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Commitments and Contingencies
12 Months Ended
Dec. 31, 2020
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies

Note 10 - Commitments and Contingencies

 

Registration and other stockholder rights

 

In connection with the various investment transactions, the Company entered into registration rights agreements with stockholders, pursuant to which the investors were granted certain demand registration rights and/or piggyback and/or resale registration rights in connection with subsequent registered offerings of the Company’s common stock.

 

Supply agreements

 

In June 2017, the Company entered into an agreement with Life Technologies Corporation, a subsidiary of Thermo Fisher Scientific (“LTC”), to supply the Company with Thermo Fisher Scientific’s QuantStudio 5 Real-Time PCR Systems (“QuantStudio 5”) to be used to run OpGen’s Acuitas AMR Gene Panel tests. Under the terms of the agreement, the Company must notify LTC of the number of QuantStudio 5s that it commits to purchase in the following quarter. As of December 31, 2020, the Company had acquired twenty-four QuantStudio 5s including none during the year ended December 31, 2020. As of December 31, 2020, the Company has not committed to acquiring additional QuantStudio 5s in the next three months.

 

Curetis places frame-work orders for Unyvero-Systems and for raw materials for its cartridge manufacturing to ensure availability during commercial ramp-up-phase and also to gain volume-scale-effects with regards to purchase prices. Some of the electronic parts used for the production of Unyvero-Systems have lead times of many months, hence it is necessary to order such systems with long-term framework-orders to ensure the demands from the market are covered. The aggregate purchase commitments over the next twelve months are approximately $3.1 million.

 

Contingencies

 

On March 11, 2020, the World Health Organization declared the outbreak of a novel coronavirus (“COVID-19”) as a global pandemic, which continues to spread throughout the United States and around the world.

As a result, the Company has experienced a material impact on its business, financial condition and results of operations for the year ended December 31, 2020 and significant business disruptions as a result of the outbreak. For example, most of the Company’s employees in the U.S. are currently working remotely from home, the Company has suspended virtually all business travel, and the Company is generally unable to physically meet with future and current customers to sell and market its products. In addition, the COVID-19 pandemic has interrupted many of the Company’s clinical activities, which might delay its ability to complete clinical trials and obtain regulatory approval for new products including FDA clearance of its Acuitas AMR Gene Panel (Isolate) product.

The Company is monitoring the impacts of COVID-19 on the global economy and on its business operations. However, at this time, it is difficult to predict how long the potential operational impacts of COVID-19 will remain in effect or to what degree they will impact the Company’s operations and financial results. An extended period of global supply chain and economic disruption could materially affect the Company’s business, results of operations, access to sources of liquidity and financial condition, as well as its ability to execute its business strategies and initiatives in their respective expected time frames. As a result, the Company is unable to estimate the potential impact on its business as of the date of this filing.