UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q/A

(Amendment No. 1)

Quarterly Report Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

For the Quarterly Period Ended September 30, 2011

 

Commission File Number: 1-13441

 

HEMISPHERX BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   52-0845822
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification No.)

 

1617 JFK Boulevard, Suite 500, Philadelphia, PA 19103

(Address of principal executive offices) (Zip Code)

 

(215) 988-0080

(Registrant's telephone number, including area code)

 

 (Former name, former address and former fiscal year, if changed since last report)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

x Yes ¨ No

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or such shorter period that the registrant was required to submit and post such files).

x Yes ¨ No

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

¨ Large accelerated filer x Accelerated filer
¨ Non-accelerated filer ¨ Smaller reporting company

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ¨ Yes x No

 

135,566,471 shares of common stock were outstanding as of November 1, 2011.

 

 

 

  

EXPLANATORY NOTE

 

This Amendment No. 1 to the Form 10-Q (this “Amendment”) amends the Quarterly Report on Form 10-Q of Hemispherx Biopharma, Inc. for the period ended September 30, 2011 filed on November 9, 2011 (the “Form 10-Q”) for the sole purpose of refiling Exhibit 10.1 & 10.2 (certain portions of which were previously omitted pursuant to a confidential treatment order granted by the Securities and Exchange Commission (the “SEC”)) and in connection therewith, to amend Part II, Item 6 of the Form 10-Q and the Exhibit Index to the Form 10-Q. As required by Rule 12b-15 under the Securities Exchange Act of 1934, as amended, Item 6 of Part II of the Form 10-Q also has been amended to contain currently dated certifications from our Chief Executive Officer and Chief Financial Officer. The currently dated certifications are attached hereto as Exhibits 31.1 and 31.2. Because no financial statements of Hemispherx Biopharma, Inc. are contained in this Amendment, we are not including certifications pursuant to 18 U.S.C. 1350.

 

No other changes, other than described above, are made to the Form 10-Q other than to update the cover page of the Form 10-Q to reflect that it is an amendment to the Form 10-Q. Unless expressly stated, this Amendment does not reflect events occurring after the filing of the Form 10-Q, nor does it modify or update in any way the disclosures contained in the Form 10-Q. Accordingly, this Amendment should be read in conjunction with the Form 10-Q and our other filings made with the SEC subsequent to the filing of the Form 10-Q.

 

 

 

  

ITEM 6: Exhibits

 

(a) Exhibits

 

10.1   Vendor Agreement with Bio Ridge Pharma, LLC, effective on August 15, 2011 and executed on September 6, 2011.
     
10.2   Vendor Agreement with Armada Healthcare, LLC, effective and executed on September 6, 2011.
     
31.1   Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company's Chief Executive Officer.
     
31.2   Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 from the Company's Chief Financial Officer.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  HEMISPHERX BIOPHARMA, INC.
   
  /s/ Thomas K. Equels
  Thomas K. Equels, Esq.
  Chief Executive Officer & President
   
  /s/ Adam Pascale
  Adam Pascale
  Chief Financial Officer
   
Date: January 13, 2017  

 

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Exhibit 10.1

 

HEMISPHERX BIOPHARMA, INC.

 

SPECIALTY DISTRIBUTOR PURCHASE AND SERVICE AGREEMENT

 

This Specialty Distributor Purchase and Service Agreement (the "Agreement") is made as of August 15, 2011 (the "Effective Date") by and between Hemispherx Biopharma, Inc., (“Hemispherx”) and Bio Ridge Pharma, LLC., 100 Campus Drive Suite 102 Florham Park, NJ 07932 (“BRP”).

 

RECITALS

 

WHEREAS, Hemispherx, is engaged in the manufacture, marketing and/or distribution of ALFERON N Injection®, an injectable formulation of Natural Alpha Interferon (hereinafter referred to alternatively as “Product”.

 

WHEREAS, BRP is a licensed specialty distributor in the United States and its territories (the "Territory") and is willing to purchase and resell Product in accordance with the terms and conditions of this Agreement; and

 

WHEREAS, BRP desires to become the exclusive, authorized distributor of Product and provide ancillary services related to the distribution of Product, as defined and provided herein, and Hemispherx is willing to appoint BRP as the exclusive distributor of Product and purchase such ancillary services related to the distribution of Product, in accordance with the terms and conditions of this Agreement.

 

NOW THEREFORE, in consideration of the premises and mutual promises set forth herein, the parties agree as follows:

 

1.0 Appointment as the Authorized Distributor and Product Purchases

 

1.1         Appointment as an Authorized Distributor . Subject to the terms and conditions of this Agreement, Hemispherx hereby appoints BRP as a distributor of Product solely for resale in the Territory. As a distributor of Product, BRP will distribute Product in accordance with the terms of this Agreement.

 

1.2         Direct Purchase from Hemispherx. BRP agrees that it will purchase Product exclusively from Hemispherx. BRP shall not source, purchase, trade, exchange or otherwise obtain Product from any entity other than Hemispherx.

 

1.3         Price. Hemispherx agrees to sell to BRP the Product at the price set forth in Exhibit A attached hereto (the "Purchase Price"). Hemispherx will notify BRP of price changes within seven (7) days notice to allow time to update BRP system files.

 

1.3         Payment . Payments for Product purchases shall be made to Hemispherx in United States dollars via Electronic Funds Transfer (EFT) according to the terms in Exhibit A . Dates for eligibility for prompt pay discounts set forth in Exhibit A are firm and any payments received from BRP after the date for eligibility of the prompt pay discount shall be for payment in full of the outstanding invoice. If that day falls on a Saturday, Sunday or Bank Holiday, payment will be due on the next business day.

 

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1.4         Ordering Procedures. All purchases of Product shall be made via a purchase order submitted to Hemispherx via Electronic Data Interchange (EDI). In the event EDI is unavailable at a given time, BRP may submit a purchase order to Hemispherx using an alternative method: (i) via fax using the Hemispherx Purchase Order Form ; or (ii) by calling Hemispherx Customer Service at. For tracking purposes, BRP agrees to use the Customer Identification Number assigned to it on all purchase orders.

 

1.5         Purchase Orders Subject to Hemispherx Review. Each purchase order by BRP is subject to review and acceptance by Hemispherx. Hemispherx may hold orders or reduce order quantities in its sole discretion for any of the following reasons:

 

1.5.1         Product is on backorder . A backorder for Product shall remain active for sixty (60) days. If Product becomes available within the sixty (60) day limit, the Product will be shipped at the price in effect on the date the order was received and accepted. If the Product remains on backorder for more than sixty (60) days, the backordered quantity will be canceled on the sixtieth (60) day and BRP will be notified. Cancelled backorders must be re-ordered by BRP at the price in effect on the date of subsequent order. Notwithstanding the above, if BRP re-orders product within three (3) business days following cancellation of the backorder, the order will be re-entered at the price in effect on the day of the original product purchase order.

 

1.5.2         Product is in short supply or is expected to enter a period of short supply . Some or all of the purchase order will be placed on hold and allocation of the Product in short supply or expected to enter a period of short supply shall be made in the sole discretion of Hemispherx.

 

1.5.3         BRP’s credit limit is exceeded . In the event BRP's credit limit with Hemispherx is exceeded, BRP may reduce the purchase order or submit a formal request to Hemispherx to increase BRP's credit limit. Credit limits are established in the sole discretion of Hemispherx and its Credit and Collections Department.

 

1.6         Shipment/Risk of Loss . Shipments by Hemispherx to BRP will be made within five (5) business days after receipt and acceptance of a purchase order. Product shall be shipped FOB destination, freight prepaid. Title and risk of loss pass to BRP upon BRP’s acceptance of delivery as demonstrated by written signature of BRP’s representative. Hemispherx shall pay all standard charges for freight, insurance, fees, and all other packing and shipping charges related to delivery of Product to BRP, provided however, if BRP requests expedited shipment, special routing or special handling of a shipment which results in a higher transportation cost than would be incurred in a delivery but for such request(s), the extra cost incurred by Hemispherx will be added to BRP’s invoice. Hemispherx shall not be liable for any costs (including, without limitation, the replacement cost) of any Product shipped or alleged to have been shipped by BRP to a customer in the event customer does not receive said shipment.

 

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1.7         Inspection/Defect/Return of Product. BRP shall promptly inspect all shipments of Product delivered to BRP and report any damage, defect, loss in transit, or other shipping errors to Hemispherx Customer Service () within five (5) business days of receipt by BRP. Hemispherx will, in its sole discretion, issue either a credit or replacement for any Product which is damaged or defective if the damage or defect existed prior to delivery to BRP and BRP has not violated any applicable requirements regarding storage and handling. Hemispherx may ask for return of the damaged or defective Product or direct that such Product be destroyed. Hemispherx agrees to reimburse BRP for all standard shipping costs related to such returns or destruction in the form of a credit to BRP’s account. Hemispherx will not reimburse BRP for any other expenses associated with a damaged or defective Product.

 

1.8         Recall . BRP agrees to administer recalls, warning letters, quarantines or withdrawals in accordance with Hemispherx instructions. Hemispherx agrees to reimburse BRP for all direct costs related to the foregoing which are pre-approved by Hemispherx in writing. With regard to recalls, Hemispherx endeavors to comply with all HDMA guidelines.

 

1.9         Returned Goods . BRP agrees to comply with Hemispherx’s Return Goods Policy (attached hereto as Exhibit B ) which shall be applicable to all purchases of Product hereunder.

 

1.10          Shipping, Handling and Storage . BRP agrees that it will comply with all rules and regulations of every governmental authority having jurisdiction over the shipping, handling, storage, distribution, and dispensing of Product and that it will conform to all labeled specifications concerning its shipping, handling and storage. BRP represents and warrants that all facilities to which Product will be shipped are licensed to handle such product in accordance with all applicable state and federal requirements. BRP shall not repackage, obscure or otherwise alter the original container of the Product. BRP will submit written documentation of state licensing to Hemispherx promptly following execution of this Agreement.  

 

2.0 BRP Service Requirements

 

2.1         Resale in the Territory/Resale Efforts. BRP agrees to use reasonable efforts to sell and promote the Product in the Territory, as defined in Exhibit D, and will not take any action inconsistent with such obligation.

 

2.2         Provide Data and Information. Hemispherx requires certain data and information to verify Product inventories and BRP’s timely performance of services and for purposes of evaluating Hemispherx’s sales force activity and productivity. BRP agrees to supply daily (prior to 6 pm EST) EDI 852 inventory reports and weekly (prior to 6 pm EST each Monday) EDI 867 reports. The specifications for each of these reports are included in Exhibit C . Hemispherx agrees to cooperate with BRP with respect to BRP's reporting obligations as reasonably requested by BRP to meet its obligations under this Section 2.2. In the event BRP, due to pre-existing agreement with its customer, is unable to provide any of the data required by this Section 2.2, BRP will so notify Hemispherx and identify the customer whose data BRP cannot provide.

 

2.3         Adverse Experiences Reports. BRP agrees to provide written reports of adverse events reported to it. If BRP learns, or is advised of any serious and unexpected side effects, as defined in FDA regulations (21CFR314.80), BRP is to immediately notify the Hemispherx Drug Safety Department at within twenty-four (24) hours of receiving such of learning of such adverse event.

 

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2.4         Lapse in Licensure . BRP shall notify Hemispherx within ten (10) business days of its termination, suspension, revocation, forfeiture or non-renewal of any license required for BRP to comply with its obligations under this Agreement.

 

2.5         Contract Administration . BRP shall administer Hemispherx contracts with BRP’s customers in accordance with the following requirements:

 

Recognize and administer contracts (including amendments to same) between Hemispherx and customers of BRP within two (2) days of receipt of notice from Hemispherx. Contracts may be direct with such customers, or indirect through Participating Pharmacies under the Armada Health Care Group Purchasing Organization Agreement in effect between Armada Health Care and Hemispherx (“GPO Agreement”). Participating Pharmacies are defined as those ARMADA member facilities that fall within the approved Class of Trade as defined in Exhibit B of the GPO Agreement, have agreed to the terms as detailed in Exhibit A of the GPO Agreement, and that have been qualified by Armada and ultimately approved by Hemispherx. BRP also agrees, upon notice from Hemispherx, to recognize and administer special pricing offers (“blanket offers”) made to, and accepted by, customers of BRP within particular classes of trade even if there is no formal written agreement between Hemispherx and such customer. The requirements of the preceding sentence shall apply regardless of whether or not the customer is a member of a GPO and regardless of whether or not Hemispherx has, or does not have, an agreement covering such pricing offer with the customer’s GPO. Nothing in this section will limit the distribution of Product by BRP to any entity (doctor, clinic, pharmacy, etc) that may want to purchase Product at the then current WAC price. These entities may be identified by Hemispherx, BRP or may include those entities that call either Hemispherx or BRP to source product.

 

2.6         GPO Member Lists . BRP shall provide Hemispherx with a membership list updated quarterly containing the following information:

 

- Full legal name of member organization
- Address
- Number of Covered Lives
- Formulary Type
- Start Date and Termination Date
- DEA#
- HIN ID#

 

2.7         Monitor Buying Patterns . Monitor buying patterns of its customers to help identify and prevent to the best of its ability speculative buying patterns or buying patterns from customers that are greater than 15% above normal and customary monthly demand, and limit purchases when appropriate.

 

2.8         Notify of Anticipated Increases in Buying . To the extent such information is otherwise publicly available, provide no less than four (4) weeks advance notice to Hemispherx in the event it anticipates any event which will cause a change in excess of 20% in BRP’s ordering pattern (e.g., acquisition or loss of a significant customer).

 

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2.9         No diversion of Product . BRP will not divert Product or knowingly purchase and resell Diverted Product. Diverted Product shall include (i) Product that has been manufactured by Hemispherx but is expired, defective, or out of specification and diverted from planned destruction, (ii) Product that has been stolen, (iii) Product packaged in other than a standard sized or unit of measure currently offered by Hemispherx’s United States Business Unit and clearly so indicated on the packaging, (iv) Product sold at a discount to a specific channel of distribution (i.e., managed care, GPO member, 340B/PHS covered entity, etc.) that is resold outside the authorized channel of distribution, and (v) Product originally intended for sale in any country other than the United States.

 

2.10          Subcontractors . Notwithstanding anything herein to the contrary, BRP may enter into a Drug Distribution Agreement between BRP and Smith Medical Partners, LLC, (“Smith Medical”) or another third party subcontractor, to perform certain services set forth in this Agreement with respect to Product. BRP agrees that it remains responsible to Hemispherx for the performance of all such services as required by the terms and conditions set forth in this Agreement, including but not limited to the Representations and Warranties set forth in Section 6.0.

 

3.0 Service Fees. In exchange for services provided as specified in this Agreement, specifically section 2.0 and Exhibit D, Hemispherx agrees to pay BRP service fees depicted below (the "Service Fee"). The Service Fee shall be calculated and credited against BRP's account quarterly by Hemispherx within sixty (60) days. Quarterly payments will are based on actual purchases total purchases made by BRP from Hemispherx as defined in Section 3.2 below.

 

3.1         Service Fee Schedule: Storage and Call Center fees related to Products are to commence on the day of Product receipt and pro-rated for the month if not received on the first day of the month.

 

ALFERON-N
Storage* and Call Center   $1,750 per month except when the Distribution Fee paid to BRP exceeds  $225,000 in any given year
   
Exclusive Distribution Fee    
Annual Purchases $0 through  $3,000,000 6.0% of sales
Annual Purchases $3,000,001  > $100,000,000 3.3% of sales
Annual Purchases > $100,000,001 1.4% of sales

 

AMPLIGEN
Storage* and Call Center $1,750 per month

 

3.2         Calculation of Percentage. Hemispherx will pay BRP 6.0% (six) on all total sales up to the first $3,000,000 (three million dollars) from Hemispherx to BRP in a calendar year. In addition to the 6.0% on the first $3,000,000, Hemispherx will pay BRP 3.3% on all total sales up to the next $97,000,000 (ninety seven million dollars) from Hemispherx to BRP in a calendar year. In addition to payment on the first $100,000,000 detailed above, Hemispherx will pay 1.4% on all total sales over $100,000,000 (one hundred million dollars) from Hemispherx to BRP in a calendar year. Total sales are defined as all purchases made by BRP from Hemispherx at the wholesaler acquisition price (WAC) in effect at the time of ordering.

 

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3.3         Restrictions on Use of Service Fee Payments . BRP agrees that no payment of service fees made pursuant to this Agreement will be passed in whole or in part, directly or indirectly, to any customer or client or affiliate of BRP. Any payments for services provided pursuant to this Agreement are intended solely for payment of the services provided and do not reflect a discount on the purchase price of the Product and shall not be used in such a manner, directly or indirectly.

 

3.4         Exceptions to Exclusivity . BRP will, from time to time be requested to ship Ampligen and/or Alferon N to Hemispherx’s Manufacturing Facility & Development Center located at 783 Jersey Avenue, New Brunswick, NJ 08901. Hemispherx shall pay all standard charges for freight, insurance, fees, and all other packing and shipping charges related to delivery of Ampligen and/or Alferon N under this section to Hemispherx by BRP. Of such product, Ampligen will be provided to study sites in the US under Hemispherx AMP 511 study and for countries outside the Territory and Alferon N for countries outside the Territory, neither of which will be in violation of the exclusivity provision of this agreement and will not carry any Distribution Fee.

 

4.0 Accounting For and Reporting Prices and Fees .

 

4.1        BRP agrees that, if it should have an obligation on behalf of itself or on behalf of any of its customers, to report discounts earned under this Agreement in compliance with applicable federal, state or local laws, including but not limited to the Medicare and Medicaid laws, it will fully and accurately account for, and report the total value of such discounts in a way that complies with all such laws.

 

4.2        BRP agrees to provide, upon request of a representative of the U.S. Secretary of Health and Human Services, a State Medicaid agency or any other federally funded health care program, all information concerning the prices paid and fees earned under this Agreement.

 

4.3        If BRP has contractual relationships with any customers requiring disclosure of prices paid and fees earned under agreements such as this, BRP agrees that it will disclose such information in such detail as is required by such agreements and by any applicable law or regulation.

 

5.0 Recordkeeping, Audits and Inspections.

 

5.1        BRP agrees that during the Term of this Agreement (as defined below) and for a period of two (2) years after its expiration or termination, BRP shall keep and maintain all records related to its purchases and services under this Agreement, including, without limitation, with respect to its disposition of Product. BRP shall, upon receipt of a written request from Hemispherx, furnish such records and information in a format reasonably acceptable to Hemispherx within thirty (30) days of receipt of such request. This requirement is independent and does not in any way limit the requirement to supply information pursuant to Sections 2 and 3.

 

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5.2        BRP agrees to permit Hemispherx or its agents to conduct periodic audits of the relevant books and records relating to BRP's compliance with the terms of this Agreement, including, without limitation, records related to prescriptions received for the Product written and the dispensing of the Product. Any audits shall be at Hemispherx's expense and shall be conducted upon reasonable advance notice during regular business hours at BRP's principal office and in such manner as not to unduly interfere with BRP's operations.

 

5.3        For purposes of insuring compliance with the terms of this Agreement, Hemispherx may request that BRP provide to Hemispherx, within thirty (30) days after written request, a certification of compliance from a senior officer or executive with financial oversight responsibility for BRP attesting to BRP's compliance with the terms of this Agreement.

 

5.4        Hemispherx agrees that all inspections and audits shall be subject to the requirements of and shall be in compliance with all state and federal laws regarding the confidentiality of medical and prescription records, including, without limitation, HIPAA.

 

6.0 Representations and Warranties .

 

6.1 Representations and Warranties of Hemispherx .

 

6.1.1 Hemispherx hereby represents and warrants to BRP that:

 

6.1.1.1 Each shipment of Product delivered pursuant to this Agreement shall be of merchantable quality; and

 

6.1.1.2 Each shipment of Product shall not, on the date of shipment by Hemispherx, be adulterated or misbranded within the meaning of the Federal Food, Drug and Cosmetic Act or within the meaning of any state or local law as to which the definitions of "misbranding" or "adulteration" are substantially the same as those contained in the Federal Act, as such laws are in effect on the date of such shipment.

 

6.1.1.3 Each warranty set forth in this Section 6.1 is in lieu of all other warranties, express or implied, and Hemispherx expressly disclaims any and all other warranties including, without limitation, any warranty of merchantability or fitness for any particular purpose. Hemispherx makes no warranty whatsoever, express or implied, and assumes no liability to BRP or anyone else in respect of: (i) the purity, standards or other characteristics of Product if its immediate container has been opened by BRP or anyone else after shipment by Hemispherx other than immediately prior to its use; (ii) the continued availability of Product; or (iii) the use of Product other than as specified its prescribing information.

 

6.2 Representations and Warranties of BRP .

 

6.2.1 BRP hereby represents and warrants to BRP that:

 

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6.2.1.1 BRP has, and at all times during the term of this Agreement will maintain, all governmental licenses, permits and approvals required to market, promote, distribute, offer for sale and sell the Product in the Territory and to conduct all other activities under this Agreement;

 

6.2.1.2 BRP will at all times during the term of this Agreement maintain the highest standards of quality to protect the integrity of the Product;

 

6.2.1.3 BRP does not, and during the time of this Agreement will not (1) employ an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) ("Debarred Individual") to provide services in any capacity to a person that has an approved or pending drug product application, or an employer, employee or partner of such a Debarred Individual or, (2) utilize a corporation, partnership or association that has been debarred by FDA pursuant to 21 U.SC. § 335(a) or (b) ("Debarred Entity") from submitting or assisting in the submission of a drug application, or an employee, partner, shareholder, member, subsidiary, or Affiliate of a Debarred Entity. BRP further warrants and presents that it has no knowledge of any circumstances which may affect the accuracy of the foregoing representations, including, without limitation, knowledge of any FDA investigations of, or debarment proceedings against, BRP or any person or entity performing services or rendering assistance which is in any way related to activities taken pursuant to this Agreement, at any time during the Term, becomes aware of any such circumstances; and

 

6.2.1.4 BRP does not, and during the time of this Agreement will not employ an individual who has been or is at such time included in the List of Excluded Individuals/Entities or in the List of Parties Excluded from Federal Procurement and Nonprocurement Programs.

 

7.0 Indemnification .

 

7.1        BRP shall be solely responsible for, and agrees to defend, indemnify, and hold harmless Hemispherx and its affiliates, shareholders, directors, officers and employees (indemnitees) from and against any and all claims, causes of action, obligations, liability, liens, indebtedness, debts, judgments, damages (exclusive of lost profits) losses, costs, expenses, and fees (including, without limitation, reasonable attorneys fees) to the extent arising from or related to breach or default under any representation, warranty, covenant, obligation or promise made by BRP or an affiliate of BRP, provided, however, that BRP shall not be obligated to defend, indemnify, or hold harmless any intended indemnitee from claims to the extent such claims result from that intended indemnitee’s willful, wanton or negligent act or omission or from that indemnitee’s breach of the terms of this Agreement. This indemnity is conditioned upon the intended indemnitee's giving prompt notice to BRP of any claim which may be covered by this indemnity, permitting BRP to handle such claim as it determines most appropriate, cooperating fully with BRP in its handling of such claim, and not making or offering to make any settlement of such claim without the prior written consent of BRP. IN NO EVENT WILL BRP BE LIABLE FOR INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES OR LOST PROFITS.

 

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7.2        Hemispherx shall be solely responsible for and agrees to defend, indemnify, and hold harmless BRP and its affiliates, shareholders, directors, officers and employees (including Smith Medical or any other third party contractor, in the event that that BRP enters into a Drug Distribution Agreement with Smith Medical or any other third party subcontractor, as set forth in Section 2.10, (“Indemnitees”) from and against any and all claims, causes of action, obligations, liability, liens, indebtedness, debts, judgments, damages (exclusive of lost profits) losses, costs, expenses, and fees (including, without limitation, reasonable attorneys fees) to the extent arising from or related to breach or default under any representation, warranty, covenant, obligation or promise made by Hemispherx or a Hemispherx affiliate, provided, however, that Hemispherx shall not be obligated to defend, indemnify, or hold harmless any intended Indemnitee from claims arising out of the willful, wanton or negligent act or omission of an Indemnitee (including, for purposes of this indemnity, the use of Product outside its labeled indications) or from an Indemnitee’s breach of the terms of this Agreement (or, in the case of Smith Medical or any other third party subcontractor, a breach of the terms of its Drug Distribution Agreement with BRP, if such agreement is executed). This indemnity is conditioned upon the Indemnitee giving prompt notice to Hemispherx of any claim which may be covered by this indemnity, permitting Hemispherx to handle such claim as it determines most appropriate, cooperating fully with Hemispherx in its handling of such claim, and not making or offering to make any settlement of such claim without the prior written consent of Hemispherx. IN NO EVENT WILL HEMISPHERX BE LIABLE FOR INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES OR LOST PROFITS.

 

7.3        Additionally, Hemispherx shall be solely responsible for and agrees to defend, indemnify, and hold harmless BRP and its affiliates, shareholders, directors, officers and employees (including Smith Medical or any other third party subcontractor, in the event that that BRP enters into a Drug Distribution Agreement with Smith Medical or any other third party contractor, as set forth in Section 2.10, (“Indemnitees”) from and against any and all claims, causes of action, obligations, liability, liens, indebtedness, debts, judgments, damages (exclusive of lost profits), losses, costs, expenses, and fees (including, without limitation, reasonable attorneys fees) to the extent arising, directly or indirectly, out of (i) any claim that Hemispherx has violated Applicable Laws or that Products made, sold, supplied, or delivered by or on behalf of Hemispherx may be alleged or determined to be adulterated, misbranded or otherwise not in full compliance with or in contravention of applicable laws at the time of shipment or delivery hereunder, (ii) any claim that the design, manufacture or packaging of any Product is defective or improper in any manner or not suited for the purposes for which such Product is intended, (iii) any claim that any Product infringes any proprietary or intellectual property rights of any person, including infringement of any trademarks or service names, trade names, trade secrets, inventions, patents or violation of any copyright laws or any other applicable federal, state or local laws, and (iv) any claim of negligence, strict product liability, willful misconduct or breach of this Agreement by Hemispherx, provided, however, that Hemispherx shall not be obligated to defend, indemnify, or hold harmless any intended Indemnitee from claims arising out of a grossly negligent act or omission of an Indemnitee (including, for purposes of this indemnity, the distribution by an Indemnitee of Product outside its labeled indications) or from an Indemnitee’s breach of the terms of this Agreement (or, in the case of Smith Medical or any other third party subcontractor, a breach of the terms of its Drug Distribution Agreement with BRP, if such agreement is executed).

 

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7.4        In the case of Smith Medical or any other third party subcontractor, any indemnity set forth herein shall be further limited to the extent claims, causes of action, obligations, liability, liens, indebtedness, debts, judgments, damages (exclusive of lost profits), losses, costs, expenses, and fees (including, without limitation, reasonable attorneys fees) to the extent arise, directly or indirectly, from Smith Medical’s or any other third party subcontractor ‘s performance of services related to Product pursuant to its Drug Distribution Agreement with BRP.

 

8.0 Term and Termination of Agreement

 

8.1        The term of this Agreement shall begin on the Effective Date and shall expire one (1) year thereafter unless earlier terminated in accordance with this Agreement (the "Term"). The Term may be extended upon the mutual written agreement of the parties.

 

8.2        Either party may terminate this Agreement upon the occurrence of a material breach by the other party, which material breach has not been cured within thirty (30) days after receipt of written notice thereof by the breached party from the other.

 

8.3        This Agreement may be terminated by either party without cause upon not less than sixty (60) days' prior written notice to the other party.

 

8.4        The termination or expiration of this Agreement shall not affect the rights and obligations of the parties accruing prior to the effective date of termination. Provisions concerning record keeping and audits, confidentiality, indemnity and governing law shall survive for seven (7) years following the effective date of termination. In addition, BRP shall remain liable for any unpaid invoices.

 

8.5        BRP agrees that, in the event of early termination, Hemispherx shall not be liable to BRP for any compensation other than what has properly been earned for services provided during the Term, which will be prorated to the extent such termination is effective within a quarter.

 

8.6        Notwithstanding anything in this Agreement to the contrary, Hemispherx reserves the right to discontinue the manufacture, sale and/or distribution of Product in its sole discretion. Hemispherx will not, in the event of Product discontinuance, accept responsibility for any cost or expenses which BRP may have to pay to acquire substitute product(s) from other vendors. This provision will prevail over any contrary language contained in bid requests, solicitations, invitations to bid and similar documents.

 

8.7        Upon the expiration or termination of this Agreement, BRP agrees to (i) transfer all Product accounts maintained by BRP to an entity designated by Hemispherx, and (ii) to cooperate in good faith in any and all such efforts by Hemispherx to ensure an orderly transition of such customers. Hemispherx agrees to reimburse BRP for its reasonable out of pocket costs incurred by BRP which are directly attributable to BRP's compliance with this Section 8.7, to the extent such costs are approved in writing by Hemispherx in advance.

 

10

 

 

9.0 General Provisions

 

9.1         Affiliate Defined . For purposes of this Agreement, the term "BRP" and “Hemispherx” shall include affiliates of BRP and affiliates of Hemispherx respectively. "Affiliate" shall mean any individual, corporation or other business entity which, directly or indirectly, controls a party, is controlled by a party, or is under common control with a party. "Control" shall mean possession of the power to direct, or cause the direction of the management and policies of a corporation or other entity whether through the ownership of voting securities, by contract or otherwise.

 

9.2         Legal Action . Each party will promptly notify the other of any legal or regulatory action or threatened action arising in connection with this Agreement.

 

9.3         Entire Agreement/Waiver . This Agreement constitutes the entire understanding between the parties with respect to its subject matter and supersedes all prior and contemporaneous understandings and agreements. The terms and conditions of this Agreement may not be waived, modified or amended in any way by conduct, custom or course of dealing; instead, they may be waived only by a written document signed by both parties. The waiver by a party of any term or condition of this Agreement shall not be deemed to be a waiver of any subsequent breach by the other party of the same term or condition or any other term or condition hereof. The subsequent acceptance of performance by a party of any breached term or condition of this Agreement shall not be deemed to be a waiver of any preceding breach by the other party of the same term or condition or any other term or condition of this Agreement, regardless of whether the accepting party knew or did not know of the preceding breach at the time of acceptance of such performance.

 

9.4         Notices . All notices to be given hereunder shall be in writing, addressed to the attention of the president of the party being notified, and shall be deemed duly given when mailed by certified mail, return receipt requested, postage prepaid, or by recognized overnight courier service, to the address below.

 

To Hemispherx:

Hemispherx Biopharma, Inc.

One Penn Center

1617 JFK Boulevard, Suite 660

Philadelphia, PA 19103

Attention: William A. Carter, M.D.

 

To BRP:

Bio Ridge Pharma, LLC.

100 Campus Drive Suite 102

Florham Park, NJ 07932

 

9.5         Force Majeure . Noncompliance with the obligations hereunder for reasons of Force Majeure shall not constitute a breach of any terms or conditions hereunder, but shall relieve the parties of the obligations of this Agreement for as long as the Force Majeure remains, without extending its Term. For purposes of this Agreement, Force Majeure shall be defined as: laws or regulations or acts of any government or agency thereof; judicial action; inability of a third-party manufacturer to supply; acts of God; war, terrorism, or civil commotion; destruction of production facilities and/or materials; fire; flood; explosions; earthquake or storm; labor disturbances; any health reform legislation which materially alters the commercial benefit of this Agreement; failure of public utilities or common carrier; or any other causes beyond the reasonable control of the parties.

 

11

 

  

9.6         Amendments . Except as explicitly provided herein, no changes, amendments, or alterations to this Agreement shall be effective unless in writing and signed by a duly authorized representative of Hemispherx and BRP.

 

9.7         Independent Contractor . BRP acknowledges that, in entering this Agreement, it is acting as an independent contractor and that it does not have the right to, and will not at any time, transact any business in the name of Hemispherx or obligate it in any manner, character or description, and Hemispherx shall not, under any circumstances unless prior written consent has been given, be liable for any agreement, contract, representation or warranty, which the BRP may hereafter enter into or make.

 

9.8         Confidentiality . Each party agrees to maintain the confidentiality of any proprietary or confidential information (“Confidential Information”) of the other to which it has gained access during the performance of this Agreement. Confidential Information may not be used or disclosed to any third party (other than a party’s affiliates, employees, officers, directors or other authorized representatives) except with the prior written consent of the party whose information is being disclosed. Each party shall use the same care to prevent disclosure, publication, or dissemination of such Confidential Information as is used to protect its own confidential information, but not less than reasonable care. Confidential Information shall not include any information which is (i) already lawfully known to, or independently developed by, or for, a party, (ii) disclosed in lawfully published materials, (iii) generally known to the public through no fault of the party receiving the Confidential Information, or (iv) lawfully obtained from any third party having a right to disclose. A party may also disclose Confidential Information as required by law, provided however, that in anticipation of such required disclosure, the disclosing party shall give maximum practical advance notice to the other and, at the other’s expense, cooperate with the other’s efforts to request confidential treatment of such Confidential Information by the recipient to the extent afforded by law. Customer agrees not to disclose any of the terms and conditions of this Agreement to any third party, other than Customer’s affiliates, employees, officers, directors or other authorized representatives who have a need to know such information. Confidential Information shall not include information orally disclosed unless such Information is promptly reduced to writing with a copy (marked “Confidential”) delivered to the party charged with maintaining its secrecy.

 

9.9         Trademarks . BRP agrees that Hemispherx is the owner, and is entitled to the exclusive use, of each and every trade name and trademark which it now possesses, is now using, or may hereafter use and/or which Hemispherx or its agent or an affiliate has heretofore registered, or may hereafter register, in the United States or any foreign country and that BRP will not derive any legal right to any of Hemispherx’s trade names or trademarks and will not now or at any time hereafter use, register, or attempt to use or register such trade names or trademarks, except as expressly authorized in writing by Hemispherx. No right is granted to BRP to use any trade name or trademark of Hemispherx in connection with BRP’s business. In the event that BRP wishes to create any material, other than materials used in the ordinary course of its business, using any trade name or trademark of Hemispherx, such material shall be forwarded to Hemispherx in advance of such use for approval by Hemispherx.

 

12

 

  

9.10          Assignment . This Agreement and the rights and obligations hereunder may not be assigned or transferred by either party without the prior written consent of the other party; provided, however, that Hemispherx may assign this Agreement without BRP's consent to an Affiliate of Hemispherx or in connection with the merger, consolidation or sale of all or substantially all of its assets.

 

9.11          Disputes . If a dispute arises between the parties under this Agreement, the parties agree that, prior to either pursuing other available remedies, decision-making individuals from each party will promptly meet, either in person or by telephone, to attempt in good faith to negotiate a resolution of the dispute. If, within sixty days after such meeting, the parties are unable to resolve the dispute (or such longer time as the parties may agree) either party is free to pursue its legal remedies.

 

9.12          Insurance . BRP agrees that it shall maintain comprehensive general liability insurance in an amount not less than $3,000,000.00 United States Dollars ($3 Million USD) per person and per occurrence, 5,000,000.00 United States Dollars ($5 Million USD) in the aggregate for physical injury and property damage. Hemispherx agrees that it shall maintain comprehensive general liability insurance in an amount not less than 3,000,000.00 United States Dollars ($3 Million USD) per person and per occurrence, 3,000,000.00 United States Dollars ($3 Million USD) in the aggregate for physical injury and property damage. Hemispherx agrees that it shall maintain comprehensive product liability insurance in an amount not less than 5,000,000.00 United States Dollars ($5 Million USD) per person and per occurrence, 5,000,000.00 United States Dollars ($5 Million USD) in the aggregate for physical injury and property damage. Each party shall provide proof of such insurance if requested by the other party.

 

9.13          Governing Law and Jurisdiction . The validity, interpretation and performance of this Agreement shall be governed by and construed in accordance with the laws of the State of New Jersey without regard to the principles of conflicts of law. All actions arising under this Agreement shall be brought in a court of competent subject matter jurisdiction in the State of Connecticut and both parties agree to accept the personal jurisdiction of such court. IN ANY CONTROVERSY OR CLAIM, WHETHER BASED IN CONTRACT, TORT OR OTHER LEGAL THEORY, ARISING OUT OF OR RELATING TO THIS AGREEMENT, ITS ENFORCEABILITY OR VALIDITY, OR THE PERFORMANCE OR BREACH THEREOF OR THE RELATIONSHIPS ESTABLISHED THEREUNDER, ALL PARTIES HEREBY IRREVOCABLY WAIVE THEIR RIGHT TO TRIAL BY JURY.

 

9.14          Effect of Invalidity of any Provision . If any provision(s) of this Agreement shall be held to be invalid, illegal, or unenforceable, the validity, legality and enforceability of the remaining provisions hereof shall not in any way be impaired thereby, and such remaining provisions shall continue to be valid, binding and enforceable, only so long as the intent of the parties can be achieved. Otherwise, this Agreement shall terminate.

 

13

 

 

9.15          Compliance with Laws . Hemispherx and BRP each agree that they will separately be responsible for securing and maintaining all required licenses, permits and certificates applicable to their respective operations and each shall comply with any and all applicable federal, state and local laws, and regulations adopted there under, including but not limited to, (i) the Federal Food Drug and Cosmetic Act, (ii) the Social Security Act; (iii) HIPAA, (iv) all federal and state health care anti-fraud and abuse laws, and (v) all state privacy, and consumer protection laws, including those relating to the use of medical and prescription information for commercial purposes.

 

IN WITNESS WHEREOF, the parties have hereunto set the signatures of their authorized representatives.

 

Bio Ridge Pharma, LLC   Hemispherx Biopharma, Inc.
100 Campus Drive Suite 102   One Penn Center
Florham Park, NJ 07932   1617 JFK Boulevard, Suite 660
Philadelphia, PA 19103    
     
By:     By:  
Printed Name: Lawrence S. Irene, R.Ph.   Printed Name: William A. Carter, M.D.
Title; CEO   Title: Chairman and CEO
         

 

14

 

 

List of Exhibits

 

Exhibit A – Price and Payment Terms

Exhibit B – Product Return Goods Policy

Exhibit C – 852 and 867 Data Requirements

Exhibit D - Services

15

 

 

Exhibit A

 

Price and Payment Terms

 

Price

 

Product is available at wholesale list price (Wholesale Acquisition Cost or WAC) current at the time of order placement.

 

Payment Terms

 

2 % 30, net 31

 

16

 

 

Exhibit B

 

Hemispherx Returned Goods Policy

 

This Return Goods Policy is for all Hemispherx products, Alferon N® and Ampligen®, distributed by Bio Ridge Pharma, Inc.

 

The following products are eligible for return and reimbursement:

 

· Out dated product: Product within two (2) months prior or six (6) months past expiration date noted on product;
AND

 

· Product in its original container and bearing its original label.
OR

 

· Product which Hemispherx has specified be returned

 

The following products are not eligible for return and reimbursement:

 

· Product that is not out-dated.

 

· Product in which the lot number and/or expiration date is missing, illegible, covered, and/or unreadable on original container.

 

· Product that has been damaged due to improper storage or handling, fire, flood, or catastrophe.

 

· Product that has been sold expressly on a non-returnable basis.

 

· Product that is not in its original container and/or not bearing its original label.

 

· Product that is in its original container with a prescription label attached.

 

· Product that has been repackaged

 

· Partial vials..

 

· Product obtained illegally or via diverted means.

 

· Product purchased on the "secondary source" market or from a distributor other than BioRidge. .

 

· Product that Hemispherx determines, in its sole discretion, is otherwise adulterated, misbranded, or counterfeit.

 

Hemispherx will only accept returns shipped to BioRidge Pharma. All eligible products shall be shipped in a safe, secure, and reliable manner, and in compliance with all applicable federal, state and local laws, regulations and statutes. It is the shipper's responsibility to securely package all return goods to prevent breakage during transit and otherwise comply with laws and regulations applicable to the packaging, shipping and transport of return goods shipments. Hemispherx is not responsible for shipments lost and/or damaged in transit. Hemispherx recommends that all customers insure return goods shipments.

 

17

 

  

Hemispherx will audit the quantities of return goods and final reimbursement will be based on Hemispherx count. All products will be reimbursed based on the priced paid. Direct purchasing customers reimbursement will be issued in the form of a credit or product replacement to the appropriate party.

 

To assist in accurate credit memo processing, please include the following information with the return goods shipment:

 

1. Purchaser ‘s name and mailing address.

 

2. Date and quantity purchased

 

Return goods shipments which are deemed to be outside of this policy will not be returned to the customer or the third party processor and no reimbursement will be issued by Hemispherx. Hemispherx return goods policy is subject to change at any time and without prior notice to other parties.

 

18

 

 

Exhibit C

 

852 and 867 Data Requirements

 

Data Elements of EDI 852 File Type

 

Data Element   Description
Account identifier   Unique identifier to Authorized Distributor.  DUNN’s number.
Account Name   Constant alpha name for Authorized Distributor.  This should be the “sold to” name of the account.
Distribution location identifier   Unique identifier of each “sold from” location or “Distribution Center” – should be the location’s DEA number
Product Activity Date (Header)   Include start and end date.  YYYYMMDD for both.
Product NDC   National Drug Code (eleven digit) no hyphenation – include leading zeros where applicable.
Product Activity Date (Detail)   Date product shipped.
Product Description   Product name/Description of Product in Authorized Distributor’s system that corresponds to the NDC referenced above.  Include brand name, strength, form, and size/unit of measure.
Quantity On Hand   Total vials on hand per distribution location including, but not limited to quantity available for sale to all Providers plus quantity committed, plus quantity held, plus quantity allocated at the end period of Product Activity Date, and any other vials physically on hand within a Distribution Center excluding only the products deemed unsaleable by some sort of damage or expired dating of the Product. All saleable product owned by Wholesaler.
Quantity On Order   Total vials on hand per distribution location including, but not limited to quantity on order from manufacturer or Product awaiting receipt from another Distribution Center at the end period of Product Activity Date.  This includes inter-Distribution Center transfers and any other Product orders expected to be received into the Distribution Center regardless of the source.
Quantity Sold   Total vials shipped for 100% of Customers during Product Activity Date
Quantity Demanded   Total vials ordered/demanded/ requested for 100% of Customers during Product Activity Date
Total Quantity Shorted   Total vials shorted for 100% of Customers.  Ordered/demanded, but not able to fill within 24 hours of the date ordered/demanded.
Quantity shorted manufacturer supply issue   As a subset of Total Quantity Shorted, quantity shorted due to a manufacturer backorder or allocation issue.  Quantity shorted ordered/demanded, but not able to be filled within 24 hours of the date ordered/demanded specific to each specific “sold to” Customer due to manufacturer supply issue.
Quantity Transferred   Total vials transferred during Product Activity Date for 100% of Distribution Centers.  Transfers should be inter-Distribution Center transfers only.  All other Product movement should be recorded as a Product sale or withdrawal.
Quantity Withdrawn   Total vials withdrawn from inventory during the Product Activity Date.
Quantity Withdrawn (unsaleable goods)   The subset of Quantity Withdrawn from inventory during the Product Activity Date because Product is deemed unsaleable and sent to distributor morgue.
Quantity Held (QH)   All product held from reported inventory
Quantity Committed (QC)   Product in reported inventory and committed for sale
Quantity Shorted (LS)   Quantity shorted due to Hemispherx supply issues.
Total Quantity Shorted (QO)   Quantity shorted other than Hemispherx supply issue.
Quantity Damaged (QD)   Product removed from inventory due to unsaleablity.

 

19

 

 

Data Elements of EDI 867 File Type

 

 

Data Element   Description
Account identifier   Unique identifier to Authorized Distributor.  DUNN’s number.
Account Name   Constant alpha name for Authorized Distributor.  This should be the “sold from” name of the account.
Distribution location identifier   Unique identifier of each “sold from” location or “Distribution Center” – should be the location’s DEA number
Invoice Date   Include date of transfer.  YYYYMMDD
Product National Drug Code (NDC)   National Drug Code (eleven digit) no hyphenation – include leading zeros where applicable.
Customer City    
Invoice number  (DI)   Invoice # to the end customer
Unit of measure    
Contract number (CT)    
Quantity   All product movement including sales, inter-company, intra-company transfers and returns
Product Transferred Type   Code identifying type of product transfer
Customer Name   Location name “xyz pharmacy”
Customer DEA   DEA of that Customer
Customer HIN   HIN of that Customer (where applicable)
Customer Address   Physical shipping address of the Customer that coincides with the Customer pharmacy license.
Customer Address 2   Additional Physical shipping address of the Customer that coincides with the Customer pharmacy license.  Suite, building, etc.
Customer state    
Customer zip code    

 

20

 

 

Exhibit D

 

Services

 

I. SERVICES:

 

1. WAREHOUSEING
a. Per Section 1.11

 

2. RECEIVING
a. Per Section 1.8

 

3. DISTRIBUTION
a. Per Section 1.11

 

4. CUSTOMER SERVICE
a. BioRidge will employ the following resources sufficiently dedicated to the sale and service of Alferon-N:
  i. Professional order management telephonic sales representatives. These people will process orders, track order rates, order lapses etc., in an effort to maintain pharmacy focus and ordering of Alferon.
 ii. Making monthly contact with purchasers/pharmacies via telephonic means, to discuss patient specific ordering including the timing or refill orders in their usual reports
iii. Accounting personnel to perform accounts receivable, inventory monitoring , sales reporting and tracking
b. BioRidge will provide adequate personnel to handle a dedicated inbound phone line (or lines) for Hemispherx's customers to phone in purchase orders, for inquiries, and for general information.
c. BioRidge will staff the Hemispherx Customer Service inbound phone line during normal business hours, Monday through Friday, except for the following holidays (subject to change).: Christmas Day, New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day
d. BioRidge will be responsible for the training of the customer service representative and backup representative(s). Hemispherx will provide company and product specific information for training of customer service representatives assigned to Hemispherx.
e. BioRidge will be responsible for initial set up and on-going maintenance of customer master files.
f. BioRidge will accept customer orders by electronic data interchange (EDI), phone or fax.
g. BioRidge will use commercially reasonable efforts to answer inbound phone calls within the first thirty (30) seconds, and enter orders accurately
h. As a backup to the customer service representatives, a voice mail system will be maintained to accept telephone orders and to collect messages from customers.
i. Providing access to, during normal business hours, to sales associates to address appropriate inquires from Hemispherx in support of Alferon-N . Sales associates answer Hemispherx questions
j. Providing access to information related to the purchase history of the Alferon-N customers as well as all relevant transaction related information that provides reasonable sales forecasting data.

 

21

 

 

5. ORDER ENTRY
a. Hemispherx will determine minimum order and order line quantity and BioRidge will enter orders accordingly. This will be determined prior to launch and will initially be in line with Hemispherx anticipated launch forecast and initial demand estimates. Beyond launch a weekly average will be established that will be maintained in inventory by BioRidge to meet market demand.
b. Hemispherx will instruct its customers and trading partners to place orders based on the Hemispherx's Distribution Agreement.
c. Hemispherx will determine what customers shall pay for premium freight, special handling, and emergency order processing.
d. BioRidge will use commercially reasonable effort to enter orders accurately. BioRidge measures the accuracy of orders entered and will report this attribute periodically.

 

6. CUSTOMER CREDIT
a. BioRidge will establish credit limits for each customer or groups of customers.
b. BioRidge’s system will monitor orders and outstanding account receivable against the customer's credit limit and hold orders where credit limits are exceeded.
c. BioRidge may elect to place a customer's account on credit hold so that all orders are reviewed prior to shipment.
d. BioRidge will review and approve all customer orders held for credit limits prior to shipment and will notify Hemispherx of those customers whose orders are being held.

 

7. PRICING AND TERMS
a. BioRidge will perform system maintenance of pricing and terms. Hemispherx will provide to BioRidge in writing any changes to prices or terms. BioRidge will be responsible for updating the BioRidge system within 48 hours of receipt of such notice or as Hemispherx may otherwise instruct.
b. BioRidge employees are bound by the confidentiality provisions of the Agreement between BioRidge and Hemispherx and, as such, shall not disclose Hemispherx sales data or pricing information outside the specific Hemispherx employees who have a need to know of this information in the course of performing their routine job responsibilities.

 

8. INVOICING
a. BioRidge Customer Service will use commercially reasonable efforts to mail invoices the morning following shipment of product, or transmit by electronic data interchange (EDI), where installed, the same day of shipment of product, to customer's billing address.
b. For any order shipped after the close of business, the invoice will be prepared and mailed the following business day.
c. BioRidge will make its best effort to process invoices as timely and accurately as possible.

 

9. RECALL ASSISTANCE
a. See Section 1.19

 

10. SYSTEMS
a. Hemispherx retains ownership to all data in the BioRidge system related to Hemispherx’s business.
b. BioRidge will maintain security of the Hemispherx's data in files segregated and inaccessible to other BioRidge customers,, or to any other entity as determined by the Hemispherx.
c. Reporting and interfaces will be defined by Hemispherx and jointly agreed upon with BioRidge.
d. BioRidge will maintain all systems within the change control SOPs.

 

22

 

    

Exhibit 10.2

 

 

 

 

 

AGREEMENT

 

Between

 

ARMADA HEALTH CARE, L.L.C.

 

And

 

HEMISPHERX BIOPHARMA, INC.

 

 

 

MANUFACTURER AGREEMENT

 

CONTRACT #   ______________

 

THIS AGREEMENT is entered into by and between Armada Health Care, L.L.C., a New Jersey corporation, having offices at 100 Campus Drive, Suite 102, Florham Park, NJ 07932 (“Armada”) and Hemispherx Biopharma, Inc. , a Delaware corporation, having its headquarter offices at 1617 JFK Boulevard, Suite 660 Philadelphia, Pa 19103 (“Supplier”). This Agreement constitutes the entire agreement between the parties with respect to its subject matter and this Agreement supersedes all prior concerning the subject matter of this Agreement.

 

WHEREAS, Armada is a group purchasing organization (“ GPO ”), operating in accordance with the group purchasing organizations safe harbor at 42 C.F.R. § 1001.952 (j) (the “ GPO Safe Harbor ”); and

 

WHEREAS, as a GPO , Armada, on behalf of its Members (hereinafter defined) negotiates and maintains contracts with manufacturers and distributors of healthcare products, including but not limited to pharmaceutical and medical surgical products, as well as service providers, collectively known as “Suppliers” to offer rebates (“Contract Rebates”) on specific products to the Members or sell specific products to the Members at agreed-to prices (“Award Prices’); and

 

WHEREAS , Supplier by submitting a written proposal to ARMADA providing information detailing the rebate amount and/or price, quantity, value and technology of all products which Supplier would offer to Members, has shown willingness to provide said products to members and such written proposal is incorporated herein by reference (hereinafter referred to as “Supplier’s Response”) and attached hereto as Exhibit A ; and

 

 

 

 

 

WHEREAS , based upon the representations, covenants and warranties contained in Supplier’s Response, all of which are deemed to be material, ARMADA has selected Supplier to provide Members with the products and services described in Supplier Response at the Contract Rebate and/or Award Price levels set forth therein and upon the terms and conditions set forth herein;

 

NOW, THEREFORE , in consideration of mutual promises contained herein, Supplier’s Response and other good and valuable consideration, ARMADA and Supplier agree as follows:

 

TERMS AND CONDITIONS

 

1. Term – the period of time for which this Agreement will be in effect, August 15, 2011 through August 14, 2012

 

2. Contract Number(s) – Supplier shall provide contract number(s) upon submission of Agreement to ARMADA. Contract number(s) shall remain consistent in all forms of communication throughout the term of this Agreement to all authorized and applicable parties, including BioRidge Pharma.

 

3. Products, Contract Rebates and Contract Prices - Product line, Contract Rebates and Award Prices offered under this agreement should be identified as Exhibit A . Contract Rebate and Award Price information should remain confidential and will be released to ARMADA members and potential program participants only.

 

4. Price Protection - Supplier agrees that the prices, quality, value and technology of all Products sold under this Agreement shall be market competitive throughout the Term. During the Term, Supplier shall provide prompt written notice to ARMADA of all Products offered for sale by Supplier on terms that are more favorable to an offeree than the terms of this Agreement. Supplier shall lower the Award Price or increase any discount applicable for the purchase of Products to assure market competitiveness for Members. If at any time during the Term ARMADA receives information indicating that Supplier’s prices, quality, value or technology are not market competitive, ARMADA may provide written notice of such information to Supplier, and Supplier shall, within ten (10) business days, advise ARMADA in writing of and fully implement all adjustments necessary to assure market competitiveness to Members. Market Competitiveness shall be based on pricing offered to similar entities within a class of trade and excludes pricing made available to entities outside the United States or any pricing offered to any Government Entity (i.e. VA, DoD, PHS, etc.).

 

5. Price Notifications - Supplier shall provide not less than forty-five (45)-days’ prior written notice to ARMADA and not less than seven (7)-days’ prior written notice to BioRidge Pharma of any change in pricing terms permitted by this Agreement. For purposes of the foregoing notification requirements, a change in pricing terms shall mean any change that affects the delivered price to the Member, including, without limitation, changes in list prices, discounts, pricing tiers or schedules. Such written notice shall be provided in such format and in such detail as may be required by ARMADA and shall include, at a minimum, sufficient information to determine line item pricing of the Products for all affected Members.

 

6. Class of Trade Form - Supplier shall complete the Class of Trade Form as set forth in Exhibit B . Each unique contract number requires a separate Class of Trade Form.

 

Confidential   1

 

 

 

7. Eligibility to Participate - This proposal is extended to all ARMADA member facilities that fall within the approved Class of Trade defined in Exhibit B, agree to the terms as detailed in Exhibit A, and have been qualified by Armada and ultimately approved by Supplier (“Participating Members”). ARMADA may also from time to time identify members that may meet the requirements of the Agreement (“Potential Participating Member”). These Potential Participating Pharmacies will be submitted for review and final approval by Supplier at which time they will become “Eligible Members”. ARMADA reserves the right to delete members during the period of this agreement by providing the Supplier thirty (30) days written notice .

 

8. Usage Data ” shall mean a data file at the NDC level for all Products bought or returned to authorized wholesaler as shown in Exhibit G ; Required Usage Data Format.

 

9. WAC shall mean the US Dollar wholesale acquisition cost for a given pharmaceutical product by the National Drug Code (“NDC”) number in effect as of the first day of the calendar quarter as established by Supplier.

 

10. Contract Implementation - Supplier will endeavor to implement this agreement within thirty (30) days of signing. This implementation will include contacting ARMADA facilities and/or if applicable, providing pricing and contract information to the authorized distributor listed on Exhibit C . Supplier will provide copies of all correspondence to distributor providing contract information. Failure to comply with this condition may result in the cancellation of the agreement.

 

11. Commitment - Armada will commit significant time and resources into the implementation of this program, in consideration of this Supplier agrees not to implement the same or similar programs with other similar organizations. Additionally, Supplier agrees to not offer equal or better terms to any ARMADA member on a direct basis.

 

12. Return Goods Policy - Supplier must provide a formal policy to ARMADA members for the return of defective products or products received by error. The policy should include the contact person's name and phone number responsible for processing returns and providing return authorization. In addition, full credit will be issued for products returned to the Supplier. Please include policy as Exhibit D.

 

13. Product Recall - Supplier will maintain a product recall policy and procedure and will notify all ARMADA members of products affected. Please include Product Recall Policy as Exhibit E.

 

14. Material Safety Data Sheet (MSDS) - Supplier will provide ARMADA members Material Safety Data Sheets if applicable.

 

15. Distribution/Order Placement (Check one or both if applicable)

 

/  / Direct:    
  Company Name    
  Address    
  City/State/Zip    
  Telephone    
  Fax Number    
  Contact Name    
       
/  x/ From Distributor    

 

Confidential   2

 

 

 

Orders may be placed through authorized distributors. ARMADA will provide a list of those distributors ( Exhibit C ). ARMADA supports the efforts of those Suppliers that provide equal opportunities to minority distributors.

 

Note: Please attach a separate listing of your servicing distributor(s), coverage area, address and phone number.

 

16. Disruption of Product Delivery - Supplier will make all reasonable plans to see that the product(s) awarded are available when Participating Members place their orders. Products that are unavailable due to back order, but remain in production by Supplier are considered temporarily unavailable. Supplier will not be held responsible for out of stock situations that occur at the wholesaler’s distribution centers when product is available for shipment from Supplier. Supplier shall be relieved of its obligations by acts of God, riots, labor disputes, strikes, actions or defaults or material suppliers or common carriers.

 

17. Rebates

 

A. All reimbursement payments will be made monthly, by check, or electronically, via an Automated Clearing House payment to the bank account(s) designated by ARMADA within thirty (30) days after Supplier’s receipt and acceptance of Usage Data. Rebates will be calculated as a percentage of Wholesaler Acquisition Cost (“WAC”) on the day of purchase and based on the Product purchases made by ARMADA members through Authorized Wholesalers during the month. Payment for any period that is not a complete month will be based on the Product purchases made during such period. Detailed documentation of the rebate payment showing how the rebate was calculated and the reason for any discrepancy between the amounts billed and the amount paid will accompany all rebate checks. Adjustments, if found, will be paid or refunded accordingly to the appropriate party in subsequent rebate payments. In the event that no subsequent rebate payments are payable, ARMADA will refund to Supplier any overpayment within thirty (30) days of Customer’s acknowledgment of the overpayment; Supplier will remit any underpayment to ARMADA within thirty (30) days of Supplier’s acknowledgment of such underpayment.

 

B. As a condition to receiving Rebates described in Exhibit A, ARMADA shall provide to Supplier Usage Data , within thirty (30) days of the end of each month during the term of this Agreement. Both Parties agree to discuss Usage Data if found to be unacceptable to Supplier and will work to resolve issues before final determination of the acceptability of the Usage Data. The acceptability of Usage Data rests with mutual agreement between the Parties.

 

18. Insurance

 

A. Policy Requirements . Supplier shall maintain and keep in force during the Term product liability, general public liability and property damage insurance against any insurable claim or claims which might or could arise regarding Products sold by, manufactured by or purchased from Supplier. Such insurance shall contain a minimum combined single limit of liability for bodily injury and property damage in the amounts of not less than $5,000,000 per occurrence. The insurance policy shall name ARMADA, as its interests may appear, as additional insured’s. Supplier shall provide to ARMADA within fifteen (15) days after ARMADA’s request, an insurance certificate indicating the foregoing coverage and issued by an insurance company licensed to do business in the relevant states. ARMADA shall maintain and keep in force during the Term General Liability, Workers Compensation and Employers Liability, Professional Liability, Errors and Omissions Liability and Privacy and Network Security Liability.

 

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B. Amendments, Notices and Endorsements . Supplier shall not amend, in any material respect the insurance coverage without thirty (30) days’ prior written notice to ARMADA.

 

19. Administrative Fees - In consideration of the administrative and sales development services provided by ARMADA as well as the services set forth in Exhibit H, Supplier will pay ARMADA an administrative fee in an amount equal to one percent (1 % ) of the net purchases made by members, as determined from manufacturers/distributor records. ARMADA represents and warrants that fees or other amounts received from suppliers are disclosed in accordance with the requirements of 42 CFR Part 1001.952(j). The fee will be computed and paid quarterly within thirty (30) days after the last day of the quarter (payment due date).

 

Checks for administrative fee payments should be made payable:

 

To: Armada Health Care, L.L.C.
  100 Campus Drive, Suite 102
  Florham Park, NJ 07932
   
  (Attn: Finance Department)

 

Data to:  rxdata@Armadahealthcare.com

 

In order to assist ARMADA and its representatives, Supplier agrees that a qualified Manufacturer sales representative will call on ARMADA members as needed. Furthermore, Supplier will provide ARMADA monthly reports showing total purchases in units and dollars by product code. These reports will be provided in an electronic format.

 

20. Nonpayment or Insolvency of a Member or Distributor - Supplier shall have no recourse against ARMADA for failure of any Distributor or member to pay for products purchased pursuant to this agreement. If a Member or Distributor fails to pay Supplier for Products ordered by such Member or Distributor, or if a Member or Distributor becomes bankrupt or insolvent or makes an assignment for the benefit of creditors or goes into liquidation, or if proceedings are initiated for the purpose of having a receiving order or dissolution order made against a Member or Distributor, or if a Member or Distributor applies to the court for protection from its creditors, then, in any such case, this agreement shall not terminate, but, (i) in the case of a Distributor, Supplier will have the right, upon prior written notice to ARMADA and the Members, to discontinue providing Products through that Distributor, and Supplier shall thereafter provide Products to the Members directly or through another Distributor, as directed by ARMADA; and (ii) in the case of a Member, Supplier shall have the right, upon prior written notice to ARMADA and the Member, to discontinue selling Products to that Member.

 

21. Review of Supplier Records - At any time while this agreement is in effect and if applicable, ARMADA reserves the right upon giving reasonable notice to review the records of the Supplier for the purpose of verifying reported sales to members and the calculation of the sales development fee outlined in Paragraph 19. These records should be made available at the Supplier's business office during normal business hours. The cost associated with this review will be the responsibility of ARMADA unless it is determined that the sales development fee payment has been understated by twenty-five percent (25%) or more.

 

Confidential   4

 

 

 

 

A. ARMADA acknowledges that records and information received during any audit are confidential in nature, and ARMADA agrees not to disclose same to persons or parties not participating in this or ARMADA programs.

 

22. Use of Names - Supplier shall not use in any of its promotional, informational or marketing activities or materials the names, trademarks, logos, symbols or description of the business or activities of ARM ADA, Distributor or Member without in each instance obtaining the prior written consent of the person owning the rights thereto.

 

23. Confidential Information

 

A. During the Term and for two (2) years thereafter, Supplier shall:

 

(i) keep strictly confidential and hold in trust the contents of this Agreement;
(ii) keep strictly confidential and hold in trust all Confidential Information (defined below) of ARMADA, the Distributors and the Members;
(iii) not use the Confidential Information for any purpose other than Supplier’s performance of its obligations under this Agreement, without the prior written consent of ARMADA;
(iv) not disclose the Confidential Information to any third party (unless required by law) without the prior written consent of ARMADA; and
(v) not later than thirty (30) days after the expiration or earlier termination of this Agreement, return to ARMADA, the Distributor or the Member, as the case may be, any Confidential Information Supplier may have received.

 

B. Definition . As used herein, “Confidential Information,” shall consist of all information relating to the prices and usage of the Products, all documents and other materials of ARMADA, the Distributors and the Members containing information relating to the programs of ARMADA, the Distributors or the Members which are proprietary or sensitive in nature not readily available through sources in the public domain. In no event shall Supplier provide to any person any information relating to the prices it charges the Distributors for Products ordered pursuant to this Agreement without the prior written consent of ARMADA .

 

24. Compliance

 

A. Compliance With Law . Supplier represents and warrants, that at all times during the Term, that it is in, and will maintain, compliance with all federal, state and local statutes, laws, ordinances and regulations applicable to it (“Legal Requirements”) which are material to the operation of its business, the conduct of its affairs and sale of Products, including Legal Requirements pertaining to the safety, manufacturing and distribution of the Products, occupational health and safety, environmental protection, nondiscrimination, antitrust, and equal employment opportunity. During the Term, Supplier shall: (i) promptly notify ARMADA of any lawsuits, claims, administrative actions or other proceedings asserted or commenced against it which assert in whole or in part that Suppler is in noncompliance with any Legal Requirement which is material to the operation of its business, the conduct of its affairs and/or the sale of Products; and (ii) promptly provide ARMADA with true and correct copies of all written notices of adverse findings from any governmental agency, including, but not limited to, the U.S. Food and Drug Administration (“FDA”) and all written results of FDA or other governmental inspections which pertain to the Products.

 

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B. Anti-Kickback Statute. It is the parties’ intention that this arrangement comply with the federal Anti-Kickback Statute, 42 U.S.C. § 132a-7b (b) and other applicable federal and state laws and, further, that this arrangement satisfy, and the parties comply with, as applicable, the GPO safe Harbor, and discounts safe harbor regulation at 42 C.F.R § 1001.952 (h) (the “ Discounts Safe Harbor ”).

 

C. Government Program Participation . Supplier represents and warrants that it is not excluded from participation, and is not otherwise ineligible to participate, in a “Federal health care program” as defined in 42 U.S.C. 1320a-7, et seq . or in any other government payment program. In the event Supplier is excluded from participation, or becomes otherwise ineligible to participate in any such program during the Term, Supplier shall notify ARMADA in writing within three (3) days after such event, and upon the occurrence of such event, whether or not such notice is given to ARMADA, ARMADA may immediately terminate this Agreement upon written notice to Supplier.

 

D. Privacy Without limiting the generality of the foregoing, Armada represents that it and each Participating Member will comply with all laws regarding patient privacy and confidentiality, general privacy and security requirements, and communication methods including, but not limited to, HIPAA, the CAN-SPAM Act, the Telephone Consumer Protection Act, the Telemarketing Sales Rule, and applicable Texas, California, and other federal or state laws covering the same or similar topics. Armada further represents that it will take all necessary actions (i) to ensure that all participating members obtain the appropriate consents or authorizations required by law or regulation prior to the performance of services hereunder, and (ii) to ensure that all such services will be performed in accordance with any notice, opt-in, opt-out, access, envelope or other communications restrictions contained in applicable state or federal law. Armada acknowledges that Supplier has no direct interaction with participating member’s customers seeking to fill prescriptions and that Supplier accordingly relies upon Armada as an independent contractor to insure that all patient consents or authorizations required by law or regulation are obtained prior to the performance of any services contemplated under this Agreement.

 

E. Adverse Event Reporting Armada represents that it and each Participating Member agree to report adverse events reported to Armada or Participating Member during their course of their communications with patients as per Exhibit I.

 

25. Indemnification - Supplier shall release, indemnify, hold harmless, and, if requested, defend ARMADA, the Members and the Distributor, and their respective officers, directors, regents, agents, subsidiaries, affiliates and employees (collectively, the “Indemnitees”), from and against any claims, liabilities, damages, actions, costs and expenses (including, without limitation, reasonable attorneys’ fees, expert fees and court costs) of any kind or nature, whether at law or in equity, INCLUDING CLAIMS ASSERTING STRICT LIABILITY, arising from or caused in any part by (i) the breach of any representation, warranty, covenant or agreement of Supplier contained in this Agreement; (ii) the condition of any Product, including a defect in material, workmanship, design, manufacturing or formulary; or (iii) the warnings and instructions associated with any product. However, t such indemnification, hold harmless and right to defense shall not be applicable where the claim, liability, damage, actions, cost or expense arises solely as a result of an act or failure to act of Indemnitees. This Section and the obligations contained herein shall survive the expiration or earlier termination o f this Agreement. The remedies set forth in this Section are in addition to and not a limitation on any other rights or remedies that may be available against Supplier.

 

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26. Cancellation

 

ARMADA may terminate this Agreement at any time for any reason whatsoever by delivering not less than sixty (60)-days’ prior written notice to Supplier. In addition, ARMADA may terminate this Agreement immediately by delivering written notice to Supplier upon the occurrence of either of the following events:

 

(i)       Supplier breaches any term of this Agreement; or

 

(ii)      Supplier becomes insolvent, makes an assignment for the benefit of creditors, or commences liquidation proceedings; or proceedings are initiated by or against Supplier under the U.S. Bankruptcy Code; or Supplier applies to any court for protection from its creditors.

 

ARMADA’s right to terminate this Agreement due to Supplier’s breach is in addition to all other rights and remedies ARMADA, the Members or the Distributors may have resulting from such breach, including, but not limited to, ARMADA’s right to recover all lost Administrative Fees resulting from such breach through the date ninety (90) days after termination.

 

Supplier may terminate this Agreement at any time for any reason by delivering not less than sixty (60)-days prior written notice thereof to ARMADA.

 

27. Transferability - In the event that Supplier transfers legal ownership and/or marketing rights of products listed on Exhibit A to another entity during the term of this agreement, ARMADA's rights and privileges as expressed by the terms and conditions contained herein shall also be transferred upon the agreement and consent of ARMADA.

 

28. Miscellaneous

 

A. Choice of Law . This Agreement and the rights and obligations of the Partners hereunder shall in all respects be governed by and construed in accordance with the internal laws of the State of New Jersey (without regard to the conflict of laws principles of such state) including all matters of construction, validity and performance. The Partners hereto agree and submit to New Jersey courts to have jurisdiction over all matters relating to this Agreement and any lawsuits instituted by either party shall be brought in New Jersey; however, the terms of any agreement between Supplier and an Distributor or between Supplier and a Member shall be governed by and construed in accordance with the choice of law and jurisdiction provisions set forth in such agreement.

 

B. Not Responsible . ARMADA shall not be responsible or liable for any acts or failure to act of any Distributor or Member.

 

C. Third-Party Beneficiaries . All Distributors and Members are intended to be third-party beneficiaries of this Agreement. All terms and conditions of this Agreement, which are applicable to the Distributors, will inure to the benefit of and be enforceable by the Distributors and their respective successors and assigns. All terms and conditions of this Agreement which are applicable to the Members will inure to the benefit of and be enforceable by the Members and their respective successors and assigns.

 

29. Submission of Document - Submission of this document constitutes a legal offer. Therefore, should any or all of said document be accepted and in exchange for being designated as a contracted Supplier, said Supplier hereby agrees to be legally bound to provide each ARMADA facility, present and future on an as desired basis, any items encompassed in said document pursuant to the terms of the respective agreement.

 

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IN WITNESS WHEREOF , the Parties have executed and delivered this Agreement .

 

ACCEPTED BY:   ACCEPTED BY:
Armada Health Care, L.L.C.   Hemispherx Biopharma, Inc.
     
By: Lawrence S. Irene, R.Ph.   By: William A. Carter, M.D.
     
     
Signature   Signature
     
Title: CEO   Title : Chairman and CEO

 

Date: ______________________ ______   Date: _________________________ ____

 

Manufacturer Contract # ______________________

 

SIGNATURE BY BOTH PARTIES CONSTITUTES A LEGAL AND BINDING AGREEMENT

 

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Exhibit A

Products, Contract Rebates, Services and Fees

 

1. PRODUCT

 

NDC   Product Name   Unit of Measure
54746-0001-01   Alferon N Injection   1ml/vial

 

2. REBATE SUMMARY

 

2.1. Contract Rebates are set forth in this Section. For Participating Members the following discounts will apply in the form of a rebate off of WAC.

 

2.1.1.       Base Rebate Schedule: Supplier will provide a Base Rebate to Participating Members as indicated below off the then current WAC at time of purchase in exchange for the service described in Sections 3 and 4 below.

 

NDC   Product Name   WAC Discount
54746-0001-01   Alferon N Injection   10%

 

2.1.2.       Incremental Volume Rebate Schedule: Participating Member will be eligible to earn an Incremental Volume Rebate as indicted below off the then current WAC as time of purchase. Incremental Volume rebate will be based on monthly incremental units sales as compared to the respective members average monthly baseline unit sales, The baseline unit sales will be defined as the average monthly Product purchases for the first three months that Participating Member is on contract.

 

NDC   Product Name   WAC Discount
54746-0001-01   Alferon N Injection   10%

 

3. DATA REQUIREMENTS

 

3.1. Armada shall not provide Supplier with the names of, or any non-blinded medical information with respect to, patients or any information that is considered identifiable under HIPAA or applicable state law (“Patient Information”). Supplier agrees not to use, directly or indirectly, any methods, system, or device, whether through coding of any materials hereunder or otherwise, to attempt to identify such individuals or to correlate the identity of those individuals receiving mailings hereunder with Armada’s mailing list or other database.

 

3.2. Participating Members will be eligible to receive the discount as set forth above in exchange for such member continually providing to Armada complete and accurate data as set forth in Exhibit F.

 

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3.3. If Participating Member does not provide data in accordance with the terms of this Agreement, Supplier reserves the right to disallow access to the discount to Participating Member and its locations.

 

4. BASE SERVICES

 

Supplier will provide to each Participating Member a discount off WAC on Product purchases in exchange for such Participating Member continuing to provide services depicted in this Section 4 during the term of the Agreement. As a condition to receive price concessions here under, Participating Facility agrees to the following:

 

4.1. To offer compliance programs, case management support services to patients who elect to participate in these activities and to maintain a 24-hour/365-day a year telephone service for assistance of prescription drug-related medical emergencies to patients of Participating Pharmacy for whom Product has been or is being purchased.
4.2. To provide quality reimbursement assistance including the ability to perform benefits investigations on behalf of a patient’s pharmaceutical and medical reimbursement process, assist with the completion of prior authorization, offer appeal guidance and track claims.
4.3. To maintain inventory down to three months dating and buy Product from the authorized wholesaler or distributor as indicated in Exhibit C, and will not buy from the alternate source market. The term "alternate source" shall include, but not be limited to, Hemispherx international affiliates, trading companies, brokers, secondary market wholesalers, alternate source pharmacies, or other customers whose sole purpose is to buy and hold inventory for speculative purposes.
4.4. To have, and continue to have, an outbound sales staff sales staff or equivalent ability calling on managed care, employer groups and/or physicians.
4.5. To distribute, when available, Hemispherx approved educational materials following therapy start and during the course of therapy as necessary.
4.6 To not engage in any activity or program that disadvantages any Hemispherx Product. Nothing herein is intended to limit the right of a Participating Member to use its own best judgment in providing a suitable standard of care for its patients or to preclude the mere contracting by a Participating Member with other manufacturers of products in the relevant market.
4.7 To permit Hemispherx representatives to discuss with personnel of the Participating Member clinical issues relating to specific Hemispherx Products, formulary issues, new products, business trends, managed care strategies and other issues as agreed upon by both parties.
4.8 Participating Member will make available to Armada purchase data regarding the sale of Products as designated by Hemispherx.
4.9 Participating Member will purchase Hemispherx Products only for dispensing to its patients and not for resale to any wholesaler, retailer, institution or any other entity and Participating Member agrees to indemnify Hemispherx and bold Hemispherx harmless from and against any loss, damage, cost and expense, including attorneys' fees, with respect to any claim or demand arising from the breach of this provision.
4.10 While a Participating Member and for one year thereafter, Participating Member will maintain all reasonable relevant books, records, policies and training manua1s relating to all the services performed and obligations assumed with respect to Hemispherx Products as well as discounts claimed by Participating Member. Participating Member will permit Hemispherx or its agents, upon two business days' notice, to audit such books, records, policies, and training manuals.
4.11 To the extent Participating Member has knowledge of same Participating Member will keep all the terms and provisions of this Contract, including the discounts, confidential.

 

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4.12 Participating Members are aware of and will comply with Section 1128B(b) of the Act (42 U.S.C. 1320a-7b) when seeking reimbursement from any government or other entity for Products purchased pursuant to this Agreement. Participating Members acknowledge that the Act requires proper disclosure of any discounts, rebates, credits, reimbursements and other like programs provided for herein and agree to accurately report to private and governmental third-payers (including Medicare, Medicare Part D PDP and MA-PD Plans, and Medicaid), and other individuals and entities the net effective discount price for each Product for which a discount has been given pursuant to this Agreement to the extent required under applicable federal, state or local law or Centers for Medicare and Medicaid Services (CMS) guidance. Participating Members are specifically on notice of the reporting obligations set forth in 42 C.F.R. § 1001.952 (h). Participating Members shall request confidential treatment of any disclosure(s) made to Medicare Part D PDP and MA-PD Plans to the extent permitted by law.
4.13 Participating Member will comply with all laws regarding patient privacy and confidentiality, general privacy and security requirements, and communication methods including, but not limited to, HIPAA, the CAN~SPAM Act, the Telephone Consumer Protection Act, the Telemarketing Sales Rule and other federal or state Jaws covering the same or similar topics. Participating Members will obtain the appropriate consents or authorizations required by law or regulation prior to the performance of services, and ensure that all such services will be performed in accordance with any notice, opt-in, opt-out, access, envelope or other communications restrictions contained in applicable state or federal law.
4.14 Participating Member will provide complete and accurate data required by Armada (subject to and in accordance with the privacy provisions above)
4.15 Participating Member will maintain regular contact with its prescribers (subject to and in accordance with the privacy provisions above) to educate them on the Alferon N Injection®, make them aware of patient education materials and programs and their applicability to the patient type.
4.16 Participating Member will, to the best of their ability, utilize its physician and/or managed care sales forces to distribute information about Alferon N Injection® programs or services contained herein.

 

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Exhibit B – Class of Trade

 

 

 

To : Contract Administrators  
From : ARMADA Contract Development Contract #  __________________
RE : Alt-Site Trade Classes  

 

Please indicate on the list below which trade class your organization considers eligible:

 

All Trade Classes Nursing Home x
Acute Care (Hospital) x Nursing Home Provider x
Assisted Living   Oncology Center  
Correctional x On-Site Hospital Clinic x
Dialysis   Outpatient Clinic x
Distributor   Physician’s Office x
Group Practice x Post-Surgical Recovery  
Health Plan   Psychiatric Hospital  
HMO x Rehab Center & Chronic Disease Hospice  
HMO Group x Rehabilitation Facility  
HMO Staff x Residential Care  
Home Care   Retail  
Home Infusion x Skilled Nursing Facility  
Hospice   Specialty Pharmacy x
Immediate Care Center x Surgery Center  
Laboratory – Free Standing   Teaching Hospital x
Mail Order (no retail sales)   University/School Clinic x
MRI/Radiology      

 

Thank you in advance for your cooperation in this very important matter. Please return the completed form via fax or email ASAP. Facsimile number 973-564-8010 or email contracts@armadahealthcare.com Attn: Contract Administrator.

 

Vendor Name:  
   
Completed By:  
   
Title:  
   
Email:  
   
Phone Number:  

 

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Exhibit C

ARMADA Distributors and Wholesalers

 

Bio Ridge Pharma, LLC.

100 Campus Drive Suite 102

Florham Park, NJ 07932

 

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Exhibit D

 

Hemispherx Returned Goods Policy

 

This Return Goods Policy is for all Hemispherx products, Alferon N® and Ampligen® , distributed by Bio Ridge Pharma, Inc.

 

The following products are eligible for return and reimbursement:

 

· Out dated product: Product within two (2) months prior or six (6) months past expiration date noted on product;
AND

 

· Product in its original container and bearing its original label.
OR

 

· Product which Hemispherx has specified be returned

 

The following products are not eligible for return and reimbursement:

 

· Product that is not out-dated.

 

· Product in which the lot number and/or expiration date is missing, illegible, covered, and/or unreadable on original container.

 

· Product that has been damaged due to improper storage or handling, fire, flood, or catastrophe.

 

· Product that has been sold expressly on a non-returnable basis.

 

· Product that is not in its original container and/or not bearing its original label.

 

· Product that is in its original container with a prescription label attached.

 

· Product that has been repackaged

 

· Partial vials..

 

· Product obtained illegally or via diverted means.

 

· Product purchased on the "secondary source" market or from a distributor other than BioRidge. .

 

· Product that Hemispherx determines, in its sole discretion, is otherwise adulterated, misbranded, or counterfeit.

 

Hemispherx will only accept returns shipped to BioRidge Pharma. All eligible products shall be shipped in a safe, secure, and reliable manner, and in compliance with all applicable federal, state and local laws, regulations and statutes. It is the shipper's responsibility to securely package all return goods to prevent breakage during transit and otherwise comply with laws and regulations applicable to the packaging, shipping and transport of return goods shipments. Hemispherx is not responsible for shipments lost and/or damaged in transit. Hemispherx recommends that all customers insure return goods shipments.

 

Hemispherx will audit the quantities of return goods and final reimbursement will be based on Hemispherx count. All products will be reimbursed based on the priced paid. Direct purchasing customers reimbursement will be issued in the form of a credit or product replacement to the appropriate party.

 

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To assist in accurate credit memo processing, please include the following information with the return goods shipment:

 

1. Purchaser ‘s name and mailing address.

 

2. Date and quantity purchased

 

Return goods shipments which are deemed to be outside of this policy will not be returned to the customer or the third party processor and no reimbursement will be issued by Hemispherx. Hemispherx return goods policy is subject to change at any time and without prior notice to other parties.

 

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Exhibit E

Product Recall Policy

 

PDF version of Hemispherx Policy to be added to final PDF of Agreement.

 

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Exhibit F: RX Data

 

Category   Field   Type   Description   Values   Example   Required
Patient   PATIENT_ID   text   Patient Identifier - Id from pharmacy dispensing system           Yes
Pharmacy   PHARMACY_CONTACT                   Yes
Pharmacy   PHARMACY_CONTACT_PHONE                   Yes
Pharmacy   PHARMACY_CORP_NAME                   Yes
Pharmacy   PHARMACY_DEA   text   DEA of the pharmacy   Required if data for more than one pharmacy is supplied   AB123456789   Yes
Pharmacy   PHARMACY_DEA_NAME                   Yes
Pharmacy   PHARMACY_NABP   text   Same as NCPDP   NABP (National Association of Boards of Pharmacy) number as issued by NCPDP       Yes
Pharmacy   PHARMACY_NPI   text   National Provider ID for pharmacy           Yes
Pharmacy   PHARMACY_ZIP                   Yes
Physician   PHYSICIAN_CITY   text   Physician City           Yes
Physician   PHYSICIAN_CONTACT_PHONE                   Yes, If Available
Physician   PHYSICIAN_DEA   text   Physician DEA           Yes
Physician   PHYSICIAN_FIRST_NAME   text   Physician First Name           Yes
Physician   PHYSICIAN_LAST_NAME   text   Physician Last Name           Yes
Physician   PHYSICIAN_MIDDLE_INITIAL   text   Physician Middle Initial           Yes
Physician   PHYSICIAN_NPI   text   NPI # for Physician           Yes
Physician   PHYSICIAN_PHONE   text   Phone # for Physician           Yes, If Available
Physician   PHYSICIAN_SPEC   text   Physician Specialty       Cardiology   Yes
Physician   PHYSICIAN_STATE   text   Physician State           Yes
Physician   PHYSICIAN_STREET_ADDRESS   text   Street address for physician's office           Yes
Physician   PHYSICIAN_STREET_ADDRESS2       Second line of street address       2nd Floor - Suite 205   Yes
Physician   PHYSICIAN_TITLE       Professional designation for prescriber   MD, DO, NP, PA   MD   Yes
Physician   PHYSICIAN_ZIP   text   Physician Zip Code           Yes
Rx   COPAY   decimal   Patient out of pocket costs       10   Yes
Rx   DATE_FILLED   Date   Date RX was Dispensed       38353   Yes
Rx   DATE_SHIPPED   date   Date product was shipped           Yes
Rx   DAYS_SUPPLY   decimal   Days Supply for Quantity Dispensed       30   Yes
Rx   DAYS_SUPPLY_WRITTEN   decimal   Days Supply Written on original RX           Yes
Rx   DISPENSE_AS_WRITTEN   text   DAW Code           Yes
Rx   MAJOR_PLAN_NAME   text   Patient Health Insurance Company           Yes
Rx   MARKETING_CODE   text   Marketing Material Shipped with the Product           Yes
Rx   NDC   text   NDC of the drug dispensed, 11 digits, no dashes       11111222233   Yes

 

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Rx   PAYOR_NAME   text       Express Scripts, Medco, Caremark, etc.   Medco   Yes
Rx   PAYOR_TYPE   text   MCAID - Medicaid, MCARE - Medicare, CASH, TPP - other Third Party Plan, MED - Medical Claim       TPP   Yes
Rx   PLAN_REIMBURSEMENT   decimal   Total paid by all health plans           Yes, If Available
Rx   PRIMARY_PLAN_GROUP_NUMBER   text   Group # for primary plan           Yes
Rx   PRIMARY_PLAN_NUMBER   text   Plan #           Yes
Rx   PRODUCT DESCRIPTION   text   Product Name/Strength/Form   Used when NDC cannot be identified   ALFERON N 5MU/ML   Yes
Rx   QTY   decimal   Quantity Dispensed       90   Yes
Rx   QTY_WRITTEN   decimal   Quantity Written on RX           Yes
Rx   REFILL_NUMBER   Integer   New/Refill Code   00 = Original RX, 01 = First Refill, 02=Second Refill, etc.   02   Yes
Rx   RX_DC_DATE   date   Date RX was discontinued       38717   Yes
Rx   RX_DC_REASON   text   Reason for RX dicontinuation           Yes
Rx   RX_ICD9   text   ICD-9 code for RX       154.1   Yes
Rx   RX_ICD9_2   text   Secondary ICD-9 code for RX       154.1   Yes
Rx   RX_NUMBER   text           44518721   Yes
Rx   RX_TYPE   text   Prescription Type   1 ' = New/Refill, '0 ' = Adjustment, '1-' = Reversal       Yes
Rx   SECONDARY_PAYOR_NAME   text   Secondary Payor Name   Express Scripts, Medco, Caremark, etc.   Medco   Yes
Rx   SECONDARY_PAYOR_TYPE   text   MCAID - Medicaid, MCARE - Medicare, CASH, TPP - other Third Party Plan       TPP   Yes
Rx   TERTIARY_PAYOR_NAME   text   Tertiary Payor Name   Express Scripts, Medco, Caremark, etc.   Medco   Yes

 

Confidential   18

 

 

 

 

Exhibit G: Usage Data

 

DEA #   Member
Name
  City   State   NDC   Product
Name
  Package   Units   Gross
(WAC) Sales
Dollars
                                 
                                 
                                 
                                 
                                 

 

Confidential   19

 

 

 

 

Exhibit H

Services

 

I. Data Services

 

1. Provide efficient data collection and reporting to Supplier on a monthly basis. Data collection includes the following:
a. Unit sales data by Participating Member pharmacy for financial reporting
b. Prescription level data
2. Information Technology support. This support relates to maintaining systems needed for sales and related reporting
a. Detailed reporting to Hemispherx on program results, including trend analysis, by pharmacy, by prescriber, etc.
b. Names and addresses of prescribers will be made available to Hemispherx which may use these for periodic interviews and communication with prescribers.
c. Actionable reporting that can help drive tactical responses in the field and strategic product planning. To the extent possible, this reporting will include repeat purchases, rates of, basis for prescriptions, competitive information.

 

II. Participant Screening

 

1. Screen all potential participating pharmacies based on Supplier criteria in an effort to expanding Supplier specialty pharmacy base to approved Specialty Pharmacies.
a. Armada will screen/filter all potential pharmacies based on manufacturer criteria
b. Screening may include:
i.   SP service level criteria set by Supplier
ii. On-site visit conducted by Armada personnel for pharmacy profiling
iii. Breadth of insurance coverage of each Specialty Pharmacist (SP)
iv. Location, consistent with patient (condyloma) demographics
v. Specialty Pharmacist’s (SP) service level criteria set by Hemispherx
vi. Pharmacy sales force or not and size.
vii. Pharmacy brand and value , to be used to enhance efficacy
viii. On-site visit by Armada sales people to profile pharmacies
c. Authorization letter to be required upon completion of profile and approval by Supplier

 

III. Patient Support Program (“Program”)

 

1. Increase Patient Compliance and Length of Therapy via targeted HIPPA compliant patient interactions performed by Armada.

 

2. ELIGIBLE PATIENTS AND EXCLUSIONS. Patients eligible to participate in the Program are those who meet all of the criteria set forth in below (collectively, the “Eligible Patients”).

 

a. To be eligible to participate in the Program, a patient must meet all of the following criteria

 

i. such patient must be prescribed the Product and not otherwise be excluded by state or federal law from participating in the Program;
ii. such patient must receive the Product from a Pharmacy dispensing pharmacy participating in the Program; and
iii. such patient; must not be a resident of the State of California.

 

3. PROGRAM DESCRIPTION: The Program will focus on increasing patient adherence to the physician prescribed therapy for patients through the following Product specific patient support services:

 

Confidential   20

 

 

 

 

a. New to Program Call: Armada will call each eligible patient to whom Pharmacy dispenses Product with the purpose of (a) setting treatment expectations, (b) outlining treatment benefits, (c) uncovering and addressing additional barriers to treatment and (d) affording the patient the opportunity to opt-in to the Program.

 

i. Performed by: Pharmacy Tech, Nurse or Pharmacist.
ii. Method: Telephone.
iii. Intervention Schedule: Initiated within eight days of patient’s fill.
iv. Attempts: A maximum of three call attempts.

 

b. Welcome to Program Letter : Armada will mail to enrolled patients information such as an overview of the Program, a clinical education on the therapy and condition and other relevant welcome-to-therapy content, including a description of the method(s) by which enrolled patients may opt-out of the Program.

 

i. Performed by: Automated process.
ii. Method: Letter mailed to the patient address on file.
iii. Intervention Schedule: At the time of enrollment in the Program.

 

c. Late to Refill Call: Armada will call and assist enrolled patients with respect to placing refills and addressing any barriers to therapy. The content of the call will vary according to the enrolled patient’s needs.

 

i. Performed by: Pharmacy Tech, Nurse or Pharmacist.
ii. Method: Telephone.
iii. Intervention Schedule: Initiated when an enrolled patient is confirmed to have not filled a prescription five to seven days after the original refill date. Each Late to Refill Call will occur within fifteen days of the original refill date.
iv. Attempts: A maximum of three call attempts.

 

d. Unable to Reach Letter:

 

i. Performed by: Automated process.
ii. Method: Letter mailed to the patient address on file.
iii. Intervention Schedule: After three attempts have been made by telephone to call the enrolled patient after such patient’s failure to refill.

 

IV. Sales and Marketing Support at Launch and Ongoing

 

1. Armada will designate Brian Burke, Vice President of Marketing, as Project Manager, to develop, coordinate and manage all aspects of the Hemispherx Program implementation with appropriate personnel from each member pharmacy. The Project Manager will have access to all Armada resources to assure schedules are met, the implementation is smooth, and the success of the program is maximized.

 

2. The first most practical step in the deployment of this program is to leverage the combined resources of both Hemispherx field staff and Armada member pharmacies in their respective geographies. Armada will work with our member pharmacies to pro-actively meet and coordinate efforts with Hemispherx managers. Armada member pharmacies have developed many valuable relationships with prescribing physician offices in their service areas.

 

3. A Launch Packet will be developed and distributed to all Armada participating pharmacies within 90 days after execution of this Agreement. This launch packet will include:
a. Two separate web-based training sessions be developed and conducted for Participating Pharmacies wherein Armada can generate excitement and commitment to the Hemispherx program. One of these will pertain to the medical and clinical aspects of Alferon N including an overview of Hemispherx and another will pertain to the Sales, Promotional, and Pricing Program for Alferon N.

 

Confidential   21

 

 

 

 

b. Prepared discussion scripts to guide the pharmacist in the essential talking points applicable to Alferon N with both patients and prescribers.
c. Promotional and educational brochures and booklets for physicians and patients which Armada will see are distributed by Participating Pharmacies.
d. Presentations regarding clinical studies of Alferon N.
e. Web sites where Participating Pharmacies can find and direct physicians and patients to find information on Alferon N and the condition(s) it treats.
f. When and as needed and doable, developing pharmacy branded communications materials to further promote program awareness.
g. Armada will identify the major prescribing physicians and separate them into Tier 1 (High volume prescribers) equals 1-2Rx/day, Tier 2 < 1Rx. Initially concentrate sales efforts on Tier 1 prescribers.

 

4. Armada will undertake the following on-going actions and activities

 

i. Providing on-going promotion to Participating Pharmacies, both physical and e-media.
ii. Providing product related training to pharmacists for Alferon-N including the scope and terms of the Alferon-N purchasing program
iii. Providing general training on patient support programs when available.
iv. Training pharmacies on the patient support programs available
v. To the extent possible, determine why they prescribe Alferon N or why not and for what type patients.

 

Confidential   22

 

 

 

Exhibit I

Adverse Events

 

Armada represents that it and each Participating Member agree to comply with any and all governmental laws, regulations and/or orders that are applicable now and in the future in connection with adverse experience collection and reporting. Provider agrees to comply with Supplier’s instructions, as set forth below, surrounding the reporting of adverse experiences to Suppier that have been reported to Armada or Participating Member.

 

(a) A serious adverse experience (AE) is any adverse drug experience occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability or a congenital birth defect.

 

(b) Unexpected adverse drug experience is defined as:

 

(i) Any adverse drug experience that is not listed in the current labeling for the drug product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labeling but differ from the event due to greater severity or specificity. Unexpected, as used in this definition, refers to an adverse drug experience that has not been previously observed (included in the labeling).

 

(c) Certain information, while not meeting the above definition of an AE/ADR, shall nonetheless be transmitted to Hemispherx. This information, hereinafter referred to as “Other Information Reportable to Hemispherx,” includes:

 

(i) A case involving a pregnancy exposure to the product, except for exposure to prenatal vitamins;
(ii) Report of lactation exposure to the product; or
(iii) AE(s)/ADR(s) of special interest as designated by Hemispherx or a local regulatory authority.

 

(d) Hemispherx shall be solely responsible for all pharmacovigilance activities regarding the Product including but not limited to: adverse experience or adverse drug reaction reporting including literature review and associated reporting; AE/ADR follow-up reporting; preparation and submission of all safety reports to the FDA as required per US Code of Federal Regulations (CFR), title 21 §314.80; maintaining the global safety database; all interactions with health authorities; periodic submission; labeling modifications; risk management; safety monitoring an detection and safety measure (e.g., Dear Doctor Letter, restriction on distribution).

 

Confidential   23

 

 

 

(e) To the extent Provider or any of its employees or agents become aware of or receive any information regarding an AE/ADR or Other Information Reportable to Hemispherx associated with the use of a Product, Provider shall promptly provide Hemispherx with such information within two (2) calendar days of the date received by Provider or any of its employees or agents. Provider shall attempt to obtain the minimal criteria needed to report an AE/ADR. Minimal criteria includes the following:

 

(i) Knowledge of a patient or specific patient identified (e.g., date of birth, age or gender);
(ii) A suspect Hemispherx medicinal product
(iii) An identifiable reporting source (e.g., doctor. Dentist, nurse or consumer, their name and address if available); and
(iv) Suspected AE/ADR.

 

(f) All AE/ADR or Other Information Reportable to Hemispherx received by Provider or any of its employees or agents shall be forwarded (by fax or overnight mail) in English to Hemispherx on Provider’s standard form (a sample of which is shall be provided by Hemispherx) within two (2) calendar days of the date received by Provider or any of its employees or agents. Information shall be sent as follows to Supplier:

 

1. Facsimile: [To be provided] or
2. Overnight courier to:

 

[To be provided]

 

Confidential   24

   

EXHIBIT 31.1

 

CERTIFICATIONS PURSUANT TO SECTION 302 OF SARBANES-OXLEY ACT OF 2002

 

I, Thomas K. Equels certify that:

 

1. I have reviewed this quarterly report on Form 10-Q/A of Hemispherx Biopharma, Inc. (the “Registrant”);

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;

 

4. The Registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

 

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c. Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d. Disclosed in this report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and

 

5. The Registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of the Registrant's board of directors (or persons performing the equivalent functions):

 

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and

 

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting.

 

Date: January 13, 2017    
    /s/ Thomas K. Equels
    Thomas K. Equels, Esq.
    Chief Executive Officer

 

  

 

 

   

EXHIBIT 31.2

 

CERTIFICATIONS PURSUANT TO SECTION 302 OF SARBANES-OXLEY ACT OF 2002

 

I, Adam Pascale, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q/A of Hemispherx Biopharma, Inc. (the “Registrant”);

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the Registrant as of, and for, the periods presented in this report;

 

4. The Registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the Registrant and have:

 

a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the Registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c. Evaluated the effectiveness of the Registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d. Disclosed in this report any change in the Registrant's internal control over financial reporting that occurred during the Registrant's most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Registrant's internal control over financial reporting; and

 

5. The Registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the Registrant's auditors and the audit committee of the Registrant's board of directors (or persons performing the equivalent functions):

 

a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the Registrant's ability to record, process, summarize and report financial information; and

 

b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the Registrant's internal control over financial reporting.

 

Date: January 13, 2017    
    /s/ Adam Pascale
    Adam Pascale
    Chief Financial Officer