XML 29 R15.htm IDEA: XBRL DOCUMENT v3.19.1
Research, Consulting and Supply Agreements
12 Months Ended
Dec. 31, 2018
Research Consulting And Supply Agreements  
Research, Consulting and Supply Agreements

(9) Research, Consulting and Supply Agreements

 

In 2016, we entered into a five-year agreement (the “Impatients Agreement”) with Impatients, N.V. (“myTomorrows”), a Netherlands based company, for the commencement and management of an EAP in Europe and Turkey (the “Territory”) related to ME/CFS. Pursuant to the agreement, myTomorrows, as our exclusive service provider and distributor in the Territory, is performing EAP activities.

 

In 2017, we entered into a purchase order with Jubilant pursuant to which Jubilant will manufacture batches of Ampligen® for the Company. Two commercial size batches were filled and finished for human use in 2018. We paid Jubilant $320,000 in 2017 and $1,078,000 in 2018 for a total of $1,398,000 to date for these services.

 

In 2017, Hemispherx filed a complaint in the Philadelphia County Court of Common Pleas Civil Trial Division against Nitto Avecia Pharma Services, Inc. (“NAPS”), the successor to Avrio Biopharmaceuticals, LLC (“Avrio”), primarily for breach of contract. Pursuant to the applicable agreement, Avrio was to provide fill and finish services of Ampligen®. Hemispherx sought damages due to Avrio’s failures and omissions during the fill and finish process which led to a loss of product. In June 2017, NAPS filed an answer denying liability and counter claiming breach of contract by Hemispherx. In March of 2018, the parties agreed to fully resolve their dispute by agreement for a satisfactory payment to Hemispherx and additional consideration. There was a gain of $474,000 resulting from the settlement of litigation with Nitto Avecia Pharma Services, Inc

 

The Company has an agreement with Asembia, formerly Armada Healthcare, LLC to undertake the marketing, education and sales of Alferon N Injection® throughout the United States. This agreement also provides start-up along with ongoing sales and marketing support to the Company. In August 2017, the Company extended this agreement through August 14, 2019 subject to the same terms and conditions. The Company incurred no fees for the years ended December 31, 2018, and 2017, pursuant to the original and amended agreements.

 

In 2017, we announced that the EAP through our agreement with myTomorrows designed to enable access of Ampligen to ME/CFS patients has been extended to pancreatic cancer patients beginning in the Netherlands. myTomorrows is our exclusive service provider in Europe and Turkey and will manage all EAP activities relating to the pancreatic cancer extension of the program.

 

In 2018, we signed two amendments to the EAP with myTomorrows. The first extended the territory to cover Canada to treat pancreatic cancer patients, pending government approval and the second to be our exclusive service provider for special access activities in Canada for the supply of Ampligen for the treatment of ME/CFS.