Recro Pharma, Inc. (NASDAQ:REPH) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On July14, 2017, Recro Pharma, Inc., through its subsidiary Recro Ireland Limited (collectively, the “Company”) entered into a Master Manufacturing Services Agreement (the “Master Agreement”) and a related Product Agreement (the “Product Agreement,” and together with the Master Agreement, the “Agreements”) with Patheon UK Limited (“Patheon”), each effective as of July14, 2017. The Master Agreement governs the general terms under which Patheon, or one of its affiliates, will provide manufacturing services to the Company for the drug products specified by the Company from time to time. The Product Agreement relates specifically to manufacturing services for injectable meloxicam.
Under the terms of the Product Agreement, Recro will supply bulk injectable meloxicam formulation to Patheon for sterile fill-finish at Patheon’s Monza, Italy manufacturing site. The Company has agreed to purchase from Patheon a certain percentage of its annual requirements in a specified territory of any drug manufactured under the Master Agreement, however the Company is not required to purchase any minimum quantities of injectable meloxicam or any other drug product under the Agreements. to the terms of the Agreements, the Company has granted to Patheon a non-exclusive license to its intellectual property solely for the purpose of enabling Patheon to perform the manufacturing services under the Agreements.
The Agreements expire on December31, 2020 and will automatically renew thereafter for successive two-year periods unless terminated by either party upon prior written notice. The Company may terminate each Agreement upon prior notice if (i)a governmental authority prevents the Company from importing, exporting, purchasing or selling the underlying product, (ii)the underlying product is discontinued in the market or (iii)Patheon fails to timely deliver batches of the underlying product (injectable meloxicam in the case of the Product Agreement). Patheon may terminate the Master Agreement or the Product Agreement if the Company assigns any rights thereunder to a Patheon competitor or to a non-credit worthy substitute. Either party may also terminate each Agreement for material, uncured breaches or in the event of the other party’s bankruptcy.
The Agreements contain customary representations, warranties, mutual indemnities, limitations of liability and confidentiality provisions.
The foregoing description of the Agreements does not purport to be complete and is qualified in its entirety by the Agreements, copies of which the Company intends to file as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ending September30, 2017.
About Recro Pharma, Inc. (NASDAQ:REPH)
Recro Pharma, Inc. is a clinical-stage specialty pharmaceutical company. The Company is engaged in developing products for hospitals and ambulatory care settings that is developing non-opioid products for treatment of serious acute pain. The Company’s lead product candidate is an injectable form of meloxicam. Its product candidates for pain indications include injectable meloxicam, a product candidate in development for the treatment of acute post-operative pain; Dex-IN, a product candidate under development for the treatment of post-operative pain; Dex-SL, a product candidate for the treatment of chronic pain, and Fadolmidine (Fado), a product candidate used by injection into the spine for pain associated with surgery or certain types of chronic pain and which the Company pursues as a topical product for local application to treat serious pain associated with nerve damage to local tissues (neuropathies), especially of the lower extremities, which can occur in diabetic patients.