Amendment No. 1 to Manufacturing Agreement between Merck & Co., Inc. and Regeneron Pharmaceuticals, Inc.

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Summary

Merck & Co., Inc. and Regeneron Pharmaceuticals, Inc. have agreed to clarify how batches of an intermediate product, manufactured by Regeneron during a specific period, will be treated under their manufacturing agreement. All batches produced during the consistency and validation period, but before confirming that earlier batches meet required specifications, will be considered as manufactured in the first contract year, even if the contract year starts later. Both parties have signed to confirm this mutual understanding.

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EX-10.4.1 3 y06183exv10w4w1.txt AMENDMENT #1 TO MANUFACTURING AGREEMENT Exhibit 10.4.1 [Merck & Co., Inc. Letterhead] September 18, 1995 Mr. Murray Goldberg Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, New York 10591 Dear Murray: This shall serve to reflect our total understanding of the status of batches of INTERMEDIATE manufactured by Regeneron during a period of time following the actual manufacture of [**] batches during the CONSISTENCY and VALIDATION period but prior to the determination that such [**] batches do conform to all applicable specifications and may be released. "All batches manufactured during the CONSISTENCY and VALIDATION period, but prior to such determination of conformity of the prior [**] batches shall be determined to have been manufactured during the first contract year notwithstanding the fact that the contract year may not commence for some period of time following their actual manufacture." If the foregoing adequately expresses our mutual understanding, would you kindly so indicate by signing, dating and returning to us the enclosed copy of this letter agreement. Very truly yours, MERCK & CO., INC. By: /s/John Pashko THE FOREGOING IS ACCEPTED AND REPRESENTS OUR MUTUAL UNDERSTANDING OF THE AGREEMENT: REGENERON PHARMACEUTICALS, INC. By: /s/Murray Goldberg - ----------------------------------------------- Title: Vice President-Finance & Administration