Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) Files An 8-K Entry into a Material Definitive AgreementItem 1.01
On June 14, 2017, Tetraphase Pharmaceuticals, Inc. (the Company) and Patheon UK Limited and certain of its affiliates (collectively, Patheon) entered into a Master Manufacturing Services Agreement (the Master Agreement). Under the Master Agreement, the Company is responsible for supplying the active pharmaceutical ingredient for eravacycline to Patheon, and Patheon is responsible for manufacturing eravacycline, conducting quality control, quality assurance, analytical testing and stability testing and packaging.
The Company expects to enter into two related Product Agreements (each a Product Agreement) to the Master Agreement to govern the terms and conditions of Patheons manufacture of commercial supplies of eravacycline, the Companys lead product candidate, at Patheons Greenville, North Carolina and Ferentino, Italy manufacturing sites. Each Product Agreement that the Company may enter into from time to time will be governed by the terms of the Master Agreement, unless expressly modified in such Product Agreement.
to the Master Agreement, the Company has agreed to order from Patheon at least a certain percentage of its annual commercial requirements for eravacycline in the United States and European Union each year for the term of the Master Agreement.
The Master Agreement has an initial term ending December 31, 2022, and will automatically renew after the initial term for successive terms of two years each, unless either party gives notice of its intention to terminate the Master Agreement at least 18 months prior to the end of the then current term.
The Company may terminate a Product Agreement upon 30 days prior written notice if any governmental agency takes any action that prevents the Company from importing, exporting, purchasing or selling eravacycline.
Either party may terminate the Master Agreement or a Product Agreement (a) upon written notice if the other party has failed to remedy a material breach under the Master Agreement or a Product Agreement within a specified time following receipt of written notice of such breach, and (b) immediately upon written notice to the other party in the event that the other party is declared insolvent or bankrupt, a voluntary petition of bankruptcy is filed in any court by such other party or the Master Agreement or a Product Agreement is assigned by such other party for the benefit of creditors.
Patheon may terminate the Master Agreement or a Product Agreement upon six months written notice if the Company assigns the Master Agreement to an assignee that, in the opinion of Patheon acting reasonably, is (i) not a creditworthy substitute for the Company, or (ii) a competitor of Patheon.
The Master Agreement contains, among other provisions, customary representations and warranties by the parties, a grant to Patheon of certain limited license rights to the Companys intellectual property in connection with Patheons performance of the services under the Master Agreement, certain indemnification rights in favor of both parties, limitations of liability and customary confidentiality provisions.
The foregoing description of the material terms of the Master Agreement does not purport to be complete and is subject to, and is qualified in its entirety by, reference to the Master Agreement, which will be filed as an exhibit to the Companys Quarterly Report on Form 10-Q for the fiscal quarter ending June 30, 2017. The Company intends to seek confidential treatment for certain portions of the Master Agreement to a Confidential Treatment Request submitted to the Securities and Exchange Commission to Rule 24b-2 under the Securities Exchange Act of 1934, as amended.
About Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH)
Tetraphase Pharmaceuticals, Inc. (Tetraphase) is a clinical-stage biopharmaceutical company. The Company uses its chemistry technology to create antibiotics for multidrug-resistant infections. It is developing its lead product candidate, eravacycline, a fully synthetic tetracycline derivative, as a spectrum intravenous (IV) and oral antibiotic for use as a first-line empiric monotherapy for the treatment of multidrug-resistant infections. It has developed eravacycline using its chemistry technology. The Company’s TP-271 is a fully synthetic spectrum preclinical compound that the Company developed for respiratory diseases caused by bacterial biothreat pathogens. The Company created TP-271 using its chemistry technology. In its development program for TP-271, the Company has conducted a number of in vitro, toxicology and animal studies to evaluate the efficacy of TP-271 against biothreat pathogens. It also develops TP-6076 for multidrug-resistant Gram- negative infections.