Example ContractsClausesRegulatory Materials
Regulatory Materials
Regulatory Materials contract clause examples

Regulatory Materials. The Opt-Out Party will grant to the Continuing Party a right of reference under all Regulatory Materials and Regulatory Approvals for such Reversion Product that are Controlled by the Opt-Out Party or its Affiliates (other than Regulatory Materials and Regulatory Approvals for the Manufacture of the ACTR T-cells or the SGI Antibodies, as applicable, which will be retained by Unum or SGI, respectively), unless and until assigned to the Continuing Party pursuant to any Transition Agreement.

Following the Effective Date of this Agreement, but not before the payment of the consideration under Section 7.01 by Licensee to Merck, Merck shall transfer to Licensee, in a mutually agreed manner, the ​ reasonably within the possession and control of Merck and necessary for Licensee to make, use and sell the Licensed Product. Any obligation of Merck to transfer such tangible material to Licensee and to provide assistance and support with such materials will not extend beyond ​ days after the Effective Date and will only be to the extent possible by the expenditure of commercially reasonable efforts.

All Regulatory Materials, including INDs and NDAs, relating to any Development Candidates and Products in the Shared Territory will be owned by, and will be the sole property of, Unum. All such Regulatory Materials and Regulatory Approvals in the Shared Territory will be filed and held in the name of Unum.

Tenant shall not cause or permit any Hazardous Materials (as defined below) to be brought upon, kept or used in or about the Premises, the Building or the Project in violation of Applicable Laws by Tenant or any of its employees, agents, contractors or invitees (collectively with Tenant, each a “Tenant Party”). If # Tenant breaches such obligation, # the presence of Hazardous Materials as a result of such a breach results in contamination of the Project, any portion thereof, or any adjacent property, # contamination of the Premises otherwise occurs during the Term or any extension or renewal hereof or any holding over by Tenant hereunder or # contamination of the Project occurs as a result of Hazardous Materials that are placed on or under or are released into the Project by a Tenant Party, then Tenant shall Indemnify the Landlord Indemnitees from and against any and all Claims of any kind or nature, including # diminution in value of the Project or any portion thereof, # damages for the loss or restriction on use of rentable or usable space or of any amenity of the Project, # damages arising from any adverse impact on marketing of space in the Project or any portion thereof and # sums paid in settlement of Claims that arise before, during or after the Term as a result of such breach or contamination. This Indemnification by Tenant includes costs incurred in connection with any investigation of site conditions or any clean-up, remedial, removal or restoration work required by any Governmental Authority because of Hazardous Materials present in the air, soil or groundwater above, on, under or about the Project. Without limiting the foregoing, if the presence of any Hazardous Materials in, on, under or about the Project, any portion thereof or any adjacent property caused or permitted by any Tenant Party results in any contamination of the Project, any portion thereof or any adjacent property, then Tenant shall promptly take all actions at its sole cost and expense as are necessary to return the Project, any portion thereof or any adjacent property to its respective condition existing prior to the time of such contamination; provided that Landlord’s written approval of such action shall first be obtained, which approval Landlord shall not unreasonably withhold; and provided, further, that it shall be reasonable for Landlord to withhold its consent if such actions could have a material adverse long-term or short-term effect on the Project, any portion thereof or any adjacent property. Tenant’s obligations under this Section shall not be affected, reduced or limited by any limitation on the amount or type of damages, compensation or benefits payable by or for Tenant under workers’ compensation acts, disability benefit acts, employee benefit acts or similar legislation. Notwithstanding the foregoing, Landlord shall Indemnify the Tenant Parties from and against any and all Claims arising from the presence of Hazardous Materials at the Project in violation of Applicable Laws as of the Execution Date, unless placed at the Project by a Tenant Party.

Other Materials. On each date on which the Company is required to deliver a certificate pursuant to [Section 7(1)], the Company shall have furnished to the Agent such appropriate further information, certificates and documents as the Agent may reasonably request and which are usually and customarily furnished by an issuer of securities in connection with a securities offering of the type contemplated hereby. All such opinions, certificates, letters and other documents will be in compliance with the provisions hereof.

Are hazardous materials used or stored? If so, continue with the next question. If not, go to [Section 3.0].

Disclosure Materials. The Mortgagor has executed a statement to the effect that the Mortgagor has received all disclosure materials required by, and [[Organization C:Organization]] has complied with, all applicable law with respect to the making of the Mortgage Loans. [[Organization C:Organization]] shall maintain such statement in the Mortgage File.

If Items or any services provided hereunder include Hazardous Materials, Supplier represents and warrants that Supplier and its personnel providing services to Buyer understand the nature of and hazards associated with the design and/or service of Items including handling, transportation, and use of such Hazardous Materials, as applicable to Supplier. Prior to causing Hazardous Materials to be on Buyer’s properly, Supplier shall obtain written approval from Buyer’s Site Environmental/Health/Safety organization. Supplier will be responsible for and indemnify Buyer from any liability to any third party (including governmental agencies) resulting from the actions of Supplier or its contractors in connection with: # providing such Hazardous Materials to Buyer; and/or # the use of such Hazardous Materials in providing services to Buyer.

The JDC will develop and implement procedures for drafting and review of Regulatory Materials for Development Candidates and Products in the Territory, which procedures will provide sufficient time for each Party to provide substantive comments prior to the filing of such Regulatory Materials. Such procedures will provide each Party with full and complete access, on a real-time basis, to all Regulatory Materials and Regulatory Approvals as such materials are being drafted, and, after those materials have been submitted to a Regulatory Authority, will permit each Party to obtain copies of all such materials, including in electronic format, at reasonable times. Such procedures and related timelines will accommodate each Party’s reasonable requests to obtain the feedback of Regulatory Authorities with respect to potential submissions in order to permit each Party to ensure that submissions and Regulatory Approvals for Products throughout the Territory are reasonably consistent.

“Regulatory Materials” means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture, market, sell or otherwise Commercialize a Product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, MAAs and NDAs (as applications, but not the approvals with respect thereto) and DMFs, or the equivalent applications to the equivalent Regulatory Authority in any other regulatory jurisdiction.

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