Initial Development Plan Not later than the Effective Date, Licensee shall have provided Merck with an initial Development plan for the Licensed Product in the Field in the Territory, which shall be incorporated as part of this Agreement as Attachment 3.02(a) (as may be amended in accordance with this Agreement, the “Development Plan”). **CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.
Development Schedule The Project shall substantially comply with the specific timetables and triggers for action set forth in Article 5 of this Agreement. The parties acknowledge that, as provided in G.S. 160A-400.25(b), the failure to meet a commencement or completion date shall not, in and of itself, constitute a material breach of this Agreement pursuant to G.S. 160A-400.27 but must be judged based upon the totality of the circumstances.
Update Each year the Plant Training Committee shall prepare an Update that reviews the Findings and modifies them based on changed circumstances, measures the success of the Training Program against its objectives and modifies the Training Program accordingly.
Tests and Preclinical and Clinical Trials The studies, tests and preclinical and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder (collectively, “FFDCA”); the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the General Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate in all material respects and fairly present the data derived from such studies, tests and trials; except to the extent disclosed in the Registration Statement, the General Disclosure Package and the Prospectus, the Company is not aware of any studies, tests or trials, the results of which the Company believes reasonably call into question the study, test, or trial results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical state of development; and, except to the extent disclosed in the Registration Statement, the General Disclosure Package or the Prospectus, neither the Company nor any Subsidiary has received any notices or correspondence from the FDA or any Governmental Entity requiring the termination or suspension of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Commercial Supply Celgene shall Manufacture and supply all Commercial Supplies.
Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.
Clinical Development Licensee will have sole responsibility for and sole decision making over the clinical development of any Product arising from the Research Program in the Field. Notwithstanding the foregoing, if Licensee wishes to conduct clinical development of a Development Candidate at Penn and Penn has the clinical expertise, interest and ability to run such a trial as assessed at Penn’s sole discretion, such a study will be conducted under a separate Clinical Trial Agreement to be negotiated by the Parties prior to initiation of such study. Such separate clinical trial agreement will include a detailed clinical development plan, including costs and time lines for conducting the Clinical Trial.
TECHNICAL SUPPORT SERVICES 2.1 The technical support services (the "Services"): Party A agrees to provide to Party B the relevant services requested by Party B, which are specified in Exhibit 1 attached hereto ("Exhibit 1").
EXECUTION VERSION If the foregoing is in accordance with your understanding of our agreement, please sign and return to the Company the enclosed duplicate hereof, whereupon this letter and your acceptance shall represent a binding agreement among the Company and the several Underwriters. Very truly yours, AIRCASTLE LIMITED By: /s/ Xxxxx Xxxxxx Name: Xxxxx Xxxxxx Title: Chief Operating Officer and General Counsel [Underwriting Agreement] The foregoing Agreement is hereby confirmed and accepted as of the date specified in Schedule I hereto. XXXXXXX, SACHS & CO. By: /s/ Xxxxxxx Xxxxxx Name: Xxxxxxx Xxxxxx Title: Managing Director For itself and the other several Underwriters named in Schedule II to the foregoing Agreement. CITIGROUP GLOBAL MARKETS INC. By: /s/ Xxxxxxx Xxxxx Name: Xxxxxxx Xxxxx Title: Managing Director For itself and the other several Underwriters named in Schedule II to the foregoing Agreement. X.X. XXXXXX SECURITIES LLC By: /s/ Xxxxxxx Xxxxxxxxxxxxx Name: Xxxxxxx Xxxxxxxxxxxxx Title: Executive Director For itself and the other several Underwriters named in Schedule II to the foregoing Agreement. [Underwriting Agreement] RBC CAPITAL MARKETS, LLC By: /s/ Xxxxx X. Xxxxx Name: Xxxxx X. Xxxxx Title: Managing Director; Head of US Leveraged Finance For itself and the other several Underwriters named in Schedule II to the foregoing Agreement. SCHEDULE I Underwriting Agreement dated March 12, 2014 Registration Statement No. 333-182242 Representatives: Xxxxxxx, Sachs & Co. Citigroup Global Markets Inc. X.X. Xxxxxx Securities LLC RBC Capital Markets, LLC Title, Purchase Price and Description of Securities: Title: 5.125% Senior Notes due 2021 Principal amount: $500,000,000 Purchase price: 98.50% of the principal amount, plus accrued interest, if any, from March 26, 2014 Sinking fund provisions: None.
Transfer Pricing The Company and each of its Subsidiaries are in compliance in all material respects with all applicable transfer pricing Laws and regulations, including the execution and maintenance of contemporaneous documentation substantiating the transfer pricing practices and methodology and conducting intercompany transactions at arm’s length.
