patheon_amendmentno4toma






  AMENDMENT NO. 4 TO MANUFACTURING AND COMMERCIAL SUPPLY AGREEMENT    This Amendment No. 4 to Manufacturing and Commercial Supply Agreement (“Amendment  No. 4”) is dated as of September 15, 2022 (the “Amendment No. 4 Effective Date”) and is  entered into between Patheon Austria GmbH & Co KG, with its principal offices located at St.  Peter Strasse 25, A-4020 Linz, Austria (“Patheon”), and Tricida, Inc., a Delaware corporation,  with its principal offices located at 7000 Shoreline Court, Suite 201, South San Francisco, CA  94080 (“Tricida”), in order to amend the Manufacturing and Commercial Supply Agreement  between the parties dated as of October 4, 2019, as amended by Amendment No. 1 dated March  30, 2021, Amendment No. 2 dated August 26, 2021, and Amendment No. 3 dated July 1, 2022  (collectively, the “Agreement”). Each of Patheon and Tricida are sometimes referred to herein as  “Party” or “Parties”.    WHEREAS, consistent with the terms of Section 4 of Amendment No. 3, the Parties have reached  agreement on  work and wish to  set forth the terms herein.    NOW, THEREFORE, the Parties hereby agree as follows:    1. . The Parties will  work on a    incorporating an i during the     , and subject to the following conditions:    a. The remaining  window (as set forth in Section 2 below)  shall be used for the  of the  .  If the     .  A        . Both Parties commit to an  of the   in accordance with applicable industry standards (   ).  b. The    will be discussed  between the technical teams in good faith to ensure compliance with cGMPs and  relevant regulations, but will ultimately be determined by Tricida.   c. The    is attached hereto as  Appendix 1.  The  shall be subject to   ; the technical teams shall discuss  in good  faith and  will ultimately be determined by Tricida.  In the event that     ,  the technical teams will discuss in good faith a    and the JSC will meet and discuss in good faith   .  d. In order to , up to       , at Tricida’s determination.   will be discussed  between the technical teams in good faith but will ultimately be determined by Tricida.      





 






Page 2 of 4  Tricida – Patheon – Amendment 4 to Manufacturing and Commercial Supply Agreement  2. .  The  described in Section 3(c) of Amendment No. 3 is currently f , however Patheon will apply reasonable efforts to  . The   execution of this Amendment No. 4 will be used for   as described in Section 1 above.  3. .  Tricida will pay Patheon a total of  s as described in Section 1 above at  the following  Tricida will pay a of to Patheon for  , upon receipt of appropriate  documentation.  4. . The terms of Amendment No. 3 shall remain unchanged.  This includes, for the avoidance of doubt, that Tricida will pay   at the .  will be used for .    delivered that meets the Product Warranty during the   will be as set forth in Amendment No. 3 and will be made  .  The  to Patheon for the  .  Following  the , to the extent that Patheon   under the CSA and Amendment No. 3 and  under Amendment 3 ( ).   5. Miscellaneous. All capitalized terms used herein that are not otherwise defined shall have the meaning given to them in the Agreement.  All references to Sections and Exhibits shall refer to Sections and Exhibit to the Agreement unless otherwise specifically stated. Except as expressly amended above, all the terms and conditions of the Agreement remain unchanged and in full force and effect.  The Agreement, as amended by this Amendment No. 4, contains the entire understanding of the Parties with respect to the subject matter hereof.  This Amendment No. 4 may be executed in counterparts, each of which shall be deemed an original, and all of which, taken together, shall constitute one and the same agreement.  No modification, amendment, or waiver of this Amendment No. 4 will be effective unless in writing and executed and delivered by the Parties. 





 






Page 3 of 4  Tricida – Patheon – Amendment 4 to Manufacturing and Commercial Supply Agreement  IN WITNESS THEREOF, the Parties have entered into this Amendment No. 4 as of the  Amendment No. 4 Effective Date.  PATHEON AUSTRIA GMBH & CO KG TRICIDA, INC.  By: /s/ Michael Stanek_____________ By: /s/ Gerrit Klaerner_____________ Name: Michael Stanek_____________ Name: Gerrit Klaerner_____________ Title: VP & GM API Global__________ Title: CEO______________________ By: /s/ Klaus Hilber________________ Legal Review: __________________  Name: Klaus Hilber________________ Finance Review: ________________  Title: VP & Global Lead Counsel DSD 





 






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