Interactions. GSK shall have, at its expense, the responsibility for all interactions with any Regulatory Authority in the GSK Territory and for filing, obtaining and maintaining approvals for development and commercialization of Licensed Products for applications in the Field in the GSK Territory, subject to the limitations in Section 2.1.1, including any MAA or Marketing Authorization therefor. Notwithstanding the foregoing, Santarus shall be able to communicate with any Regulatory Authority in the GSK Territory regarding any Licensed Product, but only to the extent that such communication is (a) reasonably necessary to comply with the terms of this Agreement or any Applicable Law, (b) relates to manufacture of Licensed Products for use or sale outside the GSK Territory or (c) relates to clinical trials of Licensed Products in the GSK Territory that are intended to support Regulatory Approvals outside the GSK Territory, which clinical trials conducted by Santarus or its Affiliates have been approved in advance by GSK, which approval shall not be unreasonably withheld, conditioned or delayed. Santarus shall provide GSK at least thirty (30) days advance notice (or, if thirty (30) days advance notice is not possible, such advance notice that is possible under the circumstances) of any meetings between Santarus and Regulatory Authorities in the GSK Territory relating to the activities set out in (a), (b) or (c) above. Santarus shall provide to GSK copies of correspondence received by Santarus from Regulatory Authorities in the GSK Territory promptly (within ten (10) Business Days following Santarus’ receipt thereof), and Santarus shall (i) provide GSK an opportunity to review and comment on such Regulatory Filings and correspondence with Regulatory Authorities in the GSK Territory prior to submission, and (ii) consider in good faith the comments of GSK in such Regulatory Filings and correspondence. To the extent not prohibited by Applicable Laws, GSK shall own all Regulatory Filings filed by or under authority of it for the Licensed Products for applications in the Field in the GSK Territory. For clarity, as between the Parties, Santarus shall retain the right and, at its expense, the responsibility for all interactions with any Regulatory Authority and filing, obtaining and maintaining approvals for development and commercialization of Licensed Products outside the GSK Territory, including any MAA or Marketing Authorization therefor.
Interactions. Ethical issues in SPIDER will be scrutinized in close synergy with data management, pilot and legal issues activities, conducted under Task 1.4 (Data Management), WP7 (SPIDER Demonstration and Evaluation) and Task 2.2 (Analysis of Ethical, Privacy and Legal Requirements) respectively. Ethical issues also apply for the user requirements elicitation phase associated with Task 2.1 (Analysis of User and Cybersecurity Requirements). The interaction between the abovementioned SPIDER activities is illustrated in Figure 1.
Interactions. OV shall be responsible for taking the lead with all interactions with Regulatory Authorities (meetings, telephone, etc.) in a given country in the Territory and for other regulatory matters related to the mBC Clinical Trial in such country in the Territory as permitted by Applicable Law. R-Pharm shall be entitled to have reasonable representation (but no more than two people unless otherwise mutually agreed) present at all meetings or other substantive interactions with Regulatory Authorities (and OV shall provide notice to R-Pharm sufficiently in advance of any such meeting or interaction unless such advance notice is not possible due to the urgency of the situation, in which case OV shall inform R-Pharm of the content of such a meeting as soon as reasonably possible after the meeting has taken place).
Interactions. Potent CYP3A4 inducers such as rifampicin, phenobarbital, carbamazepine, phenytoin or St John's Wort are not recommended. Administration of dronedarone to patients receiving digoxin will bring about an increase in the plasma digoxin concentration and thus precipitate symptoms and signs associated with digoxin toxicity. Clinical, ECG and biological monitoring is recommended, and digoxin dose should be halved. A synergistic effect on heart rate and atrioventricular conduction is also possible. The co- administration of beta-blockers or calcium antagonists with depressant effect on sinus and atrio- ventricular node should be undertaken with caution. These medicinal products should be initiated at low dose and up-titration should be done only after ECG assessment. In patients already on calcium antagonists or beta blockers at time of dronedarone initiation, an ECG should be performed and the dose should be adjusted if needed. Statins should be used with caution. Lower starting dose and maintenance doses of statins should be considered and patients monitored for clinical signs of muscular toxicity. Patients should be warned to avoid grapefruit juice beverages while taking dronedarone.
Interactions. When at the work location, the employee with a disability routinely interacts with co-workers and customers/patrons who do not have disabilities to the same extent as a worker without disabilities filling the same or similar position would interact with co-workers and customers/patrons who do not have disabilities. Co-workers and customers/patrons do not include supervisors or provider agency staff providing supported employment or personal care supports to the employee with a disability.
Interactions. Seller shall communicate to Buyer all issues that arise related to the clauses in this document.
Interactions. 8.5 The Base Pack includes up to one thousand (1,000) Interactions per month. Any unused Interactions will not accrue or ‘roll over’ from one month to the next.
Interactions organizational structures From the analysis it shows that many professional organization adhere strongly to an organizational structure in their disaster response operations. These procedures and processes are often inspired from the ‘command and control (C2)’ approach, derived from the organizational structure employed by armed forces. While this organizational structure provides an –apparently- optimal control of the situation it requires a single person or entity in the organization to have an absolute overview of the situation to make decisions. The centralization of the decisions, responsibility and thus the information flow, makes the disaster response organizations quite strict while at the same time putting quite high pressures on the accountable persons. Finally such structures also provide less flexibility to act on specific opportunities that arise in the response, such as spontaneous volunteers and take away autonomy from communities to articulate and direct the disaster response to their vision. This fundamental change in the overall organization of the disaster response, envisioned in the COBACORE concept requires a careful consideration in regards to the alignment of the existing structures of professional organizations. When COBACORE is implemented it becomes a mediating platform between the various affected community, responding volunteer communities and professional’s responding organizations. This changes the role of the professional organization significantly, for example from a command-and-control organization to a broker or mediating organization that connects the needs of the affected community with the offered support from various volunteer and professional organizations. In other words, there will no longer be an overall hierarchical structure, but rather a network of communities of which the interactions are monitored and facilitated by the responsible government agencies, support by the COBACORE platform. A more specific example are the teams operating COBACORE and facilitating these interactions. Analog to the Webcare teams of professional service organizations these teams well actively engage with the various users in the platform to mediate. One of the key questions becomes the accountability of the users acting on the platform and the mandate of these teams. On the roadmap towards a situation where the disaster response and recovery operations are facilitated through a mediating platform and a network of organizations and com...
Interactions. Improve communication with the community and help ensure transparency with our Citizen Interaction Center, a configurable website that can be linked to an agency’s existing home page. • Enable submissions from citizens for tips, incident reports, complaints, and compliments • Investigators can publish wanted posters and rewards for information. Responses are routed directly to the case folder and investigators receive instant alerts • Citizen complaints or excessive force allegations are routed directly to internal affairs teams and agency leadership is instantly alerted Incidents Supports police work from the field to investigations, and vice versa: • Integration with ShotSpotter Respond to alert Investigators to screen and follow-up on gunshot detection events that patrol officers respond to. • Capture tips and field intelligence from patrol and other agency divisions in real time. • Automatically route reports for review and notify supervisors and investigative units about new matters requiring attention. • Search, analyze, and link associated incidents • Investigators can create bulletins and broadcast BOLOs across the entire agency Investigations Helps investigators find patterns, assess solvability, and track follow-up activities; tracks case progress for any type of case; provides command staff with complete oversight through real time dashboards and reports. • Associate case folders across different units to streamline information sharing • Assign tasks in a case to team members for follow-up • Invite co-workers to collaborate on cases and grant access privileges to others as needed • Share forensics, photos, videos and reports with other work units, departments, and the DA’s office • Record investigative steps within customized worksheets tailored for each case type • Automatically route casework through review and approval process Intelligence Study criminal data, identify trends, support law enforcement investigations, and increase understanding of crime in a secure and CFR-compliant solution. • Compile suspicious activity tips, security assessment and threat reports • Conduct link analysis and connect the dots between people, phone records, casework, and investigative leads • Review gang member database and track activity • Register confidential informants and protect their identity • Designate intelligence to be reviewed, retained, or purged to automatically maintain compliance with 28 Code of Federal Regulations part 23.
Interactions. TG can interact with the user in several ways. Basically, using this task, it is possible to perform a subset of actions that HMI can perform. The most important difference is that the object to manipulate can be chosen simply by selecting the objects itself from the graphic and applying the correct action by choosing from a menu. For instance, if the user wants to change the real time event for a train, using the HMI he/she has to input somewhere the train number, using TG he/she has just to select the train from the graphic and choose “change time” action from a menu. A list of possible actions that can be initiated by TG follows. Change a train theoretical timetable Change real events time for a train (departure time, arrival time) Select a new path (this is possible only using the Path Selection HMI) Solve a conflict Get data about slowdowns and disruptions Get the list of trains that will cross a station What actions are really necessary for OnTime is yet a matter of discussion.
