Summary CMC Section Sample Clauses

Summary CMC Section. To the extent required, Bayer shall either: (i) be responsible for the preparation and delivery to Licensee of the Summary CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in an NDA or NDA Equivalent in accordance with Applicable Laws and as the Parties may mutually agree; or (ii) provide Licensee with all data and information (including, without limitation, all Information) required to complete the Summary CMC Section in accordance with Applicable Laws. Licensee shall provide Bayer, as soon as practicable, with a copy of any comments received by Licensee from a Governmental Authority relating to the Summary CMC Section and Bayer shall provide or, at Licensee’s request, cooperate with Licensee to provide, a response to such comments as soon as practicable. In the event that there is a deficiency in the Summary CMC Section attributable to Bayer (including as a result of any deficiency in or changes required to be made to the DMF), then Bayer shall be responsible for correcting such deficiency, at Bayer’s expense, and shall use Commercially Reasonable Efforts to do so as soon as practicable. *** INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.
AutoNDA by SimpleDocs
Summary CMC Section. Notwithstanding the provisions of Section 3.3, with respect to the Summary CMC Section, to the extent required, Schering shall either (i) be responsible for the preparation and delivery to Licensee of the Summary CMC Section in electronic and hard copy form and the latter in format suitable for inclusion in the NDA in accordance with applicable law and regulatory standards and as the Parties may mutually agree or (ii) provide Licensee with all data and information required to complete the Summary CMC Section in accordance with applicable law and regulatory standards. Licensee shall provide Schering as soon as practicable with a copy of any comments received by Licensee from the FDA relating to the Summary CMC Section and Schering shall provide or, at Licensee’s request, cooperate with Licensee to provide, a response to such comments as soon as practicable. In the event that there is a deficiency in the Summary CMC Section attributable to Schering (including as a result of any deficiency in or changes required to be made to the DMF), then Schering shall be responsible for correcting such deficiency, at Schering’s expense, and shall use Commercially Reasonable Efforts to do so as soon as practicable.

Related to Summary CMC Section

  • Overview Oxxx Xxxxxx played quarterback for the Cleveland Browns, and is considered one of the most dominant players of the NFL’s early years. He led the Browns to the championship game every season from 1946 to 1955, winning 7 times. He was also a 3-time league MVP. · He was selected All-League in 9 of his 10 seasons. Career highlights include throwing for 4 touchdowns in the 1950 title win, as well as 3 passing and 3 running touchdowns in the 1954 title game. · He would later coach Coast Guard for 9 seasons, over 2 separate stints. He was elected to the Pro Football Hall of Fame in 1965 Asset Description Overview and authentication: · PSA Card Facts states, “This important rookie card is one of the keys to the 1950 Bxxxxx set...This card is subject to the typical condition obstacles of the issue, including staining along the reverse that tends to penetrate the cardboard and downgrade the card...This popular issue is recognized as the first full-color, nationally distributed set of the post-World War II era.” · Graded a 9 by PSA, this card is one of 9 to receive that grade with NONE graded higher out of 720 total submissions to PSA. · PSA 9 copies sell very infrequently with the most recent sale being for $20,713 on 10/10/20. Notable Features: Graded Mint by PSA Notable Defects: There are none. Depreciation: The Company treats Memorabilia and Collectibles assets as collectible and therefore will not depreciate or amortize the SERIES #OttoGraham1950BowmanPSA9 going forward. Schedules to Thirteenth Amendment to Limited Liability Company Agreement – Collectable Sports Assets, LLC – Page 93 of 127 Schedule XXXIXto Thirteenth Amendment to Collectable Sports Assets, LLC Amended and Restated Limited Liability Company Agreement Series Designation of #ALKALINE1954TOPPSPSA9, a series of Collectable Sports Assets, LLC Capitalized terms used but not defined herein have the meanings assigned to such terms in the Limited Liability Company Agreement of Collectable Sports Assets, LLC, as in effect as of the effective date set forth below (the “Agreement”). References to Sections and Articles set forth herein are references to Sections and Articles of the Agreement. Name of Series #ALKALINE1954TOPPSPSA9, a series of Collectable Sports Assets, LLC, a Delaware limited liability company Date of establishment September 9, 2021 Managing Member CS Asset Manager, LLC, a Delaware limited liability company, is appointed as the Managing Member of #ALKALINE1954TOPPSPSA9 with effect from the effective date hereof and shall continue to act as the Managing Member of #ALKALINE1954TOPPSPSA9 until dissolution of #ALKALINE1954TOPPSPSA9 pursuant to Section 11.1(b) or its removal and replacement pursuant to Section 4.3 or ARTICLE X. Initial Member CS Asset Manager, LLC, a Delaware limited liability company Series Asset The Series Assets of #ALKALINE1954TOPPSPSA9 shall comprise the asset as further described in Schedule 1 attached hereto, which will be acquired by #ALKALINE1954TOPPSPSA9 through that certain Consignment Agreement dated as of August 30, 2021, as it may be amended from time to time, and any assets and liabilities associated with such asset and such other assets and liabilities acquired by #ALKALINE1954TOPPSPSA9 from time to time, as determined by the Managing Member in its sole discretion. Asset Manager CS Asset Manager, LLC, a Delaware limited liability company. Management Fee As stated in Section 7.1 of the Agreement. Issuance Subject to Section 6.3(a)(i), the maximum number of #ALKALINE1954TOPPSPSA9 Interests the Company can issue may not exceed the purchase price, in the aggregate, of $50,000. Number of #ALKALINE1954TOPPSPSA9 Interests held by the Managing Member and its Affiliates The Managing Member must purchase a minimum of 0.5% and may purchase additional #ALKALINE1954TOPPSPSA9 Interests (including in excess of 10%), in its sole discretion, through the Offering. Broker Dalmore Group, LLC, a New York limited liability company. Brokerage Fee Up to 1.00% of the gross proceeds of the Interests from #ALKALINE1954TOPPSPSA9 sold at the Initial Offering of the #ALKALINE1954TOPPSPSA9 Interests (excluding the #ALKALINE1954TOPPSPSA9 Interests acquired by any Person other than Investor Members). Schedules to Thirteenth Amendment to Limited Liability Company Agreement – Collectable Sports Assets, LLC – Page 94 of 127 Other rights Holders of #ALKALINE1954TOPPSPSA9 Interests shall have no conversion, exchange, sinking fund, redemption or appraisal rights, no preemptive rights to subscribe for any securities of the Company and no preferential rights to distributions of #ALKALINE1954TOPPSPSA9 Interests. Officers There shall initially be no specific officers associated with #ALKALINE1954TOPPSPSA9, although, the Managing Member may appoint Officers of #ALKALINE1954TOPPSPSA9 from time to time, in its sole discretion. Aggregate Ownership Limit As stated in Section 1.1. Minimum Interests One (1) Interest per Member. Schedule 1 Investment Overview · Upon completion of the SERIES #AlKaline1954ToppsPSA9 Offering, SERIES #AlKaline1954ToppsPSA9 will purchase a Ax Xxxxxx 1954 Topps PSA 9 (The “Underlying Asset” with respect to SERIES #AlKaline1954ToppsPSA9, as applicable), the specifications of which are set forth below.

  • Service Description The Transfer Agent updates the System daily to reflect each day's business activity. The Fund relies upon the timely update of information in order to respond to investor's inquiries. The Transfer Agent will provide Dreyfus with a System report indicating the time of day that files were updated and available for Dreyfus. The timeliness of availability of these screens with updated information will determine the Transfer Agent's level of performance.

  • SERVICE LEVEL DESCRIPTION The Fund Accounting Agreement is hereby amended by deleting the Service Level Description attached thereto and replacing it in its entirety with the Service Level Description attached hereto.

  • Product Description The Products are described in the Product Unique Attachment(s). Products also include all FRUs, CSPs, Product code, and Product documentation.

  • GENERAL SERVICE DESCRIPTION Service Provider currently provides active medical, pharmacy(Rx) and dental administration for coverages provided through Empire and Anthem (medical), Medco(Rx), MetLife(dental) and SHPS (FSA) (Empire, Anthem, Medco, MetLife and SHPS collectively, the “Vendors”) for its U.S. Active, Salaried, Eligible Employees (“Covered Employees”). Service Provider shall keep the current contracts with the Vendors and the ITT CORPORATION SALARIED MEDICAL AND DENTAL PLAN (PLAN NUMBER 502 EIN 00-0000000) and the ITT Salaried Medical Plan and Salaried Dental Plan General Plan Terms (collectively, the “Plans”) and all coverage thereunder in full force through December 31, 2011 for Service Recipient’s Covered Employees. All claims of Service Recipient’s Covered Employees made under the Plans and incurred on or prior to December 31, 2011 the (“2011 Plan Year”) will be adjudicated in accordance with the current contract and Service Provider will continue to take such actions on behalf of Service Recipient’s Covered Employees as if such employees are employees of Service Provider. All medical, dental, pharmacy and FSA claims of Service Recipient’s Covered Employees made under the Plans (the “Claims”) will be paid by the Vendors on behalf of the Service Provider. Service Recipient will pay Service Provider for coverage based on 2011 budget premium rates previously set for the calendar year 2011 and described in the “Pricing” section below. Service Recipient will pay Service Provider monthly premium payments for this service, for any full or partial months, based on actual enrollment for the months covered post-spin using enrollments as of the first (1st) calendar day of the month, commencing on the day after the Distribution Date. Service Recipient will prepare and deliver to Service Provider a monthly self xxxx containing cost breakdown by business unit and plan tier as set forth on Attachment A, within five (5) Business Days after the beginning of each calendar month. The Service Recipient will be required to pay the Service Provider the monthly premium payments within ten (10) Business Days after the beginning of each calendar month. A detailed listing of Service Recipient’s employees covered, including the Plans and enrollment tier in which they are enrolled, will be made available to Service Provider upon its reasonable request. Service Provider will retain responsibility for executing funding of Claim payments and eligibility management with Vendors through December 31, 2013. Service Provider will conduct a Headcount True-Up (as defined below) of the monthly premiums and establish an Incurred But Not Reported (“IBNR”) claims reserve for Claims incurred prior to December 31, 2011 date, but paid after that date, and conduct a reconciliation of such reserve. See “Headcount True-Up” and “IBNR Reconciliation” sections under Additional Pricing for details.

  • Quality Service Standards/NAV Errors Price Associates and the Fund may, from time to time, agree to certain quality service standards, with respect to the Services hereunder. In the event Price Associates is the party responsible for causing an error in the computation of the net asset value for a Fund or share class of a Fund (“NAV Error”), the actions that are required to be taken as to such NAV Error shall be made in accordance with the Fund’s Net Asset Value Error Correction Policy and Procedures (“NAV Error Policy”) attached hereto as Schedule II.

  • Aircraft Description The Option Aircraft are described by Boeing Detail Specification D6-38808, Revision E, dated September 15, 1995, as amended and revised pursuant to the Agreement.

  • Project Description The Project Description may be changed from time to time by, or with the consent of, the Company provided that any such change shall also be filed with the Issuer and provided further that no change in the Project Description shall materially change the function of the Project Facilities unless the Trustee shall have received (i) an Engineer's certificate that such changes will not impair the significance or character of the Project Facilities as Pollution Control Facilities and (ii) an Opinion of Bond Counsel or ruling of the Internal Revenue Service to the effect that such amendment will not adversely affect the exclusion of interest on the Bonds from gross income for federal income tax purposes.

  • Descriptions and Summaries The statements included in the Registration Statement and the Disclosure Package under the captions “Cash Distribution Policy,” “The Partnership Agreement” and “Investment in Targa Resources Partners LP by Employee Benefit Plans” and under the caption “Certain Relationships and Related Transactions, and Director Independence,” in the Partnership’s Annual Report on Form 10-K for the year ended December 31, 2009 (“2009 Annual Report”) insofar as they purport to constitute summaries of the terms of Federal or Texas statutes, rules or regulations or the Delaware LP Act, the Delaware LLC Act or the DGCL, any legal and governmental proceedings or any contracts, constitute accurate summaries of the terms of such statutes, rules and regulations, legal and governmental proceedings and contracts in all material respects. The description of the Federal statutes, rules and regulations set forth in the 2009 Annual Report under “Business—Regulation of Operations” and “Business—Environmental, Health and Safety Matters” constitute accurate summaries of the terms of such statutes, rules and regulations in all material respects.

  • Computational Materials and Structural Term Sheets (a) Not later than 10:30 a.m., New York time, on the business day before the date on which the Current Report relating to the Offered Certificates of a Series is required to be filed by the Company with the Commission pursuant to Section 5(b) hereof, the Underwriter shall deliver to the Company five complete copies of all materials provided by the Underwriter to prospective investors in such Offered Certificates that constitute (i) "Computational Materials" within the meaning of the no-action letter dated May 20, 1994 issued by the Division of Corporation Finance of the Commission to Xxxxxx, Xxxxxxx Acceptance Corporation I, Xxxxxx, Peabody & Co. Incorporated, and Xxxxxx Structured Asset Corporation and the no-action letter dated May 27, 1994 issued by the Division of Corporation Finance of the Commission to the Public Securities Association (together, the "Xxxxxx Letters"), the filing of which material is a condition of the relief granted in such letter (such materials being the "Computational Materials"), and (ii) "Structural Term Sheets" within the meaning of the no-action letter dated February 17, 1995 issued by the Division of Corporation Finance of the Commission to the Public Securities Association (the "PSA Letter"), the filing of which material is a condition of the relief granted in such letter (such materials being the "Structural Term Sheets"). Each delivery of Computational Materials and Structural Term Sheets to the Company pursuant to this paragraph (a) shall be effected by delivering four copies of such materials to counsel for the Company on behalf of the Company at the address specified in Section 3 hereof and one copy of such materials to the Company.

Draft better contracts in just 5 minutes Get the weekly Law Insider newsletter packed with expert videos, webinars, ebooks, and more!