U.S. Manufacture. To the extent required, Licensee agrees to abide by the Preference for United States Industry as set forth in 37 CFR 401.14 (I).
U.S. Manufacture. LICENSEE agrees that any Licensed Products will be manufactured substantially in the United States of America as required by 00 Xxxxxx Xxxxxx Code Section 204.
U.S. Manufacture. To the extent required by applicable United States laws, if at all, Licensee agrees that Licensed Products will be manufactured in the United States, or its territories, subject to such waivers as may be required, or obtained, if at all, from the United States Department of Health and Human Services, or its designee.
U.S. Manufacture. Licensee shall manufacture Licensed Products leased, used or sold in the United States substantially in the United States as required by 35 U.S.C. 204 and 37 C.F.R. 401 et. seq., as amended. Licensee shall also require any Affiliate(s) or Sublicensee(s) to comply with this U.S. manufacture requirement.
U.S. Manufacture. If applicable, Licensee agrees that it and its Sublicensees will abide by the Preference for United States Industry as set forth in 37 C.F.R. Section 401.14(I), which requires that any Licensed Product sold in the United States shall be [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. manufactured substantially in the United States.
U.S. Manufacture. To the extent TGTX manufactures Licensed Products (e.g. if TGTX and CTI agree that CTI will no longer be the sole manufacturer of Licensed Products), TGTX shall manufacture Licensed Products leased, used or sold in the United States substantially in the United States as required by 35 U.S.C. 204 and 37 C.F.R. 401 et. seq., as amended. TGTX shall also require any Affiliate(s) or Sublicensee(s) to comply with this U.S. manufacture requirement. Notwithstanding the foregoing, if TGTX or its Affiliate(s) or Sublicensee(s) determines that it is not commercially feasible or reasonable to manufacture such Licensed Products in the United States or determines that it is necessary to have additional manufacturers outside the United States for back-up supply or to supply Licensed Products outside the United States, then CTI agrees to make reasonable efforts to assist TGTX, or its Affiliate(s) or Sublicensee(s), as applicable, at TGTX’ expense, in obtaining any necessary permission from the appropriate government authorities to manufacture such Licensed Products outside the United States.
U.S. Manufacture. To comply with United States government regulations for the licensing of federally funded inventions, Celgene, its Affiliates and any Sublicensees will commit that Licensed Products covered by the Salk Patent Rights sold in the United States will be manufactured substantially in the United States to the extent required by Applicable Law. Notwithstanding the foregoing, during the Agreement Term, upon Celgene’s request, Acceleron agrees to seek a waiver from the United States government with respect to the requirement that Licensed Products for sale in the United States be manufactured substantially in the United States. Celgene understands that Acceleron cannot guarantee that such waiver can be obtained.
U.S. Manufacture. To the extent required by U.S. law or by the terms of any U.S. Government funding agreement with respect to the Licensed Patents, Licensed Products for sale in the U.S. will be manufactured or produced substantially in the U.S.
U.S. Manufacture. Subject to Article 6, in partial consideration of the rights granted by Lonza to Akouos under this Agreement, Akouos shall, unless waived, manufacture in the United States Licensed Products which are leased, used or sold in the United States. Akouos shall also require any Affiliate(s) or Sublicensee(s) to comply with this U.S. manufacture requirement.
U.S. Manufacture. CTI shall manufacture Licensed Products leased, used or sold in the United States substantially in the United States as required by 35 U.S.C. 204 and 37 C.F.R. 401 et. seq., as amended. CTI shall also require any Affiliate(s) or Sublicensee(s) to comply with this U.S. manufacture requirement. Notwithstanding the foregoing, if CTI or its Affiliate(s) or Sublicensee(s) determines that it is not commercially feasible or reasonable to manufacture such Licensed Products in the United States or determines that it is necessary to have additional manufacturers outside the United States for back-up supply or to supply Licensed Products outside the United States, then DFCI agrees to make reasonable efforts to assist CTI, or its Affiliate(s) or Sublicensee(s), as applicable, at CTI’ expense, in obtaining any necessary permission from the appropriate government authorities to manufacture such Licensed Products outside the United States.
