Versartis, Inc. (NASDAQ:VSAR) Files An 8-K Entry into a Material Definitive Agreement

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Versartis, Inc. (NASDAQ:VSAR) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01 Entry into a Material Definitive Agreement

On December 21, 2016, Versartis, Inc. (“we” or “us”) through our subsidiary, Versartis GmbH, entered into a Commercial Supply Agreement with Boehringer Ingelheim Biopharmaceuticals GmbH (“BI”), to which we engaged BI as a contract manufacturer to manufacture the bulk drug substance for our proprietary long-acting human growth hormone, somavaratan (VRS-317), fill it into the final container and closure and supply such drug product to us for commercial use.

Under the agreement, each calendar year we are required to reserve minimum drug substance manufacturing capacity, order from BI a minimum number of batches of drug substance, and purchase and take possession of a minimum number of batches of drug product. If we do not order and purchase these minimum quantities, we will need to pay fees to BI based on the shortfalls in our product orders or purchases, unless there is a supply failure or supply interruption by BI. The agreement includes customary terms and conditions relating to, among other things, forecast, ordering, delivery, inspection, acceptance and product warranties.

The initial term of the agreement continues for a period of eight years and, after the initial term, the agreement will automatically renew for periods of three years each. The agreement may be earlier terminated by either party for technical reasons if BI is unable to implement or consistently perform the manufacturing process on a commercial scale. We have the right to terminate this agreement if we are unable to achieve the clinical targets or target product profile for somavaratan or if we are unable to obtain regulatory approval of the product. The agreement may also be terminated by either party for the other party’s uncured material breach, insolvency, and certain change of control and force majeure events. In addition, either party may terminate the agreement without cause upon three years’ advance notice.

Upon termination of the agreement or if our demand for the product exceeds the maximum capacity reservation at BI, we have the right to add an additional manufacturing site or transfer the entire manufacturing process to ourselves or our designee.

The foregoing is only a summary of the material terms of the Agreement, does not purport to be a complete description of the rights and obligations of the parties thereunder and is qualified in its entirety by reference to the agreement that will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016.


About Versartis, Inc. (NASDAQ:VSAR)

Versartis, Inc. is an endocrine-focused biopharmaceutical company. The Company is engaged in developing long-acting recombinant human growth hormone (rhGH), somavaratan (VRS-317), for growth hormone deficiency (GHD), an orphan disease. The Company’s product pipeline includes VRS-317 and XTEN Technology. The Company’s VRS-317 combines the rhGH amino acid sequence utilized in approved rhGH products with a half-life extension technology, XTEN, to enable less frequent administration. The XTEN technology consists of hydrophilic amino acids added at the genetic level as part of the manufacturing process. The Company’s XTEN is a recombinant polypeptide designed to extend the in vivo half-life of peptides and proteins in a tunable manner. The XTEN sequence consists of hydrophilic amino acids and possesses various additional properties, which are used for the development of protein pharmaceuticals.

Versartis, Inc. (NASDAQ:VSAR) Recent Trading Information

Versartis, Inc. (NASDAQ:VSAR) closed its last trading session down -0.55 at 15.15 with 143,473 shares trading hands.