Common use of Multi-Party Data Rights Clause in Contracts

Multi-Party Data Rights. For clinical protocol(s) where Investigational Agent is used in combination with another investigational agent supplied to NCI pursuant to a CTA or CRADA between NCI and an entity not a Party to this CRADA [hereinafter referred to as “Third Party”], the access and use of Multi-Party Data by the Collaborator and Third Party shall be co-exclusive as follows: 8.9.1 NCI will provide both Collaborator and Third Party with notice regarding the existence and nature of the agreements governing their collaborations with NIH, the design of the proposed combination protocol(s), and the existence of any obligations that might restrict NCI’s participation in the proposed Combination protocols. 8.9.2 Collaborator shall agree to permit use of the Multi-Party Data from these trials by Third Party to the extent necessary to allow Third Party to develop, obtain regulatory approval for, or commercialize its own investigational agent(s). However, this provision will not apply unless Third Party also agrees to Collaborator’s reciprocal use of Multi-Party Data. 8.9.3 Collaborator and Third Party must agree in writing prior to the commencement of the combination trial(s) that each will use the Multi-Party Data solely for the development, regulatory approval, and commercialization of its own investigational agent(s). Add a new Article 8.10 as follows:

Multi-Party Data Rights. For clinical protocol(sProtocol(s) and Non-Clinical Study(ies) where Investigational Agent is used in combination with another investigational agent supplied to NCI pursuant to a CTA or CRADA between NCI and an entity not a Party to this CRADA [(hereinafter referred to as “Third Party”]), the access and use of Multi-Party Data by the Collaborator and Third Party shall be co-exclusive as follows: 8.9.1 NCI will provide both Collaborator and Third Party with notice regarding the existence and nature of the agreements governing their collaborations with NIH, the design of the proposed combination protocol(sProtocol(s) or Non-Clinical Study(ies), and the existence of any obligations that might restrict NCI’s participation in the proposed Combination protocolscombination Protocols or Non-Clinical Study(ies). 8.9.2 Collaborator shall agree to permit use of the Multi-Party Data from these trials by Third Party to the extent necessary to allow Third Party to develop, obtain regulatory approval for, or commercialize its own investigational agent(s). However, this provision will not apply unless Third Party also agrees to Collaborator’s reciprocal use of Multi-Party Data. 8.9.3 Collaborator and Third Party must agree in writing writing, by signing the drug approval forms for clinical Protocols, prior to the commencement of the combination trial(sProtocol(s) or Non-Clinical Study(ies) that each will use the Multi-Party Data solely for the development, regulatory approval, and commercialization of its own investigational agent(s). Add a new Article 8.10 as follows:.

Multi-Party Data Rights. For clinical protocol(s) where Investigational Agent is used in combination with another investigational agent supplied to NCI pursuant to a CTA or CRADA between NCI and an entity not a Party to this CRADA [hereinafter referred to as “Third Party”], the access and use of Multi-Party Data by the Collaborator and Third Party shall be co-exclusive as follows: 8.9.1 NCI will provide both Collaborator and Third Party with notice regarding the existence and nature of the agreements governing their collaborations with NIH, the design of the proposed combination protocol(s), and the existence of any obligations that might restrict NCI’s participation in the proposed Combination combination protocols. 8.9.2 Collaborator shall agree to permit use of the Multi-Party Data from these trials by Third Party to the extent necessary to allow Third Party to develop, obtain regulatory approval for, or commercialize its own investigational agent(s). However, this provision will not apply unless Third Party also agrees to Collaborator’s reciprocal use of Multi-Party Data. 8.9.3 Collaborator and Third Party must agree in writing prior to the commencement of the combination trial(s) that each will use the Multi-Party Data solely for the development, regulatory approval, and commercialization of its own investigational agent(s). Add a new Article 8.10 as follows:.

Multi-Party Data Rights. For mutually agreed upon clinical protocol(sProtocol(s) where Investigational Agent Test Article is used in combination with another investigational agent supplied to NCI IC pursuant to a CTA or CRADA between NCI IC and an entity not a Party to this CRADA [(hereinafter referred to as “Third Party”]), or for non-clinical study(ies) where research involving combinations of proprietary materials from more than one collaborator as documented in more than one agreement, the access and use of Multi-Party Data by the Collaborator and Third Party shall be co-exclusive as follows: 8.9.1 NCI 8.8.1 IC will provide both Collaborator and Third Party with notice regarding the existence and nature of the agreements governing their collaborations with NIHthe use of the Test Article and Third Party’s investigational agent, the design of the proposed combination protocol(sProtocol(s) or non-clinical study(ies), and the existence of any obligations that might restrict NCIIC’s participation in the proposed Combination protocolscombination Protocols or non-clinical study(ies). 8.9.2 8.8.2 Collaborator shall agree in writing to permit use of the Multi-Party Data from these trials by Third Party to the extent necessary to allow Third Party to develop, obtain regulatory approval for, or commercialize its own investigational agent(s). However, this provision will not apply unless Third Party also agrees to Collaborator’s reciprocal use of Multi-Party Data. 8.9.3 8.8.3 Collaborator and Third Party must agree in writing prior to the commencement of the combination trial(sProtocol(s) or non-clinical study(ies) that each will use the Multi-Party Data solely for the development, regulatory approval, and commercialization of its own investigational agent(s). Add a new Article 8.10 as follows:.

Multi-Party Data Rights. For clinical protocol(s) where Investigational Agent is in which Test Article will be used in combination with another other investigational agent material(s) supplied to NCI pursuant to ICD under a CTA or CRADA between NCI and separate agreement by an entity that is not a Party to this CRADA [hereinafter referred to as “Third Party”], the access and use of Multi-Party Data by the Collaborator and Third Party shall will be co-exclusive as follows: 8.9.1 NCI (a) ICD will provide both Collaborator and Third Party with notice regarding the existence and nature of the agreements governing their collaborations with NIHICD, the design of the proposed combination protocol(s), ) and the existence of any obligations that might restrict NCI’s ICD,s participation in the proposed Combination combination protocols. 8.9.2 (b) Collaborator shall agree to will permit use of the Multi-Party Data from these trials by Third Party to the extent necessary to allow Third Party to develop, obtain regulatory approval for, or commercialize its own investigational agent(smaterial(s). However, However this provision will not apply unless Third Party also agrees to Collaborator’s reciprocal use of Multi-Party Data. 8.9.3 (c) Collaborator and Third Party must agree in writing prior to the commencement of the combination trial(s) trials that each will use the Multi-Party Data solely for the development, regulatory approval, and commercialization of its own investigational agent(smaterial(s). Add a new Article 8.10 as follows:.

Multi-Party Data Rights. For mutually agreed upon clinical protocol(sProtocol(s) where Investigational Agent Test Article is used in combination with another investigational agent supplied to NCI IC pursuant to a CTA or CRADA between NCI IC and an entity not a Party to this CRADA [(hereinafter referred to as “Third Party”]), or for non-clinical study(ies) where research involving combinations of proprietary materials from more than one collaborator as documented in more than one agreement, the access and use of Multi-Party Data by the Collaborator and Third Party shall be co-exclusive as follows: 8.9.1 NCI 8.8.1 IC will provide both Collaborator and Third Party with notice regarding the existence and nature of the agreements governing their collaborations with NIHthe use of the Test Article and Third Party’s investigational agent, the design of the proposed combination protocol(sProtocol(s) or non-clinical study(ies), and the existence of any obligations that might restrict NCIIC’s participation in the proposed Combination protocolscombination Protocols or non-clinical study(ies). 8.9.2 8.8.2 Collaborator shall agree to permit use of the Multi-Party Data from these trials by Third Party to the extent necessary to allow Third Party to develop, obtain regulatory approval for, or commercialize its own investigational agent(s). However, this provision will not apply unless Third Party also agrees to Collaborator’s reciprocal use of Multi-Party Data. 8.9.3 8.8.3 Collaborator and Third Party must agree in writing prior to the commencement of the combination trial(sProtocol(s) or non-clinical study(ies) that each will use the Multi-Party Data solely for the development, regulatory approval, and commercialization of its own investigational agent(s). Add a new Article 8.10 as follows:PHS ICT-CRADA Case Ref. No. 02734 MODEL ADOPTED June 18, 2009

Multi-Party Data Rights. For clinical protocol(sProtocol(s) where Investigational Formulary Agent is used in combination with another investigational agent supplied to NCI pursuant to a CTA or another Formulary CRADA between NCI and an entity not a Party to this CRADA [or another agreement between the institution that Approved Investigator is associated with and an entity not a Party to this CRADA (hereinafter referred to as “Third Party”]), the access and use of Multi-Party Data by the Collaborator and Third Party shall be co-exclusive and reciprocal as follows: 8.9.1 NCI will provide both Collaborator and Third Party with notice regarding the existence and nature of the agreements governing their collaborations with NIH, and the design of the proposed combination protocol(sProtocol(s), and the existence of any obligations that might restrict NCI’s participation in the proposed Combination protocols., 8.9.2 Collaborator shall agree to permit use of the Multi-Party Data from these trials by Third Party to the extent necessary to allow Third Party to develop, obtain regulatory approval for, or commercialize its own investigational agent(s). However, this provision will not apply unless Third Party also agrees to Collaborator’s reciprocal use of Multi-Party Data. 8.9.3 Collaborator and Third Party must agree in writing prior to the commencement of the combination trial(s) that each will use the Multi-Party Data solely for the development, regulatory approval, and commercialization of its own investigational agent(s). Add a new Article 8.10 as follows:

Multi-Party Data Rights. For clinical protocol(sProtocol(s) and Non-Clinical Study(ies) where Investigational Agent is used in combination with another investigational agent supplied to NCI pursuant to a CTA or CRADA between NCI and an entity not a Party to this CRADA [(hereinafter referred to as “Third Party”]), the access and use of Multi-Party Data by the Collaborator and Third Party shall be co-exclusive as follows: 8.9.1 NCI will provide both Collaborator and Third Party with notice regarding the existence and nature of the agreements governing their collaborations with NIHNCI, the design of the proposed combination protocol(sProtocol(s) or Non-Clinical Study(ies), and the existence of any obligations that might restrict NCI’s 's participation in the proposed Combination protocolscombination Protocols or Non-Clinical Study(ies). 8.9.2 Collaborator shall agree to permit use of the Multi-Party Data from these trials by Third Party to the extent necessary to allow Third Party to develop, obtain regulatory approval for, or commercialize its own investigational agent(s). However, this provision will not apply unless Third Party also agrees to Collaborator’s reciprocal use of Multi-Party Data, which is documented by the signed Drug Approval Form. 8.9.3 Collaborator and Third Party must agree in writing prior to the commencement of the combination trial(s) that each will use the Multi-Party Data solely for the development, regulatory approval, and commercialization of its own investigational agent(s). Add a new Article 8.10 as follows:

Multi-Party Data Rights. For clinical protocol(sProtocol(s) and Non-Clinical Study(ies) where Investigational Agent is used in combination with another investigational agent supplied to NCI pursuant to a CTA or CRADA between NCI and an entity not a Party to this CRADA [(hereinafter referred to as “Third Party”]), the access and use of Multi-Party Data by the Collaborator and Third Party shall be co-exclusive as follows: 8.9.1 NCI will provide both Collaborator and Third Party with notice regarding the existence and nature of the agreements governing their collaborations with NIH, the design of the proposed combination protocol(sProtocol(s) or Non-Clinical Study(ies), and the existence of any obligations that might restrict NCI’s 's participation in the proposed Combination protocolscombination Protocols or Non-Clinical Study(ies). 8.9.2 Collaborator shall agree to permit use of the Multi-Party Data from these trials by Third Party to the extent necessary to allow Third Party to develop, obtain regulatory approval for, or commercialize its own investigational agent(s). However, this provision will not apply unless Third Party also agrees to Collaborator’s reciprocal use of Multi-Party Data. 8.9.3 Collaborator and Third Party must agree in writing writing, by signing the drug approval forms for clinical Protocols, prior to the commencement of the combination trial(sProtocol(s) or Non-Clinical Study(ies) that each will use the Multi-Party Data solely for the development, regulatory approval, and commercialization of its own investigational agent(s). Add a new Article 8.10 as follows:.

Multi-Party Data Rights. For clinical protocol(sProtocol(s) where Investigational Formulary Agent is used in combination with another investigational agent supplied to NCI pursuant to a CTA or another Formulary CRADA between NCI and an entity not a Party to this CRADA [or another agreement between the Institution that Approved Investigator is associated with and an entity not a Party to this CRADA (hereinafter referred to as “Third Party”]), the access and use of Multi-Party Data by the Collaborator and Third Party shall be co-exclusive and reciprocal as follows: 8.9.1 NCI will provide both Collaborator and Third Party with notice regarding the existence and nature of the agreements governing their collaborations with NIH, and the design of the proposed combination protocol(sProtocol(s), and the existence of any obligations that might restrict NCI’s participation in the proposed Combination protocols., 8.9.2 Collaborator shall agree to permit use of the Multi-Party Data from these trials by Third Party to the extent necessary to allow Third Party to develop, obtain regulatory approval for, or commercialize its own investigational agent(s). However, this provision will not apply unless Third Party also agrees to Collaborator’s reciprocal use of Multi-Party Data. 8.9.3 Collaborator and Third Party must agree in writing prior to the commencement of the combination trial(s) that each will use the Multi-Party Data solely for the development, regulatory approval, and commercialization of its own investigational agent(s). Add a new Article 8.10 as follows: