CURRENT STATUS; GENERAL Sample Clauses

CURRENT STATUS; GENERAL. Prior to the Effective Date, Sepracor (alone or with Third Parties) has conducted pre-clinical and clinical studies of the Product, and on 23rd July 2007 submitted a MAA for the Product to the EMEA for review under the centralized procedure.
Sample 1
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CURRENT STATUS; GENERAL. (a) Prior to the Effective Date, Millennium (alone or with Third Parties) has conducted and continues to conduct pre-clinical and/or clinical studies (registration and/or non-registration) of the Licensed Product in and outside the Territory. (b) From and after the Effective Date, as more particularly described and solely to the extent expressly provided in this Agreement below, (i) GSK will be responsible for all Development of the Licensed Product that GSK may in its sole discretion propose to initiate and execute that pertain solely to the Territory, including registration and non-registration trials (including Phase IV Clinical Studies, post-approval studies and Investigator Sponsored Clinical Studies) and, (ii) Millennium (alone, with Third Parties or by a Third Party itself) will continue to be responsible for Development of the Licensed Product (A) outside the Territory, and (B) inside the Territory to the extent permitted by this Agreement, including registration and non-registration trials inside and outside the Territory (including Phase IV Clinical Studies, post-approval studies and Investigator Sponsored Clinical Studies). (c) As of the Effective Date, Schering has identified its ongoing Development activities in the Territory as set forth in EXHIBIT C hereto (the "Ongoing Development Activities"). Promptly after the Effective Date, GSK shall notify Millennium of [**] such Ongoing Development Activities. [**] the Ongoing Development Activities, [**] with respect to such Ongoing Development Activities, [**] the Ongoing Development Activities in [**] Ongoing Development Activities [**] in the Territory [**]. (d) The foregoing provisions of Section 4.1(b) notwithstanding, GSK acknowledges that Millennium (alone, with Third Parties or by a Third Party itself) will retain the right to conduct Development activities in the Territory where such Development activity is conducted in support of Millennium's Development or Commercialization efforts for the Licensed Product outside the Territory, provided, that Millennium will (i) notify GSK prior to initiating any such Development activities in the Territory (whether such activities are to be conducted by Millennium, its Third Party licensee or both) and provide GSK with [**] provided by GSK, and (iii) discuss with GSK in good faith the implementation of such activity with due consideration to [**] in the Territory. However, final decision-making authority regarding any such Development activities for the...
Sample 1
CURRENT STATUS; GENERAL. (a) Prior to the Effective Date, Millennium has independently (i) initiated an international Phase III Clinical Study of the Product for the First Indication and (ii) initiated Phase II Clinical Studies for [**] and other clinical and non-clinical studies for various [**]. The Parties have agreed to continue the Development of the Product in accordance with the Development Plan. (b) The GPT shall coordinate the global Development of the Product to obtain Regulatory Approvals for the First Indication and all subsequent indications covered by the Development Plan in the United States and the License Territory. The GPT will, subject to JSC review and approval, determine additional indications, if any, for which the Product shall be Developed, and shall, subject to the JSC's oversight, direct the clinical and regulatory program for the Product.
Sample 1

Related to CURRENT STATUS; GENERAL

  • Current Status Sacramento County recently adopted a revised American River Parkway Plan which includes specific policies related to implementing water flows protective of the lower American River ecosystem. The Parkway Plan serves as a guide for other local, state and federal agencies with authority within the American River Parkway under the Wild and Scenic Rivers Act and the Urban American River Parkway Preservation Act. Sacramento County, through the Water Forum, is in the process of preparing a draft environmental impact report to institute the FMS consistent with the American River Parkway Plan and the coequal goals of the Water Forum Agreement by entering into an operations agreement with Reclamation or by seeking to modify Reclamation’s Folsom Dam water right permits or other measures. Reclamation has been operating the Folsom and Nimbus Dams in accordance with the minimum release requirements of the FMS since 2006. In 2009, the National Marine Fisheries Service (NMFS) included the FMS flow, operational criteria, American River Group, and monitoring requirements in the Reasonable and Prudent Alternatives of the Biological Opinion (BO) for operating the CVP. The NMFS BO also called for an iterative temperature management planning process that is consistent with the water temperature objectives of the FMS. The Water Forum is currently investigating the potential for an improved Flow Standard for the lower American River that would provide increased protection of salmonid species and improved water supply reliability.

  • Limitation to Preserve REIT Status Notwithstanding anything else in this Agreement, to the extent that the amount to be paid, credited, distributed or reimbursed by the Partnership to any REIT Partner or its officers, directors, employees or agents, whether as a reimbursement, fee, expense or indemnity (a “REIT Payment”), would constitute gross income to the REIT Partner for purposes of Code Section 856(c)(2) or Code Section 856(c)(3), then, notwithstanding any other provision of this Agreement, the amount of such REIT Payments, as selected by the General Partner in its discretion from among items of potential distribution, reimbursement, fees, expenses and indemnities, shall be reduced for any Partnership Year so that the REIT Payments, as so reduced, for or with respect to such REIT Partner shall not exceed the lesser of: (i) an amount equal to the excess, if any, of (a) four and nine-tenths percent (4.9%) of the REIT Partner’s total gross income (but excluding the amount of any REIT Payments and amounts excluded from gross income pursuant to Section 856(c)(5)(G) of the Code) for the Partnership Year that is described in subsections (A) through (I) of Code Section 856(c)(2) over (b) the amount of gross income (within the meaning of Code Section 856(c)(2)) derived by the REIT Partner from sources other than those described in subsections (A) through (I) of Code Section 856(c)(2) (but not including the amount of any REIT Payments and amounts excluded from gross income pursuant to Section 856(c)(5)(G) of the Code); or (ii) an amount equal to the excess, if any, of (a) twenty-four percent (24%) of the REIT Partner’s total gross income (but excluding the amount of any REIT Payments and amounts excluded from gross income pursuant to Section 856(c)(5)(G) of the Code) for the Partnership Year that is described in subsections (A) through (I) of Code Section 856(c)(3) over (b) the amount of gross income (within the meaning of Code Section 856(c)(3)) derived by the REIT Partner from sources other than those described in subsections (A) through (I) of Code Section 856(c)(3) (but not including the amount of any REIT Payments and amounts excluded from gross income pursuant to Section 856(c)(5)(G) of the Code); provided, however, that REIT Payments in excess of the amounts set forth in clauses (i) and (ii) above may be made if the General Partner, as a condition precedent, obtains an opinion of tax counsel that the receipt of such excess amounts should not adversely affect the REIT Partner’s ability to qualify as a REIT. To the extent that REIT Payments may not be made in a Partnership Year as a consequence of the limitations set forth in this Section 15.12, such REIT Payments shall carry over and shall be treated as arising in the following Partnership Year if such carry over does not adversely affect the REIT Partner’s ability to qualify as a REIT, provided, however, that any such REIT Payment shall not be carried over more than three Partnership Years, and any such remaining payments shall no longer be due and payable. The purpose of the limitations contained in this Section 15.12 is to prevent any REIT Partner from failing to qualify as a REIT under the Code by reason of such REIT Partner’s share of items, including distributions, reimbursements, fees, expenses or indemnities, receivable directly or indirectly from the Partnership, and this Section 15.12 shall be interpreted and applied to effectuate such purpose.

  • Ownership Certificates for Tax Purposes The Custodian shall execute ownership and other certificates and affidavits for all federal and state tax purposes in connection with receipt of income or other payments with respect to domestic securities of each Portfolio held by it and in connection with transfers of securities.

  • CERTIFICATION REGARDING DEBARMENT, SUSPENSION, INELIGIBILITY AND VOLUNTARY EXCLUSION

  • Certification Regarding Termination of Contract for Non-Compliance (Tex Gov. Code 552.374)

  • Permanent Status ‌ An employee will attain permanent status in a job classification upon their successful completion of a probationary, trial service or transition review period.

  • Return of Contribution Nonrecourse to Other Members Except as provided by law, upon dissolution, each member shall look solely to the assets of the Company for the return of the member's capital contribution. If the Company property remaining after the payment or discharge of the Company's debts and liabilities is insufficient to return the cash contribution of one or more members, such member or members shall have no recourse against any other member or the Board.

  • Independent Status The employees, volunteers, or agents of each party who are engaged in the performance of this Agreement will continue to be employees, volunteers, or agents of that party and will not for any purpose be employees, volunteers, or agents of the other party.

  • Student Status Licensee must maintain status as a student registered at Cal Poly with a minimum of eight (8) Cal Poly quarter units or if a graduate student, four (4) units. Exception requests must be submitted in writing to University Housing for approval (or contact the Disability Resource Center if disability related) if Licensee falls below these minimums. Dropping below the minimum is not considered a standard for cancellation and will not release the Licensee from paying any housing-related fees. The University may, at its sole option and discretion, revoke this License in accordance with the provisions herein if the Licensee fails to enroll in the minimum units, or drops below the minimum unit requirement after the beginning of the academic fee period.

  • Certification of Funds; Budget and Fiscal Provisions; Termination in the Event of Non-Appropriation This Agreement is subject to the budget and fiscal provisions of the City’s Charter. Charges will accrue only after prior written authorization certified by the Controller, and the amount of City’s obligation hereunder shall not at any time exceed the amount certified for the purpose and period stated in such advance authorization. This Agreement will terminate without penalty, liability or expense of any kind to City at the end of any fiscal year if funds are not appropriated for the next succeeding fiscal year. If funds are appropriated for a portion of the fiscal year, this Agreement will terminate, without penalty, liability or expense of any kind at the end of the term for which funds are appropriated. City has no obligation to make appropriations for this Agreement in lieu of appropriations for new or other agreements. City budget decisions are subject to the discretion of the Mayor and the Board of Supervisors. Contractor’s assumption of risk of possible non-appropriation is part of the consideration for this Agreement. THIS SECTION CONTROLS AGAINST ANY AND ALL OTHER PROVISIONS OF THIS AGREEMENT.

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