Development Reports. Licensee shall provide Merck with reasonably detailed reports describing its progress with respect to its Development efforts under this Agreement (hereinafter Development Reports). Such Development Reports shall be furnished annually until the First Commercial Sale. Each Development Report shall include the following information for the Licensed Product: a description of the Development work conducted during the year in reasonable detail, including clinical studies, formulation work, manufacturing work, and other testing work and regulatory activity; timelines for such work; and key decision gates and milestones anticipated for such work. All Development Reports created by Licensee shall be deemed the Proprietary Information of Licensee and are subject to the confidentiality obligations of Article IX.
Development Plan. An initial development plan is attached hereto as Exhibit A (such plan, as may be amended by time to time pursuant to this Agreement, the Development Plan). The Development Plan is a high-level summary of the Development activities Allergan anticipates being necessary to obtain Regulatory Approval for Licensed Products for the First Indication in the U.S. and [[Unknown Identifier]] Countries for which Allergan is using Commercially Reasonable Efforts to Develop and seek Regulatory Approval for a Licensed Product in the First Indication. For as long as Development activities under this Agreement are ongoing, on or before each anniversary of the Effective Date, Allergan shall prepare an amendment, as appropriate, to the then-current Development Plan to reflect material changes or additions to the Development of Licensed Products for the First Indication in the U.S. and [[Unknown Identifier]] Countries. Allergan shall submit all amendments to the Development Plan to UroGen and, upon such submission, the amended Development Plan will become effective and supersede the previous Development Plan.
Development Records. Allergan shall maintain, in good scientific manner, complete and accurate books and records pertaining to its Development activities hereunder, in sufficient detail to verify compliance with its obligations under this Agreement and which shall be appropriate for patent and regulatory purposes, in compliance with Applicable Law and properly reflect all work done and results achieved in the performance of its Development activities hereunder, which books and records shall record only such activities and shall not include or be commingled with records of activities outside the scope of this Agreement. Such books and records shall be retained by Allergan for at least years after the expiration or termination of this Agreement in its entirety or for such longer period as may be required by Applicable Law.
Business. Landlord acknowledges that it is not the intent of this Section 30 to prohibit Tenant from using the Premises for the Permitted Use. Tenant may operate its business according to prudent industry practices so long as the use or presence of Hazardous Materials is strictly and properly monitored according to all then applicable Environmental Requirements. As a material inducement to Landlord to allow Tenant to use Hazardous Materials in connection with its business, Tenant agrees to deliver to Landlord prior to the Commencement Date a list identifying each type of Hazardous Materials to be brought upon, kept, used, stored, handled, treated, generated on, or released or disposed of from, the Premises and setting forth any and all governmental approvals or permits required in connection with the presence, use, storage, handling, treatment, generation, release or disposal of such Hazardous Materials on or from the Premises (Hazardous Materials List). Tenant shall deliver to Landlord an updated Hazardous Materials List at least once a year listing all Hazardous Materials which Tenant is required to disclose to any Governmental Authority (e.g., the fire department) in connection with its use or occupancy of the Premises. Tenant shall deliver to Landlord true and correct copies of the following documents (the Haz Mat Documents) relating to the use, storage, handling, treatment, generation, release or disposal of Hazardous Materials prior to the Commencement Date, or if unavailable at that time, concurrent with the receipt from or submission to a Governmental Authority: permits; approvals; reports and correspondence; storage and management plans, notice of violations of any Legal Requirements; plans relating to the installation of any storage tanks to be installed in or under the Project (provided, said installation of tanks shall only be permitted after Landlord has given Tenant its written consent to do so, which consent may be withheld in Landlords sole and absolute discretion); all closure plans or any other documents required by any and all federal, state and local Governmental Authorities for any storage tanks installed in, on or under the Project for the closure of any such tanks; and a Surrender Plan (to the extent surrender in accordance with Section 28 cannot be accomplished in 3 months). Tenant is not required, however, to provide Landlord with any portion(s) of the Haz Mat Documents containing information of a proprietary nature which, in and of themselves, do not contain a reference to any Hazardous Materials or hazardous activities. It is not the intent of this Section to provide Landlord with information which could be detrimental to Tenants business should such information become possessed by Tenants competitors.
Business. The Company will not, and will not permit any Subsidiary to, enter into any material business other than the businesses in which the Company and its Subsidiaries are engaged on the Third Restatement Date and reasonable extensions thereof.
Development Candidates; Early Clinical Development Plan. SGI will pay to Unum one hundred percent (100%) of all Manufacturing Costs relating to ACTR T-cells incurred by Unum to support Development of Development Candidates in accordance with the Early Clinical Development Plan as Development Costs pursuant to Section 6.5(b).
The terms under which Unum will supply clinical supplies of ACTR T-cells to SGI for use as part of the Development Candidates in the Territory will be set forth in a supply agreement to be entered into between the Parties no later than days prior to the date of Initiation of a Clinical Trial of the first Development Candidate in the Territory (the ACTR T-cell Clinical Supply Agreement). Such ACTR T-cell Clinical Supply Agreement will contain customary terms and conditions, including quality, and otherwise be consistent with this Agreement.
Development Costs Relating to Initial Development Activities. [ ]
Business Purpose. None of the Secured Obligations is a Consumer Transaction, as defined in the U.C.C., and none of the Collateral has been or will be purchased or held primarily for personal, family or household purposes.
Business Days. “Business Day” is any day that is not a Saturday, Sunday or a day on which banks in New York City are required to be closed.
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