Representations and Warranties of Isis. Isis hereby represents and warrants to Biogen Idec, as of the Effective Date, that: 8.2.1. To the best of its knowledge and belief, there are no additional licenses (beyond those that would be granted to Biogen Idec under Section 4.1.1 upon the exercise of the Option for a Product arising under the ISIS-DMPKRx R&D Plan) under any intellectual property owned or Controlled by Isis or its Affiliates as of the Effective Date that would be required in order for Biogen Idec to further Develop and Commercialize a Product. 8.2.2. The Licensed Technology existing as of the Effective Date constitutes all of the Patent Rights and Know-How Controlled by Isis as of the Effective Date that are necessary to Develop, Manufacture or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D Plan in the Field. Isis has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Licensed Technology in a manner that conflicts with any rights granted to Biogen Idec hereunder. 8.2.3. Neither Isis nor its Affiliates owns or Controls any Patent Rights or Know How covering formulation or delivery technology as of the Effective Date that would be useful or necessary in order for Biogen Idec to further Develop or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D Plan. 8.2.4. There are no claims, judgments or settlements against or owed by Isis or its Affiliates or pending against Isis or, to the best of Isis’ knowledge, threatened against Isis, in each case relating to the Isis Technology that could impact activities under this Agreement. To the best of Isis’ knowledge, there are no claims, judgments or settlements against or owed by any Third Party that is party to a Prior Agreement, or pending or threatened claims or litigation against any Third Party that is party to a Prior Agreement, in each case relating to the Isis Technology that would impact activities under this Agreement. 8.2.5. SCHEDULE 8.2.5(a), SCHEDULE 8.2.5(b) and SCHEDULE 8.2.5(c) set forth true, correct and complete lists of all Isis Core Technology Patents, Isis Manufacturing and Analytical Patents, and Isis Product-Specific Patents that apply to the Compounds contemplated under the ISIS-DMPKRx R&D Plan as of the Effective Date, respectively, and indicates whether each such Patent Right is owned by Isis or licensed by Isis from a Third Party and if so, identifies the licensor or sublicensor from which the Patent Right is licensed. Isis Controls such Patent Rights existing as of the Effective Date and is entitled to grant all rights and licenses (or sublicenses, as the case may be) under such Patent Rights it purports to grant to Biogen Idec under this Agreement. 8.2.6. At the Effective Date (a) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude that any Licensed Patent is invalid or un-enforceable, (b) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude the inventorship of each Licensed Patent is not properly identified on each patent, (c) all official fees, maintenance fees and annuities for the Licensed Patents have been paid and all administrative procedures with governmental agencies have been completed, and (d) none of the Isis Product Specific Patents is currently involved in any interference, reissue, re-examination, cancellation or opposition proceeding and neither Isis, nor any of its Affiliates, has received any written notice from any person, or has knowledge, of such actual or threatened proceeding. 8.2.7. SCHEDULE 6.8.1 sets forth true, correct and complete lists of all Isis In-License Agreements relating to Licensed Technology necessary or useful to conduct the research, Development, Manufacture or Commercialization of Compounds as contemplated under the ISIS-DMPKRx R&D Plan existing on the Effective Date. All Isis In-License Agreements are in full force and effect and have not been modified or amended. Neither Isis nor, to the best knowledge of Isis, the Third Party licensor in an Isis In-License Agreement is in default with respect to a material obligation under such Isis In-License Agreement, and neither such party has claimed or has grounds upon which to claim that the other party is in default with respect to a material obligation under, any Isis In-License Agreement. 8.2.8. SCHEDULE 8.2.8 is a complete and accurate list of all agreements that create Third Party Obligations that affect the rights granted by Isis to Biogen Idec under this Agreement. 8.2.9. To the best of Isis’ knowledge, the Development, Manufacture (as manufactured by Isis at its facility as of the Effective Date) and Commercialization of Compounds as contemplated by the ISIS-DMPKRx R&D Plan and this Agreement does not [***] or [***]. 8.2.10. As of the Effective Date, Isis has no [***].
Appears in 1 contract
Samples: DMPK Research, Development, Option and License Agreement (Isis Pharmaceuticals Inc)
Representations and Warranties of Isis. Isis hereby represents and warrants to Biogen IdecRoche, as of the Effective Date, that:
8.2.1. To the best of its knowledge and belief, there are no additional licenses (beyond those that would be granted to Biogen Idec Roche under Section 4.1.1 upon the exercise of the Option for a Product arising under the ISISIsis Development Candidate-DMPKRx R&D Plan) under any intellectual property owned or Controlled by Isis or its Affiliates as of the Effective Date that would be required in order for Biogen Idec Roche to further Develop and Commercialize a ProductProduct arising under the Isis Development Candidate-R&D Plan existing on the Effective Date.
8.2.2. The Licensed Technology existing as of the Effective Date constitutes all of the Patent Rights and Know-How Controlled by Isis as of the Effective Date that are necessary to Develop, Manufacture or Commercialize Compounds contemplated under the ISISIsis Development Candidate-DMPKRx R&D Plan existing on the Effective Date in the Field. Isis has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Licensed Technology in a manner that conflicts with any rights granted to Biogen Idec Roche hereunder.
8.2.3. Neither Isis nor its Affiliates owns or Controls any Patent Rights or Know How covering formulation or delivery technology as of the Effective Date that would be useful or necessary in order for Biogen Idec to further Develop or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D Plan.
8.2.4. There are no claims, judgments or settlements against or owed by Isis or its Affiliates or pending against Isis or, to the best of Isis’ knowledge, threatened against Isis, in each case relating to the Isis Technology that could impact activities under this Agreement. To the best of Isis’ knowledge, there are no claims, judgments or settlements against or owed by any Third Party that is party to a Prior Agreement, or pending or threatened claims or litigation against any Third Party that is party to a Prior Agreement, in each case relating to the Isis Technology that would impact activities under this Agreement.
8.2.58.2.4. SCHEDULE 8.2.5(a8.2.4(a), SCHEDULE 8.2.5(b8.2.4(b) and SCHEDULE 8.2.5(c8.2.4(c) set forth true, correct and complete lists of all Isis Core Technology Patents, Isis Manufacturing and Analytical Patents, and Isis Product-Specific Patents that apply to the Compounds contemplated under the ISISIsis Development Candidate-DMPKRx R&D Plan as of the Effective Date, respectively, and indicates whether each such Patent Right is owned by Isis or licensed by Isis from a Third Party and if so, identifies the licensor or sublicensor from which the Patent Right is licensed. Isis Controls such Patent Rights existing as of the Effective Date and is entitled to grant all rights and licenses (or sublicenses, as the case may be) under such Patent Rights it purports to grant to Biogen Idec Roche under this Agreement.
8.2.6. At the Effective Date (a) there There is no fact or circumstance known by Isis that would cause Isis to reasonably conclude that any Licensed Patent is invalid or un-enforceable, (b) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude the inventorship of each Licensed Patent is not properly identified on each patent, (c) all official fees, maintenance fees and annuities for the Licensed Patents have been paid and all administrative procedures with governmental agencies have been completed, and (d) none of the Isis Product Product-Specific Patents is that would be licensed by Isis to Roche upon Option exercise under this Agreement are currently involved in any interference, reissue, re-examination, cancellation or opposition proceeding and neither Isis, nor any of its Affiliates, has received any written notice from any person, or has knowledge, of such actual or threatened proceeding, and (e) to the best of Isis’ knowledge and belief, Roche’s practice of the inventions claimed in the Isis Product-Specific Patents in the performance of the Roche R&D Activities contemplated as of the Effective Date will not [***].
8.2.78.2.6. SCHEDULE 6.8.1 6.11.1 sets forth true, correct and complete lists of all Isis In-License Agreements relating to Licensed Technology necessary or useful to conduct the research, Development, Manufacture or Commercialization of Compounds as contemplated under the ISISIsis Development Candidate-DMPKRx R&D Plan existing on the Effective Date. All Isis In-License Agreements are in full force and effect and have not been modified or amended. Neither Isis nor, to the best knowledge of Isis, the Third Party licensor in an Isis In-License Agreement is in default with respect to a material obligation under such Isis In-License Agreement, and neither such party has claimed or has grounds upon which to claim that the other party is in default with respect to a material obligation under, any Isis In-License Agreement.
8.2.88.2.7. SCHEDULE 8.2.8 8.2.7 is a complete and accurate list of all agreements that create Third Party Obligations that affect the rights granted by Isis to Biogen Idec Roche under this Agreement.
8.2.9. To Agreement with respect to Isis Development Candidates contemplated by the best of Isis’ knowledge, the Development, Manufacture (as manufactured by Isis at its facility as of R&D Plans on the Effective Date) and Commercialization of Compounds as contemplated by the ISIS-DMPKRx R&D Plan and this Agreement does not [***] or [***].
8.2.108.2.8. As of the Effective Date, Isis has no [***]all rights necessary to grant the option and licenses contained in this Agreement, and has the ability to work exclusively with Roche as set forth in this Agreement, including the covenants granted in Section 2.1.
Appears in 1 contract
Samples: HTT Research, Development, Option and License Agreement (Isis Pharmaceuticals Inc)
Representations and Warranties of Isis. Isis Xxxx hereby represents and warrants to Biogen IdecRoche, as of the Effective Date, that:
8.2.1. To the best of its knowledge and belief, there are no additional licenses (beyond those that would be granted to Biogen Idec Roche under Section 4.1.1 upon the exercise of the Option for a Product arising under the ISISIsis Development Candidate-DMPKRx R&D Plan) under any intellectual property owned or Controlled by Isis Xxxx or its Affiliates as of the Effective Date that would be required in order for Biogen Idec Roche to further Develop and Commercialize a ProductProduct arising under the Isis Development Candidate-R&D Plan existing on the Effective Date.
8.2.2. The Licensed Technology existing as of the Effective Date constitutes all of the Patent Rights and Know-How Controlled by Isis Xxxx as of the Effective Date that are necessary to Develop, Manufacture or Commercialize Compounds contemplated under the ISISIsis Development Candidate-DMPKRx R&D Plan existing on the Effective Date in the Field. Isis Xxxx has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Licensed Technology in a manner that conflicts with any rights granted to Biogen Idec Roche hereunder.
8.2.3. Neither Isis nor its Affiliates owns or Controls any Patent Rights or Know How covering formulation or delivery technology as of the Effective Date that would be useful or necessary in order for Biogen Idec to further Develop or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D Plan.
8.2.4. There are no claims, judgments or settlements against or owed by Isis or its Affiliates or pending against Isis or, to the best of Isis’ knowledge, threatened against IsisXxxx, in each case relating to the Isis Technology that could impact activities under this Agreement. To the best of Isis’ knowledge, there are no claims, judgments or settlements against or owed by any Third Party that is party to a Prior Agreement, or pending or threatened claims or litigation against any Third Party that is party to a Prior Agreement, in each case relating to the Isis Technology that would impact activities under this Agreement.
8.2.5. SCHEDULE 8.2.5(a), SCHEDULE 8.2.5(b) and SCHEDULE 8.2.5(c) set forth true, correct and complete lists of all Isis Core Technology Patents, Isis Manufacturing and Analytical Patents, and Isis Product-Specific Patents that apply to the Compounds contemplated under the ISIS-DMPKRx R&D Plan as of the Effective Date, respectively, and indicates whether each such Patent Right is owned by Isis or licensed by Isis from a Third Party and if so, identifies the licensor or sublicensor from which the Patent Right is licensed. Isis Controls such Patent Rights existing as of the Effective Date and is entitled to grant all rights and licenses (or sublicenses, as the case may be) under such Patent Rights it purports to grant to Biogen Idec under this Agreement.
8.2.6. At the Effective Date (a) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude that any Licensed Patent is invalid or un-enforceable, (b) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude the inventorship of each Licensed Patent is not properly identified on each patent, (c) all official fees, maintenance fees and annuities for the Licensed Patents have been paid and all administrative procedures with governmental agencies have been completed, and (d) none of the Isis Product Specific Patents is currently involved in any interference, reissue, re-examination, cancellation or opposition proceeding and neither Isis, nor any of its Affiliates, has received any written notice from any person, or has knowledge, of such actual or threatened proceeding.
8.2.7. SCHEDULE 6.8.1 sets forth true, correct and complete lists of all Isis In-License Agreements relating to Licensed Technology necessary or useful to conduct the research, Development, Manufacture or Commercialization of Compounds as contemplated under the ISIS-DMPKRx R&D Plan existing on the Effective Date. All Isis In-License Agreements are in full force and effect and have not been modified or amended. Neither Isis nor, to the best knowledge of Isis, the Third Party licensor in an Isis In-License Agreement is in default with respect to a material obligation under such Isis In-License Agreement, and neither such party has claimed or has grounds upon which to claim that the other party is in default with respect to a material obligation under, any Isis In-License Agreement.
8.2.8. SCHEDULE 8.2.8 is a complete and accurate list of all agreements that create Third Party Obligations that affect the rights granted by Isis to Biogen Idec under this Agreement.
8.2.9. To the best of Isis’ knowledge, the Development, Manufacture (as manufactured by Isis at its facility as of the Effective Date) and Commercialization of Compounds as contemplated by the ISIS-DMPKRx R&D Plan and this Agreement does not [***] or [***].
8.2.10. As of the Effective Date, Isis has no [***].
Appears in 1 contract
Samples: HTT Research, Development, Option and License Agreement (Ionis Pharmaceuticals Inc)
Representations and Warranties of Isis. Isis hereby represents and warrants to Biogen Idec, as of the Effective Date, that:
8.2.1. Isis Controls the Licensed Patents existing as of the Effective Date and is entitled to grant all rights and licenses (or sublicenses, as the case may be) it purports to grant to Biogen Idec under this Agreement, in each case solely as they relate to ISIS 396443.
8.2.2. To the best of its knowledge and belief, there are no additional licenses (beyond those that would be granted to Biogen Idec under Section 4.1.1 upon the exercise of the Option for a Product arising under the ISIS-DMPKRx R&D PlanOption) under any intellectual property owned or Controlled by Isis or its Affiliates as of the Effective Date that would be required in order for Biogen Idec to further Develop and Commercialize a the Product.
8.2.28.2.3. The Licensed Technology existing as of the Effective Date constitutes all of the Patent Rights and Know-How Controlled by Isis as of the Effective Date that are necessary to Develop, Manufacture or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D Plan ISIS 396443 in the Field. Isis has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Licensed Technology in a manner that conflicts with any rights granted to Biogen Idec hereunder.
8.2.38.2.4. Neither Isis nor its Affiliates owns or Controls any Patent Rights or Know How covering formulation or delivery technology as of the Effective Date that would be useful or necessary in order for Biogen Idec to further Develop or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D PlanISIS 396443.
8.2.48.2.5. There are no claims, judgments or settlements against or owed by Isis or its Affiliates or pending against Isis or, to the best of Isis’ knowledge, threatened against Isis, in each case relating to the Isis Technology that could impact activities under this Agreement. To the best of Isis’ knowledge, there are no claims, judgments or settlements against or owed by any Third Party that is party to a Prior Agreement, or pending or threatened claims or litigation against any Third Party that is party to a Prior Agreement, in each case relating to the Isis Technology that would impact activities under this Agreement.
8.2.58.2.6. SCHEDULE 8.2.5(a8.2.6(a), SCHEDULE 8.2.5(b8.2.6(b) and SCHEDULE 8.2.5(c8.2.6(c) set forth true, correct and complete lists of all Isis Core Technology Patents, Isis Manufacturing and Analytical Patents, and Isis Product-Specific Patents that apply to the Compounds contemplated under the ISIS-DMPKRx R&D Plan ISIS 396443 as of the Effective Date, respectively, and indicates whether each such Patent Right is owned by Isis or licensed by Isis from a Third Party and if so, identifies the licensor or sublicensor from which the Patent Right is licensed. Isis Controls such Patent Rights existing as of the Effective Date and is entitled to grant all rights and licenses (or sublicenses, as the case may be) under such Patent Rights it purports to grant to Biogen Idec under this Agreement.
8.2.68.2.7. At the Effective Date (a) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude that any Licensed Patent is invalid or un-enforceable, (b) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude the inventorship of each Licensed Patent is not properly identified on each patent, (c) all official fees, maintenance fees and annuities for the Licensed Patents have been paid and all administrative procedures with governmental agencies have been completed, and (d) none of the Isis Product Specific Patents is currently involved in any interference, reissue, re-examination, cancellation or opposition proceeding and neither Isis, nor any of its Affiliates, has received any written notice from any person, or has knowledge, of such actual or threatened proceeding.
8.2.78.2.8. SCHEDULE 6.8.1 sets forth true, correct and complete lists of all Isis In-License Agreements relating to Licensed Technology necessary or useful to conduct the research, Development, Manufacture or Commercialization of Compounds ISIS 396443 as contemplated under the ISIS-DMPKRx R&D SMNRx Development Plan existing on the Effective Date. All Isis In-License Agreements are in full force and effect and have not been modified or amended. Neither Isis nor, to the best knowledge of Isis, the Third Party licensor in an Isis In-License Agreement is in default with respect to a material obligation under such Isis In-License Agreement, and neither such party has claimed or has grounds upon which to claim that the other party is in default with respect to a material obligation under, any Isis In-License Agreement.
8.2.88.2.9. SCHEDULE 8.2.8 8.2.9 is a complete and accurate list of all agreements that create Third Party Obligations that affect the rights granted by Isis to Biogen Idec under this Agreement.
8.2.98.2.10. To the best of Isis’ knowledge, the Development, Manufacture (as manufactured by Isis at its facility as of the Effective Date) and Commercialization of Compounds ISIS 396443 as contemplated by the ISIS-DMPKRx R&D SMNRX Development Plan and this Agreement does not [***] or [***].
8.2.108.2.11. As of the Effective Date, Isis has no [***].
Appears in 1 contract
Samples: Development, Option and License Agreement (Isis Pharmaceuticals Inc)
Representations and Warranties of Isis. Isis hereby represents and warrants to Biogen Idec, as of the Effective Date, that:
8.2.1. To the best of its knowledge and belief, there are no additional licenses (beyond those that would be granted to Biogen Idec under Section 4.1.1 upon the exercise of the Option for a Product arising under the ISIS-DMPKRx R&D PlanCollaboration Programs) under any intellectual property owned or Controlled by Isis or its Affiliates as of the Effective Date that would be required in order for Biogen Idec to further Develop and Commercialize a Product.
8.2.2. The Licensed Technology existing as of the Effective Date constitutes all of the Patent Rights and Know-How Controlled by Isis as of the Effective Date that are necessary to Develop, Manufacture or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D Plan Collaboration Programs in the Field. Isis has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Licensed Technology in a manner that conflicts with any rights granted to Biogen Idec hereunder.
8.2.3. Neither Isis nor its Affiliates owns or Controls any Patent Rights or Know How covering formulation or delivery technology as of the Effective Date that would be useful or necessary in order for Biogen Idec to further Develop or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D PlanCollaboration Programs.
8.2.4. There are no claims, judgments or settlements against or owed by Isis or its Affiliates or pending against Isis or, to the best of Isis’ knowledge, threatened against Isis, in each case relating to the Isis Technology that could impact activities under this Agreement. To the best of Isis’ knowledge, there are no claims, judgments or settlements against or owed by any Third Party that is party to a Prior Agreement, or pending or threatened claims or litigation against any Third Party that is party to a Prior Agreement, in each case relating to the Isis Technology that would impact activities under this Agreement.
8.2.5. SCHEDULE 8.2.5(a8.2.4(a), SCHEDULE 8.2.5(b8.2.4(b) and SCHEDULE 8.2.5(c8.2.4(c) set forth true, correct and complete lists of all Isis Core Technology Patents, and Isis Manufacturing and Analytical Patents, and Isis Product-Specific Patents that apply to the Compounds contemplated under the ISIS-DMPKRx R&D Plan Collaboration Programs as of the Effective DateDate (the “Isis Platform Technology”), respectively, and indicates whether each such Patent Right is owned by Isis or licensed by Isis from a Third Party and if so, identifies the licensor or sublicensor from which the Patent Right is licensed. Isis Controls such Patent Rights existing as of the Effective Date and is entitled to grant all rights and licenses (or sublicenses, as the case may be) under such Patent Rights it purports to grant to Biogen Idec under this Agreement.
8.2.5. There are no claims, judgments or settlements against or owed by Isis or its Affiliates or pending against Isis or, to the best of Isis’ knowledge, threatened against Isis, in each case relating to the Isis Platform Technology, Isis Manufacturing and Analytical Know-How, Isis Know-How, Collaboration Targets or High Interest Targets that could impact activities under this Agreement. To the best of Isis’ knowledge, there are no claims, judgments or settlements against or owed by any Third Party that is party to a Prior Agreement, or pending or threatened claims or litigation against any Third Party that is party to a Prior Agreement, in each case relating to the Isis Platform Technology, Isis Manufacturing and Analytical Know-How, Isis Know-How, Collaboration Targets or High Interest Targets that would impact activities under this Agreement.
8.2.6. At the Effective Date (a) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude that any Licensed Isis Core Technology Patent or Isis Manufacturing and Analytical Patent is invalid or un-enforceable, (b) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude the inventorship of each Licensed Isis Core Technology Patent or Isis Manufacturing and Analytical Patent is not properly identified on each patent, and (c) all official fees, maintenance fees and annuities for the Licensed Patents Isis Core Technology Patent or Isis Manufacturing and Analytical Patent have been paid and all administrative procedures with governmental agencies have been completed, and (d) none of the Isis Product Specific Patents is currently involved in any interference, reissue, re-examination, cancellation or opposition proceeding and neither Isis, nor any of its Affiliates, has received any written notice from any person, or has knowledge, of such actual or threatened proceeding.
8.2.7. Isis has set forth on SCHEDULE 6.8.1 sets forth or in a separate written agreement with Biogen Idec true, correct and complete lists of all the agreements with Third Party licensors or sellers pursuant to which Isis In-License Agreements relating to has licensed or acquired the Licensed Technology Controlled by Isis as of the Effective Date licensed to Biogen Idec under Section 4.1.1 that is necessary or useful to conduct the research, Development, Manufacture or Commercialization of any High Interest Target listed on the High Interest Target List as of the Effective Date and any Compounds as contemplated under the ISIS-DMPKRx R&D Plan existing on the Effective DateCollaboration Program targeting [***]. All Isis In-License Agreements are in full force and effect and have not been modified or amended. Neither Isis nor, to the best knowledge of Isis, the Third Party licensor in an Isis In-License Agreement is in default with respect to a material obligation under such Isis In-License Agreement, and neither such party has claimed or has grounds upon which to claim that the other party is in default with respect to a material obligation under, any Isis In-License Agreement.
8.2.8. SCHEDULE 8.2.8 is a complete and accurate list of all agreements that create Third Party Obligations with respect to the Isis Core Technology Patents and Isis Manufacturing and Analytical Patents that affect the rights granted by Isis to Biogen Idec under this Agreement.
8.2.9. To the best of Isis’ knowledge, the Development, Manufacture (as manufactured by Isis at its facility as of the Effective Date) and Commercialization of Compounds as contemplated by the ISIS-DMPKRx R&D Plan and this Agreement does not [***] or [***].
8.2.10. As of the Effective Date, Isis has no [***].
Appears in 1 contract
Representations and Warranties of Isis. Isis hereby represents and warrants to Biogen Idec, as of the Effective Date, that:
8.2.1. To the best of its knowledge and belief, there are no additional licenses (beyond those that would be granted to Biogen Idec under Section 4.1.1 4.1.1(a) upon the exercise of the Option for a Collaboration Product arising under the ISIS-DMPKRx R&D PlanCollaboration Programs) under any intellectual property owned or Controlled by Isis or its Affiliates as of the Effective Date that would be required in order for Biogen Idec to further Develop and Commercialize a Collaboration Product.
8.2.2. The Licensed Technology existing as of the Effective Date constitutes all of the Patent Rights and Know-How Controlled by Isis as of the Effective Date that are necessary to Develop, Manufacture or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D Plan Collaboration Programs in the Field. Isis has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Licensed Technology in a manner that conflicts with any rights granted to Biogen Idec hereunderhereunder with respect to Collaboration Products.
8.2.3. Neither Isis nor its Affiliates owns or Controls any Patent Rights or Know How covering formulation or delivery technology as of the Effective Date that would be useful or necessary in order for Biogen Idec to further Develop or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D PlanCollaboration Programs.
8.2.4. There are no claims, judgments or settlements against or owed by Isis or its Affiliates or pending against Isis or, to the best of Isis’ knowledge, threatened against Isis, in each case relating to the Isis Technology that could impact activities under this Agreement. To the best of Isis’ knowledge, there are no claims, judgments or settlements against or owed by any Third Party that is party to a Prior Agreement, or pending or threatened claims or litigation against any Third Party that is party to a Prior Agreement, in each case relating to the Isis Technology that would impact activities under this Agreement.
8.2.5. SCHEDULE 8.2.5(a), SCHEDULE 8.2.5(b8.2.4(a) and SCHEDULE 8.2.5(c8.2.4(b) set forth true, correct and complete lists of all Isis Core Technology Patents, Patents and Isis Manufacturing and Analytical Patents, and Isis Product-Specific Patents that apply to the Compounds contemplated under the ISIS-DMPKRx R&D Plan Collaboration Programs as of the Effective DateDate (the “Isis Platform Technology”), respectively, and indicates whether each such Patent Right is owned by Isis or licensed by Isis from a Third Party and if so, identifies the licensor or sublicensor from which the Patent Right is licensed. Isis Controls such Patent Rights existing as of the Effective Date and is entitled to grant all rights and licenses (or sublicenses, as the case may be) under such Patent Rights it purports to grant to Biogen Idec under this Agreement.
8.2.5. There are no claims, judgments or settlements against or owed by Isis or its Affiliates or pending against Isis or, to the best of Isis’ knowledge, threatened against Isis, in each case relating to the Isis Platform Technology, Isis Manufacturing and Analytical Know-How, Isis Know-How, Collaboration Targets or High Interest Targets that could impact activities under this Agreement. To the best of Isis’ knowledge, there are no claims, judgments or settlements against or owed by any Third Party that is party to a Prior Agreement, or pending or threatened claims or litigation against any Third Party that is party to a Prior Agreement, in each case relating to the Isis Platform Technology, Isis Manufacturing and Analytical Know-How, Isis Know-How or High Interest Targets that would impact activities under this Agreement.
8.2.6. At the Effective Date (a) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude that any Licensed Isis Core Technology Patent or Isis Manufacturing and Analytical Patent is invalid or un-enforceable, (b) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude the inventorship of each Licensed Isis Core Technology Patent or Isis Manufacturing and Analytical Patent is not properly identified on each patent, and (c) all official fees, maintenance fees and annuities for the Licensed Patents Isis Core Technology Patent or Isis Manufacturing and Analytical Patent have been paid and all administrative procedures with governmental agencies have been completed, and (d) none of the Isis Product Specific Patents is currently involved in any interference, reissue, re-examination, cancellation or opposition proceeding and neither Isis, nor any of its Affiliates, has received any written notice from any person, or has knowledge, of such actual or threatened proceeding.
8.2.7. Isis has set forth on SCHEDULE 6.8.1 sets forth 6.13.1 or in a separate written agreement with Biogen Idec true, correct and complete lists of all the agreements with Third Party licensors or sellers pursuant to which Isis In-License Agreements relating to has licensed or acquired the Licensed Technology Controlled by Isis as of the Effective Date licensed to Biogen Idec under Section 4.1.1(a) that is necessary or useful to conduct the research, Development, Manufacture or Commercialization of Compounds any High Interest Target listed on the High Interest Target List as contemplated under the ISIS-DMPKRx R&D Plan existing on of the Effective Date. All Isis In-License Agreements are in full force and effect and have not been modified or amended. Neither Isis nor, to the best knowledge of Isis, the Third Party licensor in an Isis In-License Agreement is in default with respect to a material obligation under such Isis In-License Agreement, and neither such party has claimed or has grounds upon which to claim that the other party is in default with respect to a material obligation under, any Isis In-License Agreement.
8.2.8. SCHEDULE 8.2.8 is a complete and accurate list of all agreements that create Third Party Obligations with respect to the Isis Core Technology Patents and Isis Manufacturing and Analytical Patents that affect the rights granted by Isis to Biogen Idec under this AgreementAgreement with respect to Collaboration Programs.
8.2.9. To the best of Isis’ knowledge, the Development, Manufacture (as manufactured by Isis at its facility as of the Effective Date) and Commercialization of Compounds as contemplated by the ISIS-DMPKRx R&D Plan and this Agreement does not [***] or [***].
8.2.10. As of the Effective Date, Isis has no [***].
Appears in 1 contract
Representations and Warranties of Isis. Isis hereby represents and warrants to Biogen IdecJBI, as of the Effective Date, that:
8.2.1. 8.2.1 To the best of its knowledge and belief, there are no additional licenses (beyond those that would be granted to Biogen Idec JBI under Section 4.1.1 upon the exercise of the Option for a Product arising under the ISIS-DMPKRx R&D PlanDrug Discovery Programs) under any intellectual property owned or Controlled by Isis or its Affiliates as of the Effective Date that would be required in order for Biogen Idec JBI to further Develop and Commercialize a Product.
8.2.2. The Licensed Technology existing as of the Effective Date constitutes all of the Patent Rights and Know-How Controlled by Isis as of the Effective Date that are necessary to Develop, Manufacture or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D Plan in the Field. Isis has not previously assigned, transferred, conveyed or otherwise encumbered its right, title and interest in the Licensed Technology in a manner that conflicts with any rights granted to Biogen Idec hereunder.
8.2.3. Neither Isis nor its Affiliates owns or Controls any Patent Rights or Know How covering formulation or delivery technology as of the Effective Date that would be useful or necessary in order for Biogen Idec to further Develop or Commercialize Compounds contemplated under the ISIS-DMPKRx R&D Plan.
8.2.4. There are no claims, judgments or settlements against or owed by Isis or its Affiliates or pending against Isis or, to the best of Isis’ knowledge, threatened against Isis, in each case relating to the Isis Technology that could impact activities under this Agreement. To the best of Isis’ knowledge, there are no claims, judgments or settlements against or owed by any Third Party that is party to a Prior Agreement, or pending or threatened claims or litigation against any Third Party that is party to a Prior Agreement, in each case relating to the Isis Technology that would impact activities under this Agreement.
8.2.5. SCHEDULE 8.2.5(a8.2.2 Schedule 8.2.2(a), SCHEDULE 8.2.5(bSchedule 8.2.2(b), Schedule 8.2.2(c) and SCHEDULE 8.2.5(cSchedule 8.2.2(d) set forth true, correct and complete lists of all Isis Core Technology Patents, Isis Manufacturing and Analytical Patents, and Isis Product-Specific Formulation Patents that apply to the Compounds contemplated under the ISIS-DMPKRx R&D Plan Drug Discovery Programs as of the Effective DateDate (the “Isis Platform Technology”), respectively, and indicates whether each such Patent Right is owned by Isis or licensed by Isis from a Third Party and if so, identifies the licensor or sublicensor from which the Patent Right is licensed. Isis Controls such Patent Rights existing as of the Effective Date and is entitled to grant all rights and licenses (or sublicenses, as the case may be) under such Patent Rights it purports to grant to Biogen Idec JBI under this Agreement.
8.2.6. At the Effective Date (a) there is 8.2.3 There are no fact claims, judgments or circumstance known settlements against or owed by Isis that would cause or its Affiliates or pending against Isis to reasonably conclude that any Licensed Patent is invalid or un-enforceable, (b) there is no fact or circumstance known by Isis that would cause Isis to reasonably conclude the inventorship of each Licensed Patent is not properly identified on each patent, (c) all official fees, maintenance fees and annuities for the Licensed Patents have been paid and all administrative procedures with governmental agencies have been completed, and (d) none of the Isis Product Specific Patents is currently involved in any interference, reissue, re-examination, cancellation or opposition proceeding and neither Isis, nor any of its Affiliates, has received any written notice from any person, or has knowledge, of such actual or threatened proceeding.
8.2.7. SCHEDULE 6.8.1 sets forth true, correct and complete lists of all Isis In-License Agreements relating to Licensed Technology necessary or useful to conduct the research, Development, Manufacture or Commercialization of Compounds as contemplated under the ISIS-DMPKRx R&D Plan existing on the Effective Date. All Isis In-License Agreements are in full force and effect and have not been modified or amended. Neither Isis noror, to the best knowledge of Isis’ knowledge, threatened against Isis, in each case relating to the Third Party licensor in an Isis In-License Agreement is in default with respect to a material obligation under such Platform Technology or Collaboration Targets that would prevent Isis In-License Agreement, and neither such party has claimed or has grounds upon which to claim that from performing the other party is in default with respect to a material obligation under, any Isis In-License Agreement.
8.2.8. SCHEDULE 8.2.8 is a complete and accurate list of all agreements that create Third Party Obligations that affect the rights granted by Isis to Biogen Idec activities under this Agreement.
8.2.9Agreement or from granting JBI the licenses under Section 4.1. To the best of Isis’ knowledge, there are no claims, judgments or settlements against or owed by any Third Party that is party to a Prior Agreement, or pending or threatened claims or litigation against any Third Party that is party to a Prior Agreement, in each case relating to the Development, Manufacture (as manufactured by Isis at its facility as of Platform Technology or Collaboration Targets that would prevent Isis from performing the Effective Date) and Commercialization of Compounds as contemplated by the ISIS-DMPKRx R&D Plan and activities under this Agreement does not [***] or [***]from granting JBI the licenses under Section 4.1.
8.2.10. As of the Effective Date, Isis has no [***].
Appears in 1 contract
Samples: Research Collaboration, Option and License Agreement (Isis Pharmaceuticals Inc)