Ownership and Use of Clinical Data. All Clinical Data, including raw data and results, generated under this Agreement shall be jointly owned by BioLineRx and Merck. Merck hereby assigns to BioLineRx an undivided one-half interest in, to and under the Clinical Data. BioLineRx hereby assigns to Merck an undivided one-half interest in, to and under the Clinical Data. If such assignment cannot or does not occur, including in circumstances where such assignment is precluded by law, the Party with the obligation to assign hereby grants the other Party a non-exclusive license, with the right to grant sublicenses and to assign its license rights to the Clinical Data to any Person, in each case without the consent of the granting Party and without any accounting to such Party; provided that each such sublicensee and assignee is bound in writing to comply with the terms of this Agreement that are relevant to use and exploitation of such Clinical Data. BioLineRx shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term BioLineRx shall grant Merck access to all Clinical Data and any portions of BioLineRx’s database that include Clinical Data. Notwithstanding the foregoing, and subject to the remaining provisions of this Section 3.8, [*] provided, however, that the foregoing shall not limit or restrict either Party’s ability to use the Clinical Data as may be necessary to comply with Applicable Law or as may be necessary to comply with its internal policies and procedures with respect to pharmacovigilance and adverse event reporting. For the avoidance of doubt, BioLineRx shall be free to use/share (including publish) data and results from the Study, including Clinical Data, which are solely related to the single-agent use of the BioLineRx Compound and are not related to the Combination, and which have been generated during the treatment period in which the BioLineRx Compound is used in monotherapy. Neither Party shall disclose the Clinical Data to a Third Party except to the extent that such Clinical Data has been published as provided in Section 12.2 [*].
Ownership and Use of Clinical Data. Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.
3.8.1. Adaptimmune shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term, Adaptimmune shall grant Merck access to all Clinical Data and any portions of Adaptimmune’s database that include Clinical Data.
3.8.2. Notwithstanding the foregoing, and subject to the remaining provisions of this Section 3.8 and Section 9.4 or as otherwise permitted under this Agreement (including as set forth in Section 3.12 with respect to disclosure to GSK), before publication of the Clinical Data in accordance Article 12: *** provided, however, that the foregoing shall not limit or restrict either Party’s ability to (A) use or disclose the Clinical Data as may be necessary to comply with Applicable Law or with such Party’s internal policies and procedures with respect to pharmacovigilance and adverse event reporting or (B) share with Third Parties or Affiliates Toxicity and Safety Data where because of severity, frequency or lack of reversibility either Party needs to use such Toxicity and Safety Data with respect to its own Compound or the Combination to ensure patient safety or (C) to Subcontractors solely as necessary to perform its subcontracted obligations contemplated by this Agreement or the Study.
Ownership and Use of Clinical Data. Xxxxxx shall be the owner of all data and information generated by and in connection with the Clinical Studies and Xxxxxx initiated post-marketing studies including data analysis and clinical study reports (collectively, the “Clinical Data”) for use in the Field in the Xxxxxx Territory. Xxxxxx shall have the right during the Term to use all data from the Clinical Studies and Xxxxxx initiated post-marketing studies in connection with its performance of its obligations under this Agreement. Notwithstanding the foregoing, Kamada shall have the right to use all Clinical Data for use in registering, developing or marketing the Product in the Kamada Territory and, upon termination of this Agreement, except for early termination by Xxxxxx in accordance with Section 15.2(a) or Section 15.2(b), the Xxxxxx Territory, and Xxxxxx hereby grants to Kamada an irrevocable, perpetual, royalty-free license to all rights related to such data.
Ownership and Use of Clinical Data. Kamada shall be the owner of all data and information generated by and in connection with the Phase II/III and Phase IV Clinical Studies set forth in the above Sections 3.2(a)(i) and 3.2(a)(ii), while Kamada and Chiesi shall jointly own all data and information generated by and in connection with the other Clinical Studies, including the Additional Clinical Studies and Chiesi initiated post-marketing Clinical Studies including data analysis and Clinical Study reports (collectively, the “Clinical Data”). Starting from the Effective Date and afterwards on an ongoing basis during the Term, Kamada shall provide Chiesi with Clinical Data relating to the use of the Product in the Territory and Chiesi shall have the right, during the Term, to use all Clinical Data from the Clinical Studies in connection with the performance of its obligations under this Agreement. For the avoidance of doubt, all Clinical Data shall be regarded as Confidential Information of Kamada.
Ownership and Use of Clinical Data. 3.8.1 Company shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term, Company shall grant Merck access to all Clinical Data.
3.8.2 Notwithstanding the foregoing, before publication of the Clinical Data in accordance with Article 12, *; provided, however, that the foregoing shall not limit or restrict either Party’s ability to (i) use or disclose the Clinical Data as may be necessary to comply with Applicable Law or with such Party’s internal policies and procedures with respect to pharmacovigilance and adverse event reporting or (ii) share with Third Parties or Affiliates Toxicity and Safety Data where because of severity, frequency or lack of reversibility either Party needs to use such Toxicity and Safety Data with respect to its own Compound or the Combination to ensure patient safety.
Ownership and Use of Clinical Data. 3.8.1 All Clinical Data shall be jointly owned by Rexahn and Merck. [***].
3.8.2 Notwithstanding the foregoing, [***] provided, however, that the foregoing shall not limit or restrict either Party’s ability to (i) use or disclose the Clinical Data as may be necessary to comply with Applicable Law or with such Party’s internal policies and procedures with respect to pharmacovigilance and adverse event reporting, or (ii) share with Third Parties or Affiliates Toxicity and Safety Data where because of severity, frequency or lack of reversibility either Party needs to use such Toxicity and Safety Data with respect to its own Compound or the Combination to ensure patient safety. The Parties will furthermore consult and cooperate fully with each other on the provisions of this Agreement to be redacted in any filings required to be made by the Parties with the Securities and Exchange Commission or similar governmental agency in the U.S. or abroad, or as otherwise required by Applicable Law to protect to the fullest extent possible the Confidential Information of the Parties.
3.8.3 Notwithstanding anything to the contrary in this Section 3.8, [***].
3.8.4 If either Party desires to [***] which is not in accordance with this Section 3.8, such [***] shall require: (A) the advanced written consent of the other Party (which shall be at such Party’s sole discretion); and (B) such Third Party must be under obligations of confidentiality and non-use at least as stringent as those set forth in Section 9.1 of this Agreement.
Ownership and Use of Clinical Data. 3.8.1. [***].
3.8.2. [***]. Company shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term and for [***] days thereafter, Company shall grant MSD access to all Clinical Data.
3.8.3. Notwithstanding the foregoing, before publication of the Joint Clinical Data in accordance with Article 12, [***]; provided, however, that the foregoing shall not limit or restrict either Party’s ability to (i) use or disclose the Joint Clinical Data as may be necessary to comply with Applicable Law or with such Party’s internal policies and procedures with respect to pharmacovigilance and adverse event reporting; (ii) share with Third Parties or Affiliates Toxicity and Safety Data where because of severity, frequency or lack of reversibility either Party needs to use such Toxicity and Safety Data with respect to its own Compound or the Combination to ensure patient safety [***].
Ownership and Use of Clinical Data. 3.8.1. [***]. Intensity shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term, Intensity shall grant MSD access to all Clinical Data. [***].
3.8.2. Notwithstanding Section 3.8.1, before publication of the Clinical Data in accordance with Article 12, neither Party may disclose the Clinical Data publicly or to a Third Party without the consent of the other Party and each Party’s use of such unpublished Clinical Data is restricted to: [***]; provided, however, that the foregoing shall not limit or restrict either Party’s ability to [***].
Ownership and Use of Clinical Data. 3.8.1. [***]. FLX shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term, FLX shall [***] all Clinical Data [***].
3.8.2. Notwithstanding the foregoing, before publication of the Clinical Data in accordance with Article 12, neither Party may disclose the Clinical Data publicly or to a Third Party without the consent of the other Party and each Party’s use of such unpublished Clinical Data is restricted to: [***]; provided, however, that the foregoing shall not limit or restrict either Party’s ability to [***].
3.8.3. [***].
Ownership and Use of Clinical Data. 3.8.1. All Clinical Data shall be jointly owned by FLX and Merck. Merck hereby assigns to FLX an undivided one-half interest in, to and under the Clinical Data. FLX hereby assigns to Merck an undivided one-half interest in, to and under the Clinical Data. [***]. FLX shall maintain the Clinical Data in its internal database; provided, however, that at all times during the Term, FLX shall [***] all Clinical Data [***].
3.8.2. Notwithstanding the foregoing, before publication of the Clinical Data in accordance with Article 12, neither Party may disclose the Clinical Data publicly or to a Third Party without the consent of the other Party and each Party’s use of such unpublished Clinical Data is restricted to: [***]; provided, however, that the foregoing shall not limit or restrict either Party’s ability to [***].
3.8.3. [***].
