Document:

Unassociated Document

ADMA Biologics, Inc.

Confidential Materials Omitted and Filed Separately with the

Securities and Exchange Commission

Confidential Portions denoted by [***]

 

PLASMA SUPPLY AGREEMENT

 

THIS PLASMA SUPPLY AGREEMENT (“Agreement”) between Biotest Pharmaceuticals Corporation, a Delaware corporation, having a place of business at 5800 Park of Commerce Boulevard NW, Boca Raton, Florida 33487 (“BPC”) and ADMA Biologics, Inc., a Delaware corporation, having a place of business at 65 Commerce Way, Hackensack, New Jersey 07601 (“ADMA”) shall be effective as of June 22, 2012 (the “Effective Date”).  BPC and ADMA are each sometimes referred to herein individually as a “Party” or collectively as the “Parties.”

 

RECITALS

 

WHEREAS, ADMA desires to sell, and BPC desires to purchase certain quantities of normal source plasma (“Plasma”) to be used by BPC in the manufacturing of a Human Immune Globulin (“Product”), solely on the terms and conditions set forth in this Agreement;

 

PROVISIONS

 

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, and with the intent to be legally bound hereby, ADMA and BPC agree as follows:

 

	
A.

	
PURCHASE AND SALE OF PLASMA

.

1.           TERM OF AGREEMENT

 

.  Unless terminated earlier as provided herein, the term of this Agreement shall continue until December 31, 2014 from the Effective Date (the “Initial Term”).  After the Initial Term, this Agreement may be renewed on an annual basis upon the mutual consent of the Parties.  Each Party agrees that it will endeavor, in good faith, to conclude any negotiations relating to such renewals [***] before the expiration of this Agreement

 

2.           PRICE AND VOLUMES

 

 

	
YEAR

	
PRODUCT

	
VOLUME

	
PRICE

	
2012

	
Normal Source Plasma [***]

	
[***]

	
[***]

	
2012

	
Normal Source Plasma

	
[***]

	
[***]

	
2013

	
Normal Source Plasma

	
[***]

	
[***]

	
2014

	
Normal Source Plasma

	
[***]

	
[***]

 

  

- 1 -

  

 

a.           The price of all purchases of Plasma under this Agreement [***].  Any additional required testing as specified by FDA (or foreign equivalent) or due to a change in BPC’s Specifications, will be billed to BPC at [***].

 

Beginning in 2014, the pricing for Plasma will be the price in effect as of December 31, 2013, per liter, [***].  [***] is defined as the [***].

 

b.           BPC agrees to provide to ADMA a forecast, [***] of the Effective Date of this Agreement, for the desired 2012 quantities of Plasma, as defined in the table above.  ADMA will confirm [***] the minimum quantities it will provide to BPC for 2012 (“2012 Plasma Minimum”).  BPC will then issue a binding purchase order for the 2012 Plasma Minimum.  [***] 2012 Plasma Minimum [***].

 

c.           In addition, for 2013 and 2014, BPC agrees to provide to ADMA a forecast, [***] the start of the next calendar year of the agreement [***].  ADMA will confirm [***] the minimum quantities it will provide to BPC (“Annual Plasma Minimum”).  BPC will then issue a binding purchase order for the Annual Plasma Minimum.  [***] the volume as specified in the binding purchase order [***]of the current contract year of its [***].

 

3.           PAYMENT TERM

 

Subject to Section C hereof, all Plasma shall be paid for [***].  Payments shall become delinquent [***].  Any undisputed payments not paid [***] after BPC receives notification from ADMA of said late payment shall accrue interest to be paid at the rate of [***].  Invoice to be issued [***].  All payments due hereunder to ADMA shall be sent to ADMA at the times set forth herein by wire transfer to such accounts as ADMA may designate to BPC.

 

	
  

	
Invoices to BPC will be directed to:

	
  

	
Biotest Pharmaceuticals Corporation

	
  

	
[***]

	
  

	
5800 Park of Commerce Boulevard NW

	
  

	
Boca Raton, Florida  33487

	
  

	
[***]

 

4.           INSPECTION AND ACCEPTANCE.

a.             BPC shall inspect each shipment of Plasma for conformity with the BPC’s specifications as set forth in Exhibit A (Specifications) [***] of the Plasma’s arrival at BPC’s facility.  BPC shall promptly notify BPC in writing of its determination of any non-conformity of the Plasma with BPC Specifications (“Non-conformity Notice”).

b.             If a Non-conformity Notice is received by ADMA, the Parties shall meet to determine whether such Plasma meets the BPC Specifications.  If it is determined that the Plasma does not meet the BPC Specifications, ADMA shall [***], as promptly as possible, taking into account the time required to [***].  In the event the Parties fail to agree whether or not any given shipment of Plasma conforms with the BPC Specifications, then the matter will be promptly referred to an independent expert agreed in good faith by the Parties, whose decision shall be binding on the Parties.  The cost of referral to the expert will be borne by [***].

 

  

- 2 -

  

 

c.             For each shipment of Plasma delivered, ADMA shall provide BPC with a quality certificate and other industry standard documents required by regulatory authorities relating to the Plasma.

5.           SHIPMENT TERMS.  [***].  ADMA will invoice BPC for the Plasma at time of delivery to [***] and [***].  BPC will take ownership and bear all risk of loss upon [***].

 

	
B.

	
QUALITY OF PLASMA

 

	
  

	
1.

	
All Plasma sold under this Agreement by ADMA to BPC shall meet BPC’s Specifications.

 

	
  

	
2.

	
ADMA shall supply to BPC for the Initial Term, and any extensions thereof, Plasma to be derived from automated plasmapheresis procedures conducted at Center as specified in Exhibit B.  ADMA warrants that the Center is FDA approved and IQPP certified.

 

	
  

	
3.

	
Upon BPC’s application to the German Health Authority (“GHA”), ADMA shall use best efforts to take all necessary steps as soon as possible to become compliant with the GHA regulations and receive certification from the GHA.

 

	
  

	
4.

	
ADMA and BPC shall execute a mutually agreeable Quality Agreement [***] of the Effective Date.

 

	
  

	
5.

	
[***].

 

	
  

	
6.

	
BPC shall have the right to conduct periodic inspections of ADMA’s centers and facilities dealing with the Plasma at times mutually agreeable to the parties.  Such inspections shall be limited to matters directly related to this Agreement and shall be conducted in conformance with generally accepted industry practices.  BPC will provide ADMA with not less than [***] prior to any of its inspections, unless mutually agreed otherwise by the parties.  Upon receipt of BPC’s audit report, ADMA shall [***] to send a response to the appropriate BPC, outlining the corrective actions that ADMA will take at its expense, to correct the audit deficiencies.  Further, ADMA agrees to provide BPC with copies of all written reports (including FDA 483’s) and correspondence between ADMA and any governmental agency regarding any such inspection or review of records [***] (i) receipt of any such report or correspondence from the governmental agency or (ii) the issuance or delivery of any response or correspondence by ADMA; provided, however, that in the event the report or correspondence relates to a serious problem that could affect the continuous supply, or quality of the Plasma, then ADMA agrees to use all reasonable efforts to notify BPC [***] of receipt of such report or correspondence and to provide BPC with a copy of such report or correspondence.

 

  

- 3 -

  

 

	
C.

	
LIMITED WARRANTY   ADMA represents and warrants to BPC that the Plasma has been collected and produced in accordance with BPC Specifications and BPC approved SOP’s.  ADMA represents, warrants and agrees that any and all  Plasma shall be collected, produced and delivered in accordance with all local, state and national laws, regulations and requirements.  BPC shall have all rights and remedies available to it under this Agreement and shall not be obligated to buy or pay for any  Plasma which does not, in all respects, comply with the BPC Specifications and applicable law, rules and regulations and as otherwise required by this Agreement, provided BPC must submit notification of rejection [***] of receipt of such  Plasma.  This warranty shall be further limited by the expiry of the  Plasma and shall not apply to any expired  Plasma.               

 

 

 

	
D.

	
MISCELLANEOUS

 

1.           CONFIDENTIALITY.

 

a.           The Parties agree to maintain the confidentiality of the contents of this Agreement and the dealings between the Parties with the same degree of care as they use to protect their own proprietary, confidential or trade secret information.  The Parties shall not disclose to any third party any confidential information received from the other hereunder without that other Party’s prior written consent and shall use it only for the purpose of this Agreement.  The Parties agree to hold the name and location of any and all testing labs and facilities as well as names of key personnel at the testing labs as confidential information.  Said obligation of secrecy shall not apply to any information which (a) was in the public domain at the time of its disclosure or thereafter becomes part of the public domain by publication or otherwise subsequent to the time of disclosure under this Agreement through no fault of the receiving party; or (b) was known to the receiving party or in its possession prior to or at the time of disclosure as shown by written records; or (c) is independently developed by the receiving party without use of the other Party’s confidential information as shown by written documentation; or (d) is disclosed with the written approval of the disclosing party; or (e) is rightfully furnished to the receiving party by a third party having the authority to disclose such confidential information without restrictions; or (f) is disclosed by law or regulation or in response to a valid order of a court or other governmental body, or is required for registration of a product by competent authorities, but only to the extent of and for the purpose of such law, regulation, order or registration, and only if the receiving party first notifies the disclosing party of the required disclosure and permits the disclosing party, at its expense, to seek an appropriate legal remedy to maintain the information in secret.

 

b.           The above obligations shall survive the termination of this Agreement and shall continue with respect to donor information without limit of time and in respect of other confidential information for [***].

 

2.           RELATIONSHIP OF THE PARTIESThe relationship between ADMA and BPC during the term of this Agreement, including extensions and renewals, is strictly that of buyer and seller.  Neither Party is in any way the legal representative, agent, joint venturer nor partner of the other for any purpose whatsoever nor neither has any control or authority whatsoever to bind the other Party or any other person with respect to the other Party.

 

  

- 4 -

  

 

3.           INDEMNIFICATION  ADMA and BPC hereby indemnify and agree to hold harmless each other and their respective affiliates, agents, employees, officers and directors, from and against any and all third party claims, losses, liabilities, damages, reasonable attorneys’ fees, costs and expenses (hereinafter “Claims”) which may be sustained by and/or claimed against the other Party by virtue of their negligent acts, negligent omissions or the negligent handling or furnishing of materials or performance of services rendered by the other Party, the willful misconduct by the other Party or its officers, employees or agents or any representation, warranty or agreement contained in this Agreement being breached, untrue or materially misleading, by omission or otherwise.  Said indemnification will be capped at the dollar value of Plasma purchased in the year in which the relevant claim arises.  The indemnifying party’s liability shall be reduced to the extent any such Claims arise as a result of the indemnified party’s own conduct or negligence.  To the extent Plasma is being used to manufacture Product to be used in research or for commercial purposes, BPC specifically shall indemnify and hold harmless ADMA, its affiliates, directors, officers, agents and employees, from any and all liability, loss or damages, including reasonable attorneys’ fees they may suffer as the result of claims, demands, costs or judgments against them caused or contributed to by the Product or any procedure required by the research protocol or related to the commercial sale of such product, if such liability, loss or damages are not directly caused or contributed to by such Plasma.

 

4.           LIMITATION OF LIABILITY  IN NO EVENT WILL EITHER PARTY HAVE ANY LIABILITY FOR ANY LOSS OF INCOME, PROFIT, INTEREST OR SAVINGS BY THE OTHER PARTY OR FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR SPECIAL DAMAGES SUFFERED BY THE OTHER PARTY, ARISING FROM OR RELATED TO THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, THE SALE OR USE OF ANY  PLASMA, REGARDLESS OF THE FORM OF ACTION, AND WHETHER IN CONTRACT, INDEMNITY, WARRANTY OR TORT INCLUDING WITHOUT LIMITATION STRICT LIABILITY AND NEGLIGENCE OR ANY OTHER LEGAL OR EQUITABLE GROUNDS, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSSES OR DAMAGES.  THIS LIMITATION WILL NOT APPLY TO ANY LIABILITY FOR DAMAGES THAT MAY RESULT FROM THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF A PARTY.

 

The Party from whom indemnity is sought shall be entitled at its option to defend or control the defense and/or settlement of any such claim.

 

Each Party shall notify the other of any claim or potential claim or liability as soon as it becomes aware that such claim, potential claim or liability has arisen and shall provide to the other, all-reasonable assistance in respect thereof.

 

5.           INSURANCE  ADMA and BPC shall each be required to maintain general and product liability insurance in an amount of [***].  Before commencing any work hereunder, the Parties shall furnish certificates evidencing the insurance required by this Section.  The Parties shall give each other [***] days advance written notice in the event the insurance required by this Section is materially modified, or cancelled or otherwise terminated for any reason.

 

	
E.

	
TERMINATION

 

1.           In addition to any other remedy it may have, either Party shall have the right to terminate this Agreement [***] of written notice thereof.

 

2.           Upon giving the appropriate written notice, either Party may terminate this Agreement upon the occurrence of the following event:  a proceeding under any bankruptcy, reorganization, arrangement of debts, insolvency or receivership law is filed by or against the other Party, and is not dismissed or stayed [***], or a receiver or trustee is appointed for all or a substantial portion of the assets of the other Party, or the other Party makes an assignment for the benefit of its creditors or becomes insolvent.

 

  

- 5 -

  

 

3.           Upon termination of this Agreement, BPC must pay for any  Plasma already delivered to BPC.  Notwithstanding anything to the contrary set forth herein, the Parties’ obligations under this Agreement in Sections B, C, D, E and H shall survive the termination of this Agreement to the extent necessary to give effect to their reasonable intentions.

 

	
F.

	
FORCE MAJEURE

 

1.           Neither Party shall be liable for non-performance caused by strikes, fires, explosions, Acts of God, riots, civil or international war, acts of terrorism,  an unexpected downturn in the acceptable donor population adversely affecting the industry as a whole, inability to obtain  Plasma because of Force Majeure at the producing location, or any other similar or dissimilar cause beyond the reasonable control of either Party which renders the performance of a Party’s obligations so difficult or costly as to make such performance commercially unreasonable.  The affected Party shall immediately inform the other of such occurrences and the termination thereof.

 

2.           Upon giving notice to the other Party, a Party affected by an event of Force Majeure shall be released without any liability on its part from the performance of its obligations under this Agreement, except for the obligation to pay any amounts due and owing hereunder, but only to the extent and only for the period that its performance of such obligations is prevented by the event of Force Majeure.  Such notice shall include a description of the nature of the event of Force Majeure, and its cause and possible consequences.  The Party claiming Force Majeure shall promptly notify the other Party of the termination of such event.

 

3.           Should the period of Force Majeure continue for more [***], then the Party not suffering the Force Majeure event may terminate this Agreement upon giving written notice to the other Party.

 

	
G.

	
REMEDIES EXCLUSIVE

 

1.           The rights and remedies available to ADMA and BPC under this Agreement among the Parties are exclusive.

 

2.           [***].

 

H.           DISCLOSURES AND PUBLICITY.  Neither ADMA, on the one hand, nor BPC, on the other hand, shall, without the approval of the other, make any press release or other public announcement concerning the transactions contemplated by this Agreement, except as and to the extent that any such Party shall be so obligated by law, in which case the other Party shall be advised and the Parties shall use their commercially reasonable efforts to cause a mutually agreeable release or announcement to be issued; provided, however, that the foregoing shall not preclude communications or disclosures necessary to implement the provisions of this Agreement or to comply with the accounting and disclosure obligations of the Securities and Exchange Commission (“SEC”) or the rules of any stock exchange or NASDAQ.  Notwithstanding any contrary term contained in the confidentiality provisions of this Agreement, to the extent that either Party determines that it or the other Party is required to file or register this Agreement, a summary thereof, or a notification thereof, and/or descriptions related thereto, to comply with the requirements of an applicable stock exchange, SEC regulation, or any Governmental Authority, including the SEC, or to enable either Party to obtain debt or equity financing, such Party shall use its best efforts to provide the maximum amount of advance written notice of any such required disclosure to the other Party, to the extent practicable, with a minimum advance notice [***].  Prior to making any such filing, registration or notification, the Parties shall consult with respect thereto regarding confidentiality.  The Parties shall cooperate, each at its own expense, in such filing, registration or notification, including such confidential treatment request, and shall execute all documents reasonably required in connection therewith.

 

  

- 6 -

  

 

I.           ASSIGNMENT.  Neither Party shall assign this Agreement or any of its rights or obligations hereunder without the express written consent of the other Party, except as hereinafter provided.  Any such consent shall not be unreasonably withheld.  With notice to the other Party, either Party without the other Party’s consent may assign this Agreement to (i) its affiliate, or (ii) a successor to all or substantially all of the assets relating to the business of that Party which is involved in the fulfillment of its obligations under this Agreement, which shall expressly assume in writing the performance of all of the terms and conditions of this Agreement then to be performed by such successor as if it were named herein as a Party.

 

 

J.           NOTICES  All notices, demands, requests, consents or approvals required under this Agreement must be in writing and delivered personally to the Party or sent by overnight courier service or facsimile, addressed to such Party as set forth below (or to such other address or facsimile number as such Party may hereafter specify for the purpose by notice to the other Party hereto):

 

	
  

	
To BPC:

	
[***]

	
  

	
[***]

	
  

	
Biotest Pharmaceuticals Corporation

	
  

	
5800 Park of Commerce Boulevard NW

	
  

	
Boca Raton, FL   33487

	
  

	
[***]

 

	
  

	
With a copy to:

	
  

	
[***]

	
  

	
Biotest Pharmaceuticals Corporation

	
  

	
5800 Park of Commerce Boulevard NW

	
  

	
Boca Raton, FL   33487

	
  

	
[***]

 

	
  

	
To ADMA:

	
Adam Grossman

	
  

	
Chief Executive Officer

	
  

	
ADMA Biologics, Inc.

	
  

	
65 Commerce Way

	
  

	
Hackensack, NJ  07601

	
  

	
Fax:  201-478-5552

 

	
  

	
With a copy to:

	
  

	
General Counsel

	
  

	
ADMA Biologics, Inc.

	
  

	
65 Commerce Way

	
  

	
Hackensack, NJ 07601

 

All notices, requests, consents and other communications hereunder shall be deemed to have been properly given (a) if by hand, at the time of the delivery thereof to the receiving party at the address of such Party set forth above, (b) if made by facsimile transmission, at the time that receipt thereof has been acknowledged by electronic confirmation or otherwise, (c) if sent by overnight courier, on the next business day following the day such notice is delivered to the courier service, or (d) if sent by registered or certified mail, on the fifth business day following the day such mailing is made.

 

  

- 7 -

  

 

K.           INTEGRATION; EFFECT OF AMENDMENT  This Agreement, including all attachments, schedules or other agreements specifically incorporated by reference, constitute the entire agreement among the Parties with respect to the subject matter of this Agreement and supersede any and all other prior written or oral agreements, understandings, negotiations or discussions among the Parties with respect to the subject matter of this Agreement.  This Agreement may not be modified or amended in any respect except by an instrument in writing signed by both of the Parties.

 

L.           CHOICE OF LAW  This Agreement shall be governed by, and construed under laws of the State of Delaware, without regard to its conflict of laws principles.

 

M.           REPRESENTATIONS AND WARRANTIES  Each party hereto hereby represents and warrants to the other as follows:  (i) each party hereto has all requisite power and authority to enter into this Agreement and to consummate the transactions contemplated hereby, (ii) the execution and delivery of this Agreement and the consummation by such party of the transactions contemplated hereby have been duly authorized by all necessary action on the part of such party, (iii) this Agreement has been duly and validly executed and delivered by such party and constitutes the valid and binding obligation of such party, enforceable against such party in accordance with its terms and (iv) the execution and delivery of this Agreement and the consummation by such party of the transactions contemplated hereby does not and will not (a) require the consent of or registration with, any court, federal state, local or foreign governmental or regulatory body, or (b) constitute a default (with or without notice or lapse of time, or both) under or conflict with any contract, agreement or order to which such party is a party or by which such party or any of its properties or assets is subject or bound.

 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement by their duly authorized officers as of the day and year first written above.

 

ADMA Biologics, Inc.                                                                           Biotest Pharmaceuticals Corporation

 

	
By:  /s/ Adam Grossman

	  	
By:  /s/ Jordan Siegel

	  	  	  
	
Name:  Adam Grossman

	  	
Name:  Jordan Siegel

	  	  	  
	
Title:  President & CEO

	  	
Title:  Chief Executive Officer

	  	  	  
	
Date:  June 22, 2012

	  	
Date:  June 22, 2012

 

  

- 8 -

  

 

EXHIBIT A

 

SPECIFICATIONS

 

  

  

  

 

[Biotest Logo]

BIOTEST PHARMACEUTICALS CORPORATION

SOURCE PLASMA SPECIFICATIONS

 

[***]

 

A.           ORIGIN OF PLASMA

 

	
  

	
1.

	
Source Plasma must be collected from donors at USA—FDA licensed plasma center(s) and in accordance to all applicable laws and any relevant FDA Memoranda and Guidance documents.

 

	
  

	
2.

	
If applicable, Source Plasma must be collected in accordance to current applicable EU regulations and the European Pharmacopoeia Monograph for “Human Plasma for Fractionation”

 

	
  

	
3.

	
Plasma centers must be IQPP certified and adhere to PPTA voluntary standards.  Source Plasma must be from plasma centers in compliance with PPTA IQPP Viral Marker Standards.

 

	
  

	
4.

	
Source Plasma must be processed and stored according to All Applicable laws.

 

	
  

	
5.

	
Copies of FDA registrations and European certificates (if applicable) shall be provided for each plasma center and testing laboratory.  Updates to these documents shall be provided on an annual basis.

 

B.           SELECTION AND EXCLUSION CRITERIA FOR DONORS AND PLASMA  DONATIONS

 

	
  

	
1.

	
The donor/donation selection shall be in accordance with all applicable laws and any relevant FDA guidelines; the current EU regulations (if applicable) and any relevant technical annexes and directives.

 

	
  

	
2.

	
The donor eligibility criteria shall comply with the current FDA regulations and with applicable EU directives.

 

	
  

	
3.

	
Acceptable plasma shall be only from Qualified Donors as defined by IQPP standards.

 

C.           TESTING SPECIFICATIONS

 

	
  

	
1.

	
Serology tests on individual units shall be in accordance with FDA requirements and performed with FDA-licensed test kits.  Each unit shall be tested and found negative for the following:

 

	
  

	
·

	
[***]

	
  

	
·

	
[***]

	
  

	
·

	
[***]

 

	
  

	
2.

	
Nucleic Acid Amplification tests (NAT) to be performed in accordance to FDA requirements (mini pools) and found negative for:

 

	
  

	
·

	
[***]

	
  

	
·

	
[***]

	
  

	
·

	
[***]

 

BPC Source Plasma Specifications                                                                                                                                                                               Rev 03 July 12

page 1 of 7

  

 

	
  

	
3.

	
Additional NAT tests to be performed in accordance to established USA and European guidelines:

 

	
  

	
·

	
[***]

	
  

	
·

	
[***]

 

	
  

	
4.

	
Each donor must be tested and found negative in accordance to USA and European requirements for:

 

	
  

	
·

	
[***]

	
  

	
·

	
[***]

 

	
  

	
5.

	
Any additional tests or modifications of existing tests shall be implemented as soon as they are required by the FDA and/or the European Pharmacopoeia monograph.

 

	
  

	
6.

	
A list of all current test kits or methods shall be submitted to BPC, and updated in the event a test or method is changed.

 

D.           PLASMA COLLECTION AND PROCESSING PROCEDURES

 

	
  

	
1.

	
Source Plasma collection in bottles In accordance to FDA and European requirements (If applicable) current at the time of donation.

 

	
  

	
2.

	
Procedures must be maintained and followed to ensure all donations are traceable to the individual donors.

 

	
  

	
3.

	
Each Source Plasma bottle will be labeled with at least the following information:

 

	
  

	
·

	
Supplier name and license number

	
  

	
·

	
Plasma Type

	
  

	
·

	
Unit identification will be by means of bar-coded [***]

	
  

	
·

	
Volume

	
  

	
·

	
Anticoagulant composition

	
  

	
·

	
Storage temperature

	
  

	
·

	
Expiration date

	
  

	
·

	
Plasma bottle lot number (on bottle)

 

	
  

	
4.

	
Source Plasma must be frozen by cooling rapidly within 24 hours of collection in validated freezers to ensure that a temperature of -25°C or colder is reached at the core of each plasma unit within 12 hours of placing in the freezer.

 

	
  

	
5.

	
Source Plasma collected in non-EU approved plasma centers must be frozen at -20°C or colder immediately upon collection in accordance to FDA requirements.

 

BPC Source Plasma Specifications                                                                                                                                                                               Rev 03 July 12

page 2 of 7

  

 

	
  

	
6.

	
Plasma units that fall into one of the following categories are unacceptable for shipment to BPC:

 

	
  

	
·

	
Units with reactive or positive viral marker test results; Prior or subsequent units from donors that have been found to be reactive/positive for required testing

	
  

	
·

	
Hemolyzed or lipemic units

	
  

	
·

	
Units with frozen plasma on the outside of the container

	
  

	
·

	
Broken or contaminated units

	
  

	
·

	
Untested or units with Incomplete testing

	
  

	
·

	
Applicant/Orphan units

	
  

	
·

	
Units having errors that breach traceability such as units that cannot be traced back to an individual donor.

 

E.           PLASMA STORAGE AND TRANSPORT REQUIREMENTS

 

	
  

	
1.

	
Source Plasma must be stored and transported at -20°C or colder.  All storage and transportation temperatures must be recorded and documented.

 

	
  

	
2.

	
Temperature deviations during storage or shipment must be reported to BPC prior to shipment of the plasma.  Salvaged Plasma as defined under 21 CFR is not acceptable to BPC.

 

	
  

	
3.

	
[***]

 

	
  

	
4.

	
Each packing case will be labeled at least with the following information:

 

	
  

	
·

	
Supplier name and license number

	
  

	
·

	
Plasma Type

	
  

	
·

	
Shipment ID #

	
  

	
·

	
Bar-coded Case number [***]

 

F.           LOOKBACK AND POST-DONATION PROCEDURES

 

	
  

	
1.

	
Plasma Supplier must have a Lookback and Notification procedure In place to report information that impacts the safety of Source Plasma shipped to BPC.  This procedure must be compliant with FDA, State, EU (when applicable) and PPTA requirements.

 

	
  

	
2.

	
Plasma Supplier must notify BPC in writing within three (3) business days of discovery of any of the following events:

 

	
  

	
·

	
Receipt of reactive test results from a donor from whom prior or subsequent units have been shipped to BPC.  Confirmatory/supplemental results must be reported within twenty-one (21) calendar days of the bleed date of the reactive unit.

	
  

	
·

	
Receipt of Post Donation Information (e.g. tattoo, body piercing, high risk behavior) from a donor from whom prior or subsequent units have been [***]

 

	
  

	
3.

	
Lookback reports and Post-Donation information must be forwarded to BPC electronically to the attention of:

 

[***]

Atten:  [***]

Phone:  [***]

 

BPC Source Plasma Specifications                                                                                                                                                                               Rev 03 July 12

page 3 of 7

  

 

G.           EPIDEMIOLOGICAL DATA REPORTS

 

	
  

	
1.

	
Each plasma center must comply with PPTA IQPP Viral Marker Standards and EMEA data (if applicable) reporting requirements.  Reports must be provided to BPC annually or more frequently upon request.

 

H.           REQUIRED SHIPMENT DOCUMENTATION

 

	
  

	
1.

	
Each shipment of Plasma must have the following shipment documentation and electronic information associated with it.

 

	
  

	
·

	
Bill of Lading (copy)

	
  

	
·

	
Certificate of Quality [***]

	
  

	
·

	
Shipping Report Summary

	
  

	
·

	
Shipment Report Detail

	
  

	
·

	
Plasma Packing and Test Report Forms

	
  

	
·

	
E-File [***]

	
  

	
·

	
Temperature Exposure Form/Statement [***]

 

	
  

	
2.

	
The Bill of Lading shall include the following information:

 

	
  

	
·

	
Unique shipment number

	
  

	
·

	
Bill of Lading #

	
  

	
·

	
Shipment date

	
  

	
·

	
Collecting facility’s name and address

	
  

	
·

	
Plasma type

	
  

	
·

	
Total volume of shipment

	
  

	
·

	
Total number of units in the shipment

	
  

	
·

	
Total number of cases in the shipment

 

	
  

	
3.

	
The Shipping Report Summary shall include the following information:

 

	
  

	
·

	
Shipment number

	
  

	
·

	
Collecting facllity’s name and address

	
  

	
·

	
License #

	
  

	
·

	
Plasma type

	
  

	
·

	
Cases, units and volume

	
  

	
·

	
Total cases, units and volume of shipment

	
  

	
·

	
Earliest and latest bleed date within the shipment

	
  

	
·

	
Temperature of plasma freezer at time of shipment & signature

	
  

	
·

	
Shipment date & time

	
  

	
·

	
Bill of Lading number

 

	
  

	
4.

	
The Shipping Report Detail shall include the following Information:

 

	
  

	
·

	
Shipment number

	
  

	
·

	
Shipment date

	
  

	
·

	
Collecting facility’s name and address

	
  

	
·

	
License number

	
  

	
·

	
Plasma type

	
  

	
·

	
Units and volume by case

	
  

	
·

	
Total cases, units and volume of shipment

 

BPC Source Plasma Specifications                                                                                                                                                                              Rev 03 July 12  

page 4 of 7

  

 

	
  

	
5.

	
The Plasma Packing and Test Report shall include the following information:

 

	
  

	
·

	
Shipment number

	
  

	
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Plasma type

	
  

	
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Case number [***]

	
  

	
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Collecting facility’s name and address

	
  

	
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Donation date

	
  

	
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Donor number [***]

	
  

	
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Unit number [***]

	
  

	
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Volume

	
  

	
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Test results

	
  

	
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Total units and volume for each case

	
  

	
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Signature and date of reviewer

 

	
  

	
6.

	
The originals of this documentation are to be delivered electronically to the attention of:

 

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BPC Source Plasma Specifications                                                                                                                                                                              Rev 03 July 12  

  

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BPC Source Plasma Specifications                                                                                                                                                                              Rev 03 July 12  

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BPC Source Plasma Specifications                                                                                                                                                                              Rev 03 July 12

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EXHIBIT B

 

ADMA PLASMA CENTERS

 

ADMA BioCenters Georgia Inc

 

6290 Jimmy Carter Boulevard

Suite 208

Norcross, GA 30071Unassociated Document

EMPLOYMENT AGREEMENT

This Employment Agreement (this “Agreement”) is effective as of the 18th day of July, 2012 (the “Effective Date”) by and between ADMA Biologics, Inc., a Delaware corporation with its principal place of business at 65 Commerce Way, Hackensack, NJ 07601-6302 (the “Company”), and  James Mond, MD (the “Executive”).

WITNESSETH:

WHEREAS, the Company desires to secure the employment of the Executive in accordance with the provisions of this Agreement; and

WHEREAS, the Executive desires and is willing to accept employment with the Company in accordance herewith.

NOW THEREFORE, in consideration of the promises and mutual covenants contained herein, and intending to be legally bound hereby, the parties hereto agree as follows:

1.           Employment.  The Company hereby agrees to employ the Executive, and the Executive hereby agrees to serve the Company pursuant to the terms and conditions of this Agreement, as Executive Vice President and Chief Scientific Officer/Chief Medical Officer of the Company, commencing on the Start Date and continuing until such employment relationship is terminated in accordance with the terms of this Agreement.

 

2.           Term of Employment.  The term of the Executive’s employment under this Agreement shall commence on July 18, 2012 (the “Start Date”) and, subject to earlier termination as provided herein, shall continue until the third anniversary of the Start Date (the “Term”).  Notwithstanding the previous sentence, on the third anniversary of Start Date, and each third anniversary thereafter, the term of this Agreement shall automatically be extended for an additional three years upon the terms and conditions set forth herein, unless there is delivered by either party at least 90 days prior to any scheduled expiration of the Term, such party’s intention not to further extend the term of this Agreement.

3.           Positions and Duties.  The Executive’s duties hereunder shall be those which shall be prescribed from time to time by the President and Chief Executive Officer (“CEO”) of the Company or the Board of Directors of the Company (the “Board of Directors”), or a committee designated thereby in accordance with the bylaws of the Company, and shall include such executive duties, powers and responsibilities as customarily attend the offices of Executive Vice President and Chief Scientific Officer/Chief Medical Officer of a company comparable to the Company, reporting directly to the CEO.  The Executive will hold, in addition to the offices of Executive Vice President and Chief Scientific Officer /Chief Medical Officer of the Company, such other executive offices in the Company and its subsidiaries to which he may be elected, appointed or assigned by the Board of Directors from time to time, and will discharge such executive duties in connection therewith.  The Executive shall devote substantially all of his full working time, energy and skill (reasonable absences for vacations and illness excepted), to the business of the Company as is necessary in order to perform such duties faithfully, competently and diligently.

 

  

  

  

 

4.           Compensation.  During the Term, the Executive shall receive, for all services rendered to the Company hereunder, the following:

(a)           Base Salary.  The Executive shall be paid an annual base salary of no less than Two Hundred Sixty Thousand Dollars ($260,000) (the “Base Salary”), less withholding and other deductions for benefits as provided to all employees of the Company.  The Executive’s annual base salary shall be payable in equal installments in accordance with the Company’s general payment policies but no less frequently than monthly.

(b)           Annual Performance Bonuses.  The Executive shall be eligible to receive bonuses (each, a “Bonus”) during each calendar year of his employment, of up to 20% of the Executive’s base salary then in effect, in accordance with the Company’s standard practice as determined from time to time by the CEO and the Board of Directors and based upon the Executive meeting his annual performance goals.  The targets with respect to the Bonus for the period ending December 31, 2012 (the “Initial Bonus Period”) shall be mutually agreed upon between the Executive and the CEO, subject to approval by the Compensation Committee of the Board of Directors, as soon as practicable following the Effective Date.  The targets with respect to the Bonus for each annual period following the Initial Bonus Period shall be mutually agreed upon at the beginning of each calendar year by the Executive and the CEO, subject to approval by the Compensation Committee of the Board of Directors.  Each Bonus, if any, shall be paid to the Executive not later than thirty (30) days after the issuance of the Company’s respective operating financial results and in no event later than March 15 of the calendar year following the calendar year to which the bonus relates.  No bonus will be paid for any operating period unless the Executive is an employee of the Company at the end of such operating period. At the discretion of the board, stock options may be granted based upon individual and overall corporate performance.

(c)           Incentive Compensation.  The Executive shall be eligible for awards from the Company’s incentive compensation plans, including without limitation any stock option plans, applicable to high level executive officers of the Company or to key employees of the Company or its subsidiaries, in accordance with the terms thereof and on a basis commensurate with his position and responsibilities.  The Company hereby agrees to cause the issuance to the Executive of stock options (the “Stock Options”) to purchase 106,067 shares of common stock, $0.001 par value per share, of the Company (“Common Stock”) in accordance with the Company’s 2007 Employee Stock Option Plan or a substantially equivalent stock option plan of the Company (the “Plan”).  The Stock Options shall be exercisable at a price per share equal to the Fair Market Value (as defined in the Plan) of the Common Stock on the date of grant and shall vest over a four year period from the Start Date as follows: an initial 25% of the Stock Options will become exercisable on the first anniversary of the Start Date; and the remaining Stock Options will become exercisable in equal monthly installments of the total remaining number of shares covered by the Stock Options over the following 36 months on the monthly anniversary of the Start Date.  To the maximum extent permitted by law, the Stock Options shall be incentive stock options under the Internal Revenue Code of 1986, as amended, and shall be exercisable for a period of ten years from the date of grant.

 

  

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In the event that there is (i) a Change in Control (as defined below) of the Company and (ii) within twelve (12) months following such Change in Control the Executive is terminated without Cause (as defined below) or the Executive resigns for Good Reason (as defined below), all of the unvested Stock Options shall immediately become fully vested and exercisable.

For purposes of this Agreement, the term “Change in Control” shall mean the first to occur of the following:

(i)           The effective date or date of consummation of any transaction or series of transactions (other than a transaction to which only the Company and one or more of its subsidiaries are parties) pursuant to which the Company (a) becomes a subsidiary of another entity; (b) is merged or consolidated with or into another entity; (c) engages in an exchange of shares with another entity; or (d) transfers, sells or otherwise disposes of all or substantially all of its assets to a single purchaser (other than the Executive) or a group of purchasers (none of whom is the Executive); provided, however, that this subsection (i) shall not be applicable to a transaction or series of transactions if the stockholders of the Company immediately prior to such transaction or series of transactions own, immediately after giving effect to such transaction or transactions, a majority of the voting capital stock of the successor or surviving entity; or

(ii)           The date upon which any person (other than the Executive), group of associated persons acting in concert (none of whom is the Executive) or entity becomes a direct or indirect beneficial owner of shares of stock of the Company representing an aggregate of more than fifty percent (50%) of the votes then entitled to be cast at an election of directors of the Company; provided, however, that the acquisition of shares in a bona fide public offering or private placement of securities by an investor who is acquiring such shares for investment purposes, only shall not constitute a “Change in Control”.

(d)           Benefits.  The Executive and his “dependents,” as that term may be defined under the applicable benefit plan(s) of the Company, shall be included to the extent eligible thereunder, in any and all plans, programs and policies which provide benefits for employees and their dependents.  Such plans, programs and policies include health care insurance and 401(k) plan participation, and may include long-term disability, life insurance, supplemental disability insurance, supplemental life insurance and other similar or comparable benefits made available to the Company’s employees.

(e)           Expenses.  Subject to and in accordance with the Company’s policies and procedures, the Executive hereby is authorized to incur, and, upon presentation of itemized accounts, shall be reimbursed by the Company for, any and all reasonable and necessary business-related expenses, which expenses are incurred by the Executive on behalf of the Company or any of its subsidiaries.

(f)           Vacation.  The Executive shall be entitled to vacations consistent with other executive officers of the Company, absences because of illness or other incapacity, and such other absences, whether for holiday, personal time, or for any other purpose, as set forth in the Company’s employment manual or current procedures and policies, as the case may be, as same may be amended from time-to-time.

 

  

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5.           Termination.  The Executive’s employment hereunder may be terminated only as follows:

(a)           Without Cause by the Company or Without Good Reason by Executive.  The Company may terminate the Executive’s employment hereunder without Cause only upon action by the Board of Directors, and upon no less than thirty (30) days prior written notice to the Executive.  The Executive may terminate his employment hereunder without Good Reason upon no less than sixty (60) days prior written notice to the Company.

(b)           For Cause by the Company.  The Company may terminate the Executive’s employment hereunder for Cause immediately and with prompt notice to the Executive, which cause shall be determined in good faith solely by the Board of Directors.  “Cause” for termination shall mean any of the following conduct of the Executive:

(i)           Material breach by the Executive of any provision of this Agreement or the Executive NDA (as defined below), which breach, if susceptible to cure, shall not have been cured by the Executive within ten (10) days of receipt of written notice of said breach;

(ii)           Misconduct as an employee of the Company, including but not limited to: misappropriating any funds or property of the Company; attempting to willfully obtain any personal profit from any transaction in which the Executive has an interest which is adverse to the interests of the Company; or any other act or omission which substantially impairs the Company’s ability to conduct its ordinary business in its usual manner;

(iii)           Unreasonable neglect or refusal to perform the duties assigned to the Executive under or pursuant to this Agreement;

(iv)           Conviction of or plea of nolo contendere to a felony;

(v)           The possession or use by the Executive of illegal drugs or prohibited substances, the excessive drinking of alcoholic beverages on a recurring basis which impairs the Executive’s ability to perform his duties under this Agreement, or the appearance during hours of employment on a recurring basis of being under the influence of such drugs, substances or alcohol; or

(vi)           Any other act or omission which subjects the Company or any of its subsidiaries to substantial public disrespect, scandal or ridicule.

(c)           For Good Reason by the Executive.  The Executive may terminate his employment hereunder for Good Reason; provided, however, that upon written notice of the Executive’s decision to terminate for Good Reason, the Company shall have thirty (30) days in which to cure such Good Reason.  If the Company fails to cure such Good Reason within said thirty (30) days, the Executive may terminate his employment hereunder for Good Reason.   “Good Reason” for termination by the Executive shall mean any of the following conduct of the Company:

 

  

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(i)           Material breach of any provision of this Agreement by the Company, which breach shall not have been cured by the Company within ten (10) days of receipt of written notice of said breach, notwithstanding the period set forth above;

(ii)           Failure to maintain the Executive in a position commensurate with that referred to in Section 3 of this Agreement or at the Base Salary set forth without his consent;

(iii)           The assignment to the Executive without his consent of any duties inconsistent with the Executive’s position, authority, duties or responsibilities as contemplated by Section 3 of this Agreement, or any other action by the Company which results in a diminution of such position, authority, duties or responsibilities, excluding for this purpose any isolated action not taken in bad faith an which is promptly remedied by the Company after receipt of notice thereof given by the Executive; or

 

(iv)           The relocation of Company’s principal place of business to a location outside of the New York or Philadelphia Metropolitan area.

(d)           Death.  The period of employment of the Executive hereunder shall terminate automatically in the event of his death.

(e)           Disability.  In the event that the Executive shall be unable to perform his duties hereunder for a period of ninety (90) consecutive calendar days or any one hundred eighty (180) days in any calendar year by reason of disability as a result of illness, accident or other physical or mental incapacity, the Company may, in its discretion, by giving written notice to the Executive, terminate the Executive’s employment hereunder as long as the Executive is still disabled on the effective date of such termination.

(f)           Mutual Agreement.  This Agreement may be terminated at any time by mutual agreement (the “Mutual Agreement”) of the Executive and the Company.

6.           Compensation in the Event of Termination.  In the event that the Executive’s employment pursuant to this Agreement terminates for a reason provided for in Section 5 hereof, the Company shall pay the Executive compensation as set forth below:

(a)           By Executive for Good Reason; by the Company Without Cause.  In the event that the Executive’s employment hereunder is terminated: (i) by the Executive for Good Reason pursuant to Section 5(c) hereof; or (ii) by the Company without Cause; then the Company shall continue to pay or provide, as applicable, the following compensation to the Executive:

 

  

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(i)           Base Salary, less withholding, at an annual equivalent level as set forth in Section 4(a) hereof; and

(ii)           Continuing coverage for the Executive and his eligible dependents under all of the Company’s health insurance and other benefit plans, programs and policies in effect as of the date of termination, except that, with respect to applicable group and individual insurance policies, the Company shall provide, during such period, substantially the same level of benefits as provided by such policies to the Executive prior to such termination.

The compensation referred to in clauses (i) and (ii) above shall continue to be paid or provided, as applicable, in the same manner as before termination, for a period of time ending on the date six (6) months from the date of Executive’s termination, except that with respect to Section 6(a)(ii) above, such health insurance benefits shall cease upon the earlier to occur of the expiration of such six (6) month period of time or the date upon which the Executive begins regular, full-time employment with a third party and is eligible to commence health insurance coverage.  The Executive shall not be required to mitigate the amount of payment provided for in this Section 6(a) by seeking employment or otherwise, nor shall any amounts received from employment or otherwise by the Executive offset in any manner the obligation of the Company hereunder.

(b)           By Company Upon Termination of Agreement Due to Executive’s Disability; Upon Mutual Agreement; by Company for Cause; or by Executive Without Good Reason.  In the event of (i) the Company’s termination of the Executive’s employment hereunder for disability pursuant to Section 5(e) hereof; (ii) termination by Mutual Agreement; (iii) termination by the Company for Cause; or (iv) termination by the Executive without Good Reason, the Executive will be paid any salary and benefits earned and unpaid to the date of termination, and will be entitled to no other payments from the Company.

(c)           By Company Upon Termination of Agreement Due to Executive’s Death.  In the event of the Company’s termination of the Executive’s employment hereunder for death pursuant to Section 5(d) hereof the estate of the Executive will be paid any salary and benefits earned and unpaid to the date of death, and will continue to pay the Base Salary to Executive’s estate for sixty (60) days in the manner set forth in Section 4(a) hereof.

7.           Effect of Termination.  In the event of termination of this Agreement as provided herein, neither the Company nor the Executive shall have any remaining duties or obligations hereunder except that:

(a)           The Executive shall:

(i)           Immediately repay to the Company all amounts due to the Company, if any;

(ii)           Promptly return to the Company all property and confidential information of the Company; and

 

  

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(iii)           Promptly resign all directorships and officerships he may hold with the Company and its affiliates.

(b)           The Company shall:

(i)           Pay the Executive’s accrued Base Salary and any other accrued benefits under Section 4 hereof;

(ii)           Reimburse the Executive for expenses already incurred in accordance with Section 4(e) hereof;

(iii)           To the extent required by law, pay or otherwise provide for any benefits, payments or continuation or conversion rights in accordance with the provision of any benefit plan of which the Executive or any of his dependents is or was a participant; and

(iv)           Pay the Executive or his beneficiaries any compensation due pursuant to Section 6 hereof.

(c)           The Executive shall remain bound by the terms and conditions contained in the Executive NDA following termination of employment.  If the Executive violates any of the restrictions contained therein, any applicable restrictive periods shall be increased by the period of time from the commencement of any such violation until the time such violation shall be cured by the Executive to the satisfaction of the Company, and the Company may withhold any and all payments, otherwise due and owing to the Executive under this Agreement to the extent permitted by law.

(d)           The Executive agrees that the payments and/or benefits described in this Agreement shall be his sole and exclusive remedy in the event that the Company terminates his employment, and he shall be entitled to no further compensation for any damage or injury arising out of the termination of his employment by the Company, including payments or benefits set forth in any severance pay policy maintained by the Company, the payments and/or benefits so described being in full and complete satisfaction of any and all obligations owing to the Executive pursuant to this Agreement or otherwise in connection with the Executive’s employment, and the Executive shall provide an unconditional release of the Company and its subsidiaries and affiliates, and their respective directors, officers, employees and stockholders, or any of them, from any and all claims, liabilities or obligations under any severance or termination arrangements of the Company or any of its subsidiaries or affiliates, or otherwise related to the Executive’s employment with the Company in exchange for (and as a condition to receipt of) such payments.

 

  

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8.           Resolution of Differences Over Breach of Agreement.  Except as otherwise provided herein, any controversy or claim arising out of, or relating to, this Agreement, or the breach hereof, shall be reviewed in the first instance in accordance with the Company’s internal review procedures, if any, with recourse thereafter, for temporary or preliminary injunctive relief only, to the courts having jurisdiction thereof, and if any relief other than injunctive relief is sought, then to arbitration in the State of New Jersey in accordance with the rules of the American Arbitration Association, and judgments upon the award rendered by the arbitrator(s) may be entered in any court having jurisdiction thereof.  Nothing herein shall be construed as prohibiting the Company from pursuing any other remedies available to it for such breach or threatened breach, including the recovery of damages, from the Executive.

9.           Waiver.  The waiver by a party hereto of any breach by the other party hereto of any provision of this Agreement shall not operate or be construed as a waiver of any subsequent breach by a party hereto.

10.           Assignment; Severance Upon Change of Control.  This Agreement shall be binding upon and inure to the benefit of the successors and assigns of the Company, and the Company shall be obligated to require a successor (whether by stock transfer or the transfer or sale of all or substantially all of the Company’s assets) (the “Successor”) to expressly assume its obligation hereunder.  In the absence of such assumption, or if following a Change of Control, this Agreement is terminated by the Executive with Good Reason or by the Successor without Cause during the twelve (12) month period following the Change of Control, the Company shall pay and provide to the Executive the amount and benefits which would have been payable  and/or provided to the Executive had the Executive been terminated by the Company without Cause, as set forth in Section 5(a), however the period of time set forth in Section 6(a) shall be extended to twelve (12) months.  This Agreement shall inure to the benefit of and be enforceable by the Executive or his legal representatives, executors, administrators, successors, heirs, distributes, devises and legatees. The Executive may not assign any of his duties, responsibilities, obligations or positions hereunder to any person; any such purported assignment by him shall be void and of no force and effect.

11.           Notices.  Any notices required or permitted to be given under this Agreement shall be sufficient if in writing, and if personally delivered or when sent by first claim certified or registered mail, postage prepaid, return receipt requested--in the case of the Executive, to his residence address as set forth below, and in the case of the Company, to the address of its principal place of business as set forth above, in care of the Board of Directors--or to such other person or at such other address with respect to each party as such party shall notify the other in writing.

12.           Additional Representation of Executive.  The Executive represents and warrants that he is not party to any agreement which would prohibit him from entering into this Agreement or performing fully his obligation hereunder.

13.           Survival of Certain Provisions.  The obligations of the Executive set forth in Paragraphs 7 and 8 of this Agreement and in the Company’s Executive NDA attached as Exhibit A hereto, represent independent covenants by which the Executive is, and will remain, bound notwithstanding any breach by the Company, and shall survive the termination of this Agreement.

 

  

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14.           Construction of Agreement.

(a)           Governing Law.  This Agreement shall be governed by and its provisions construed and enforced in accordance with the internal laws of the State of New Jersey without reference to its principles regarding conflicts of law.

(b)           Severability.  In the event that any one or more of the provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the validity, legality or enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

(c)           Headings.  The descriptive headings of the several paragraphs of this Agreement are inserted for convenience of reference only and shall not constitute a part of this Agreement.

15.           Entire Agreement.  This Agreement, the Executive NDA and the Incentive Stock Option Agreement to be entered into between the Executive and the Company evidencing the grant of the Stock Options, contain the entire agreement of the parties concerning the Executive’s employment and all promises, representations, understandings, arrangements and prior agreements on such subject are merged herein and superseded hereby, including without limitation, the term sheet between the parties dated June 26, 2012.  The provisions of this Agreement may not be amended, modified, repealed, waived, extended or discharged except by an agreement in writing signed by the party against whom enforcement of any amendment, modification, repeal, waiver, extension or discharge is sought.  No person other than a duly authorized officer of the Company shall have authority, on behalf of the Company, to agree to amend, modify, repeal, waive, extend or discharge any provision of this Agreement or anything in reference thereto or to exercise any of the Company’s rights to terminate or to fail to extend this Agreement.

16.           Executive Proprietary Information and Intellectual Property Agreement.  As a condition to the Executive’s employment hereunder, on the date hereof, the Executive shall execute and deliver a copy of the Executive Confidentiality and Assignment Agreement, a copy of which is attached as Exhibit A hereto (the “Executive NDA”).  The Executive hereby acknowledges and agrees that the terms of the Executive NDA are incorporated herein by reference and made part hereof as though fully set forth herein, and the Executive hereby acknowledges and agrees that he has reviewed and will continue to be bound by the terms thereof following the termination of his employment with the Company, as set forth in the Executive NDA.

 

  

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17.           Cooperation.  Without limitation to any other provision herein set forth herein, during and after the Executive’s employment, the Executive shall reasonably cooperate with the Company in the defense or prosecution of any claims or actions now in existence or which may be brought in the future against or on behalf of the Company which relate to events or occurrences that transpired while the Executive was employed by the Company; provided, however, that such cooperation shall not materially and adversely affect the Executive or expose the Executive to an increased probability of civil or criminal litigation.  The Executive’s cooperation in connection with such claims or actions shall include, but not be limited to, being available to meet with counsel to prepare for discovery or trial and to act as a witness on behalf of the Company at mutually convenient times.  During and after the Executive’s employment, the Executive also shall cooperate fully with the Company in connection with any investigation or review of any federal, state or local regulatory authority as any such investigation or review relates to events or occurrences that transpired while the Executive was employed by the Company.  The Company shall reimburse the Executive for all costs and expenses incurred in connection with his performance under this Section 17, including, but not limited to, reasonable attorneys’ fees and costs, provided that the Executive shall not incur costs and expenses in excess of $1,000 in the aggregate without the prior written consent of the Company.   For the avoidance of doubt, this Section 17 shall survive any termination of the Executive’s employment and any termination of this Agreement.

18.           409A.  The parties intend that the payments and benefits provided for in this Agreement to either be exempt from Section 409A of the Internal Revenue Code, as amended (the “Code”) or be provided in a manner that complies with Section 409A of the Code.  To the extent that any provision in this Agreement is ambiguous as to its compliance with Section 409A of the Code, the provision shall be read in such a manner so that no payments due under this Agreement shall be subject to an "additional tax" as defined in Section 409A(a)(1)(B) of the Code.  For purposes of Section 409A of the Code, each payment made under this Agreement shall be treated as a separate payment.  In no event may the Executive, directly or indirectly, designate the calendar year of payment.  Notwithstanding anything contained herein to the contrary, all payments and benefits which are payable upon a termination of employment hereunder shall be paid or provided only upon those terminations of employment that constitute a ‘separation from service’ from the Company within the meaning of Section 409A of the Code (determined after applying the presumptions set forth in Treas. Reg. Section 1.409A-1(h)(1)).  All reimbursements provided under this Agreement shall be made or provided in accordance with the requirements of Section 409A, including, where applicable, the requirement that (i) any reimbursement is for expenses incurred during the Executive’s lifetime (or during a shorter period of time specified in this Agreement), (ii) the amount of expenses eligible for reimbursement during a calendar year may not affect the expenses eligible for reimbursement in any other calendar year, (iii) the reimbursement of an eligible expense will be made on or before the last day of the calendar year following the year in which the expense is incurred, and (iv) the right to reimbursement is not subject to liquidation or exchange for another benefit

19.           Non-Disparagement.  During the Term and thereafter, the Executive agrees not to defame, disparage or criticize the Company, its business plan, procedures, products, services, development, finances, financial condition, capabilities or other aspect of its business, or any of its shareholders in any medium (whether oral, written, electronic or otherwise, whether currently existing or hereafter created), to any person or entity, without limitation in time.  Notwithstanding the foregoing sentence, the Executive may confer in confidence with his advisors and make truthful statements as required by law, or make statements to the Board of Directors of the Company.  Company agrees that its officers and directors will not defame, disparage, or criticize Executive to any person or entity, without limitation in time.  Notwithstanding the foregoing sentence, the Company may confer in confidence with its advisors and make truthful statements as required by law.  This Section 19 shall survive any termination of the Executive’s employment and any termination of this Agreement.

 

  

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20.           Indemnification.  The Executive shall be entitled  to the benefit of such indemnification and liability insurance as is available to all other officers of the Company.

21.           Counterparts.  This Agreement may be executed in one or more counterparts (including via facsimile or other electronic transmission), each of which shall be deemed an original and all of which together shall constitute one and the same instrument.

[SIGNATURE PAGE FOLLOWS]

 

  

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IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed as of the date first above written.

	 	ADMA BIOLOGICS, INC.	 
	 	 	 	 
	
 

	
By: 

	/s/ Adam Grossman	 
	 	 	Name:  Adam Grossman	 
	 	 	Title:    Chief Executive Officer	 
	 	 	 	 
	 	 	 	 
	 	 	/s/ James Mond, MD	 
	 	 	James Mond, MD	 

 

  

  

  

EXHIBIT A

NON-COMPETITION AND NON-SOLICITATION AGREEMENT

This NON-COMPETITION AND NON-SOLICITATION AGREEMENT (this “Agreement”), dated July 18, 2012, is entered into by and between ADMA Biologics, Inc., a Delaware corporation (the “Company”), and James Mond, MD (“Executive”).

PRELIMINARY STATEMENTS

WHEREAS, the Company has entered into an employment agreement with Executive that provides for the execution of this Agreement by Executive as consideration for the commitments and obligations provided for therein (the “Employment Agreement”).

NOW, THEREFORE, in consideration of the premises and the mutual agreements and covenants hereinafter set forth, and intending to be legally bound, the Company and Executive hereby agree as follows:

STATEMENT OF AGREEMENT

1.           Non-Competition. Executive absolutely and unconditionally covenants and agrees that for the period commencing on the Start Date as set forth in the Employment Agreement, and continuing during his employment with the Company and for a period of six months thereafter (the “Restrictive Period”), Executive will not, anywhere within North America, either directly or indirectly, solely or jointly with any other person or persons, as an employee, consultant or advisor, or as an individual proprietor, partner, stockholder, director, officer, joint venturer, investor, lender or in any other capacity (whether or not engaged in business for profit), engage or participate in a Competing Business (defined below). Nothing herein contained shall, however, prohibit Executive’s acquisition or ownership of stock or securities listed on a national or regional securities exchange or the Nasdaq Stock Market, so long as such investments, in the aggregate, in any particular business enterprise constitute less than five percent (5%) of the total issued and outstanding stock and securities of such enterprise. The term “Competing Business” means (i) the development and commercialization of human plasma and plasma-derived therapeutics, and (ii) any other business being conducted by the Company.

2.           Non-Solicitation. Executive absolutely and unconditionally covenants and agrees that during the Restrictive Period, Executive will not, either directly or indirectly, for any reason, whether for Executive’s own account or for the account of any other person, natural or legal, without the prior written consent of the Company: (i) solicit, employ, deal with or otherwise interfere with any contract or relationship of the Company with any employee, officer, director or any independent contractor of the Company, while such person or entity is employed by or associated with the Company or in the case of former employees within one year of the termination of such person’s employment with the Company during the Restrictive Period; (ii) solicit, accept, deal with or otherwise interfere with any contract or relationship of the Company with any independent contractor, customer, client or supplier of the Company or with any person, natural or legal; or (iii) solicit or otherwise interfere with any existing or proposed contract between the Company and any other person, natural or legal.

 

  

  

  

 

3.           Confidential Information.

(a)           Use and Treatment of Confidential Information. Executive agrees not to disclose, divulge, publish, communicate, publicize, disseminate or otherwise reveal, either directly or indirectly, any Confidential Information to any person, natural or legal. The term “Confidential Information” means all information in any form relating to the past, present or future business affairs, including without limitation, research, development or business plans, operations or systems, of the Company or a person not a party to this Agreement whose information the Company has in its possession under obligations of confidentiality, which is disclosed by the Company to Executive or which is produced or developed while Executive is an owner of, employee or director of the Company. The term “Confidential Information” shall not include any information of the Company which (i) becomes publicly known through no wrongful act of Executive, (ii) is received from a person not a party to this Agreement who is free to disclose it to Executive, or (iii) is lawfully required to be disclosed to any governmental agency or is otherwise required to be disclosed by law, subpoena or court order but only to the extent of such requirement, provided that before making such disclosure Executive shall give the Company an adequate opportunity to interpose an objection or take action to assure confidential handling of such information.

(b)           Ownership and Return of Confidential Information. All Confidential Information disclosed to or obtained by Executive in tangible form (including, without limitation, information incorporated in computer software or held in electronic storage media) shall be and remain the property of the Company. All Confidential Information possessed by Executive at the time he ceases employment with the Company shall be returned to the Company at such time. Upon the return of Confidential Information, it shall not thereafter be retained in any form, in whole or in part, by Executive.

(c)           Work Product Assignment. Executive hereby assigns to the Company all of his right, title and interest in and to, and shall disclose promptly to the Company, any and all work product, developments, inventions, ideas and discoveries, and works of authorship developed, discovered, improved, authored, derived, invented or acquired by Executive during the period of his employment by the Company (collectively, “Work Product”), whether or not during business hours, that are either related to the scope of Executive’s employment by the Company or make use, in any manner, of the resources of the Company, and agrees that such Work Product shall be and shall remain the exclusive property of the Company. The parties hereto understand that the term Work Product includes, but is not limited to, all work product developed, discovered, improved, authored, derived, invented or acquired by Executive that: (A) incorporates or reflects any Confidential Information; (B) is to any extent developed utilizing any computer equipment or software of or licensed to the Company or any supplies, equipment or facilities of or provided by the Company; (C) relates to the business of the Company or the Company’s actual or anticipated research and development with respect to Confidential Information; or (D) results from any work performed by Executive for the Company.

 

  

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4.           Remedies Upon Breach. The parties acknowledge that Confidential Information and the other protections afforded to the Company by this Agreement are valuable and unique and that any breach of any of the covenants contained in this Agreement will result in irreparable and substantial injury to the Company for which it will not have an adequate remedy at law. In the event of a breach or threatened breach of any of the covenants contained in this Agreement, the Company shall be entitled to obtain from any court having jurisdiction, with respect to the Executive, temporary, preliminary and permanent injunctive relief prohibiting any such breach. Any such relief shall be in addition to and not in lieu of any appropriate relief in the way of monetary damages and equitable accounting of all earnings, profits and other benefits arising from such violation, which rights shall be cumulative and in addition to any other rights or remedies to which the Company may be entitled.

5.           Miscellaneous.

(a)           Notice. Any notice required or permitted hereunder shall be given in writing and shall be deemed effectively given upon the earliest of (i) personal delivery, (ii) actual receipt or (iii) the third full day following deposit in the United States mail with postage prepaid, addressed to the Company at its principal offices, to the attention of the Board of Directors of the Company (the “Board”) with a copy to the Secretary, or, if to Executive, to such home or other address as Executive has most recently provided in writing to the Company.

(b)           Assignment; Binding Effect. Neither Executive nor the Company may assign this Agreement without the prior written consent of the other party, except that the Company may assign this Agreement to any affiliate thereof, or to any subsequent purchaser of the Company or all or substantially all of the assets of the Company, or by operation of law. This Agreement shall be binding upon the heirs, executors, and administrators of Executive.

(c)           Choice of Law; Consent to Jurisdiction; Waiver of Jury Trial. THIS AGREEMENT SHALL BE GOVERNED BY, CONSTRUED IN ACCORDANCE WITH AND ENFORCED UNDER THE LAWS OF THE STATE OF NEW JERSEY. ALL SUITS, ACTIONS OR PROCEEDINGS ARISING OUT OF OR RELATING TO THIS AGREEMENT, SHALL BE BROUGHT IN A STATE OR FEDERAL COURT LOCATED IN THE STATE OF NEW JERSEY, WHICH COURTS SHALL BE THE EXCLUSIVE FORUM FOR ALL SUCH SUITS, ACTIONS OR PROCEEDINGS. EXECUTIVE AND THE COMPANY HEREBY WANE ANY OBJECTION WHICH HE OR IT MAY NOW OR HEREAFTER HAVE TO THE LAYING OF VENUE IN ANY SUCH COURT OR ANY SUCH SUIT, ACTION OR PROCEEDING. EXECUTIVE AND THE COMPANY HEREBY IRREVOCABLY CONSENT AND SUBMIT THEMSELVES TO THE JURISDICTION OF THE COURTS OF THE STATE OF NEW JERSEY FOR THE PURPOSES OF ANY SUIT, ACTION OR PROCEEDING ARISING OUT OF THIS AGREEMENT. EXECUTIVE AND THE COMPANY HEREBY WAIVE ANY RIGHT TO A TRIAL BY JURY IN ANY SUIT, ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT AND AGREE THAT ANY SUCH SUIT, ACTION OR PROCEEDING SHALL BE TRIED BEFORE A COURT AND NOT BEFORE A JURY.

 

  

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(d)           Amendment; Waiver. No modification, amendment or termination of this Agreement shall be valid unless made in writing and signed by the parties hereto, and approved by the Board (but not including Executive). Any waiver by any party of any violation of, breach of or default under any provision of this Agreement, by the other party shall not be construed as, or constitute, a continuing waiver of such provision, or waiver of any other violation of breach of or default under any other provision of this Agreement.

(e)           Severability. Any provision of this Agreement which is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent possible without invalidating the remaining provisions hereof or affecting the validity or enforceability of such provision in any other jurisdiction.

(f)           Survival of Certain Obligations. The obligations of the Company and Executive set forth in this Agreement which by their terms extend beyond or survive the termination of this Agreement shall not be affected or diminished in any way by the termination of this Agreement.

(g)           Headings. The headings in this Agreement are intended solely for convenience and shall be disregarded in interpreting it.

(h)           Third Parties.  Nothing expressed or implied in this Agreement is intended, or shall be construed, to confer upon or give any person or entity other than the Company and Executive any rights or remedies under, or by reason of, this Agreement.

(i)           Counterparts.  This Agreement may be executed in counterparts, and all of such counterparts (including facsimile and PDF), when separate counterparts have been executed by the parties hereto, shall be deemed to be one and the same agreement.

(j)           Consideration.  For consideration of the promises of Executive herein set forth, the Company has entered in to an employment agreement with Executive.

[Signature Page Follows]

 

  

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IN WITNESS WHEREOF, the Company and Executive have executed this Non- Competition and Non-Solicitation Agreement as of the date first written above.

	 	ADMA BIOLOGICS, INC.	 
	 	 	 	 
	
 

	
By: 

	/s/ Adam Grossman	 
	 	 	Name:  Adam Grossman	 
	 	 	Title:    Chief Executive Officer	 
	 	 	 	 
	 	EXECUTIVE	 
	 	 	 	 
	 	 	/s/ James Mond, MD	 
	 	 	James Mond, MD

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