Existing Regulatory Materials Sample Clauses
The 'Existing Regulatory Materials' clause defines how current laws, regulations, and official guidance documents are incorporated into the agreement. It typically specifies that any references to regulatory requirements are based on the rules and standards in effect as of the agreement date, and may clarify whether future changes to these materials will impact the parties' obligations. This clause ensures both parties have a clear understanding of which regulatory framework governs their actions, reducing uncertainty and potential disputes over compliance requirements.
Existing Regulatory Materials. Except to the extent notified otherwise in writing by ▇▇▇▇▇▇, on a Licensed Product-by-Licensed Product basis, Nurix will assign and transfer (and hereby does assign and transfer as of the applicable Degrader License Effective Date), to Seagen (or its designee), no later than ten (10) Business Days after the applicable Degrader License Effective Date all Regulatory Materials (if any) for the applicable Licensed Degraders Controlled by or on behalf of Nurix or its Affiliates as of the applicable Degrader License Effective Date (the “Existing Regulatory Materials”), including by providing true, accurate and complete hard and electronic copies thereof to Seagen. From and after such assignment and transfer, Seagen (or its designee) will have the sole right, in its sole discretion, to file, maintain and hold title to all such Existing Regulatory Materials.
Existing Regulatory Materials. Prior to the transfer of any Regulatory Materials for the Licensed Compound held or filed by or on behalf of BeiGene or its Affiliates prior to the Effective Date (the “Existing Regulatory Materials”) in accordance the Regulatory Transition Plan, BeiGene (or its designee) shall, subject to Section 4.1, have the sole right to file, maintain, and hold title to such Existing Regulatory Materials.
Existing Regulatory Materials. On a Licensed Program-by-Licensed Program basis, GenFleet will assign and transfer (and hereby does assign and transfer), or cause to be assigned and transferred to the extent not Controlled by GenFleet, to Verastem (or its designee) within [***] days after the applicable Option Effective Date any and all Regulatory Materials and Regulatory Approvals (if any) for the Licensed Compounds or Licensed Products for such Licensed Program in the Territory Controlled by or on behalf of GenFleet or its Affiliates (the “Existing Regulatory Materials”), including by providing true, accurate, and complete copies thereof to Verastem. GenFleet will obtain all approvals (including HGRAC Approvals), consents, permits, and licenses and complete all necessary security assessments or data protection impact assessments to allow Verastem’s access to such Existing Regulatory Materials. From and after the assignment and transfer of the Existing Regulatory Materials, Verastem will have the sole right, itself or with or through its Affiliates or designated Third Parties, in its sole discretion, to file, maintain, and hold title to all such Existing Regulatory Materials in the Territory.
Existing Regulatory Materials. Except to the extent notified otherwise in writing by Gilead, on a Licensed Product-by-Licensed Product basis, Nurix will assign and transfer (and hereby does assign and transfer as of the applicable License Option Effective Date), or cause to be assigned and transferred to the extent not owned by Nurix, to Gilead (or its designee), no later than ten (10) days after the applicable License Option Effective Date any and all Regulatory Materials for the applicable Licensed Products Controlled by or on behalf of Nurix, its Affiliates or contractors as of or prior to the applicable License Option Effective Date (the “Existing Regulatory Materials”), including by providing true, accurate and complete hard and electronic copies thereof to Gilead. From and after such assignment and transfer, Gilead (or its designee) will have the sole right, in its sole discretion, to file, maintain and hold title to all such Existing Regulatory Materials.
Existing Regulatory Materials. Prior to the transfer of all Regulatory Materials for the Licensed Compound held or filed by or on behalf of Eisai or its Affiliates prior to the Effective Date (the “Existing Regulatory Materials”) in accordance with the Regulatory Transition Plan, Eisai (or its designee) shall have the right to file, maintain, and hold title to such Existing Regulatory Materials; provided, that, with respect to any such filings and maintenance, Eisai shall previously have consulted and coordinated with and shall implement all comments received from Pharmavant with respect thereto.
Existing Regulatory Materials. Except to the extent notified otherwise in writing by Sanofi, on a Licensed Product-by-Licensed Product basis, Nurix will assign and transfer (and hereby does assign and transfer), or cause to be assigned and transferred to the extent not owned by Nurix, to Sanofi (or its designee) within [*] days after the Effective Date any and all Regulatory Materials for the applicable Development Candidates, backups thereto [*] and Licensed Products Controlled by or on behalf of Nurix, its Affiliates or contractors (the “Existing Regulatory Materials”), including by providing true, accurate and complete hard and electronic copies thereof to Sanofi. From and after such assignment and transfer, Sanofi (or its designee) will have the sole right, in its sole discretion, to file, maintain and hold title to all such Existing Regulatory Materials.
Existing Regulatory Materials. Except to the extent notified otherwise in writing by Gilead, Agenus shall assign and transfer (and hereby does assign and transfer), or cause to be assigned and transferred to the extent not owned by Agenus, to Gilead (or its designee), no later than [******] after the Effective Date any and all Regulatory Materials for the Licensed Products held by or on behalf of Agenus, its Affiliates or contractors as of or prior to the Effective Date (the “Existing Regulatory Materials”), including providing true, accurate, and complete hard or electronic copies thereof to Gilead. From and after such assignment and transfer, Gilead (or its designee) shall have the sole right, in its sole discretion, to file, maintain, and hold title to all Existing Regulatory Materials.
Existing Regulatory Materials. (i) Existing Regulatory Materials for the Bevacizumab Licensed Products. Promptly after the Effective Date, Innovent shall assign and transfer (and hereby does assign and transfer), or cause to be assigned and transferred to the extent not owned by Innovent, to Coherus (or its designee), any and all Regulatory Materials for the Bevacizumab Licensed Products in the Territory held by or on behalf of Innovent, its Affiliates or contractors as of or prior to the Effective Date (the “Bevacizumab
Existing Regulatory Materials. Immunomedics shall continue to be the owner of all Regulatory Materials related to the Product in the Field Controlled by Immunomedics as of the Effective Date (the “Immunomedics Regulatory Materials”). Within *** of this Agreement, Immunomedics shall provide Licensee with copies of material Immunomedics Regulatory Materials in its possession. Immunomedics hereby grants to Licensee a right of reference to the Immunomedics Regulatory Materials solely for the purposes of obtaining and maintaining Regulatory Approvals for the Product in the Field in the Territory pursuant to this Agreement.