Interactions Sample Clauses
The 'Interactions' clause defines how parties to an agreement will communicate, collaborate, or coordinate with each other during the course of their relationship. It typically outlines the methods and frequency of communication, the responsibilities of each party in sharing information, and any protocols for joint decision-making or dispute resolution. For example, it may require regular meetings, designate points of contact, or specify how feedback and approvals are to be handled. The core function of this clause is to ensure smooth cooperation and prevent misunderstandings by establishing clear expectations for ongoing interactions between the parties.
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.
Figure 1: SPIDER ethical issues interrelations
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. 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. (a) To the extent permitted by the relevant regulatory authority and by Law, Iovance shall be solely and exclusively responsible for all interactions and communications with and reports to the applicable regulatory authorities related to the Products and/or Services.
(b) To the extent that the relevant regulatory authority will not or is not permitted by Law to directly interact with Iovance, copies of (or summaries in the case of oral communications, interactions, and reports) all interactions and communications with, and reports to, the applicable regulatory authority related to the Products and/or Services (whether written or oral) shall be submitted to Iovance by Company, in reasonable and sufficient time prior to submission to the applicable regulatory authority, for Iovance’s prior review and approval. For clarity, this may include Iovance providing on-site, but indirect, assistance to Company in connection with a regulatory interaction. Company will incorporate all of Iovance’s comments in good faith that are factually accurate and not contrary to Company’s responsibility under Law.
(c) Company shall be responsible for all interactions and communications with and reports to the applicable regulatory authorities that are not related to the Products and/or Services, but that could reasonably be expected to impact the Products and/or Services. Company, however, shall provide copies of all communications, interactions, and reports proposed for submission (or summaries in the case of oral communications, interactions, and reports) that could reasonably be expected to impact the Product and/or Services, to Iovance, in reasonable and sufficient time prior to submission to the applicable regulatory authority, for Iovance’s prior comment. Company will consider all of Iovance’s comments in good faith.
(d) In addition to the requirements of the foregoing subsections (b) and (c), Company shall furnish Iovance with final copies (or summaries or minutes in the case of oral communications, interactions, and reports) of all communications and interactions with, and reports to any applicable regulatory authority that relate to or could reasonably be expected to otherwise impact the Products and/or Services.
(e) After any of the foregoing interactions, communications, or reports, Company shall notify Iovance and provide Iovance with copies (or summaries or minutes in the case of oral communications, reports, and interactions) of any further communications with or rec...
Interactions. Amiodarone has a long half-life therefore drug interactions may occur over several weeks following amiodarone being stopped. Common drug interactions are listed below: • Anticoagulants - clearance of warfarin is reduced, therefore INR increases. Warfarin dose should be reduced by 33-50% and INR monitored weekly. Exposure to dabigatran is increased so the dose may need to be decreased to reduce the risk of bleeding. This will be completed by the specialist prior to entry into shared care. • Digoxin - plasma concentration of digoxin increased. Dose reduction of up to 50% is advised. Digoxin levels should be monitored along with ECG monitoring. This will be completed by the specialist prior to entry into shared care. GP to continue routine monitoring. • Flecainide - plasma concentrations of flecainide increased. Reduce flecainide dose by 50%. This will be completed by the specialist prior to entry into shared care. • Diltiazem, verapamil and beta-blockers - increased risk of cardiodepression and bradycardia. These medicines are not to be initiated by a GP for patients already prescribed amiodarone. Discuss with specialist. • Phenytoin -can increase phenytoin levels – reduce phenytoin dose and monitor phenytoin levels. Specialist will refer to neurology if commenced on amiodarone for advice upon dose adjustments, levels and alternatives. • Statins - increased risk of muscular toxicity. Recommended that maximum dose of simvastatin used is 20mg daily. No dose recommendation is available for atorvastatin and fluvastatin. If a statin is indicated, consider rosuvastatin or pravastatin. • Grapefruit juice- increases plasma concentration of amiodarone therefore should be avoided. • Any medication that prolongs QT interval- increased risk of torsades de pointes when amiodarone is administered with erythromycin, co-trimoxazole, pentamidine, lithium, tricyclic antidepressants, some antipsychotics, fluouroquinolones (use with moxifloxacin is contraindicated), antimalarials, antihistamines such as terfenadine, astemizole and mizolastine and also class 1a antiarrhythmic drugs such as disopyramide, quinidine, procainamide, and class III antiarrythmic drugs such as sotalol, bretylium. Co-administration of amiodarone with drugs known to prolong the QT interval must be based on a careful assessment of the potential risks and benefits for each patient since the risk of torsade de pointes may increase and patients should be monitored for QT prolongation. • Drugs which may cause ...
Interactions. The Desktop Services Manager will provide the Divisional Liaisons with a report of service activity at the end of the Fall and Spring semesters, as well as meet with the liaison as needed to identify upcoming situational priorities and discuss items of importance to both ITS and the division. Should the primary DSS be absent from work for more than ten consecutive business days, the DSM will attempt to assign additional support tickets to the remaining personnel to avoid issues from queuing for too long, negatively impacting divisional productivity.
Interactions. Responses by the applicant are usually immediate, appropriate, and informative. The applicant initiates and maintains exchanges even when dealing with an unexpected turn of events. The applicant deals adequately with apparent misunderstandings by checking, confirming, or clarifying.
Interactions. Licensor hereby grants to Licensee a nonexclusive license to distribute Interactions library as part of the work created with the Software. Licensee may use, duplicate, and distribute the Interactions library in such work either for their own use or for distribution to a third party, and Licensee may license such work to end users and to third parties, who may also further license such work to end users.
Interactions. 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.