Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 24b-2 under the Exchange Act of 1934, as amended.Confidential Portions are marked: [***]

 

THIS AMENDED AND RESTATED PLASMA SUPPLY AGREEMENT (this “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 465 Rt 17 South, Ramsey, NJ  07446 (“ADMA”)  shall be effective as of March 23, 2016 (the “Effective Date”).  BPC and ADMA are each sometimes referred to herein individually as a “Party” or collectively as the “Parties.”

 

 

WHEREAS, BPC and ADMA are Parties to that certain Plasma Supply Agreement, with an effective date of June 22, 2012, ( the “Original Agreement”);

 

WHEREAS, BPC and ADMA entered into Amendment No. 1 and Amendment No. 2 to the Original Agreement, with effective dates of February 25, 2014 and March 25, 2015, respectively, to extend the term of the Original Agreement and amend certain provisions regarding pricing and volume  (the "Amendments" and together with the Original Agreement, the “Prior Agreement”); and

 

WHEREAS, BPC and ADMA wish to amend and restate the entirety of the Prior Agreement and memorialize the amendment of certain revised provisions in the Prior Agreement.

 

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 hereby that the Prior Agreement shall be amended and restated in its entirety as set forth herein, and the parties to this Agreement further agree as follows:

 

A.	PURCHASE AND SALE OF  PLASMA.

 

1.           TERM OF AGREEMENT.  Unless terminated earlier as provided herein, the term of the Agreement shall expire on December 31, 2018 (the “Initial Term”).  The Agreement may be renewed for an additional [***] term upon the mutual consent of the Parties.  Each Party agrees to notify the other in writing of its intention to extend, or not to extend, the term of Agreement [***] prior to the expiration of the term of this Agreement.

 

 

a.             ADMA NORCROSS PLASMA CENTER (“Norcross Center”)

i.           ADMA and BPC agree that during the term of this Agreement, BPC shall purchase [***] Plasma produced at the ADMA plasma center, located at 6290 Jimmy Carter Boulevard, Suite 208, Norcross, Georgia (the “Norcross Center”) that is not collected by ADMA for its own use (“Available Plasma”).

 

ii.           For the period commencing as of the Effective Date of this Amendment No. 2, and ending [***], BPC’s purchase price from ADMA for Plasma from the Norcross Center shall be $[***] per liter.

 

iii.           For the period commencing [***], and ending on [***], BPC’s purchase price from ADMA for Plasma from the Norcross Center, shall be [***]

 

 

Notwithstanding the foregoing, in no event shall any price [***] unless otherwise agreed to in writing by the Parties.

 

iv.           For the period commencing [***], the pricing for Plasma from the Norcross Center shall be [***].  Notwithstanding the foregoing, in no event shall any price [***] unless otherwise agreed to in writing by the Parties.

 

b.             ADMA MARIETTA PLASMA CENTER (“Marietta Center”)

i.           ADMA and BPC agree that during the term of this Agreement, BPC shall purchase Plasma from ADMA’s second plasma facility located in Marietta, Georgia (the “Marietta Center”), in an amount [***], pursuant to the terms and conditions of the Agreement, provided the Plasma meets BPC’s Specifications, and is FDA and GHA (German Health Authorities) certified.  Notwithstanding the foregoing, during the [***] that the Marietta Center is operational, and prior to ADMA having obtaining GHA certification for the Marietta Center, BPC agrees to purchase Plasma from the Marietta Center at the levels set forth in the preceding sentence provided that the Marietta Center has received FDA approval.

 

ii.           For the period commencing as of the Effective Date of this Amendment No. 2, and ending on [***], BPC’s purchase price from ADMA for [***] of Plasma from the Marietta Center shall be $[***] per liter.

 

iii.           For the period commencing on [***], and ending [***], BPC’s purchase price from ADMA for [***] of Plasma from the Marietta Center, will be [***].  Notwithstanding the foregoing, in no event shall any price [***] unless otherwise agreed to in writing by the parties.

 

iv.           For the period commencing [***], BPC’s purchase price from ADMA for Plasma for [***] of Plasma from the Marietta Center, will be [***].  Notwithstanding the foregoing, in no event shall any price [***] unless otherwise agreed to in writing by the parties.

 

v.           In addition to the minimum [***] of Plasma, for each year during the term of the Agreement, ADMA shall offer to sell to BPC and BPC shall

 

 

 

purchase, Plasma produced at the Marietta Center [***] (“[***] Plasma”).  For the period commencing on [***], and ending [***], BPC’s purchase price for the [***] Plasma from the Marietta Center will be $[***] per liter.

 

vi.           For the period commencing [***], BPC’s purchase price from ADMA for [***] Plasma from the Marietta Center, will be the [***]. Notwithstanding the foregoing, in no event shall any price [***] unless otherwise agreed to in writing by the parties.

 

c.

BPC’s purchase price of Plasma from ADMA under this Agreement includes [***].  Any additional required testing as specified by the FDA (or foreign equivalent), or due to a change in BPC’s Specifications, will be billed to BPC at ADMA’s actual costs.

 

 

Subject to Section C hereof, all Plasma shall be paid for within thirty (30) days from the date of invoice.  Payments shall become delinquent ten (10) days after BPC receives notification from ADMA that there is a late payment.  Any undisputed payments not paid within ten days after BPC receives notification from ADMA of said late payment shall accrue interest to be paid at the rate of 12% per annum, subject to the maximum allowed by law.  Invoice to be issued upon shipping from ADMA’s Centers (as defined below). 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.

 

Biotest Pharmaceuticals Corporation

Accounts Payable

5800 Park of Commerce Boulevard NW

Boca Raton, Florida  33487

Email:­­­­­­­­­­­­­­­­­­­­­­­ ***@***

 

4.           INSPECTION AND ACCEPTANCE.

a.             BPC and ADMA shall agree in writing upon specifications for Plasma to be delivered to BPC by ADMA ("BPC's Specifications"). BPC shall inspect each shipment of Plasma for conformity with BPC’s specifications within thirty (30) days 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 replace any non-conforming Plasma, as promptly as possible, taking into account the time required to produce such quantities of Plasma. 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 the Party determined to have been in error as to conformity, or lack thereof, with the BPC Specifications.

 

 

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.  Delivery of Plasma shall be [***].  ADMA will invoice BPC for the Plasma at time of delivery to RxCrossroads.  [***].

 

However, a surcharge may be allowed, with BPC’s written approval, when fuel prices exceed [***] of the cost of fuel over the prior year.  ADMA will submit fuel prices per gallon effective on a date ten calendar days prior to the requested price increase.  Accordingly, ADMA will offer a reduced rate to the BPC when fuel prices decrease below the [***] variance.

 

B.	QUALITY OF  PLASMA.

 

1.

All Plasma sold under this Agrement 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 the ADMA plasma collection centers listed on Exhibit A (each, a "Center" and together the "Centers").  ADMA warrants that each 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 within thirty (30) days  of the Effective Date.

 

5.

BPC shall bear the expense of unusable Plasma due to a recall or look back, or the destruction of any Plasma due to post-donation “look back” issues in accordance with FDA regulations and guidance, after the date of shipment of Plasma to RxCrossroads.

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 thirty (30) days’ notice prior to any of its inspections, unless mutually agreed otherwise by the parties. Upon receipt of BPC’s audit report, ADMA shall have thirty (30) days to send a response to 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 within thirty (30) days of (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 within five (5) days of receipt of such report or correspondence and to provide BPC with a copy of such report or correspondence.

 

 

 

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 within thirty (30) days 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.

 

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.

 

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 a period of five (5) years.

 

2.           RELATIONSHIP OF THE PARTIES.   The 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.

 

 

 

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 Five Million Dollars ($5,000,000).  Before commencing any work hereunder, the Parties shall furnish certificates evidencing the insurance required by this Section.  The Parties shall give each other thirty (30) 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 if the other Party fails to remedy and make good any material default in the performance of any material condition or obligation under this Agreement within sixty (60) days 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 within sixty (60) days, 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.

 

 

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 than ninety (90) days, 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.           BPC agrees that all donor information supplied by ADMA and antibody test results supplied by ADMA are the property of ADMA and that BPC has no right to share this information with any other Party or use the information for its own commercial use, but may use the information to comply with regulatory requirements and for its own record keeping requirements. This information shall be considered confidential.

 

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 period of three (3) business days.  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.

 

 

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.

 

 

To BPC:

Ileana Carlisle

Chief Executive Officer

Biotest Pharmaceuticals Corporation

5800 Park of Commerce Boulevard NW

Boca Raton, FL   33487

Fax: 561 ###-###-####

 

With a copy to:

Legal Department

Biotest Pharmaceuticals Corporation

5800 Park of Commerce Boulevard NW

Boca Raton, FL   33487

Fax: 561 ###-###-####

 

To ADMA:

Adam Grossman

Chief Executive Officer

ADMA Biologics, Inc.

465 Rt 17 South

Ramsey, NJ  07446

Fax: 201 ###-###-####

 

With a copy to:

General Counsel

ADMA Biologics, Inc.

465 Rt 17 South

Ramsey, NJ  07446

 

 

 

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.

 

 

 

 

N.            ENTIRE AGREEMENT.  This Agreement (including any Schedules and Exhibits hereto) constitutes the full and entire understanding and agreement between the parties with respect to the subject matter hereof, and any other written or oral agreement relating to the subject matter hereof existing between the parties is expressly canceled.  The Prior Agreement shall be deemed amended and restated and superseded and replaced in its entirety by this Agreement, and the Prior Agreement shall be of no further force or effect.  BPC and ADMA hereby expressly consent and agree to this amendment and restatement of the Prior Agreement.

 

 

 

 

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 BioCenters Georgia Inc

 

 

6290 Jimmy Carter Boulevard

Suite 208

Norcross, GA 30071

 

 

3000 Windy Hill Rd., SE

Suite 220

Marietta, GA 30067