance of its duties and obligations hereunder until all outstanding undisputed amounts are fully paid.  Any suspension by [***] shall extend any deadlines for performance by [***] of its duties and obligations under this Agreement for a time period equal to the number of days between the date of receipt of [***] notice of suspension and the date [***] receives full payment of all outstanding undisputed amounts.

 

 

[***]

 

 

2.3.2           Final Invoice.  [***] shall complete its invoicing process [***] after communication of Project completion.  If any [***] remain in storage, or if other Services are still to be performed, the parties agree that invoicing shall continue until such [***] are removed from [***] storage facilities, or relevant Services are completed.

2.3.3           Fee Increases.  [***] may offset any increased costs of operations by [***] written notice to Client.  Any such increase shall not exceed the [***] ending on the last day of the month immediately preceding the effective date of the increase, as measured (i)   in the United States, by the [***].

2.4            Taxes.  Client shall pay any sales, use, excise, transfer, value-added, goods and services, services, consumption, or other similar tax (if any) imposed by any governmental authority in connection with, or attributable to, Client's receipt of the Services hereunder or in connection with, or attributable to, the issuance of any invoice by [***] to Client for such  Services.  [***] shall be entitled to invoice Client for any such taxes as may be required by applicable law, and Client shall pay such amounts as invoiced by [***].

3.	TERM AND TERMINATION

3.1           Term.  This Agreement shall be effective as of the Effective Date, and shall terminate at the conclusion of the Project Services, unless earlier terminated as provided herein.

3.2.1.           For Material Breach.  If either party (the “non-breaching party”) believes the other party (the “breaching party”) is in material breach of any obligations hereunder, the non-breaching party shall have the right to terminate this Agreement by providing the breaching party with written notice specifying the material breach(es) and indicating clearly its intention to terminate the Agreement [***] after the breaching party receives such notice.  If the breaching party cures such breach within such [***], the non-breaching party’s notice shall be void.  If the breaching party does not cure such breach within such [***], the Agreement shall terminate at the end of such [***].

3.2.2.           Without Cause.  Either party may terminate this Agreement by providing the other party with written notice of termination at least [***] prior to the effective date of such termination.

 

[***]

 

 

3.2.3           Effect of Termination.  Unless otherwise provided specifically in (a) this Agreement or (b) a separate written document signed by both parties, upon termination or expiration of this Agreement, the parties shall each be released from their obligations hereunder, and this Agreement shall have no further force or effect; provided, however, that Sections 2, 3.2.3, 4, 5, 6, 7, 8.1, 11.2, 11.3, 11.5, 11.6, 11.8 and 11.9 shall survive termination of this Agreement.

 

4.           INTELLECTUAL PROPERTY

4.1           Client Ownership of Data; Inventions. All data, test results, studies and other information generated by [***] in performing the Services (the “Data”) shall be the property of the Client.  All proprietary, non-public information concerning (a) the Project, (b) materials, compounds, formulations, methods, processes, Assays and drugs or proprietary reagents used in or for the Project, and (c) Client’s operations (including basic scientific data, prior clinical or laboratory data, formulation information, and research programs supplied by Client to [***] and not in the public domain) (“Client’s Confidential Information”) shall be considered confidential and shall remain the sole property of Client.  Further, except as otherwise provided in Section 4.2 below, all rights to any discovery or invention conceived (or conceived and reduced to practice) in the direct performance of the work conducted under this Agreement (each, an “Invention”) shall belong to Client.  [***] shall promptly disclose to Client any Invention arising from this Agreement.  [***] agrees to assign to Client, upon written request of Client, the sole and exclusive ownership of any Invention hereunder, subject to payment by Client of all reasonable expenses incurred by [***] in connection therewith.  Any further protection or perfection of such Invention shall be Client’s responsibility.  [***] represents, warrants and covenants that all persons involved in or working on the Project on behalf of [***] and/or its Affiliates have assigned or shall assign all right, title and interest in and to all Data and Inventions to Client.

 

4.2           [***] Intellectual Property. Notwithstanding anything in this Agreement to the contrary, Client and [***] agree that [***] possesses certain intellectual property, including but not limited to inventions, know-how, trade secrets, analytical methods, standard operating procedures, computer technical expertise, software and statistical methodologies originated by [***] prior to or under or during the term of this Agreement without benefit of Information provided by Client that is the sole property of [***] (“[***] Intellectual Property”).  Further, to the extent that [***] makes any improvement or addition to [***] Intellectual Property relating solely to central or diagnostic laboratory analyses and services and/or medical diagnostic assays and methods in the course of performing this Agreement or otherwise, such improvement and/or addition to [***] Intellectual Property shall be the sole and exclusive property of [***].  Finally, in the course of working with [***] hereunder, Client may become aware of other, non-public information about [***] and its business that [***] considers confidential, which shall be considered confidential and shall remain the sole property of [***] (such information, together with [***] Intellectual Property, is referred to hereinafter as “[***] Confidential Information”).

 

4.3           Limitations on Use of Assay.  [***] agrees and acknowledges that Client paid for the development and validation of the testing assay (“Assay”) and as such, the testing assay is the sole property of the Client and shall only be utilized for the Client.

 

5.	CONFIDENTIALITY OBLIGATIONS

5.1           Protection and Non-use of Confidential Information. [***] and Client each agree to keep in strict confidence and not to disclose Confidential Information of either Party hereto or their Affiliates or subsidiaries to any third party or use such Confidential Information for any purpose other than for the performance of this Agreement without the prior written consent of the other Party hereto.  Each Party may disclose the other Party’s Confidential Information to its Affiliates, employees and agents performing any of that Party’s obligations or Services hereunder who have a need to know such Confidential Information and are bound by obligations of confidentiality and non-use equal to or greater than those contained herein.  Each Party agrees to maintain the other Party’s Confidential Information with a reasonable level of protection from disclosure (but in no event less than that accorded its own Confidential Information), and to take all reasonable precautions to prevent the unauthorized disclosure to any third party of the Confidential Information that it receives hereunder.  The above notwithstanding, the receiving Party’s obligations of confidence and non-use with respect to the Confidential Information disclosed hereunder shall not include:

 

[***]

 

 

(a) Information that at the time of disclosure to the receiving Party is in the public domain, or that thereafter becomes part of the public domain through no fault of the receiving Party;

 

(b) Information that is known to the receiving Party prior to the time of disclosure to the receiving Party, as evidenced by its contemporaneous written records;

 

(c) Information that has been or is disclosed to the receiving Party in good faith by a third party who was not, or is not, under any obligation to keep the Information confidential;

 

(d) Information that is independently developed by or on behalf of the receiving Party, without access to or reliance on the Information received hereunder; or

 

(e) Information that is required to be disclosed by law, including without limitation for litigation, FDA (or foreign equivalent) or SEC requirements or to enforce the terms hereof, provided that the receiving Party gives the disclosing Party prompt notice of such required disclosure and the opportunity to oppose or limit such disclosure.

5.2           Term of Confidentiality. The obligations of confidentiality and non-use set forth herein shall remain in effect for a period of [***] after the last date on which Confidential Information is disclosed by one Party to the other hereunder, or termination of this Agreement, whichever date occurs last.

6.	INDEMNIFICATION/LIMITATION OF LIABILITY/INSURANCE

6.1           Indemnification

 

 

 

 

[***]

 

 

7.	DISPUTES/CHOICE OF LAW

7.1.1           Choice of Law/Forum Selection. This Agreement shall be construed and enforced in accordance with the laws of the State of [***] without regard to the conflict of law provisions thereof.  Jurisdiction and venue for litigation of any dispute, controversy or claim arising out of, or in connection with, this Agreement shall be only in a United States federal court or a state court in the state of [***].  Each of the Parties hereby expressly submits to the personal jurisdiction of the foregoing courts located in [***], and waives any objection or defense based on personal jurisdiction or venue that might otherwise be asserted to proceedings in such courts.  Except as specifically provided herein, in any litigation, each Party shall bear its own fees and expenses, including attorneys’ fees.

8.	REGULATORY COMPLIANCE

8.1.1           General.  Each of the Parties represents and warrants to the other Party that it will comply with all laws, rules and regulations applicable to this Agreement ("Applicable Laws"), including, but not limited to, applicable privacy and security regulations and GCP (Good Clinical Practice).  Failure by either Party to comply with any Applicable Laws shall be considered a material breach of this Agreement.

 

8.1.2           Data Retention.

 

a)           [***] will follow all applicable guidelines (including, but not limited to, all applicable Food and Drug Administration (“FDA”) guidelines), laws and regulations with regard to the storage and disposal of clinical trials records

c)           Client-Specific Requirements.  Client will advise [***] in writing of any data retention requirements that exceed the standards described in 8.1.2 (a) and 8.1.2(b) above.  [***] will use reasonable efforts to accommodate such requirements for an additional charge.

8.1.3.1 Shipment of infectious substances. Client represents and warrants that unless it has specifically informed [***] otherwise on the [***], no shipments sent by Client shall contain risk group 4 pathogens (Category A pathogens as defined in the IATA Dangerous Goods Regulations).  Client acknowledges that under the IATA Dangerous Goods Regulations (i) risk group 4 Category A pathogens should not be transported as Biological substance, category B specimens formerly known as diagnostic specimens and (ii) the shipper, not [***], is responsible for classifying the shipment properly.

 

[***]

 

 

8.1.3.2  Shipment of other Dangerous Goods.  The shipment of other dangerous goods, such as certain chemicals and dry ice, (“Dangerous Goods”) is subject to local, national, and international laws and regulations.  The person placing the Dangerous Goods in the shipping package is responsible for ensuring that the package, when shipped, meets the requirements of all applicable regulations and any local laws (including any training requirements).  Any information provided by [***] in its [***], Investigator instructions, Investigator meetings, or otherwise, is not intended to be, and should not be considered as, training in the handling of dangerous goods.

9.

AUDIT

 

During the term of this Agreement and at reasonable times and upon reasonable advance notice, Client may, at Client’s sole cost and expense and in accordance with applicable security policies and procedures of [***], visit [***] facilities to conduct quality assurance audits in connection with the work being performed under this Agreement.  Third-party auditors will be required to sign [***] standard Confidentiality Agreement at the time of their visit to any [***] facility.  Client shall advise [***] in writing, of any special or unusual record keeping needs for the Project and [***] will use reasonable efforts to accommodate Client’s requirements.  Additional charges may apply for any requirements in excess of [***] usual record keeping process.

10.	ASSIGNMENT OF RIGHTS

 

Except as provided specifically in the Agreement, neither Party may assign this Agreement or any right or interest hereunder without the prior written consent of the other Party.  Any attempted assignment in violation hereof shall be void.  Either Party may assign the Agreement to a successor entity to whom such Party transfers or assigns all or substantially all of its assets or transfers a controlling interest in the Party, or to its parent corporation (if any).  The assigning Party shall provide written notice to the other Party of such assignment.

11.	MISCELLANEOUS

11.1             Informed Consent.  Unless otherwise specified in this Agreement or an Exhibit, the parties agree that [***] shall not be required to obtain any required patient consents pertaining to its Services performed hereunder, including without limitation testing of DNA or genetic material.  Client and Client’s clinical investigators are responsible for obtaining informed consent for all subjects participating in the Project and for ensuring that the informed consent and Project [***] allow for the performance of all Services to be ordered by Client and its investigators and provided by [***] under this Agreement.  Client shall inform [***] promptly if informed consent is withdrawn to ensure that no further Services are performed on specimens covered by such informed consent.

11.2             Independent Contractor.  [***] is performing the Services as an independent contractor, and not as an employee, agent, partner of, or joint venture with Client.  Neither Party has any authority to bind or act on behalf of the other except as specifically stated herein.

11.3             Entire Agreement.  This Agreement contains the entire understanding between the Parties hereto with respect to the subject matter hereof and supersedes any and all prior agreements, understandings and arrangements between the Parties relating to the subject matter hereof.  No amendment, change, modification or alteration of the terms and conditions hereof shall be binding unless set forth in written form and signed by all the Parties hereto.

 

[***]

 

 

11.4             Manner of Notice.  All notices permitted under the terms of this Agreement shall be deemed to have been given if delivered personally, or when sent by overnight registered letter or commercial courier to the respective registered addresses of each Party as indicated below:

 

11.5           Publication.  Neither Party shall use the other’s name, trademarks, servicemarks, or other aspects of its corporate identity in any advertising, scientific or professional publications, or promotional literature of any type until prior written approval has been obtained from the other Party.

11.6           No Waiver.  The failure of either Party to exercise or enforce any right conferred upon it hereunder shall not be a waiver of any such right and shall not prevent the exercise or performance thereof at any time or times thereafter; nor shall a waiver of any right hereunder at any given time, including rights to any payments, be deemed a waiver thereof for any other time.

11.7           Force Majeure.  No Party to this Agreement shall be liable for failure to perform any duty or obligation that such Party may have under this Agreement where such failure has been occasioned by any act of God, fire, strike, inevitable accident, war or any cause outside the reasonable control of the Party who had the duty to perform; provided, however, that the non-performing Party shall give prompt notice to the other Party of the reason for its non-performance and its reasonable best estimate of when performance would begin again.  The non-performing Party shall promptly begin to perform again after the intervening event has concluded.

11.8           Severability.  If any provision of this Agreement is held to be illegal, invalid, or unenforceable by a court of competent jurisdiction, the Parties shall, if possible, agree on a legal, valid and enforceable substitute provision which is as similar in effect to the deleted provision as possible.  The remaining portion of this Agreement not declared illegal, invalid or unenforceable shall, in any event, remain valid and effective for the term remaining unless the provision found illegal, invalid or unenforceable goes to the essence of this Agreement.

  

[***]

 

 

11.10   Export Control.  It is understood and agreed by the parties that [***] shall not provide Services or support to any entity or individual located in any of the countries identified in the then-current (a) list of countries subject to embargo as identified by the Department of Commerce’s Bureau of Industry and Security pursuant to the federal Export Administration Regulations and/or (b) list of sanction programs of the Treasury Department’s Office of Foreign Assets Control pursuant to 31 CFR Parts 500 et seq. (the “Prohibited Countries”).  Furthermore, Client represents, covenants and warrants that neither Client nor its participating investigators shall submit specimens or samples pursuant to this Agreement for Services or support by [***] that originate from any of the Prohibited Countries.  In the event that [***] detects or becomes aware that Client or Client's investigators submitted a specimen/sample from any of the Prohibited Countries to [***] or if it is discovered that Client or any of Client's investigators are located in one of the Prohibited Countries, [***] shall have the right to immediately terminate this Agreement.

 

[***]

 

 

IN WITNESS WHEREOF, Client and [***] have duly executed this Agreement on the first day above written.

 

 

ADMA BIOLOGICS, INC.	[***] [***]
_______________________________________	_______________________________________
Signature	Signature
Name printed ____________________________	[***]
Title: __________________________________	[***]
Date: __________________________________	Date: ___________________________________

 

[***]

 

 

 

 

The [***] is not attached to this Service Agreement.  [***] will prepare and obtain Client’s approval of this document.  Upon Client’s signature of the [***], it will become a part of this Service Agreement.

 

[***]
 

 

CONFIDENTIAL

 

[***]

 

Prepared for:	Adam Grossman (ADMA)	by: [***]
		[***]
	ADMA Biologics, Inc.	[***]
	65 Commerce Way	[***]
	Hackensack, NJ 07601	[***]
Tel: 201 ###-###-#### [***]		[***]
		[***]
Email: [***]		Email: [***]

[***]

 

 

[***]

 

28-Mar-12

 

ADMA Biologics, Inc.

65 Commerce Way

Hackensack, NJ 07601

Regarding:

[***]

[***]

 

Dear Adam :

 

Thank you for the opportunity to submit a revised proposal for your study.

 

[***] has a commitment to peak performance, superior value for our customers, teamwork, innovation and integrity.  We look forward to the opportunity to work with you to demonstrate our dedication to these values.

 

The prices given in this quotation are valid for a period of three months.

 

If you have any questions or require further assistance, please feel free to call me.

 

Yours sincerely,

 

 

[***]

[***]

 

 

[***]

 

 

 

 

[***]

 

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ADMA Biologics, Inc.		[***]
	Quote for Services

 

 

 

 

Sub Totals		Region		Billing Amount		Conversion Rate		Estimated Total Amount
		[***]		[***]		[***]		[***]
								[***]

 

Testing		Region		Billing Amount		Conversion Rate		Estimated Total Amount
		[***]		[***]		[***]		[***]
[***]								[***]

Study Management		Region		Billing Amount		Conversion Rate		Estimated Total Amount
		[***]		[***]		[***]		[***]
[***]								[***]

 

[***]

 

 

ADMA Biologics, Inc.		[***]
	Quote for Services

 

 

Testing

Region

Time Points

Quantity

Billing Currency Unit Price

Billing Amount

Conversion Rate

Estimated Total Amount

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Testing

Region

Unit

Quantity

Billing Currency Unit Price

Billing Amount

Conversion Rate

Estimated Total Amount

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Category

Name

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Month 10 4 batches

Month 11 4 batches

Month 12 4 batches

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[***]

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1250

1000

1250

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375

300

375

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0

0

0

 

[***]

 

 

 

 

1

See Study Specific Assumptions and Pricing Model, herein.  Budget excludes any “TBD” (To Be Determined) items.

 

 

1BT

Quoted fees reflect [***].

 

2BT

The sample testing fees include the [***] into a [***] laboratory, [***] of the [***], [***], [***] and [***].

 

3BT

The [***] testing fees also include [***] and [***] as applicable and agreed in the [***].  Any final result reports issued in hard copy will be sent via standard postal service or (within the continental United States only) [***] proprietary courier.

 

 

1SM

The [***] includes:

 

— [***]

— [***]

— [***]

— [***]

— [***]

— [***]

— [***]

— [***]

 

2SM

The [***] fee includes:

 

— [***]

 

[***]