Sales, Marketing, Distribution, and Supply Agreement

WHEREAS HEMISPHERX is a biopharmaceutical company with headquarters at One Penn Center, 1617 JFK Boulevard, Suite 500, Philadelphia, PA 19103, U.S. ("HEMISPHERX") and Emerge Health Pty Ltd. is a pharmaceutical company with its primary offices located at Suite 3, Level 1, 2 Theatre Place, Canterbury VIC 3126, Australia (" EMERGE”), each a “Party” together, “Parties” and

WHEREAS HEMISPHERX owns intellectual proprietary rights relating to Alferon N Injection ® [Interferon alfa-n3 (human leukocyte derived)] Alferon and

WHEREAS HEMISPHERX desires to have Alferon provided to physicians treating genital warts and other infections and diseases to which patients in Australia and New Zealand have become refractory to recombinant interferon prior to regulatory approval and to have Alferon approved by the Australian regulatory authority, Therapeutic Goods Administration (“TGA”) and New Zealand’s Medicines and Medical Devices Safety Authority (“Medsafe”)

WHEREAS HEMISPHERX presently has no registered company or subsidiary in Australia or New Zealand and

WHEREAS EMERGE has sales, marketing, distribution capabilities in Australia and New Zealand and

WHEREAS EMERGE has the ability to supply Alferon in Australia and New Zealand prior to approval by TGA and Medsafe in accordance with Australia’s Special Access Scheme (“SAS”) and New Zealand’s Section 29 of the Medicines Act (“Section 29”) and to seek to gain TGA and Medsafe approval of Alferon and subsequently to sell market and distribute Alferon in Australia and New Zealand and

WHEREAS, EMERGE desires to supply Alferon under Australia’s SAS and New Zealand’s Section 29 and to seek approval of Alferon from TGA and Medsafe to subsequently sell market and distribute Alferon in Australia and New Zealand and

WHEREAS, HEMISPHERX desires to supply and sell Alferon to EMERGE, and EMERGE is willing to purchase Alferon from HEMISPHERX

NOW THEREFORE, in consideration of the mutual covenants and agreements made herein, and for other good and valuable consideration, the receipt of which is hereby acknowledged, the Parties agree as follows:

"Affiliate" means any corporation or other business entity, which controls, is controlled by, or is under the common control of a Party.

"Alferon N Injection (“Alferon”) means an injectable formulation of Interferon Alfa-N3 (Human Leukocyte Derived)

"Alferon Data" means all data possessed by HEMISPHERX relating to the use of Alferon to treat patients in the Field and which is needed to obtain regulatory approval in the Territory. "Alferon Unit" means 1 x1ml vial containing 5 million international units (I.U.) of Alferon.

"End User" means a physician, medical facility or institution, or government agency that purchases Alferon with the intent of administering it to a patient.

"Field" means Refractory/ Recurrent Genital Warts and Recombinant Interferon Refractory.

"HEMISPHERX Intellectual Property" means all HEMISPHERX patents, patent applications, know-how, and trademarks owned or controlled by HEMISPHERX up to the termination or expiration of this Agreement.

"Refractory/ Recurrent Genital Warts” means genital warts which do not or have not responded to previous treatments.

The “Recombinant Interferon Refractory” means any patient who no longer responds positively to a recombinant interferon.

"Sales Price" means the price EMERGE and/or its Affiliates charge an End User for an Alferon Unit.

"Territory" means Australia and New Zealand.

“Transfer Price” means the price charged by HEMISPHERX to EMERGE for an Alferon Unit.

A.    HEMISPHERX hereby grants EMERGE the exclusive license to sell, market, and distribute Alferon for use in the Field in the Territory.

B.    EMERGE shall not use HEMISPHERX Intellectual Property nor sell nor permit the sale of any products that use the HEMISPHERX Intellectual Property outside the Territory or knowingly sell or have sold any products that use the HEMISPHERX Intellectual Property to any party in or outside the Territory for export or sale outside the Territory, without HEMISPHERX's prior written consent.

C.     EMERGE will have 24 months to gain TGA and Medsafe approval of Alferon from the date of submission and assuming that HEMISPHERX has provided all the appropriate documentation and technical/medical support in a timely fashion to assist with the Registration otherwise the license can be terminated by HEMISPHERX (without penalty or payment) or HEMISPHERX can extend the period for approval.

A.     HEMISPHERX will provide EMERGE:

1.    A CTD dossier for Alferon which will assist EMERGE in attaining regulatory approval in the Territory. EMERGE will keep a record of each person in EMERGE to see any part of the dossier and will provide this record to HEMISPHERX. EMERGE will not allow anyone outside EMERGE to view the dossier or any part thereof without HEMISPHERX written permission.

2.    All the appropriate information about Alferon that will assist with the promotion of Alferon in the Territory.

3.    Market place information from overseas on successful strategies and tactics that can be utilized in the Territory.

4.    Ongoing scientific and medical support.

5.    Alferon Units in quantities sufficient for EMERGE's commercial needs in the Territory.

B.    EMERGE will:

1.    Within 90 days after execution of this Agreement, prepare and provide a Business Plan, under Australia’s SAS and New Zealand’s Section 29, to be provided and attached to this Agreement as Exhibit 1, to make aware and educate physicians and patients about Alferon.

2.    Assist in determining reimbursable End User pricing of Alferon and gain reimbursement for Alferon under SAS and Section 29 and post approval of Alferon in the Territory.

3.    Assist physicians who desire to administer Alferon to their patients with the required paperwork under Australia’s SAS and New Zealand’s Section 29.

4.    Manage the cold chain logistics within the Territory from arrival to End user supply.

5.    Register Alferon as an orphan drug in the Territory.

6.    Be the sponsor, hold the product registration, and maintain all regulatory requirements as the sponsor in the Territory until HEMISPHERX establishes an Australian entity whereupon EMERGE will fully cooperative in transferring sponsorship and product registration to the HEMISPHERX Australian entity.

7.    Prepare and provide a 3-year post regulatory approval Sales, Marketing, and Distribution Plan including a 3-year minimum sale forecast and a committed dollar field sales force, product manager and marketing budget to be agreed by both Parties and a non-binding 12 month Product forecast no later than six (6) months prior to the anticipated registration and subsequent launch date, also to be agreed by both parties,

8.    Pay for all the above activities and related expenses.

9.    Hold 3 months inventory of the forecasted sales at all times.

10.    Assist in recruiting clinical trial sites and principal investigators.

11.    Provide HEMISPHERX a monthly written report of EMERGE's efforts and status thereof under this Agreement.

E.    Forecasts, Orders, Payment, and Delivery.

Following the signing of this Agreement, EMERGE will start a full and comprehensive market analysis of the potential of Alferon in an unapproved setting. This will be from a market potential and willingness to pay point of view and will be completed within 3months of the signature of this Agreement. Forecasts will then be provided for Alferon as an unapproved medicine and this data will be added as a supplement to the Business Plan (Exhibit 1).

Six (6) months prior to the approval of Alferon in the Territory:

1.     EMERGE will provide HEMISPHERX a rolling 12-month forecast of the estimated sales of Alferon Units, the first 3 months of which will be firm and the second three (3) months of which cannot vary by more than 25% when these become the first three (3) months. This forecast will be updated at 3-month intervals thereafter.

2.     In accordance with this forecast, EMERGE agrees to order Alferon from HEMISPHERX under this Agreement by submitting to HEMISPHERX written purchase orders specifying the quantity, packaging, delivery dates, and delivery location.

3.     HEMISPHERX shall manufacture Alferon as described in the purchase order from EMERGE and HEMISPHERX shall make all shipments to the location specified on EMERGE's purchase order as follows:

(a) Delivery of Products is INCOTERMS 2010, CIP. The risk of loss or damage          in transit shall be upon HEMISPHERX.

(b) Hemispherx shall pack, mark and ship Alferon in accordance with          temperature thermometer specifications as clearly set out in the QA Agreement.      Hemispherx shall package Alferon so as to prevent damage or deterioration

and shall comply with all applicable temperature and packaging laws.

4.     Unless otherwise stipulated, Alferon shall be packaged, marked, crated and otherwise prepared in accordance with HEMISPHERX's current packaging and crating practices, and good commercial practices.

5.     EMERGE will prominently display on all Alferon it sells the Alferon trademark, which shall remain the sole property of HEMISPHERX and be so noted and on a visible surface thereof and/or on tags, labels, manuals, and other materials with which Alferon is sold, the fact that the Alferon is manufactured and supplied to EMERGE by HEMISPHERX for sale in the Territory shall be clearly displayed.

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To manage a possible variation of the USD/AUD exchange rate (the “Exchange Rate”), EMERGE and HEMISPHERX will conduct a review of the evolution of the Exchange Rate over every six-month period (the “Exchange Rate Review”), within 30 days following the end of each such six-month period.

If the average Exchange Rate taken from the Reserve Bank of Australia (https//www.rba.gov.au/statistics/hist-exchange-rates/) during the previous six-month period (the “Average Exchange Rate”) varies by more than 10% (upwards or downwards) as compared to the Exchange Rate applied by the Parties under this Agreement during the same period, the Purchase Price will be adjusted accordingly to ensure that the EMERGE’s and HEMISPHERX’s margin as per the pricing provided under Clause IV. C. of this Agreement are maintained. The corresponding adjustment, calculated on the basis of the sales invoiced to the EMERGE in the corresponding six-month period, will be invoiced within 45 days following the end of the corresponding six-month period.

B.     Termination for breach will include:

2.     Insolvency, or the filing for protection under either Parties’ bankruptcy laws. Upon the filing of a petition in bankruptcy, insolvency or reorganization against or by either Party, or either Party becoming subject to a composition for creditors , whether by law or agreement, or either party going into receivership or otherwise becoming insolvent (such party hereinafter referred to as the "insolvent party"), this Agreement may be terminated by the other Party by giving written notice of termination to the insolvent Party, such termination immediately effective upon the giving of such notice of termination.

Neither this Agreement nor any rights or obligations or licenses hereunder may be assigned, pledged, transferred or encumbered by either party without the express prior written approval of the other party, except that either HEMISPHERX or EMERGE may assign this Agreement to any successor by merger or sale of substantially all of its business or assets to which this Agreement pertains, without any such consent. Any assignment in violation hereof is void.

EMERGE and HEMISPHERX each warrant and represent that it has the full right and power to make the promises set forth in this Agreement and that there are no outstanding agreements, assignments, or encumbrances inconsistent with the provisions of this Agreement.

IX.    EXCEPT AS EXPRESSLY SET FORTH IN THIS SECTION IX, HEMISPHERX MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED, REGARDING THE DEVELOPMENT, VIABILITY, COMMERCIAL OR OTHER USEFULNESS OR SUCCESS OF ALFERON AND THAT NO WARRANTY OR REPRESENTATION THAT ANYTHING MADE, USED, SOLD OR OTHERWISE PRACTICED OR ANY SERVICE PROVIDED UNDER THIS AGREEMENT WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADE SECRET, OR OTHER PROPRIETARY RIGHT, FOREIGN OR DOMESTIC, OF ANY THIRD PARTY AND MAKES NO WARRANTIES OR REPRESENTATIONS AS TO THE VALIDITY, ENFORCEABILITY OR SCOPE OF ANY HEMISPHERX INTELLECTUAL PROPERTY.

A.     INDEMNIFICATION

EMERGE and HEMISPHERX (each an "Indemnifying Party") shall indemnify, defend and hold harmless and the other Party's subsidiaries or affiliates, their agents, directors, officers, employees and assigns (the "Indemnified Parties") from and against all losses, liabilities, damages, demands and expenses (including reasonable attorneys' fees and expenses) arising out of, as a result of, or in connection with (i) the negligent actions of the Indemnifying Party, its employees or any third party acting on behalf of or under authority of the Indemnifying Party in the performance of this Agreement and/or (ii) the violation of any representation or warranty of Indemnifying Party in this Agreement. Each Party's obligations under this provision shall be subject to the other Party providing reasonable notice of any such claim. Each Party shall defend with competent counsel and pay all costs of defence, including attorneys' fees, and any and all damages and court costs awarded in respect to such claim, action or proceeding regarding the claim of infringement. The Indemnified Parties agree to permit the Indemnifying Party to defend, compromise, or settle any such claim, action or proceeding and further agree to provide all available information, and reasonable assistance to enable the other Indemnifying Party to do so. However, neither party will be liable under this indemnity for any losses, liabilities, damages, demands or expenses arising out of the gross negligence or wilful misconduct of the other party or any of its affiliates, agents, directors, officers, employees or assigns. Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE LICENSE GRANTED PURSUANT TO THIS AGREEMENT OR THE USE OR COMMERCIAL DEVELOPMENT OF ALFERON.

B.     WARRANTIES

Subject as herein provided HEMISPHERX warrants to EMERGE that:

Subject to the above WARRANTIEs, HEMISPHERX shall indemnify and hold harmless EMERGE and its respective employees from any loss, damage or claim made by a third party in respect of (i) the death or personal injury arising from the manufacture or use of the Products in the Territory or (ii) infringement of third party intellectual property, if and to the extent such loss, damage or claim is caused by any act or omission of HEMISPHERX and is not attributable directly or indirectly to the breach of any of the material terms of this Agreement by EMERGE or by any wilful default or negligent act or omission of EMERGE, its employees or its agents.

1.     The indemnity given by HEMISPHERX shall be subject to the following conditions:

Subject to clause X.B 1.), EMERGE shall defend and indemnify HEMISPHERX and its Affiliates and hold each of them harmless against all claims, demands, actions, losses, expenses, damages, liabilities, costs (including interest, penalties and reasonable attorneys' fees) and judgements suffered by each of them, which arise out of EMERGE’s negligent or wilful acts or omissions or which otherwise arise out of EMERGE’s breach of the Agreement.

Survivability. The obligations set forth in this Section X. shall survive the termination of this Agreement for the legal periods of limitation provided by US law.

F.    HEMISPHERX is the sole legal and registered owner of "Alferon® ".

1.    Good Will. EMERGE recognizes that there exists great value and good will associated with the Trademark and Intellectual Property use of "Alferon®".

2.     EMERGE agrees that it will not during the term of this Agreement, or thereafter, attack the title or any rights of HEMISPHERX in and to “Alferon®" or attack the validity of the license granted herein by HEMISPHERX and solely owned by HEMISPHERX.

K.    It is agreed that nothing contained in this Sales, Marketing, Distribution, and Supply     Agreement shall be construed as an assignment or grant to the EMERGE of any rights, title or     interest in or to "Alferon® ".

HEMISPHERX will have the option at any time to buy out this Agreement. If exercised within the first two (2) years HEMISPHERX will pay EMERGE three (3) times the Alferon sales for the preceding 12 months. If exercised after year 3, HEMISPHERX will pay EMERGE two (2) times the Alferon sales for the preceding 12 months.

If to HEMISPHERX:

William Carter, MD, Chairman and CEO

One Penn Center

1617 JFK Boulevard

Suite 500

Philadelphia, PA 19103 United States

If to EMERGE:

Chris Rossidis, Head of Commercial Operations

Suite 3, Level 1

2 Theatre Place,

Canterbury VIC 3126, Australia

E.    This Agreement may only be amended in a writing signed by both parties hereto.

This Agreement may be executed in counterparts (and by different parties hereto in different counterparts}, each of which shall constitute an original, but all of which when taken together shall constitute a single contract. This Agreement constitutes the entire contract among the parties relating to the subject matter hereof and supersede any and all previous agreements and understandings, oral or written, relating to the subject matter hereof.

This Agreement shall become effective when it shall have been executed by all parties and upon receipt of all counterparts hereof that, when taken together, bear the signatures of each of the other parties hereto. Delivery of an executed counterpart of a signature page of this Agreement by e-mail and/or telecopy shall be effective as delivery of a manually executed counterpart of this Agreement.

The words "execution," "signed," "signature," and words of like shall be deemed to include electronic signatures or the keeping of records in electronic form, each of which shall be of the same legal effect, validity or enforceability as a manually executed signature or the use of a paper-based recordkeeping system, as the case may be, to the extent and as provided for in any applicable law, including the Federal Electronic Signatures in Global and National Commerce Act, and any other similar State laws based on the Uniform Electronic Transactions Act.

IN WITNESS WHEREOF, the parties have executed this Agreement as of the date written above.

EMERGE HEALTH PTY LTD:         HEMISPHERX BIOPHARMA, INC:

s/Chris Rossidis                    s/William Carter

Chris Rossidis                     William Carter, MD

Head of Commercial Operations         Chairman and CEO

Date:                         Date:

3 August 2015                    August 6, 2015

                        

        

This Quality Agreement is entered by and between Emerge Health Pty Ltd., a pharmaceutical company with its primary offices located at Suite 3, Level 1, 2 Theatre Place, Canterbury VIC 3126, Australia (“COMPANY”) and Hemispherx Biopharma, Inc. 783 Jersey Avenue, New Brunswick, New Jersey 08901(HEB).

The purpose of this Quality Agreement is to clearly define the quality operating procedures, duties and responsibilities to be employed by COMPANY and HEB in the conduct of activities by COMPANY for Hemispherx Biopharma, Inc. The objective of these procedures and this Quality Agreement is assurance that services are conducted in a timely, consistent and uniform manner and in accordance with current laws, directives, regulations and guidelines, as may be applicable to the specific project(s). These requirements may include those defined by the U.S. FDA’s regulations At 21CFR314.80 (Post-marketing reporting of adverse drug experiences for drugs), 21CFR312.32 (IND safety reporting) 21CFR600.80 (Post marketing reporting of adverse experiences for biologics) 21CFR Parts 210 and 211 (“current Good Manufacturing Practices” or “cGMPs”) with particular interest in 21CFR211.1.42 (Warehousing), 21CFR211.150 (Distribution), 21CFR211.204 (Returned drug) and 21CFR211.208 (Drug product salvaging) and/or others that may be appropriate for the particular project.

This Quality Agreement is to be applied to the activities performed by COMPANY, for HEB as specifically defined by the Sales, Marketing, Distribution, and Supply Agreement July (“Agreement”) to which this Quality Agreement is an integral Exhibit. In the event of a conflict between the terms of the Agreement and this Quality Agreement, the terms of the Agreement shall control. Unless otherwise stated in these documents, COMPANY shall follow its Standard Operating Procedures (“SOPs”) with respect to the activities it shall carry out in accordance with the Agreement. Copies of all relevant SOPs shall be provided to HEB for review during audits.

The information and procedures contained in this Quality Agreement are confidential and subject to the terms and conditions of the confidentiality provisions as set forth in the Confidential Disclosure Agreement September 22, 2014 (“CDA”) executed by HEB and COMPANY.

This Agreement between HEB and COMPANY shall be in effect beginning the last date of execution set forth on the signature page to the Agreement (the “Effective Date”) to which this Quality Agreement is Exhibit 2 and remain in effect until HEB and COMPANY terminate the Agreement or it is superseded by a revised Quality Agreement executed by both parties. This Quality Agreement should be reviewed periodically by both parties for any needed updating, revisions, amendments, and the like. Regular periodic review of this Quality Agreement should be conducted to ensure it is up-to-date.

HEB may perform audits for initial qualification of COMPANY as well as periodic audits and “for cause” audits. At mutually agreed upon times, HEB may review standard operating and other quality control procedures and records and the records of COMPANY relating to the Agreement. Such routine and general oversight review is to be requested at least twenty (20) business days in advance, limited to two (2) persons, completed within one (1) to two (2) business days and shall be offered to HEB one (1) time each calendar year. COMPANY will make every reasonable effort to accommodate the special circumstances that may arise pursuant to “for cause” audits. The following applies to all audits:

COMPANY will provide a written response to HEB’s written audit report within twenty (20) business days of receipt of such report setting forth the corrective actions to be taken by COMPANY, if any, and a timeline for such implementation.

In the event of an inspection by any governmental or regulatory authority concerning the activities carried out under the Agreement, COMPANY shall notify HEB promptly upon learning of such an inspection, shall supply HEB with copies of any correspondence or portions of correspondence relating to HEB’s materials and shall inform HEB of the general findings and outcomes of such inspections.

COMPANY and HEB shall cooperate with each other during any such inspection, investigation or other inquiry, including applying reasonable effort, as might be practical, at allowing, upon reasonable request, a representative of HEB to be on site during such inspection, investigation or other inquiry, and providing copies of all documents related to the inspection. Each party acknowledges that it may not direct the manner in which the other party fulfills its obligations to permit inspection by governmental entities

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.

Adverse experience: Any adverse event associated with the use of a biological or drug product in humans, whether or not considered product related, including the following: an adverse event occurring in the course of the use of a biological or drug product in professional practice; an adverse event occurring from overdose of the product whether accidental or intentional; an adverse event occurring from abuse of the product; an adverse event occurring from withdrawal of the product; and any failure of expected pharmacological action.

Disability: A substantial disruption of a person’s ability to conduct normal life functions.

Life-threatening adverse experience: Any adverse experience that places the patient, in the view of the initial reporter, at immediate risk of death from the adverse experience as it occurred, i.e., it does not include an adverse experience that, had it occurred in a more severe form, might have caused death.

Labeled event: An adverse experience that is listed on the product insert as having been observed in patients who are receiving the drug product.

Drug Product: A finished dosage form, for example, tablet, capsule, or solution that contains an active ingredient generally, but not necessarily, in association with inactive ingredients

Serious adverse experience: Any adverse experience occurring at any dose that results in any of the following outcomes: Death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.

Unexpected adverse experience: Any adverse experience that is not listed in the current labelling for the biological or drug product. This includes events that may be symptomatically and pathophysiologically related to an event listed in the labelling, but differ from the event because of greater severity or specificity.

For example, under this definition, hepatic necrosis would be unexpected (by virtue of greater severity) if the labeling only referred to elevated hepatic enzymes or hepatitis. Similarly, cerebral thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if the labeling only listed cerebral vascular accidents. “Unexpected,” as used in this definition, refers to an adverse experience that has not been previously observed (i.e., included in the labeling) rather than from the perspective of such experience not being anticipated from the pharmacological properties of the pharmaceutical product.

Call report: A list of all questions, requests for circulars, and physician/patient complaints received by COMPANY's Clinical Support Department is prepared monthly by COMPANY staff and is forwarded to HEB RA/QA Department.

Audit: A systematic examination of processes, controls and systems, operating procedures, reports, records and/or data to assess COMPANY’s compliance with standards, regulatory submissions, SOPs; applicable laws, regulations, directives, standards and guidelines; the terms of this Agreement and other contracts in place defining the services being provided and to verify data integrity.

Good Manufacturing Practices (“GMPs”): The recognized pharmaceutical regulations and requirements of regulatory authorities such as those defined by the U.S. FDA’s regulations at 21CFR Parts 210 and 211.

Key Contacts: Persons at COMPANY and HEB assigned to assure proper communication and follow-up in a timely manner within both parties’ organizations. Names, titles and full contact information for Key Contacts shall be appended to this Agreement as Attachment 1 and should be maintained up-to-date during the course of the project.

Observation: A statement of fact made during an audit that is substantiated by objective evidence. HEB categorizes observations as follows:

Out-of-Specification / Out-of-Trend (“OOS / “OOT”): A result that is not within the established specifications or trend, whether these are qualitative or quantitative.

Standard Operating Procedures (“SOPs”): Procedures in effect at COMPANY that define the processes and controls by and under which activities are to be conducted to assure compliance with the appropriate Code of Federal Regulations.

To assure proper communication, notification and follow-up in a timely manner by both parties, “Key” contacts are listed in Attachment 1 of this Agreement. Key contacts shall have access to project managers and technical staff and, upon reasonable notice and as required, facilitate resolution of any issues. Every effort will be made by COMPANY to accommodate timely communications, including face-to-face meetings, with HEB.

COMPANY will maintain and follow change control SOP(s) to ensure that changes to equipment, procedures, processes, etc. occur in a controlled manner and in compliance with requirements e defined by the U.S. FDA’s regulations (see Section 2). The implementation of any change that may directly impact the integrity of the activities conducted or data being supplied for HEB will require prior written approval of HEB. COMPANY and HEB will advise the appropriate organization’s staff member (See Attachment 1) before implementation of a change, by either party, to equipment, procedures, specifications, processes, clinical protocols, product claims or facilities directly related to HEB’s specific products and processes. Each party agrees to review the proposed change in a timely manner and, at its discretion, may audit and/or request an alternative or additional change prior to the implementation of the proposed change. The respective party will review the proposed change, determine if it is reasonably practicable to implement the change and can suggest alternative or additional changes prior to the implementation of the proposed change. Change control requirements should be articulated within the specific operation’s documentation practices.

  

HEB is responsible for assuring changes are in accordance with and/or reported to the investigational, marketing and/or any other filing with regulatory agencies (IND, IMPD, CTA, NDA, MA, etc.) and for informing COMPANY of any changes requested by regulatory agencies. COMPANY agrees to keep HEB fully informed of any and all communications with regulatory agencies that may affect the services being provided to HEB by COMPANY.

This Agreement is not meant to supersede or replace controlled documents typically used to define and record the work to be conducted by COMPANY for HEB. Specific requirements of this Agreement and/or any service contracts shall be articulated within COMPANY’s current operating procedures and documentation systems.

COMPANY is responsible for:

HEB is responsible for:

HEB and COMPANY are separately 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, including but not limited to (i) the Federal Food Drug and Cosmetic Act; (ii) the Social Security Act; (iii) HIPPAA; (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.

COMPANY may enter into agreements between COMPANY and a subcontractor. COMPANY will identify the services performed by each such subcontractor. COMPANY is responsible for the performance of all services provided on behalf HEB and the compliance of each subcontractor to the terms of this Agreement. HEB will be permitted to conduct periodic audits of the subcontractors to assure compliance to applicable GMP’s, GLP’s and federal regulations (CFR’s).

The following HEB SOP’s are relevant to this Quality Agreement and interactions between HEB and COMPANY and affiliates.

 

COMPANY shall preserve all records in accordance with any applicable federal, state or local requirements. Raw data, documentation, batch records, source documents, product disposition records and reports (collectively, “Documentation”) shall be retained by COMPANY for a minimum period of two (2) years after termination or expiration of the Specialty Distributor Purchase and Service Agreement between HEB and COMPANY. COMPANY shall, upon written receipt of a written request from HEB, finish such Documentation in a format reasonably acceptable to HEB with thirty (30) days of receipt of such request. In this case, the Documentation will be shipped to the Quality Assurance Manager named in this Agreement (see Key Contact List, Attachment 1). It is the responsibility of HEB to notify COMPANY of any changes in this contact. During the retention period, documentation shall be available for inspection by HEB, its authorized agents and authorized government agencies.

In the event COMPANY is notified of a complaint, COMPANY will receive, investigate and respond to the complaint following its internal procedures. A copy of all complaint investigation documentation will be provided to HEB.

15.    Contact List of Key Personnel. See Attachment 1

IN WITNESS WHEREOF, the parties hereto have executed this Quality Agreement as of the Effective Date.

 

Signature: s/Chris Rossidis                                    

Printed Name: Chris Rossidis                                    

Title: Director, Head of Commercial Operations                            

Date: 03, August, 2015                                        

Signature: s/William A Carter                                    

Printed Name: William A Carter                                    

Title: Chief Executive Officer                                    

Date: August 6, 2015                                        

                        

                

This Return Goods Policy us for all HEB products, Alferon N^® and Alferon^® distributed by COMPANY.

The following products are eligible for return and reimbursement:

AND

OR

The following products are not eligible for return and reimbursement:

HEB will only accept returns shipped to COMPANY. 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 to prevent breakage during transit and otherwise comply with the laws and regulations applicable to the packaging, shipping, and transport of return goods shipments.

HEB is not responsible for shipments lost and/or damaged in transit. HEB recommends that all customers insure return goods shipments.

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

To assist in accurate credit memo processing, please include the following information:

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 HEB. HEB return goods policy is subject to change at any time and without prior notices to other parties.

    

 

                        

 

This Return Goods Policy us for all HEB products, Alferon N^® and Alferon^® distributed by COMPANY.

The following products are eligible for return and reimbursement:

AND

OR

The following products are not eligible for return and reimbursement:

HEB will only accept returns shipped to COMPANY. 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 to prevent breakage during transit and otherwise comply with the laws and regulations applicable to the packaging, shipping, and transport of return goods shipments.

HEB is not responsible for shipments lost and/or damaged in transit. HEB recommends that all customers insure return goods shipments.

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

To assist in accurate credit memo processing, please include the following information:

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 HEB. HEB return goods policy is subject to change at any time and without prior notices to other parties.