Access to Clinical Data Sample Clauses

Access to Clinical Data. Ostex shall provide Hologic and Serex with full access to all clinical trial data and regulatory submissions, and make available all urine samples, collected by Ostex that pertain to the NTx Assay Technology and to the activities of Hologic and Serex under this Agreement. It is acknowledged that such information will be subject to the confidentiality provisions set out in this Agreement as well as confidentiality provisions necessary to protect patient privacy; provided, however, that such information may, as necessary and appropriate, be transmitted to proper regulatory authorities in connection with the seeking of regulatory product approvals. 5.
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Access to Clinical Data. 8.1 For Co-development Activities where Zealand is the sole Sponsor, BB shall have access to use the Clinical Data in relation to and only to the extent necessary for achieving the Purposes. However, Zealand accepts that BB may use the results of the specific Co Development Activities for further academic research purposes as required by the terms of BB’s license agreement with The Trustees of Boston University.
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Access to Clinical Data. Sponsor shall obtain the consent of Study participants to share Clinical Data with Xxxxx, including for secondary purposes, in accordance with the terms of this Agreement, the Related Agreements and all Applicable Law. In addition to any obligations of Sponsor to share Clinical Data pursuant to the DSA, Sponsor shall provide Lilly a complete copy of all Clinical Data (in electronic form or other mutually agreeable alternate form) upon the earlier of (x) [*] or (y) [*] and shall provide Lilly [*]. Sponsor and Xxxxx representatives shall meet [*], and at such other times as may be reasonably requested by either Party to discuss the status of the Study and other topics that may be relevant to the Study, [*].
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Access to Clinical Data. Ostex shall provide Metrika with full access to all clinical trial data and regulatory submissions, and make available all urine samples, collected by Ostex that pertain to the NTx Assay Technology and to the activities of Metrika under this Agreement, except where disclosure of such information is prohibited by any contract by which Ostex is bound. It is acknowledged that such information will be subject to the confidentiality provisions set out in this Agreement, to the extent applicable, as well as confidentiality provisions necessary to protect patient privacy; provided, however, that such information may, as necessary and appropriate, be transmitted to proper regulatory authorities in connection with the seeking of regulatory product approvals, and may be used in connection with each party's marketing activities for the NTx/Digital Response Device, subject, in the case of all such clinical data not developed pursuant to this Agreement, to the direction and consent of Ostex.
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Access to Clinical Data. Subject to Applicable Law, Sponsor shall obtain the consent of Study participants to share Clinical Data with Lilly, including for secondary purposes that are reasonably identified to Pieris in a manner that allows for their inclusion in the consent, in accordance with the terms of this Agreement. To the extent permitted under Applicable Law, Sponsor shall provide to Lilly copies of Clinical Data, in a summary, electronic form or other mutually agreeable alternate form, (a) at major decision points during the Study to track study progress, (b) at an appropriate time to support publications, (c) as needed to support interpretation of Clinical Data including efficacy analyses as mutually agreed by the Project Managers, or (d) as otherwise agreed upon by the Project Managers. Subject to Applicable Law, Sponsor shall provide to Lilly a complete copy of the Clinical Data in the manner and format prepared by the Sponsor no later than [***] days following Study Completion. "Study Completion" shall be deemed to CONFIDENTIAL Pieris Study PRS‐343‐PCS_09_20 and Lilly’ I4T-NS-I025 Page 9 [***] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information (I) is not material and (II) would be competitively harmful if publicly disclosed.
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Access to Clinical Data. Cubist acknowledges and agrees that all data generated in connection with Development activities conducted by Cubist or its Related Parties with respect to the Products in the Field for the Cubist Territory may be used by Dyax and/or its Related Parties solely to obtain Regulatory Approval for (i) Products in the Field in the Dyax Territory and (ii) Products in the Dyax Field in all countries of the world. In consideration for the access to and use of such data, Dyax shall pay Cubist an amount equal to []* of the development costs reasonably incurred by Cubist in the generation of such data; provided that such payment shall not be required with respect to the use of any data generated by or on behalf of Cubist pursuant to the conduct of the Ongoing Phase II Study. If Dyax and/or its Related Parties wishes to obtain use of such clinical data generated by Cubist pursuant to this Section 4.4, Dyax shall provide Cubist with notice thereof, and Cubist shall provide Dyax with an invoice for []* of the development costs incurred by Cubist in the Development of such clinical data as of the date of Dyax’s written request. Cubist shall transfer the requested clinical data to Dyax and/or its Related Parties promptly after receipt of the invoiced amount.
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Access to Clinical Data. Subject to the provisions in Section 3.9, each Party shall have access to all Clinical Data (including patient records which have been de-identified in accordance with 45 CFR §164.514(b)), as and to the extent allowed in trial site agreements. Amgen shall make such Clinical Data, to the extent available and in its possession, available to Ideaya on a quarterly basis within a reasonable period of time, but not to exceed [***] Business Days, after the expiration of the calendar quarter in which such Clinical Data is available to Amgen. Amgen shall require that Study investigators obtain patient authorizations and consents required by Regulatory Authorities for clinical trial participation as well as under HIPAA, the GDPR or any other similar Applicable Law in connection with the Study, to permit such sharing of Clinical Data from the Study with Ideaya.
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Access to Clinical Data. Each party shall provide the other party with full access to all clinical trial data and regulatory submissions, in such party's possession or control. It is acknowledged that such information will be subject to the confidentiality provisions set out in this Agreement, to the extent applicable, as well as confidentiality provisions necessary to protect patient privacy; provided, however, that such information may, as necessary and appropriate, be transmitted to proper regulatory authorities in connection with the seeking of regulatory product approvals, and may be used in connection with Ostex's marketing activities for the NTx/Digital Response Device.
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Related to Access to Clinical Data

  • Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.

  • Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.

  • Clinical 1.1 Provides comprehensive evidence based nursing care and individual case management to a specific group of patients/clients including assessment, intervention and evaluation. 1.2 Undertakes clinical shifts at the direction of senior staff and the Nursing Director including participation on the on-call/after-hours/weekend roster if required. 1.3 Responsible and accountable for patient safety and quality of care through planning, coordinating, performing, facilitating, and evaluating the delivery of patient care relating to a particular group of patients, clients or staff in the practice setting. 1.4 Monitors, reviews and reports upon the standard of nursing practice to ensure that colleagues are working within the scope of nursing practice, following appropriate clinical pathways, policies, procedures and adopting a risk management approach in patient care delivery. 1.5 Participates in xxxx rounds/case conferences as appropriate. 1.6 Educates patients/carers in post discharge management and organises discharge summaries/referrals to other services, as appropriate. 1.7 Supports and liaises with patients, carers, colleagues, medical, nursing, allied health, support staff, external agencies and the private sector to provide coordinated multidisciplinary care. 1.8 Completes clinical documentation and undertakes other administrative/management tasks as required. 1.9 Participates in departmental and other meetings as required to meet organisational and service objectives. 1.10 Develops and seeks to implement change utilising expert clinical knowledge through research and evidence based best practice. 1.11 Monitors and maintains availability of consumable stock. 1.12 Complies with and demonstrates a positive commitment to Regulations, Acts and Policies relevant to nursing including the Code of Ethics for Nurses in Australia, the Code of Conduct for Nurses in Australia, the National Competency Standards for the Registered Nurse and the Poisons Act 2014 and Medicines and Poisons Regulations 2016. 1.13 Promotes and participates in team building and decision making. 1.14 Responsible for the clinical supervision of nurses at Level 1 and/or Enrolled Nurses/ Assistants in Nursing under their supervision.

  • 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.

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Technology Research Analyst Job# 1810 General Characteristics

  • Access to Data Operator shall make Data in the possession of the Operator available to the LEA within five (5) business days of a request by the LEA.

  • Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.

  • Bulk Registration Data Access to Icann Periodic Access to Thin Registration Data. In order to verify and ensure the operational stability of Registry Services as well as to facilitate compliance checks on accredited registrars, Registry Operator will provide ICANN on a weekly basis (the day to be designated by ICANN) with up-to-date Registration Data as specified below. Data will include data committed as of 00:00:00 UTC on the day previous to the one designated for retrieval by ICANN.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

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