Regulatory Work Clause Samples
The "Regulatory Work" clause defines the responsibilities and obligations of the parties regarding compliance with applicable laws, regulations, and governmental requirements relevant to the contract. Typically, this clause outlines which party is responsible for obtaining necessary permits, licenses, or approvals, and may specify procedures for handling changes in regulatory requirements during the contract term. Its core practical function is to ensure that all activities under the agreement are conducted lawfully and to allocate responsibility for regulatory compliance, thereby reducing the risk of legal violations or project delays.
Regulatory Work. LILLY shall be responsible for determining all regulatory responsibilities for the preparation and filing of all Drug Approval Applications in the name of LILLY and all activities necessary for such Drug Approval Applications including but not limited to the manufacture, marketing and sale of any Ribozyme Product. Any such work to be conducted by RPI under this Agreement will be fully-funded by LILLY as approved in the R&D Plan.
Regulatory Work. Miltenyi has established, or may from time to time establish, Master Files for one or more Miltenyi Products with one or more Regulatory Authorities in the Territory. Miltenyi shall maintain each such Master File in accordance with Applicable Laws (“Regulatory Work”). To the extent Autolus requests that Miltenyi generate any additional Master File and/or add additional information to any existing Master File, the provisions of Section 4.4 “Extension of Scope, Supplemental Services” below shall apply.
Regulatory Work. For work performed under this Agreement by XOMA personnel to (a) prepare and submit regulatory filings to enable Drug Substance manufactured and supplied by XOMA to Onyx to be used in human clinical trials, (b) carry out process validation work in connection with any potential or actual BLA filing for ONYX-015 products, (c) prepare BLAs and other documentation appropriate for obtaining Regulatory Approvals for ONYX-015 products, and (d) cooperate with Onyx in the filing and ongoing support of such BLAs, Onyx shall pay [*] of XOMA's Fully Burdened Staffing Costs. Onyx will pay such costs on a calendar quarterly basis in arrears
Regulatory Work. 16 7.5 Pre-Existing Roche Targets..........................................16
Regulatory Work. Miltenyi has established, or may from time to time establish, Master Files for one or more Miltenyi Products with one or more Regulatory Authorities in the Territory. Miltenyi shall maintain each such Master File in accordance with Applicable Laws (“Regulatory Work”). To the extent Autolus requests that Miltenyi generate any additional Master File and/or add additional information to any existing Master File, the provisions of Section 4.9 below shall apply. 9. Amendment to Section 4.4. Section 4.4 is hereby amended and replaced in its entirety to read as follows: 4.4 [Section intentionally left blank] 10. Amendment to Section 4.8.
Regulatory Work. Roche is solely responsible for the preparation and filing of all Drug Approval Applications and all activities necessary for such Drug Approval Applications relating to the manufacture, marketing and sale of any Product being developed by Roche. Such Drug Approval Applications will be filed in the name of Roche or Roche's designee.