Clinical Reports Sample Clauses

Clinical Reports. The following information/reports will be provided to Genentech in a timely manner: • FDA Meeting Minutes • IND(s) • Initial • Updates (if applicable) • Annual Report(s) • Investigator Brochure(s) • Clinical Studies: • Protocol(s) • Prior to FDA submission • First Patient-In (FPI) • First Patient-Out (FPO) • Last Patient-In (LPI) • Last Patient-Out (LPO) • Serious Adverse Event (SAE) Summary • Clinical Study Interim Analysis and Update(s) (if applicable) • Go/No-Go Decision Minutes • Clinical Study Final Report(s) • Draft • Final Copy Royalties are payable under the *** License, as follows (capitalized terms shall have the meanings defined in the *** License): a *** royalty is payable on Net Sales of gamma interferon in Approved Countries in the Territory for the prophylaxis or treatment of atopic dermatitis and/or steroid-dependent asthma, where there is substantial protection from an issued Licensed Patent for the approved indication and where the Licensee has enjoyed Market Exclusivity. The royalty rate is *** on Net Sales in the Licensed Field in Approved Countries where the Licensee enjoyed Market Exclusivity but where there is no substantial patent protection, or while the Licensed Patent applications covering the indication are still pending, provided that such applications have been diligently prepared, filed and maintained. The royalty rates described above are reduced by *** for Approved Countries where the Licensee has not enjoyed Market Exclusivity. *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Prior to the Transfer Date, as defined in Section 1.29 of this Agreement, the following activities must be completed by the appropriate Party as described below:
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Clinical Reports. Any care provided under this Provider Agreement is to be outlined to Defence in a clinical report from you (and Your Providers) (Clinical Report). The Clinical Report should contain accurate details consistent with the standards of service in clause 5 expected of you and must not be misleading. You (and Your providers) are to provide a Clinical Report after each consult for Medical Specialist and after the initial, every series of six and final consult for Allied Health. Clinical Reports are to be addressed to the referring Health Practitioner and are to be submitted within 5 business days of your consult. If a treatment plan is warranted for your proposed care, this should be included in your initial Clinical Report and progress against this plan advised in subsequent Clinical Reports. Preparation of the Clinical Report is part of the care of an EP and cannot be billed for separately. If a comprehensive Clinical Report is requested by a Defence approved Health Practitioner, this is to be treated as a Restricted Service as outlined in clause 9.5. If you do not provide a Clinical Report to accompany the services rendered by you under this Provider Agreement, Bupa retains the right to delay payment to you until this action is completed. Bupa’s automated Booking and Referral System is designed to assist you with this obligation and this system satisfies the required standards of health information transmission.
Sample 1
Clinical Reports. Reports are available for Customer’s authorized personnel to generate and use in managing the Customer’s End Users.
Sample 1
Clinical Reports. Any care provided under this Provider Agreement is to be outlined to Defence in a clinical report from you (and Your Providers) (Clinical Report). The Clinical Report should contain accurate details consistent with the standards of service in clause 6 expected of you and must not be misleading. You (and Your Providers) are to provide a Clinical Report after each consult for Medical Specialist and after the initial, every series of six and final consult for Allied Health. Clinical Reports are to be addressed to the referring Health Practitioner and are to be submitted according to the following table: Medical specialists Within five Working Days of the EPs consultation. Dental specialists A report (including a treatment plan) within three Working Days of the EPs consultation.
Sample 1
Clinical Reports. 7.10.1 Where the Contractor provides clinical services, other than under a private arrangement, to a patient who is not on its list of patients, the Contractor must, as soon as reasonably practicable, provide to the Department a clinical report relating to that consultation, and any treatment provided to the patient. 7.10.2 The Department must send a report received in accordance with clause 7.11.1 to the person with whom the patient is registered for the provision of essential services or the equivalent. 7.10.3 This clause 7.11 does not apply in relation to the provision of out of hours services provided by the Contractor on or after 1st January 2005.
Sample 1
Clinical Reports. Any care provided under this Provider Agreement is to be outlined to Open Arms in a clinical report from you (and Your Providers) (Clinical Report). The Clinical Report should contain accurate details consistent with the standards of service in clause 7 expected of you and must not be misleading. Preparation of the Clinical Report is part of the care of an EP and cannot be billed for separately by you. If you do not provide a Clinical Report to accompany the services rendered by you under this Provider Agreement, Bupa retains the right to delay payment to you until this action is completed to Bupa’s satisfaction. Bupa’s automated Booking and Referral System is designed to assist you with this obligation and this system satisfies the required standards of health information transmission. (a) Psychiatry Clinical Report Requirements You (and your Providers) are to provide a Clinical Report (Psychiatric Assessment) within five Working Days of the 5th consult with an EP in a series or at closure. Clinical Reports are to be addressed to the referring Open Arms Regional Health Centre. (b) Clinical Psychology, Psychology, Accredited Mental Health Social Worker Clinical Report Requirements You (and your Providers) are to provide a Clinical Report inclusive of a care plan within three Working Days of the 3rd consult in a series. A Clinical Report inclusive of a case review must be provided within three Working Days of the last appointment in a series or at closure. Clinical Reports are to be addressed to the referring Open Arms Regional Health Centre. You are obliged to notify the referring Open Arms Regional Health Centre (on the phone number listed on the Open Arms referral form) immediately if an EP does not attend a scheduled appointment with you (or your Provider). You must also clearly flag the appointment as DNA within iRBS.
Sample 1
Clinical Reports. The proband, VI:9 was the sixth child born to a consanguineous couple of Iraqi descent (Figure 1). She presented to clinic at approximately 11 years of age with complaints of recurrent headaches. Subsequently, she developed visual hallucinations, in the form of colors and lines and myoclonic seizures. Prior to the development of recurrent headaches, she had normal growth and development. All of her symptoms were progressive in nature, becoming more frequent and severe. The first EEG performed at 10 years was abnormal and supported a diagnosis of generalized epilepsy. In addition to epileptic seizures, the proband developed psychogenic non-epileptic seizures. By 13 years of age, she began to demonstrate signs of dementia with cognitive decline and mood disturbances. The most recent EEG at 18 years of age showed intermittent superimposed posterior 5-6 Hz background activity, recurrent generalized high voltage 4-6 Hz spike, polyspike and slow wave discharges with occasional abortive generalized high voltage spike and slow wave discharges. MRI and MRS of the brain at 18 years of age detected only a mild prominence of the subarachnoid spaces and were otherwise unremarkable. The patient’s symptoms continued to worsen with generalized and diffuse myoclonic jerks and fasciculations over much of her body, including her face and limbs. Her epilepsy and dementia also gradually worsened and she required multiple hospitalizations in the last year of her life. The patient’s seizures became intractable and she died at 20 years of age from aspiration pneumonia’. Four older sisters, VI:4, VI:5, VI:6, and VI:7, were described as having a similar clinical presentation. They first presented around the age of puberty with headaches, followed by visual hallucinations and eventually developed progressive myoclonic epilepsy. All four sisters died from complications of their disease. Two sisters, VI:8 and VI:10, have reported headaches but no documented seizure activity. They are currently 24 and 18 years old, respectively, and in good health. A younger brother, VI:11, developed headaches and visual hallucinations in the form of black spots at 11 years of age. An EEG showed generalized spike and wave complexes in addition to occipital sharp waves, but no seizure activity was recorded. He was initially treated with anticonvulsants, but medications were subsequently stopped, and he has remained seizure free for 10 months. The youngest child, VI:12, currently 11 years of age, also re...
Sample 1
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Related to Clinical Reports

  • Technical Reports All technical reports are to be prepared jointly by the Recipient/Institution conducting Work and all collaborating institutions or as deemed acceptable by the Centre’s contact.

  • Medical Reports The Employer agrees to pay the fee for medical reports required by the Employer for Sick Leave or Weekly Indemnity provisions to a maximum of fifty dollars ($50.00).

  • Research Reports Distributor acknowledges that Dealer may prepare research reports relating to the Fund that are not to be used for marketing purposes (“Research Reports”). Distributor hereby authorizes Dealer to use the name of the Fund, Distributor and BREDS in Research Reports.

  • Final Reports Within ninety (90) days of receipt of the Required Documents, the Asset Representations Reviewer shall publish its findings to the Sponsor and the Indenture Trustee. The Asset Representations Reviewer shall provide the Sponsor and the Indenture Trustee with the following reports as a result of the Asset Representations Review (collectively, the “Final Reports”):

  • Medical Records Medical records relating to Trial Subjects that are not submitted to Sponsor may include some of the same information as is included in Trial Data; however, Sponsor makes no claim of ownership to those documents or the information they contain.

  • Annual Reports Within one hundred twenty (120) days after the last day of each fiscal year of Holdings commencing with the fiscal year ending December 31, 2018 (but one hundred fifty (150) days for the fiscal year ending December 31, 2018), a copy of the consolidated balance sheet of Holdings and its Restricted Subsidiaries as of the last day of the fiscal year then ended and the consolidated statements of income and cash flows of Holdings and its Restricted Subsidiaries for the fiscal year then ended, and accompanying notes thereto, each in reasonable detail showing in comparative form the figures for the previous fiscal year (starting with the fiscal year ending December 31, 2019) accompanied in the case of the consolidated financial statements by an opinion of an independent public accounting firm of recognized national standing or other accounting firm selected by the Borrower and reasonably acceptable to the Administrative Agent (which opinion shall be unqualified as to scope, subject to the proviso below) to the effect that the consolidated financial statements have been prepared in accordance with GAAP and present fairly in all material respects the consolidated financial condition and results of operations and cash flows of Holdings and its Restricted Subsidiaries as of the close of and for such fiscal year; provided that such financial statements shall not contain a “going concern” qualification or statement, except to the extent that such a “going concern” qualification or statement relates to (A) the report and opinion accompanying the financial statements for the fiscal year ending immediately prior to the stated final maturity date of the Loans, Permitted Pari Passu Refinancing Debt, Permitted Unsecured Refinancing Debt or Permitted Junior Refinancing Debt and which qualification or statement is solely a consequence of such impending stated final maturity date or (B) any potential inability to satisfy the Financial Covenants, or any financial covenant under any other Indebtedness on a future date or in a future period; in each case, such financial statements shall be accompanied by a customary management discussion and analysis of the financial performance of Holdings and its Restricted Subsidiaries;

  • Development Reports Beginning six months after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall report to Cornell progress covering LICENSEE's (and Affiliate's and Sublicensee's) activities and efforts in the development of rights granted to LICENSEE under this Agreement for the preceding six months. The report shall include, but not be limited to, activities and efforts to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such semi-annual reports shall be due within sixty days (60) of the reporting period and shall use the form as provided herein as Appendix C.

  • Regulatory Reports Since January 1, 2018, Company and its Subsidiaries have duly filed with the FRB, the FDIC, the OCC and any other applicable Governmental Authority, in correct form, the reports and other documents required to be filed under applicable Laws and regulations and have paid all fees and assessments due and payable in connection therewith, and such reports were, in all material respects, complete and accurate and in compliance with the requirements of applicable Laws and regulations. No report, including any report filed with the OCC, the FDIC, the Federal Reserve Board, the Securities Exchange Commission or any other federal or state regulatory agency, and no report, proxy statement, registration statement or offering materials made or given to shareholders of Company or the Bank, in each case, since December 31, 2017, as of the respective dates thereof, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading. The call reports of the Bank and accompanying schedules as filed with the OCC, for each calendar quarter beginning with the quarter ended December 31, 2017, through the Closing Date have been and will be prepared in accordance with applicable regulatory requirements, including applicable regulatory accounting principles and practices through periods covered by such reports. Other than normal examinations conducted by a Governmental Authority in the Ordinary Course of Business of Company and its Subsidiaries, no Governmental Authority has notified Company or any of its Subsidiaries that it has initiated or has pending any proceeding or, to Company’s Knowledge, threatened an investigation into the business or operations of Company or any of its Subsidiaries since January 1, 2018 that would reasonably be expected to result in a Material Adverse Effect on Company. There is no material unresolved violation, criticism, or exception by any Governmental Authority with respect to any report or statement relating to any examinations or inspections of Company or any of its Subsidiaries. There have been no formal or informal inquiries by, or disagreements or disputes with, any Governmental Authority with respect to the business, operations, policies or procedures of Company or any of its Subsidiaries since January 1, 2018. Notwithstanding the foregoing, nothing in this Section 3.09 shall require Company or Bank to provide Buyer with any confidential regulatory supervisory information of Company or Bank.

  • Evaluation Reports Where a formal evaluation of an employee's performance is carried out, the employee shall be provided with a copy to read and review. Provision shall be made on the evaluation form for an employee to sign it. The form shall provide for the employee's signature in two (2) places, one indicating that the employee has read and accepts the evaluation, and the other indicating that the employee disagrees with the evaluation. The employee shall sign in one of the places provided within seven (7) calendar days. No employee may initiate a grievance regarding the contents of an evaluation report unless the signature indicates disagreement with the evaluation. The employee shall receive a copy of the evaluation report at the time of signing. An evaluation report shall not be changed after an employee has signed it, without the knowledge of the employee, and any such changes shall be subject to the grievance procedure.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

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