Outsourcing to third parties. Company shall, only after receiving prior written approval by Iovance (which such approval may be withheld in Iovance’s sole discretion), be entitled to outsource discrete portions of the Services to Third Parties, which such approval shall be received in the form of an executed Statement of Work that specifically identifies such Third Parties, the Services to be so outsourced, and the location(s) at which such outsourced Services will be performed; provided that (i) the terms of any such arrangement between such Third Party and Company are substantially identical in their effect to those set forth in this Agreement, especially in terms of confidentiality, Intellectual Property rights, and compliance with Laws, (ii) Company shall be responsible for the initial and ongoing Third Party qualification (including any appropriate validation or verification of the Services to be performed by such Third Party, including, to the extent applicable, equipment to be used by any such Third Party), to the extent required by Law, and for Company’s obligations for Services provided by any Third Party under this Agreement or any Statement of Work, and (iii) Company shall remain liable for Company’s obligations under this Agreement or any applicable Statement of Work regardless of the failure of any such Third Party to perform the subcontracted Services in accordance with this Agreement. Company hereby expressly waives any requirement that Iovance exhaust any right, power or remedy, or proceed against any such Third Party, for a breach of any of Company’s obligation or performance hereunder due to such Third Party’s failure prior to proceeding directly against Company. Subject to Section 10.4.2, Iovance shall have the right to review Company’s qualification of all Third Parties and Third Party activities under this Agreement or any Statement of Work and shall have the right to inspect or audit, itself or through a Representative, or attend any Company inspection or audit of such Third Party before providing written approval of such Third Party. Iovance’s review, audit and inspection, and attendance rights hereunder shall continue following Iovance’s written approval of the Third Party and shall further extend to any Third Party re-qualification (including any appropriate re-validation or re-verification of Services, including, to the extent applicable, equipment to be used by any such Third Party), to the extent such re-qualification is required by Law, and re-qualification of Third Party activities under this Agreement or any Statement of Work conducted by Company of any such Third Party.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Iovance Biotherapeutics, Inc.)
Outsourcing to third parties. Company shall, only after receiving prior written approval by Iovance LBIO (which such approval may be withheld in IovanceLBIO’s sole discretion), be entitled to outsource discrete portions of the Services to Third Parties, which such approval shall be received in the form of an executed Statement of Work that specifically identifies such Third Parties, the Services to be so outsourced, and the location(s) at which such outsourced Services will be performed; provided that (i) the terms of any such arrangement between such Third Party and Company are substantially identical in their effect to those set forth in this Agreement, especially in terms of confidentiality, Intellectual Property rights, and compliance with LawsLaws , (ii) Company shall be responsible for the initial and ongoing Third Party qualification (including any appropriate validation or verification of the Services to be performed by such Third Party, including, to the extent applicable, equipment to be used by any such Third Party), to the extent required by Law, and for Company’s obligations for Services provided by any Third Party under this Agreement or any Statement of Work, and (iii) Company shall remain liable for Company’s obligations under this Agreement or any applicable Statement of Work regardless of the failure of any such Third Party to perform the subcontracted Services in accordance with this Agreement. Company hereby expressly waives any requirement that Iovance LBIO exhaust any right, power or remedy, or proceed against any such Third Party, for a breach of any of Company’s obligation or performance hereunder due to such Third Party’s failure prior to proceeding directly against Company. Subject to Section 10.4.2, Iovance LBIO shall have the right to review Company’s qualification of all Third Parties and Third Party activities under this Agreement or any Statement of Work and shall have the right to inspect or audit, itself or through a Representative, or attend any Company inspection or audit of such Third Party before providing written approval of such Third Party. IovanceLBIO’s review, audit and inspection, and attendance rights hereunder shall continue following IovanceLBIO’s written approval of the Third Party and shall further extend to any Third Party re-qualification (including any appropriate re-validation or re-verification of Services, including, to the extent applicable, equipment to be used by any such Third Party), to the extent such re-qualification is required by Law, and re-qualification of Third Party activities under this Agreement or any Statement of Work conducted by Company of any such Third Party.
Appears in 1 contract
Sources: Manufacturing Services Agreement (Lion Biotechnologies, Inc.)