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 Exhibit G Third Party Royalties 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. Exhibit H TRANSFER DATE ACTIVITIES FOR COMMERCIAL SALES OF ACTIMMUNE FOR CGD 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:
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: Type of Service Provider Report Requirement 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.
Clinical Reports. Reports are available for Customer’s authorized personnel to generate and use in managing the Customer’s End Users.
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.
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...
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.
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.
