Regulatory Updates. United Therapeutics agrees to keep MannKind reasonably informed as to the regulatory strategy and regulatory activities carried out by or on behalf of United Therapeutics, its Affiliates and sublicensees relating to Product, including its material correspondence and meetings with Regulatory Authorities, by way of updates to the ESC at its meetings and as otherwise reasonably requested by MannKind.
Regulatory Updates. Except as otherwise disclosed in any public filing made by the Company and subject to the Investor’s agreement to maintain any material non-public information disclosed to it confidential in accordance with the provisions of Regulation FD, the Company covenants and agrees that it shall and shall cause each of its Subsidiaries and Schools to provide the Investor with the following at the times specified below:
(a) Within ten (10) Business Days of receipt from the DOE, each School’s debt to earnings rates as calculated by the DOE under the Gainful Employment Rule (as issued by the DOE in draft form or published by the DOE in final form, as the case may be).
(b) Within ten (10) Business Days, after the matter has come to the knowledge of the Company, written notice of: (i) any material litigation; (ii) any material governmental proceeding by any Governmental Authority or Educational Agency (other than but not limited to, routine audits, reviews and inquiries conducted by such agencies); (iii) any material National Labor Relations Board (“NLRB”) complaint or initiation of a proceeding; and (iv) any material civil investigative demand or material investigation by a Governmental Authority, Educational Agency or Consumer Protection Agency (other than routine inquiries and reviews conducted by such agencies).
(c) Within ten (10) Business Days, after knowledge thereof shall have come to the attention of the Company, any Subsidiary or any School: (i) written notice of the intent of any Educational Agency to limit, suspend, terminate, revoke, withdraw or not renew any Educational Approval of the Company or any Subsidiary or any School that is not resolvable by the Company by the filing of a form, payment of an ordinary course fee or taking such other action that is routine in the industry and (ii) written notice of any initiation of a show cause or probation action initiated by any Educational Agency against the Company, or any Subsidiary or any School.
(d) Within ten (10) Business Days after knowledge thereof shall have come to the attention of the Company, any Subsidiary or any School any final Title IV program review reports or DOE Inspector General reports.
(e) Within ten (10) Business Days of providing such information to the DOE, copies of the annual Title IV compliance audit and audited financial statements required pursuant to 34 C.F.R. § 668.23(a)-(b).
(f) Within ten (10) Business Days, after receipt, each School’s Cohort Default Rate (as issued by the DOE i...
Regulatory Updates. Amgen shall keep EnteraBio reasonably informed of all material regulatory developments relating to Products in the Territory through the annual development reports under Section 6.3 or as otherwise reasonably requested by EnteraBio from time to time.
Regulatory Updates. During the Term, each Party will keep the other Party generally apprised of the status of any Regulatory Submissions related to Product inside and outside the Territory. Licensee shall immediately notify Licensor in writing upon receipt by Licensee of any Regulatory Approval to market Product in the Territory. Licensor shall immediately notify Licensee in writing upon receipt by Licensor of any Regulatory Approvals to market Product outside the Territory.
Regulatory Updates. Whenever technically and economically ------------------ feasible, CIS shall use commercially reasonable efforts to develop modifications to the System to comply with changes in United States federal regulatory requirements. Such federal regulatory modifications will be developed at no charge so long as Customer covered under the terms of this Agreement. At Customer's request, CIS shall use all commercially reasonable efforts to modify the System to comply with state and local regulatory modifications on a "Fair Share Basis." As used herein "Fair Share Basis" means charges will be incurred on a time and material basis with costs divided by the total number of CIS Customers affected by a given modification). THE FOREGOING WARRANTIES ARE THE EXCLUSIVE WARRANTIES UNDER THIS AGREEMENT AND ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. CUSTOMER EXPRESSLY WAIVES AND SHALL NOT MAKE ANY CLAIM OF ANY KIND AGAINST CIS ARISING OUT OF THE FAILURE OF PERFORMANCE OF ANY PIECE OF EQUIPMENT, OF CIS SOFTWARE OR THIRD-PARTY SOFTWARE, OR OF THE COMMUNICATION LINES, OR OUT OF THE BREACH OF ANY WARRANTY PROVIDED BY THE MANUFACTURER OF SAID EQUIPMENT OR BY THE TELEPHONE COMPANY. CIS SHALL PASS THROUGH TO CUSTOMER THE BENEFITS OF ANY EXPRESS WARRANTIES RELATING TO THE EQUIPMENT, AND SHALL ASSIST CUSTOMER WITH ANY SUCH WARRANTY CLAIMS. CIS makes no warranty or guaranty, and hereby expressly disclaims all warranties, expressed or implied, as to the Equipment and/or Systems at the Facilities being Year 2000 compliant. CIS, however, acknowledges the need for all Software to be Year 2000 compliant and is currently making efforts in a professional, timely and workmanlike manner that it deems reasonable to address the Year 2000 compliance issues with the Software. Addressing specific Year 2000 compliance issues may result in software product replacement, or termination of the software product, service and support per the provisions of this Agreement. How to address Year 2000 issues will be determined by CIS in its sole discretion. CUSTOMER ACKNOWLEDGES THAT IT IS CUSTOMER'S SOLE OBLIGATION TO ENSURE THAT ALL EQUIPMENT AND SYSTEMS AT THE FACILITIES USED TO PROCESS CUSTOMER DATA IS YEAR 2000 COMPLIANT AND THAT TO THE EXTENT ANY ASSISTANCE IS PROVIDED BY CIS TO OBTAIN YEAR 2000 COMPLIANCE, SUCH SERVICE IS PROVIDED WITHOUT ANY WARRANTY WHATSOEVER. CUSTOMER AGREES TO RELE...
Regulatory Updates. Each Party shall keep the other Party informed of regulatory developments relating to a Product in the Field in its respective territory, either the Prometheus Territory or Xxxx Territory, through regular reports at JSC meetings and shall promptly notify the other Party in writing of any action or decision by any Regulatory Authority in its respective territory relating to a Product.
Regulatory Updates. No documentation with respect to Products Manufactured by BioLife for ORS will be provided by BioLife directly to the FDA or any other regulatory authority, except as specifically agreed to in writing by ORS and BioLife or as required by law.
Regulatory Updates. Astellas shall keep CytomX reasonably informed of all material regulatory developments and filings relating to Products in any of the Major Markets, including through the annual development reports under Section 6.4, and with respect to Cost Share Products in the Major Markets, Astellas will use good faith efforts to provide CytomX a meaningful opportunity to (a) review and comment on such filings prior to submission thereof, and Astellas will in good faith consider incorporating such comments into, any such regulatory filings in the Territory, and (b) unless such Regulatory Authorities object, participate (with Astellas in its sole discretion having the right to object to such participation by more than one (1) CytomX representative at any such meeting) in all material meetings with Regulatory Authorities relating to any Cost Share Product in any of the Major Markets solely in an observer capacity. For Cost Share Products with respect to Major Markets, Astellas will provide CytomX with a copy, in each case to the extent material, of all regulatory filings, correspondence with and minutes of meetings with Regulatory Authorities, documents included in such regulatory dossiers and Marketing Approvals.
Regulatory Updates. Company shall promptly provide TESARO with notice of the granting of any Marketing Approval of a Product obtained by Company, and TESARO shall promptly provide Company with notice of the granting of any Marketing Approval of a Single Agent Product obtained by TESARO. TESARO may disclose information to Merck and AstraZeneca with respect to Company’s regulatory activities with respect to the Products in the Company Field in the Company Territory consistent with the level of detail set forth in the Third Party Development Reports, to the extent necessary for TESARO to comply with its reporting requirements under Section 4.01(f) of the Merck License Agreement and Section 4 of each of the AstraZeneca License Agreements. Notwithstanding the foregoing, prior to disclosing such information to Merck or AstraZeneca, TESARO shall provide a draft of such disclosure to Company for review and, upon Company’s request, TESARO shall redact from such disclosure any Redactable Information. TESARO acknowledges and agrees that the information that TESARO is permitted to disclose to Merck and AstraZeneca pursuant to this Section 5.2(d) shall be sufficient to satisfy its obligations to provide information under Section 4.01(f) of the Merck License Agreement and Section 4 of each of the AstraZeneca License Agreements.
Regulatory Updates. Analysis of the General Plan Land Use Policy Map will be done by reviewing the currently adopted General Plan land use legend and map and relevant goals and policies. Consistency analysis will be conducted in GIS in order to identify land use policy map amendments needed to support the preferred land use and transportation scenario. Similarly, the permitted uses, design standards, and specifications of the zoning code will be reviewed and needed amendments drafted. The analysis and recommendations for the General Plan and Zoning Code amendments will be conducted through an iterative process, as findings from multiple analyses will inform one another. Evaluation of opportunity and constraints and recommendation for regulatory changes. Within eight months. X X X Draft Golden State Specific Plan land use map and other related regulatory amendments necessary to implement it (five hard copies). Within 12 months. X X X Given the complexity of the GSSP goals, which incorporate major land use/development and air/HSR/intercity rail transportation improvements, infrastructure improvements will require implementation over time through a detailed phasing plan. Strategic implementation sequencing will identify and prioritize implementation activities within a clearly defined project schedule. In addition, given the complexity of land ownership, the capital improvements required, and the interrelationships required to ensure coordinated implementation of development and infrastructure improvements, careful consideration and delineation of roles and responsibilities is of vast importance. Implementation partners other than the City include the CHSRA, Metrolink, Burbank Xxx Xxxx Airport Authority, Metro, along with possible state and federal partners (FAA, FRA, and FTA). There are many implementing arrangements possible as demonstrated by major integrated development/transportation projects around the U.S. and throughout California, including the Transbay Terminal project, Los Angeles Union Station, and other HSR station area master planning efforts. As we work together to develop recommendations for implementation roles and responsibilities, we will prepare and share “Lessons Learned” from other organizational arrangements and identify what is best for this project.
