Access to Clinical Data Sample Clauses
The 'Access to Clinical Data' clause defines the rights and procedures for parties to obtain and review clinical data generated during a study or project. Typically, it outlines who may access the data, under what conditions, and any confidentiality or data protection requirements that must be followed. For example, a sponsor may be granted access to anonymized patient data for regulatory submissions, while investigators may use the data for academic publications. This clause ensures transparency, facilitates compliance with regulatory standards, and clarifies data ownership and usage rights, thereby preventing disputes over data access and use.
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.
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.
Access to Clinical Data. Sponsor shall obtain the consent of Study participants to share Clinical Data with ▇▇▇▇▇, 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 ▇▇▇▇▇ 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, [*].
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.
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.
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.
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.
Access to Clinical Data. 6.2.1 Phase 1, Phase 2 Clinical Data. Each Party shall provide to the other Party the Clinical Data that is generated by or on behalf of such Party, its Affiliates, and, in the case of RAPT, Sublicensees, or, in the case of Jemincare, its licensees of the Licensed IP in the Field, in the performance of any Phase 1 Clinical Trials and Phase 2 Clinical Trials that is not a Registrational Trial. Without limiting the foregoing and as applicable, the provision of Clinical Data under this Section 6.2.1 (Phase 1, Phase 2 Clinical Data) shall be performed in accordance with the Clinical Data Transfer Plan and the PVA. Each Party may use such Clinical Data to satisfy its safety reporting obligations for the Licensed Product under Applicable Law in such Party’s Territory, and in support of seeking Regulatory Approval for the Licensed Product in such Party’s Territory, including by inclusion of such Clinical Data in regulatory filings submitted to Regulatory Authority in support of seeking Regulatory Approval for the Licensed Product in such Party’s Territory, or to perform statistical analysis under a trial protocol for the purpose of evaluating efficacy.
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.