Common use of Overview of Collaboration Clause in Contracts

Overview of Collaboration. The Parties intend and have agreed to undertake the Collaboration under this Agreement with the primary goal to Research, Develop, Manufacture and Commercialize Collaboration Products in accordance with the Collaboration with the goal of expanding and enhancing the value of such Collaboration Products, consisting, in general, of the following major components: (a) a broad program to be conducted during the POC Term for the PCV Program for the Research and Development of PCVs (including Collaboration PCV Products), pursuant to which Moderna will conduct Research and Development efforts with Merck’s participation with respect to such PCVs and establish Manufacturing capabilities for Collaboration PCV Products, as described in the POC Plan for the PCV Program and further detailed in Section 3; (b) a broad program to be conducted during the POC Term for the KRAS Program, pursuant to which the Parties will conduct Research and Development efforts with respect to SAVs Directed against KRAS (including Collaboration SAV Products Directed against KRAS) and identify Manufacturing capacity for such Collaboration SAV Products, as described in the POC Plan for the KRAS Program and further detailed in Section 3; (c) if during the SAV Research Term, the Parties do not agree to collaborate on one or more additional Targets, then a Party and its Affiliates may conduct an Internal SAV Program, pursuant to which such Party and its Affiliates may conduct Research efforts with respect to one or more SAVs Directed against such Target, as described in the Internal SAV Program Plan for such Internal SAV Program and further described in Section 3.1(d); (d) if during the SAV Research Term, the Parties mutually agree to collaborate on one or more additional SAV Targets (other than KRAS) in accordance with Section 3.1(c), a broad program to be conducted during the POC Term for such Joint SAV Program, pursuant to which the Parties will conduct Research and Development efforts with respect to such SAVs Directed against such SAV Target (including Collaboration SAV Products Directed against such SAV Target) and identify Manufacturing capacity for such Collaboration SAV Products, as described in the POC Plan for such Joint SAV Program and further detailed in Section 3; (e) for each given Program, Merck will have the right during the Merck Participation Election Period for such Program to exercise the Merck Participation Election for such Program to further participate with Moderna in the further Research, Development, Manufacture and Commercialization of mRNA Cancer Vaccines (including Collaboration Products) with respect to such Program, and to share equally the costs and benefits of, such Research, Development, Manufacture and Commercialization, subject to and in accordance with this Agreement; (f) for each given Program, if Merck exercises the Merck Participation Election for such Program, then, subject to Merck paying the Participation Election Payment for such Program in accordance with Section 9.3(a), during the Merck Participation Term for such Program: (i) the Parties will conduct further Research and Development of mRNA Cancer Vaccines (including Collaboration Products) for such Program through Regulatory Approval, with the activities to be jointly funded by the Parties in accordance with the terms of this Agreement; provided, however, that [***]; (ii) Merck shall have the sole right to Commercialize the Collaboration Products from such Program in the Territory (subject to Moderna’s right to engage in Co-Promotion activities in the United States under and in accordance with Sections 8.5 and 8.6 and any Co-Promotion Agreement(s)); (iii) the Parties will participate in profits or losses arising from the Commercialization of such Collaboration Products, all as detailed and pursuant to Section 9; and (iv) each Party will grant appropriate cross-licenses to the other Party to Research, Develop, Manufacture and Commercialize such Collaboration Products pursuant to Section 10. (g) [***]. (i) During the SAV Research Term, the Parties may review and discuss the available Clinical Data that is generated in the course of Developing Collaboration PCV Products to determine whether [***]. (1) If, during the SAV Research Term, [***], then the Parties may mutually agree to amend the applicable Plan to [***] in accordance with the Plan for such SAV Program. (2) If, during the SAV Research Term, [***], and the Parties wish to conduct Collaboration Activities for such [***], then the Parties may mutually agree to initiate a new SAV Program with respect to such [***] in accordance with Section 3.1(c). (3) [***] (ii) From time to time after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, the Parties may review and discuss the available Clinical Data that is generated in the course of Developing Collaboration PCV Products to determine whether [***]. During the discussion referenced above, a Party shall disclose to the other Party if such Party (or any of its Affiliates) is engaged in a pre-existing bona fide active and sustained research, development or commercialization program (alone or with one or more Third Parties) on any [***] based on [***]. (1) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, a pre-existing bona fide active and sustained research, development or commercialization program with respect to an [***] based on [***], then following the disclosure pursuant to clauses (ii) above in which the existence of such pre-existing program became known to both Parties, each Party shall [***]. (2) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, such [***], then the Parties may mutually agree to amend the applicable Plan to incorporate the Research, Development, Manufacture and Commercialization of [***] associated with [***] in accordance with the Plan for such [***]. (3) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, no such pre-existing program exists [***], at the written request of either Party, then any [***]s based on any such [***] shall automatically be treated [***], for so long as one or both of the Parties [***]. (iii) For the avoidance of doubt, subject to this Section 2.1(g) and Sections 10.7 and 10.8, nothing in this Agreement shall limit either Party’s (or its Affiliates’) ability to research, develop, manufacture or commercialize any [***], or grant licenses or otherwise enter into agreements with one or more Third Parties for any of those activities.

Appears in 4 contracts

Samples: Mrna Cancer Vaccine Collaboration and License Agreement, Mrna Cancer Vaccine Collaboration and License Agreement, Mrna Cancer Vaccine Collaboration and License Agreement (Moderna, Inc.)

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Overview of Collaboration. The Parties intend and have agreed to shall undertake the Collaboration a collaboration under this Agreement with the primary goal to Research, Develop, Manufacture and Commercialize Collaboration Products in accordance with the Collaboration with the goal of expanding and enhancing the value of such Collaboration Products, consisting, in general, of the following major components: (a) a broad program to be conducted during the POC Term research collaboration, for the PCV Program for purpose, inter alia, of characterizing New Collaboration Compounds and designating Lead Compounds, under the direction of the Joint Research and Development of PCVs (including Collaboration PCV Products)Incubator, pursuant to which Moderna will conduct Research and Development efforts in accordance with Merck’s participation with respect to such PCVs and establish Manufacturing capabilities for Collaboration PCV Productsa research plan agreed upon by the Parties, as described further set forth in the POC Plan for the PCV Program and further detailed in Section Article 3; (b) a broad an exploratory Development program to be conducted during (the POC Term for “Exploratory Development Program”) encompassing the KRAS Program, pursuant to which following activities: (i) the Parties will characterization of Lead Compounds and designation of Lead Compounds as Development Candidates; (ii) the conduct Research and Development efforts of Phase I Clinical Studies with respect to SAVs Directed against KRAS such Development Candidates; (iii) the conduct of Indication Survey Studies in various Indications, including Collaboration SAV Products Directed against KRAS) and identify Manufacturing capacity for such Collaboration SAV Products, the Initial Indications (as described in Section 4.3(c)) with respect to such Development Candidates; and (iv) the POC Plan evaluation of the results of Indication Survey Studies and such Development Candidates in order to determine which Development Candidates should be designated as Product Candidates for the KRAS Program further Development in a selected Indication and, where successful, seeking and obtaining Regulatory Approval, as further detailed set forth in Section 3Article 4; (c) if during on a Product Candidate-by-Product Candidate basis, at the SAV Research Termtime of designation of a Development Candidate as a Product Candidate for its selected Indication, the Parties do not agree to collaborate on one or more additional Targetsa later stage development program for each such Product Candidate (each, then a Party “Product Development Program”) which includes all Clinical Studies and its Affiliates may conduct an Internal SAV Program, pursuant to which such Party and its Affiliates may conduct Research efforts with respect to one or more SAVs Directed against such Target, as described in the Internal SAV Program Plan Non-Clinical Studies for such Internal SAV Program and further described Product Candidate with the goal of obtaining Regulatory Approval for Products containing such Product Candidate, in Section 3.1(d); (d) if during each case under the SAV Research Term, oversight of the Parties mutually agree to collaborate on one or more additional SAV Targets (other than KRAS) in accordance with Section 3.1(c), a broad program to be conducted during the POC Term for such Joint SAV Program, pursuant to which the Parties will conduct Research and Development efforts with respect to such SAVs Directed against such SAV Target (including Collaboration SAV Products Directed against such SAV Target) and identify Manufacturing capacity for such Collaboration SAV Products, as described in the POC Plan for such Joint SAV Program and further detailed in Section 3; (e) for each given Program, Merck will have the right during the Merck Participation Election Period for such Program to exercise the Merck Participation Election for such Program to further participate with Moderna in the further Research, Development, Manufacture and Commercialization of mRNA Cancer Vaccines (including Collaboration Products) with respect to such Program, and to share equally the costs and benefits of, such Research, Development, Manufacture and Commercialization, subject to applicable JDC and in accordance with this Agreement; (f) for each given Program, if Merck exercises Article 5 and the Merck Participation Election for such Program, then, subject to Merck paying the Participation Election Payment for such Program in accordance with Section 9.3(a), during the Merck Participation Term for such Program: (i) the Parties will conduct further Research and Development of mRNA Cancer Vaccines (including Collaboration Products) for such Program through Regulatory Approval, with the activities to be jointly funded by the Parties in accordance with the other terms of this Agreement; provided, however, that [***];and (iid) Merck shall have for jointly-funded Products, shared Commercialization and profit sharing of such Products within a Profit Share Region under the sole right oversight of the applicable JMC and the JEC, and pursuant to Commercialize the Collaboration Products from such Program in the Territory (subject to Moderna’s right to engage in Co-Promotion activities in the United States under and a Commercialization Plan, in accordance with Sections 8.5 Articles 7 and 8.6 11 and any Cothe other terms of this Agreement; and for unilaterally-Promotion Agreement(s)); (iii) the Parties will participate in profits or losses arising from the funded Products, unilateral Commercialization of such Collaboration ProductsProducts in the Royalty Regions, all as detailed and pursuant to Section 9; and (iv) each Party will grant appropriate cross-licenses with a royalty paid to the other Party to Researchnon- funding party, Develop, Manufacture as set forth in Articles 8 and Commercialize such Collaboration Products pursuant to Section 10. (g) [***]. (i) During the SAV Research Term, the Parties may review and discuss the available Clinical Data that is generated in the course of Developing Collaboration PCV Products to determine whether [***]. (1) If, during the SAV Research Term, [***], then the Parties may mutually agree to amend the applicable Plan to [***] in accordance with the Plan for such SAV Program. (2) If, during the SAV Research Term, [***], 11 and the Parties wish to conduct Collaboration Activities for such [***], then the Parties may mutually agree to initiate a new SAV Program with respect to such [***] in accordance with Section 3.1(c)other terms of this Agreement. (3) [***] (ii) From time to time after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, the Parties may review and discuss the available Clinical Data that is generated in the course of Developing Collaboration PCV Products to determine whether [***]. During the discussion referenced above, a Party shall disclose to the other Party if such Party (or any of its Affiliates) is engaged in a pre-existing bona fide active and sustained research, development or commercialization program (alone or with one or more Third Parties) on any [***] based on [***]. (1) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, a pre-existing bona fide active and sustained research, development or commercialization program with respect to an [***] based on [***], then following the disclosure pursuant to clauses (ii) above in which the existence of such pre-existing program became known to both Parties, each Party shall [***]. (2) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, such [***], then the Parties may mutually agree to amend the applicable Plan to incorporate the Research, Development, Manufacture and Commercialization of [***] associated with [***] in accordance with the Plan for such [***]. (3) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, no such pre-existing program exists [***], at the written request of either Party, then any [***]s based on any such [***] shall automatically be treated [***], for so long as one or both of the Parties [***]. (iii) For the avoidance of doubt, subject to this Section 2.1(g) and Sections 10.7 and 10.8, nothing in this Agreement shall limit either Party’s (or its Affiliates’) ability to research, develop, manufacture or commercialize any [***], or grant licenses or otherwise enter into agreements with one or more Third Parties for any of those activities.

Appears in 2 contracts

Samples: Collaboration Agreement (Reata Pharmaceuticals Inc), Collaboration Agreement (Reata Pharmaceuticals Inc)

Overview of Collaboration. The Parties intend and have agreed to undertake the Collaboration a broad collaboration under this Agreement with the primary goal to Research, Develop, Manufacture and Commercialize Collaboration Products in accordance with the Collaboration with the goal of expanding and enhancing the value of such Collaboration Products, consisting, in general, of the following major components:: [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. (a) the grant to Merck of a broad program worldwide, exclusive license by NGM, as of the Effective Date, with respect to be conducted during NGM’s NP201 Compounds and NP201 Products and the POC Term for continuation by the PCV Program for the Research Parties of certain research and Development of PCVs (including Collaboration PCV Products), pursuant to which Moderna will conduct Research and Development efforts with Merck’s participation development activities with respect to such PCVs compounds and establish Manufacturing capabilities for Collaboration PCV Productsproducts, all as described set forth in the POC Plan for the PCV Program and further detailed in Section Article 3; (b) a broad research and early development program to be conducted by NGM during the POC Full Research Program Term for (the KRAS “Research Program”), pursuant to which the Parties which: (i) NGM will conduct Research research, discovery and Development pre-clinical development efforts with respect to SAVs Directed against KRAS (targets, other than Excluded Targets, and including targets that NGM may identify through any activities under the Collaboration SAV Products Directed against KRAS) whether intentionally directed at identification of targets or otherwise, in an effort to identify and identify Manufacturing capacity for develop Collaboration Compounds that Modulate such Collaboration SAV Productstargets in a manner that satisfies the applicable Physiologically Relevant Threshold, without limitation with respect to a disease area of focus, as described well as NGM’s innovation efforts in the POC Plan for the KRAS Program antibody and protein engineering; to be funded by Merck, all as further detailed in Section 3Article 4; and (ii) NGM will conduct early stage clinical studies of Research Program Development Candidates arising from such research efforts through POC Trial and delivery of the Data Package associated with each POC Compound, to be funded by Merck, as further detailed in Article 4; (c) if during the SAV Research Termgrant to Merck of an exclusive option, exercisable following review of the Parties do not agree Data Package following the POC Trial for a particular POC Compound, to collaborate on one or more additional Targetsobtain an exclusive, then a Party worldwide license to such POC Compound and its Affiliates may conduct an Internal SAV Program, pursuant to which such Party and its Affiliates may conduct Research efforts with respect to one or more SAVs Directed against such TargetRelated Compounds, as described further detailed in the Internal SAV Program Plan for such Internal SAV Program and further described in Section 3.1(d)Article 5; (d) if during in the SAV Research Term, event of exercise of the Parties mutually agree to collaborate on one or more additional SAV Targets (other than KRAS) in accordance with Section 3.1(c), a broad program to be conducted during the POC Term for such Joint SAV Program, pursuant to which the Parties will conduct Research and Development efforts Merck Option with respect to such SAVs Directed against such SAV Target (including Collaboration SAV Products Directed against such SAV Target) and identify Manufacturing capacity for such Collaboration SAV Productsa given POC Compound, as described in the POC Plan for such Joint SAV Program and further detailed in Section 3; (e) for each given Program, Merck NGM will have the right during the Merck Participation Election Period for such Program an option to exercise the Merck Participation Election for such Program to further participate with Moderna in the further Research, Development, Manufacture and Commercialization of mRNA Cancer Vaccines (including Collaboration Products) with respect to such Program, and to share equally the costs and benefits of, such Research, Development, Manufacture and Commercialization, subject to and in accordance with this Agreement; (f) for each given Program, if Merck exercises the Merck Participation Election for such Program, then, subject to Merck paying the Participation Election Payment for such Program in accordance with Section 9.3(a), during the Merck Participation Term for such Program: either: (i) the Parties will conduct further Research receive milestones and Development of mRNA Cancer Vaccines (including Collaboration Products) for royalties associated with such Program through Regulatory Approval, with the activities to be jointly funded by the Parties in accordance with the terms of this AgreementPOC Compound; provided, however, that [***]; or (ii) Merck shall have the sole right to Commercialize the Collaboration Products from such Program participate in the Territory (subject Adjusted Net Sales associated with such POC Compound, in exchange for co-funding a share of the Development Costs and Allowable Expenses associated with such POC Compound, and an option to Moderna’s right to engage in Co-Promotion activities Detail such POC Compound in the United States under and in accordance with Sections 8.5 and 8.6 and any Co-Promotion Agreement(s)); (iii) the Parties will participate in profits or losses arising from the Commercialization of such Collaboration ProductsUS, all as detailed and pursuant to Section 9Article 7; and (ive) each Party will the grant appropriate cross-licenses to Merck of a worldwide, exclusive license by NGM, as of the other Party Effective Date, to Researchpursue, Develop, Manufacture and Commercialize such Collaboration Products pursuant to Section 10. (g) [***]. (i) During the SAV Research Termat its sole option, the Parties may review research and discuss the available Clinical Data development and, if successful, commercialization of Small Molecule Collaboration Compounds that is generated in the course of Developing Collaboration PCV Products to determine whether [***]. (1) If, during the SAV Research Term, [***], then the Parties may mutually agree to amend the applicable Plan to [***] in accordance with the Plan for such SAV Program. (2) If, during the SAV Research Term, [***], and the Parties wish to conduct Collaboration Activities for such [***], then the Parties may mutually agree to initiate a new SAV Program with respect to such [***] in accordance with Section 3.1(c). (3) [***] (ii) From time to time after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, the Parties may review and discuss the available Clinical Data that is generated in the course of Developing Collaboration PCV Products to determine whether [***]. During the discussion referenced above, a Party shall disclose to the other Party if such Party (or any of its Affiliates) is engaged in a pre-existing bona fide active and sustained research, development or commercialization program (alone or with potentially Modulate one or more Third Parties) on any [***] based on [***]Collaboration Targets, as further set forth in Article 6. (1) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, a pre-existing bona fide active and sustained research, development or commercialization program with respect to an [***] based on [***], then following the disclosure pursuant to clauses (ii) above in which the existence of such pre-existing program became known to both Parties, each Party shall [***]. (2) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, such [***], then the Parties may mutually agree to amend the applicable Plan to incorporate the Research, Development, Manufacture and Commercialization of [***] associated with [***] in accordance with the Plan for such [***]. (3) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, no such pre-existing program exists [***], at the written request of either Party, then any [***]s based on any such [***] shall automatically be treated [***], for so long as one or both of the Parties [***]. (iii) For the avoidance of doubt, subject to this Section 2.1(g) and Sections 10.7 and 10.8, nothing in this Agreement shall limit either Party’s (or its Affiliates’) ability to research, develop, manufacture or commercialize any [***], or grant licenses or otherwise enter into agreements with one or more Third Parties for any of those activities.

Appears in 1 contract

Samples: Research Collaboration, Product Development and License Agreement (NGM Biopharmaceuticals Inc)

Overview of Collaboration. The Parties intend and have agreed to undertake the Collaboration a broad collaboration under this Agreement with the primary goal to Research, Develop, Manufacture and Commercialize Collaboration Products in accordance with the Collaboration with the goal of expanding and enhancing the value of such Collaboration Products, consisting, in general, of the following major components: (a) the grant to Merck of a broad program worldwide, exclusive license by NGM, as of the Effective Date, with respect to be conducted during NGM’s NP201 Compounds and NP201 Products and the POC Term for continuation by the PCV Program for the Research Parties of certain research and Development of PCVs (including Collaboration PCV Products), pursuant to which Moderna will conduct Research and Development efforts with Merck’s participation development activities with respect to such PCVs compounds and establish Manufacturing capabilities for Collaboration PCV Productsproducts, all as described set forth in the POC Plan for the PCV Program and further detailed in Section Article 3; (b) a broad research and early development program to be conducted by NGM during the POC Full Research Program Term for (the KRAS “Research Program”), pursuant to which the Parties which: (i) NGM will conduct Research research, discovery and Development pre-clinical development efforts with respect to SAVs Directed against KRAS (targets, other than Excluded Targets, and including targets that NGM may identify through any activities under the Collaboration SAV Products Directed against KRAS) whether intentionally directed at identification of targets or otherwise, in an effort to identify and identify Manufacturing capacity for develop Collaboration Compounds that Modulate such Collaboration SAV Productstargets in a manner that satisfies the applicable Physiologically Relevant Threshold, without limitation with respect to a disease area of focus, as described well as NGM’s innovation efforts in the POC Plan for the KRAS Program antibody and protein engineering; to be funded by Merck, all as further detailed in Section 3Article 4; and (ii) NGM will conduct early stage clinical studies of Research Program Development Candidates arising from such research efforts through POC Trial and delivery of the Data Package associated with each POC Compound, to be funded by Merck, as further detailed in Article 4; (c) if during the SAV Research Termgrant to Merck of an exclusive option, exercisable following review of the Parties do not agree Data Package following the POC Trial for a particular POC Compound, to collaborate on one or more additional Targetsobtain an exclusive, then a Party worldwide license to such POC Compound and its Affiliates may conduct an Internal SAV Program, pursuant to which such Party and its Affiliates may conduct Research efforts with respect to one or more SAVs Directed against such TargetRelated Compounds, as described further detailed in the Internal SAV Program Plan for such Internal SAV Program and further described in Section 3.1(d)Article 5; (d) if during in the SAV Research Term, event of exercise of the Parties mutually agree to collaborate on one or more additional SAV Targets (other than KRAS) in accordance with Section 3.1(c), a broad program to be conducted during the POC Term for such Joint SAV Program, pursuant to which the Parties will conduct Research and Development efforts Merck Option with respect to such SAVs Directed against such SAV Target (including Collaboration SAV Products Directed against such SAV Target) and identify Manufacturing capacity for such Collaboration SAV Productsa given POC Compound, as described in the POC Plan for such Joint SAV Program and further detailed in Section 3; (e) for each given Program, Merck NGM will have the right during the Merck Participation Election Period for such Program an option to exercise the Merck Participation Election for such Program to further participate with Moderna in the further Research, Development, Manufacture and Commercialization of mRNA Cancer Vaccines (including Collaboration Products) with respect to such Program, and to share equally the costs and benefits of, such Research, Development, Manufacture and Commercialization, subject to and in accordance with this Agreement; (f) for each given Program, if Merck exercises the Merck Participation Election for such Program, then, subject to Merck paying the Participation Election Payment for such Program in accordance with Section 9.3(a), during the Merck Participation Term for such Program: either: (i) the Parties will conduct further Research receive milestones and Development of mRNA Cancer Vaccines (including Collaboration Products) for royalties associated with such Program through Regulatory Approval, with the activities to be jointly funded by the Parties in accordance with the terms of this AgreementPOC Compound; provided, however, that [***]; or (ii) Merck shall have the sole right to Commercialize the Collaboration Products from such Program participate in the Territory (subject Adjusted Net Sales associated with such POC Compound, in exchange for co-funding a share of the Development Costs and Allowable Expenses associated with such POC Compound, and an option to Moderna’s right to engage in Co-Promotion activities Detail such POC Compound in the United States under and in accordance with Sections 8.5 and 8.6 and any Co-Promotion Agreement(s)); (iii) the Parties will participate in profits or losses arising from the Commercialization of such Collaboration ProductsUS, all as detailed and pursuant to Section 9Article 7; and (iv) each Party will grant appropriate cross-licenses to and [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the other Party to Research, Develop, Manufacture Securities and Commercialize such Collaboration Products Exchange Commission pursuant to Section 10Rule 406 of the Securities Act of 1933, as amended. (ge) [***]. (i) During the SAV Research Termgrant to Merck of a worldwide, exclusive license by NGM, as of the Effective Date, to pursue, at its sole option, the Parties may review research and discuss the available Clinical Data development and, if successful, commercialization of Small Molecule Collaboration Compounds that is generated in the course of Developing Collaboration PCV Products to determine whether [***]. (1) If, during the SAV Research Term, [***], then the Parties may mutually agree to amend the applicable Plan to [***] in accordance with the Plan for such SAV Program. (2) If, during the SAV Research Term, [***], and the Parties wish to conduct Collaboration Activities for such [***], then the Parties may mutually agree to initiate a new SAV Program with respect to such [***] in accordance with Section 3.1(c). (3) [***] (ii) From time to time after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, the Parties may review and discuss the available Clinical Data that is generated in the course of Developing Collaboration PCV Products to determine whether [***]. During the discussion referenced above, a Party shall disclose to the other Party if such Party (or any of its Affiliates) is engaged in a pre-existing bona fide active and sustained research, development or commercialization program (alone or with potentially Modulate one or more Third Parties) on any [***] based on [***]Collaboration Targets, as further set forth in Article 6. (1) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, a pre-existing bona fide active and sustained research, development or commercialization program with respect to an [***] based on [***], then following the disclosure pursuant to clauses (ii) above in which the existence of such pre-existing program became known to both Parties, each Party shall [***]. (2) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, such [***], then the Parties may mutually agree to amend the applicable Plan to incorporate the Research, Development, Manufacture and Commercialization of [***] associated with [***] in accordance with the Plan for such [***]. (3) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, no such pre-existing program exists [***], at the written request of either Party, then any [***]s based on any such [***] shall automatically be treated [***], for so long as one or both of the Parties [***]. (iii) For the avoidance of doubt, subject to this Section 2.1(g) and Sections 10.7 and 10.8, nothing in this Agreement shall limit either Party’s (or its Affiliates’) ability to research, develop, manufacture or commercialize any [***], or grant licenses or otherwise enter into agreements with one or more Third Parties for any of those activities.

Appears in 1 contract

Samples: Research Collaboration, Product Development and License Agreement (NGM Biopharmaceuticals Inc)

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Overview of Collaboration. This Agreement shall serve as the master agreement for the collaboration of the Parties to develop, pursuant to Projects initiated under Sponsor Project Agreements, and commercialize PDP Assays in the Fields for use solely in the PDP Field. Under such collaboration, the Parties shall jointly seek and negotiate with potential Sponsors, to enter into Sponsor Project Agreements under which specific agreed Projects will be conducted to develop PDP Assays in the Fields, which shall be run on QIAGEN sequencing equipment (often in connection with QIAGEN bioinformatics analysis programs, and other QIAGEN proprietary tools, and/or with proprietary HTG tools and instruments as well), and which are to be used as companion diagnostics in the PDP Field to support the applicable Sponsor’s therapeutic development and commercialization. The development of each PDP Assay, in connection with a Project under a particular Sponsor Project Agreement, shall be conducted by the Parties intend and have collaboratively under the applicable Statement of Work, as agreed to undertake by the Collaboration under this Agreement with the primary goal to Research, Develop, Manufacture and Commercialize Collaboration Products Parties as discussed in accordance with the Collaboration with the goal of expanding and enhancing the value of such Collaboration Products, consistingSection 3.2, in general, of the following major components: connection with QIAGEN agreeing to conduct such Project. It is expected that: (a) for each Project that relates to PDP Assays based primarily on HTG IP (such as, RNA-targeted assays, HTG shall conduct most of the preliminary Development work to create the a broad program particular PDP Assay, (b) for each Project that relates to PDP Assays based primarily on QIAGEN IP (such as, certain DNA-targeted assays), QIAGEN likely will conduct most of the preliminary Development work to create the a particular PDP Assay, and (c) once such work Development work is completed, the clinical and regulatory work needed to obtain needed regulatory approvals of the PDP Assay shall be conducted during by QIAGEN in collaboration with the POC Term applicable Sponsor. It is also expected that HTG shall manufacture and supply to QIAGEN, for its use in clinical development and commercialization, the PCV Program for the Research and Development of PCVs (including Collaboration PCV Products)HTG-developed PDP Assays, pursuant to which Moderna will conduct Research and Development efforts with Merck’s participation with respect to such PCVs and establish Manufacturing capabilities for Collaboration PCV Products, as described in the POC Plan for the PCV Program and further detailed in Section 3; (b) manufacturing provisions of a broad program Supply Agreement to be conducted during the POC Term for the KRAS Program, pursuant to which the Parties will conduct Research and Development efforts with respect to SAVs Directed against KRAS (including Collaboration SAV Products Directed against KRAS) and identify Manufacturing capacity for such Collaboration SAV Products, as described in the POC Plan for the KRAS Program and further detailed in Section 3; (c) if during the SAV Research Term, the Parties do not agree to collaborate on one or more additional Targets, then a Party and its Affiliates may conduct an Internal SAV Program, pursuant to which such Party and its Affiliates may conduct Research efforts with respect to one or more SAVs Directed against such Target, as described in the Internal SAV Program Plan for such Internal SAV Program and further described in Section 3.1(d); (d) if during the SAV Research Term, the Parties mutually agree to collaborate on one or more additional SAV Targets (other than KRAS) in accordance with Section 3.1(c), a broad program to be conducted during the POC Term for such Joint SAV Program, pursuant to which the Parties will conduct Research and Development efforts with respect to such SAVs Directed against such SAV Target (including Collaboration SAV Products Directed against such SAV Target) and identify Manufacturing capacity for such Collaboration SAV Products, as described in the POC Plan for such Joint SAV Program and further detailed in Section 3; (e) for each given Program, Merck will have the right during the Merck Participation Election Period for such Program to exercise the Merck Participation Election for such Program to further participate with Moderna in the further Research, Development, Manufacture and Commercialization of mRNA Cancer Vaccines (including Collaboration Products) with respect to such Program, and to share equally the costs and benefits of, such Research, Development, Manufacture and Commercialization, subject to and in accordance with this Agreement; (f) for each given Program, if Merck exercises the Merck Participation Election for such Program, then, subject to Merck paying the Participation Election Payment for such Program in accordance with Section 9.3(a), during the Merck Participation Term for such Program: (i) the Parties will conduct further Research and Development of mRNA Cancer Vaccines (including Collaboration Products) for such Program through Regulatory Approval, with the activities to be jointly funded entered into by the Parties as contemplated in accordance with the terms of this Agreement; providedSection 8.3, however, and that [***]; (ii) Merck QIAGEN shall have the sole right to Commercialize responsibility for marketing, selling and otherwise commercializing the Collaboration Products from such Program in the Territory (subject to Moderna’s right to engage in Co-Promotion activities in the United States under and in accordance with Sections 8.5 and 8.6 and any Co-Promotion Agreement(s)); (iii) the Parties will participate in profits or losses arising from the Commercialization of such Collaboration Products, all as detailed and pursuant to Section 9; and (iv) each Party will grant appropriate cross-licenses to the other Party to Research, Develop, Manufacture and Commercialize such Collaboration Products pursuant to Section 10PDP Assays. (g) [***]. (i) During the SAV Research Term, the Parties may review and discuss the available Clinical Data that is generated in the course of Developing Collaboration PCV Products to determine whether [***]. (1) If, during the SAV Research Term, [***], then the Parties may mutually agree to amend the applicable Plan to [***] in accordance with the Plan for such SAV Program. (2) If, during the SAV Research Term, [***], and the Parties wish to conduct Collaboration Activities for such [***], then the Parties may mutually agree to initiate a new SAV Program with respect to such [***] in accordance with Section 3.1(c). (3) [***] (ii) From time to time after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, the Parties may review and discuss the available Clinical Data that is generated in the course of Developing Collaboration PCV Products to determine whether [***]. During the discussion referenced above, a Party shall disclose to the other Party if such Party (or any of its Affiliates) is engaged in a pre-existing bona fide active and sustained research, development or commercialization program (alone or with one or more Third Parties) on any [***] based on [***]. (1) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, a pre-existing bona fide active and sustained research, development or commercialization program with respect to an [***] based on [***], then following the disclosure pursuant to clauses (ii) above in which the existence of such pre-existing program became known to both Parties, each Party shall [***]. (2) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, such [***], then the Parties may mutually agree to amend the applicable Plan to incorporate the Research, Development, Manufacture and Commercialization of [***] associated with [***] in accordance with the Plan for such [***]. (3) If, after the end of the SAV Research Term and during any remaining portion of the Collaboration Term for the PCV Program, no such pre-existing program exists [***], at the written request of either Party, then any [***]s based on any such [***] shall automatically be treated [***], for so long as one or both of the Parties [***]. (iii) For the avoidance of doubt, subject to this Section 2.1(g) and Sections 10.7 and 10.8, nothing in this Agreement shall limit either Party’s (or its Affiliates’) ability to research, develop, manufacture or commercialize any [***], or grant licenses or otherwise enter into agreements with one or more Third Parties for any of those activities.

Appears in 1 contract

Samples: Master Assay Development, Commercialization and Manufacturing Agreement (HTG Molecular Diagnostics, Inc)

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