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. (a) To the extent permitted by the relevant regulatory authority and by Law, LBIO 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 LBIO, 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 LBIO by Company, in reasonable and sufficient time prior to submission to the applicable regulatory authority, for LBIO’s prior review and approval. For clarity, this may include LBIO providing on-site, but indirect, assistance to Company in connection with a regulatory interaction. Company will incorporate all of LBIO’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 LBIO, in reasonable and sufficient time prior to submission to the applicable regulatory authority, for LBIO’s prior comment. Company will consider all of LBIO’s comments in good faith.
(d) In addition to the requirements of the foregoing subsections (b) and (c), Company shall furnish LBIO 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 LBIO and provide LBIO with copies (or summaries or minutes in the case of oral communications, reports, and interactions) of any further communications with or received from, or reports to such regul...
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 conditional upon registration 1) The three institutions agree to make the following types of interaction conditional upon prior registration of interest representatives: In the European Parliament - Access to Parliament buildings: eligibility for applying for long- term access passes to the European Parliament premises of individuals representing, or working for, interest representatives; - Committee public hearings: possibility for interest representatives to be invited to 1) The three institutions agree endorse the principle to make the following certain types of interaction conditional upon prior registration of interest representatives in the Transparency Register. These include: In the three institutions Meetings between interest representatives and EU officials from the Secretary-
Interactions. It is important as with all drugs that prescriber’s check relevant information for interactions such as the BNF and SPC and also the prescribing system where available. ▪ Antidepressants: Tri or tetracyclic antidepressants (e.g. imipramine, clomipramine, mirtazapine) may impair the efficacy of pitolisant because they display histamine H1-receptor antagonist activity and possibly cancel the effect of endogenous histamine released in brain by the treatment. ▪ Anti-histamines: Anti-histamines (H1-receptor antagonists) crossing the haemato-encephalic barrier (e.g. pheniramine maleate, chlorpheniramine, diphenydramine, promethazine, mepyramine) may impair the efficacy of pitolisant. ▪ QT-prolonging substances or known to increase the risk of repolarization disorders. Combination with pitolisant should be made with a careful monitoring. ▪ With oral contraceptives, the combination with pitolisant should be avoided and a further reliable contraceptive method used. Further information can be found in the Summary of Product Characteristics
Interactions. The joint distribution for spatio-temporal interactions is modeled as a multinormal distri- bution. For example, the joint spatio-period interactions ϕ = (ϕip, i = 1, ..., N, p = 1, ..., P ) are taken as ϕ ~ N (0, τϕKµ p). The structure matrix Kµ p is the Kronecker product of Kµ for the spatial effect and Kp for the period effect, such as Kµ p = Kµ ⊗ Kp. Since both Kµ and Kp are symmetric and singular matrices, their Kronecker product Kµ p is symmetric and singular as well. Therefore, the joint density for spatio-temporal effects is improper [Xxxxxx et al., 1997]. Xxxxxx and Xxxxx [2009] pointed out that the proper posterior may not always result, thus extra care must be taken when using improper priors. As an alternative solution [Xxxxxxx, 2006b], we consider the parsimonious product interactions schemes with generic form αiβp, i = 1, ..., N, p = 1, ..., P, where αi is the structured spatial effects, subject to Σi αi = 0, while Σ βp = exp(ηp)/[1 + exp(ηp)], p = 1, ..., P — 1, and ηp is the period effects. P—1 Σ βP = 1/[1 + exp(ηp)], Given the likelihood and prior density, we can derive the posterior distribution for model parameters P (λ|y) ∝ P (y|λ)P (λ) . ∝ Qi,a,p eλiap (λiap)yiap P (ν, µ, c, s, γ, δ, ϕ1, ϕ2) Markov chain Monte Carlo (MCMC) methods have been used to sample from the posterior density. Due to the non-identifiability issues in the model parameters, certain constraints are added in the model to improve numerical stability and mixing [Xxxx, 2002]. Area, age, period and cohort effects are each adjusted by subtracting their respective means [Xxxx, 2002]. Winbugs software is used to derive the posterior distribution about model parameters from 10000 iterations after a burn-in of 1000 iterations. The convergence plots of model parameters are provided along with convergence diagnostics. The posterior estimates of main effects and interactions in the AAPC model are summarized by the mean and 90% highest posterior density (HPD) derived from posterior samples. Statistical software R and WinBUGS are used in this study.
Interactions. A multi-factor repeated measures analysis showed no interactions between information exchanged, vote number and question type (Table 10). Where two interaction contrasts were calculated, the average is given. IE by vote number 0.330 ns 0.444 ns 0.220 ns IE by question type 0.460 ns 0.182 ns N/A Vote number by question type 0.394 ns 0.532 ns N/A IE by vote number by question type 0.741 ns 0.234 ns N/A A chi-squared analysis showed no significant treatment order effect. However comparing agreement between tests (for vote 1) showed small but significant differences (Table 11). Agreement 0.45 0.39 0.41 0.004** Could these differences have caused the main effects? Even if each treatment had been done entirely with one test (which was not the case), the expected agreement difference would be only 0.06 (the test A vs test B difference). The treatment difference found was 0.42, which is seven times larger. However the main effect could explain the test differences, as the latter are all in the direction predicted by the uneven allocation of test to treatment (tests A and C were allocated 15 and 12 times respectively to the group and confidence aware treatments, while test B was only allocated 9 times). While belonging and morale correlated highly together (r = 0.794, p = 0.000), neither correlated with any later measure. The group influence found seems a property of the situation, not the standing group, and seems independent of individuals knowing each other personally, as was also found in the original conformity studies (Xxxxxxxxxxx, 1955).
Interactions. Tests for interactions will be conducted between pairs of explanatory factors and binary outcomes to assess possible interactions. As participants complete each section of the online survey, the data will immediately be transferred to a Public Health Solutions designated server that cannot be accessed publicly. At the completion of data collection, an analytic file will be prepared by the Manager of Web Development and given to the data analyst in the Research and Evaluation Unit. The survey file, which has no personal identifiers, will be removed from the server and stored in a secure site. Only the study investigators and CDC collaborators will have access to the data. Because the analytic file has no personal identifiers, a CD will be kept in a locked file in the PI’s office for up to 10 years. Participants will be assigned a unique study number. Behavioral survey (baseline, immediate post-intervention, 60-day follow-up) data will only include this unique study number. Email addresses of participants who agree to provide this information will be stored in an electronic file separate from survey data on a secure, firewall protected Public Health Solutions-managed server. The electronic file will contain email addresses linked to a participant’s unique study number. This linking file is necessary to identify and contact participants for the 60-day follow-up survey and track the result (i.e., completed follow-up or not). This file will be destroyed after the data collection period (i.e., 60-day follow-up assessments have been completed). Only the Public Health Solutions Manager of Web Development and Programming will have access to these files. Even in the highly unlikely event of a breach of the security system, the survey data exist only as a string of numbers with a few qualitative responses. The analytic data file has no personal identifiers and access will be limited to study staff. We do not anticipate that any formal confidentiality protections will be needed for this research. While the behavioral assessments will include responding to some sensitive questions related to sexual behavior, sexual orientation, and drug use, participants’ names will not be collected. In conducting previous research with similar target populations, we have not observed that individuals have expressed reluctance to participate unless we are able to promise confidentiality. We also have no reason to doubt the validity of responses without the expectation of complete confi...
