AMENDMENT NO. 2 TO DEVELOPMENT AND
MANUFACTURING SERVICES AGREEMENT
Amendment No. 2 to Development and Manufacturing and Services Agreement effective as of July 15, 2020 (the “Amendment No. 2”), between RHYTHM PHARMACEUTICALS, INC., a Delaware corporation, located at 222 Berkeley Street, 12th Floor, Boston, MA 02116, f/k/a Rhythm Metabolics, Inc. (“RHYTHM”), and Corden Pharma Brussels S.A., a Belgian company located at Rue de Ransbeek 310, 1120 Bruxelles, successor-in-interest to Peptisyntha, Inc. (“MANUFACTURER,” and together with Rhythm, the “Parties”, and each, a “Party”).
WHEREAS, Rhythm and Peptisyntha Inc. have entered into a Development and Manufacturing and Services Agreement, effective as of July 17, 2013 (the “Existing Agreement”), which was assigned from Peptisyntha Inc. to Corden Pharma Brussels S.A. f/k/a Peptisyntha S.A.; and
WHEREAS, the Parties have entered into a Quality Agreement with an effective date of March 27, 2019 superseding all previous quality assurance agreements between them (the “Quality Agreement”); and
WHEREAS, the Parties have entered into an Amendment No. 1 of the Existing Agreement effective February 20, 2020, including as Appendix B a new Setmelanotide Work Order (the “Amendment No. 1”); and
WHEREAS, any reference to the Agreement shall be understood as a reference to the Existing Agreement, as amended by Amendment No. 1; and
WHEREAS, the Parties have agreed to a Memorandum of Understanding (“MOU”) dated July 8, 2020 concerning, among other things, the terms of this Amendment No. 2, and
WHEREAS, the COVID-19 pandemic has affected the Kingdom of Belgium substantially, which led to a partial shutdown of the entire economy of the country starting mid-March 2020 and has not yet been overcome; and
WHEREAS, the Parties hereto desire to amend the Agreement to provide for a revised basis for the preparation of the manufacture of Setmelanotide API lots by Manufacturer on the terms and subject to the conditions set forth herein; and
WHEREAS, pursuant to Section 15.6 of the Agreement, the amendment contemplated by the Parties must be contained in a written agreement signed by an authorized representative of each Party.
NOW, THEREFORE, in consideration of the foregoing and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
1. Definitions. Capitalized terms used and not defined in this Amendment No. 2 have the respective meanings assigned to them in the Agreement.
2. Amendment No. 2 to the Agreement. As of the effective date of Amendment No. 2, the Agreement is hereby amended or modified as follows: