Common use of Second Site/Source Clause in Contracts

Second Site/Source. Biocon shall have the right to use the services of its Affiliates and Third Party contractors, including CMOs, to assist such Biocon in fulfilling its obligations and exercising its rights under the Commercial Supply Agreement; provided that (i) the JSC approves any contractor in advance, such approval not to be unreasonably withheld or delayed by the Equillium representatives on the JSC; (ii) none of Equillium’s rights under the Commercial Supply Agreement or this Agreement are diminished or otherwise adversely affected as a result of Biocon’s use of Affiliates or contractors; and (iii) the contractor or Affiliate has entered into a written agreement with Biocon binding such Person to the obligations Biocon has to Equillium, including obligations of intellectual property assignment and confidentiality and non-use, and containing any other provisions normal and customary for similar types of agreements consistent with the Commercial Supply Agreement and this Agreement; and provided, further, that Biocon shall at all times be responsible for the satisfactory accomplishment of its obligations under and in accordance with, and the contractor’s or Affiliate’s compliance with, the terms and conditions of the Commercial Supply Agreement and this Agreement. For clarity, for purposes of clause (i) of the preceding sentence, it shall not be unreasonable for the Equillium representatives on the JSC to withhold approval of a proposed contractor if such contractor (A) has received any Form FD-483 notice (or foreign equivalent) or any FDA or other Regulatory Authority refusal to file, rejection or warning letter that has not been fully addressed by such contractor to the satisfaction of the applicable Regulatory Authority, (B) is debarred under Applicable Laws in the US, including 21 U.S.C. §335a, or any comparable Applicable Laws outside of the US. Without prejudice to the generality of the foregoing, in the event of a Failure to Supply on Biocon’s part, the parties will evaluate alternative approaches to source the shortfall in supply, which may include, without limitation, Biocon’s performance of a manufacturing technology transfer (the reasonable costs of such technology transfer to be borne by Biocon) to a CMO identified by the JSC and appointed by the JSC with Biocon’s prior written consent, such consent not to be unreasonably withheld, to permit such CMO to manufacture ITO and Product, using the manufacturing process developed and used by Biocon, for use and distribution in the Field in the Equillium Territory.

Second Site/Source. Biocon shall have the right to use the services of its Affiliates and Third Party contractors, including CMOs, to assist such Biocon in fulfilling its obligations and exercising its rights under the Commercial Supply this Agreement; provided that (i) the JSC approves any contractor in advance, such approval not to be unreasonably withheld or delayed by the Equillium representatives on the JSC; (ii) none of Equillium’s rights under the Commercial Supply this Agreement or this the License Agreement are diminished or otherwise adversely affected as a result of Biocon’s use of Affiliates or contractors; and (iii) the contractor or Affiliate has entered into a written agreement with Biocon binding such Person to the obligations Biocon has to Equillium, including obligations of intellectual property assignment and confidentiality and non-use, and containing any other provisions normal and customary for similar types of agreements consistent with the Commercial Supply this Agreement and this the License Agreement; and provided, further, that Biocon shall at all times be responsible for the satisfactory accomplishment of its obligations under and in accordance with, and the contractor’s or Affiliate’s compliance with, the terms and conditions of the Commercial Supply this Agreement and this the License Agreement. For clarity, for purposes of clause (i) of the preceding sentence, it shall not be unreasonable for the Equillium representatives on the JSC to withhold approval of a proposed contractor if such contractor (A) has received any Form FD-483 notice (or foreign equivalent) or any FDA or other Regulatory Authority refusal to file, rejection or warning letter that has not been fully addressed by such contractor to the satisfaction of the applicable Regulatory Authority, (B) is debarred under Applicable Laws in the US, including 21 U.S.C. §335a, or any comparable Applicable Laws outside of the US. Without prejudice to the generality of the foregoing, in the event of Biocon is unable to meet Equillium’s orders submitted in accordance with this Agreement for more than […***…] consecutive calendar quarter periods (a “Failure to Supply on Biocon’s partSupply”), the parties JSC (or a manufacturing subcommittee thereof) will evaluate alternative approaches to source the shortfall in supply, which may include, without limitation, Biocon’s performance of a manufacturing technology transfer (the reasonable costs of such technology transfer to be borne by Biocon) to a CMO identified by the JSC and appointed by the JSC with Biocon’s prior written consent, such consent not to be unreasonably withheld, to permit such CMO to manufacture ITO and Product, using the manufacturing process developed and used by Biocon, for use and distribution in the Field in the Equillium Territory.

Second Site/Source. Biocon shall have the right to use the services of its Affiliates and Third Party contractors, including CMOs, to assist such Biocon in fulfilling its obligations and exercising its rights under the Commercial Supply this Agreement; provided that (i) the JSC approves any contractor in advance, such approval not to be unreasonably withheld or delayed by the Equillium representatives on the JSC; (ii) none of Equillium’s rights under the Commercial Supply this Agreement or this the License Agreement are diminished or otherwise adversely affected as a result of Biocon’s use of Affiliates or contractors; and (iii) the contractor or Affiliate has entered into a written agreement with Biocon binding such Person to the obligations Biocon has to Equillium, including obligations of intellectual property assignment and confidentiality and non-use, and containing any other provisions normal and customary for similar types of agreements consistent with the Commercial Supply this Agreement and this the License Agreement; and provided, further, that Biocon shall at all times be responsible for the satisfactory accomplishment of its obligations under and in accordance with, and the contractor’s or Affiliate’s compliance with, the terms and conditions of the Commercial Supply this Agreement and this the License Agreement. For clarity, for purposes of clause (i) of the preceding sentence, it shall not be unreasonable for the Equillium representatives on the JSC to withhold approval of a proposed contractor if such contractor (A) has received any Form FD-483 notice (or foreign equivalent) or any FDA or other Regulatory Authority refusal to file, rejection or warning letter that has not been fully addressed by such contractor to the satisfaction of the applicable Regulatory Authority, (B) is debarred under Applicable Laws in the US, including 21 U.S.C. §335a, or any comparable Applicable Laws outside of the US. Without prejudice to the generality of the foregoing, in the event of Biocon is unable to meet Xxxxxxxxx’s orders submitted in accordance with this Agreement for more than […***…] consecutive calendar quarter periods (a “Failure to Supply on Biocon’s partSupply”), the parties JSC (or a manufacturing subcommittee thereof) will evaluate alternative approaches to source the shortfall in supply, which may include, without limitation, Biocon’s performance of a manufacturing technology transfer (the reasonable costs of such technology transfer to be borne by Biocon) to a CMO identified by the JSC and appointed by the JSC with Biocon’s prior written consent, such consent not to be unreasonably withheld, to permit such CMO to manufacture ITO and Product, using the manufacturing process developed and used by Biocon, for use and distribution in the Field in the Equillium Territory.