EVOKE PHARMA, INC. (NASDAQ:EVOK) Files An 8-K Entry into a Material Definitive AgreementItem 1.01Entry into a Material Definitive Agreement.
On November 7, 2017, Evoke Pharma, Inc. (the “Company”) entered into a Manufacturing Services Agreement (the “Manufacturing Agreement”) with Patheon UK Limited, a wholly-owned subsidiary of Thermo Fisher, Inc. (“Patheon”), to which Patheon has agreed to manufacture commercial quantities of Gimoti, the Company’s nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis. Under the terms of the Manufacturing Agreement, the Company is required to purchase a certain percentage of its requirements for its Gimoti product intended for commercial sale, provided certain terms and conditions are met.
The initial term of the Manufacturing Agreement commenced on November 7, 2017 and shall continue in effect until December 31st of the year that is five years from the date Gimoti first receives approval for marketing from the U.S. Food and Drug Administration (the “FDA”) or any other foreign regulatory agencies competent to grant marketing approvals for pharmaceutical products. This initial term shall be automatically renewed for additional one year terms, unless either party provides written notice of its intention to terminate the Manufacturing Agreement upon notice within a specified time prior to the end of the then current term. Either party may terminate the Manufacturing Agreement effective immediately upon written notice to the other in the event that (i) the other party dissolves, is declared insolvent or bankrupt by a court of competent jurisdiction, (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction, or (iii) the Manufacturing Agreement is assigned for the benefit of creditors. Evoke may terminate the Manufacturing Agreement upon specified prior written notice if any governmental or regulatory authority, including, but not limited to, the FDA, takes any action, or raises any objection, that prevents Evoke from importing, exporting, purchasing, or selling Gimoti. Patheon or Evoke may terminate the Manufacturing Agreement upon specified prior written notice to the other party if Patheon or Evoke, as applicable, assigns any of its rights under the Manufacturing Agreement to an assignee that is (i) not a credit worthy substitute for the assigning party; or (ii) a competitor of assigning party. Moreover, either party may terminate the Manufacturing Agreement upon written notice to the other party where the other party has failed to remedy a material breach of any of its representations, warranties, or other obligations under the Manufacturing Agreement within a specified period of time following receipt of a written notice of the breach, subject to specified terms and conditions.
The foregoing description of the Manufacturing Agreement does not purport to be complete and is qualified in its entirety by the Manufacturing Agreement, a copy of which Evoke intends to file with its Annual Report on Form 10-K for the fiscal year ending December 31, 2017, requesting confidential treatment for certain portions
About EVOKE PHARMA, INC. (NASDAQ:EVOK)
Evoke Pharma, Inc. is a specialty pharmaceutical company. The Company is focused primarily on the development of drugs to treat gastrointestinal (GI) disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in women. EVK-001 is a formulation of Metoclopramide drug, designed to provide systemic delivery of metoclopramide through intranasal administration. The Company has evaluated EVK-001 in a multicenter, randomized, double-blind, placebo-controlled parallel group, dose-ranging Phase IIb clinical trial. The Company has commenced a Phase III clinical trial of EVK-001 in female patients with symptoms associated with acute and recurrent diabetic gastroparesis. The Phase III clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety and population pharmacokinetics of EVK-001 in adult females.