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6.3.2 Commercialization Costs. AbbVie and Capsida shall each be responsible for fifty percent (50%) of the Allowable Expenses incurred in each Calendar Year in connection with the Commercialization of the ALS Product in the Territory. |
6.3.3 ALS Product Co-Promotion Option. |
(a) Option; Notice. During the Co-Promotion Option Period, Capsida shall have the right as set forth in this Section 6.3.3 to elect to conduct up to fifty percent (50%) of the Detailing effort with respect to each ALS Product in the United States (the "Co-Promotion Option") by delivering to AbbVie a Co-Promotion Option... |
(b) Co-Promotion Agreement. If Capsida exercises the Co-Promotion Option for a given ALS Product, such co-promotion program with respect to Capsida's sales force shall be operated and managed by AbbVie in a manner similar to the manner in which AbbVie would operate and manage a co-promotion program for a similar produc... |
(c) Compensation for Co-Promotion. The Parties shall share the costs and expenses of Detailing any Co-Promotion Product in accordance with the Co-Promotion Agreement. |
6.4 Commercialization Reports. During the Royalty Term or Profit Share Term for a Licensed Product or a Licensed Ophthalmology Product, as applicable, in any Major Market, AbbVie shall provide a high-level summary on an annual basis to Capsida of its Commercialization activities with respect to such Licensed Products o... |
ARTICLE 7 MANAGEMENT OF THE COLLABORATION |
7.1 Joint Governance Committee. Pursuant to the Original Agreement, the Parties have, as of the Effective Date, established a joint governance committee with respect to the conduct of the Research Program and the Parties' activities under the Capsid Program Research Plan, the RP2 Plan, the Collaboration Program Researc... |
7.1.1 The JGC for the Neurology Program shall: |
(a) review and approve any amendments to the Capsid Program Research Plan, Collaboration Program Research Plan, or POC Plan that would result in an increase to (i) the corresponding budget estimate by more than ten percent (10%) or (ii) the associated Screening Period by more than three (3) months and review any other ... |
(b) review and approve the RP2 Plan (including any amendments thereto) for a Target; |
(c) oversee the Parties' activities under each Research Plan, direct and supervise the Parties' activities under the POC Plan, and review the Parties' progress against each Research Plan and the POC Plan; |
(d) review and approve the Additional Target Capsid Profile or Additional Target Product Profile (including any amendments thereto); |
(e) make recommendations to AbbVie regarding which Capsids to advance to Reserved Capsids or Selected Capsids; |
(f) make recommendations regarding the AbbVie Cargo, or other AbbVie Materials provided under the Research Program; |
(g) prioritize the Capsids and select benchmark Capsids and tool cargo for Optimization and Screening Activities, approve any preliminary characterization study design under the Optimization and Screening Activities, and select the final cargo vector design for each Target for each Research Stage; |
(h) coordinate the sequence and timing of Research Stages for each Target under the Research Plans; |
(i) review and approve the ALS Development Plan and Budget and the ALS Commercialization Plan (including any amendments to the foregoing) and review and approve any amendments to the POC Plan; and |
(j) perform such other functions as are set forth herein, if and as applicable, or as the Parties may mutually agree in writing. |
7.1.2 The JGC for the Ophthalmology Program shall: |
(a) review and approve any amendments or updates to the Ophthalmology Research Plan, that would result in an increase to: (i) the corresponding budget estimate by more than ten percent (10%) or (ii) the Screening Period by more than three (3) months and review any other amendments or updates to each Plan; |
(b) oversee the Parties' activities under the Ophthalmology Research Plan and review the Parties' progress against the Ophthalmology Research Plan; |
(c) make recommendations to AbbVie regarding which Capsids to advance to Reserved Ophthalmology Capsids or Selected Ophthalmology Capsids; |
(d) make recommendations regarding the AbbVie Ophthalmology Cargo, or other AbbVie Materials provided under the Ophthalmology Research Program; |
(e) prioritize the Capsids and select benchmark Capsids and tool cargo for Optimization and Screening Activities and other activities as specified in the Ophthalmology Research Plan, approve any preliminary characterization study design under the Optimization and Screening Activities, and select the final cargo vector ... |
(f) coordinate the sequence and timing of Research for each Route of Administration and the activities with respect thereof; |
(g) make recommendations to AbbVie regarding selection of the Ophthalmology Targets for the Ophthalmology Research Program (including, with respect to the Target List, the Selected Ophthalmology Targets, any substitution of the Selected Ophthalmology Targets and the Final Selected Ophthalmology Targets); and |
(h) perform such other functions as are set forth herein, if and as applicable, or as the Parties may mutually agree in writing. |
7.1.3 For clarity, once AbbVie exercises (a) a Capsid Program Option, the JGC for the Neurology Program shall no longer have jurisdiction over the Exploitation of the Licensed Capsid Program Capsids or Licensed Capsid Products by AbbVie and its Affiliates; or (b) an Ophthalmology Program Option, the JGC for the Ophthal... |
7.2 General Provisions Applicable to the JGCs. |
7.2.1 Meetings and Minutes. Each JGC shall meet quarterly or as otherwise agreed to by the Parties, with the location of such meetings alternating between locations designated by Capsida and locations designated by AbbVie, with Capsida designating the place of the first meeting. The Alliance Managers of the Parties sha... |
7.2.2 Procedural Rules. The JGCs shall have the right to adopt such standing rules as shall be necessary for its work, to the extent that such rules are not inconsistent with this Agreement. A quorum of a JGC shall exist whenever there is present at a meeting at least one (1) representative appointed by each Party. Rep... |
7.2.3 Decision-Making. Subject to the following provisions of this Section 7.2.3, and except for any Legal Disputes (which shall be governed by Section 15.6), disputes under Section 9.21.2, and matters that require the mutual agreement of the Parties or with respect to which final decision-making authority is assigned ... |
(a) Except as provided in Section 7.2.3(f), if the issue relates to the day-to-day performance of the activities under the Capsid Program Research Plan, the Collaboration Program Research Plan, or the Ophthalmology Research Plan (other than activities in respect of vector design and optimization including Expression El... |
(b) if the issue relates to Capsid engineering, process development or Manufacturing scale-up activities to be performed by Capsida for the Research Program, Capsida shall have final decision-making authority under the Research Program (for clarity, Capsida shall not have final decision-making authority with respect to... |
(c) if the issue relates to the conduct of Capsid engineering, process development or Manufacturing scale-up activities to be performed by Capsida for the Ophthalmology Research Program, Capsida shall have final decision-making authority under the Ophthalmology Research Program (for clarity, Capsida shall not have fina... |
(d) if the issue relates to the RP2 Plan for a Target, AbbVie shall have final decision-making authority to the extent the RP2 Plan is substantially similar to the then-current Capsid Program Research Plan for such Target with only such modifications as are necessary to address learnings from Research Stage One for suc... |
(e) if the issue relates to (i) Licensed Capsids or Licensed Products from and after exercise of the α-syn Program Option, Tau Program Option, Additional Capsid Program Option or Collaboration Program Option, as applicable, including approval of the ALS Development Plan and Budget, ALS Commercialization Plan or any ame... |
(f) if the issue relates to: (i) AbbVie Cargo (excluding the selection of the ALS Cargo for the Collaboration Research Program pursuant to Section 2.4), AbbVie Ophthalmology Cargo or other AbbVie Materials or the sequence and timing of Research Stages and of Research of Capsids, Targets or Routes of Administration (tho... |
(g) any other issue shall be deadlocked and neither Party shall have final decision-making authority with respect thereto. |
7.2.4 Limitations on Authority. Notwithstanding anything in this Article 7 to the contrary, (a) each Party will retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers or discretion will be delegated to or vested in the JGCs or any Working Group unless such delegation or v... |
7.2.5 Discontinuation; Disbandment. Each JGC for a Program shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband such JGC and (b) the expiration of the last Option Period without exercise by AbbVie of any Option with respect to such Program. Upon the occurrence of any of the ... |
7.3 Working Groups. From time to time, a JGC may establish and delegate duties to other committees or directed teams (each, a "Working Group") on an "as-needed" basis to oversee particular projects or activities. During the conduct of the Research Program and the Ophthalmology Research Program, prior to the applicable ... |
7.3.1 Manufacturing Working Group. Pursuant to the Original Agreement, the Parties have, as of the Effective Date, established a Manufacturing Working Group in respect of Manufacturing for the Research Program. Within thirty (30) days following the Effective Date the JGC shall establish a Manufacturing Working Group in... |
7.3.2 Research Working Group. Pursuant to the Original Agreement, the Parties have, as of the Effective Date established a Research Working Group in respect of the Research Program. Within thirty (30) days following the Effective Date the JGC shall establish a Research Working Group in respect of the Ophthalmology Rese... |
7.4 Alliance Managers. Each Party shall appoint a person(s) who shall oversee contact between the Parties for all matters between meetings of each JGC, shall be the primary contacts between the Parties after disbandment of each JGC, and shall have such other responsibilities as the Parties may agree in writing after th... |
ARTICLE 8 GRANT OF RIGHTS; EXCLUSIVITY |
8.1 Grants to AbbVie. Subject to Section 8.3 and Section 8.4, without limiting AbbVie's rights or Capsida's obligations under Section 8.8.1, Section 8.8.2 and Section 8.8.3, Capsida (on behalf of itself and its Affiliates) hereby grants to AbbVie and its Affiliates: |
8.1.1 Until the completion of all activities under the applicable Plan, a non-exclusive, royalty-free license (or sublicense), with the right to grant sublicenses in accordance with Section 8.3, under the Licensed IP solely to perform AbbVie's activities under the applicable Plan as set forth in, and subject to, the ap... |
8.1.2 Until the earlier of the expiration of the last Capsid Selection Period for a Target for a Research Stage and the date on which AbbVie has selected three (3) Selected Capsids for such Target, a non-exclusive, royalty-free license (or sublicense), with the right to grant sublicenses in accordance with Section 8.3,... |
8.1.3 Until the earlier of the expiration of the last Capsid Ophthalmology Selection Period for the last Route of Administration and the date on which AbbVie has selected three (3) Selected Ophthalmology Capsids for each Route of Administration, a non-exclusive, royalty-free license (or sublicense), with the right to g... |
8.1.4 Upon the exercise of any Capsid Program Option, the Collaboration Program Option or any Ophthalmology Program Option by AbbVie, an exclusive (even as to Capsida and its Affiliates), royalty-bearing (in accordance with Section 9.5 and, in the case of ALS Products, subject to Section 9.13) license (or sublicense), ... |
8.1.5 upon the exercise of any Initial Capsid Program Option, the Collaboration Program Option or any Ophthalmology Program Option by AbbVie, an exclusive (even as to Capsida and its Affiliates except with respect to Capsida's and its Affiliates' own internal programs) license (or sublicense) and right of reference, wi... |
8.1.6 upon the exercise of an Initial Capsid Program Option, the Collaboration Program Option or an Ophthalmology Program Option by AbbVie, a non-exclusive license, with the right to grant sublicenses in accordance with Section 8.3, to use Capsida's Corporate Names solely as required to Exploit Licensed Capsids and Lic... |
For clarity, the licenses granted pursuant to Sections 8.1.4 to 8.1.6 shall expand to include the Licensed Capsids or Licensed Ophthalmology Capsids with respect to each Option exercised by AbbVie and shall contract to exclude any Capsid that ceases to be a Licensed Capsid or Licensed Ophthalmology Capsid, as applicabl... |
8.2 Grants to Capsida. Subject to Section 8.3 and Section 8.8, without limiting Capsida's rights or AbbVie's obligations under Section 8.8.4, AbbVie hereby grants to Capsida and the other provisions of this Agreement: |
8.2.1 during the performance of its activities under the Research Program, a non-exclusive, royalty-free license and right of reference, without the right to grant sublicenses or further rights of reference (except to a permitted subcontractor), under the AbbVie Background Know-How for Research Program and the AbbVie B... |
8.2.2 during the performance of its activities under the Ophthalmology Research Program, a non-exclusive, royalty-free license and right of reference, without the right to grant sublicenses or further rights of reference (except to a permitted subcontractor), under the AbbVie Background Know-How for Ophthalmology Resea... |
8.2.3 from and after AbbVie's exercise of the Collaboration Program Option, a non-exclusive, royalty-free license, without the right to grant sublicenses or further rights of reference (except to a permitted subcontractor) under (a) AbbVie's interest in the Program IP and Joint IP, (b) AbbVie Background Know-How for AL... |
8.2.4 from and after the ALS Reversion Triggering Event, and Capsida's exercise of its rights under Section 4.4 to assume, at its sole cost and expense, control of the Development, Manufacturing and Commercialization of the ALS Product in accordance with Section 4.4, an exclusive (except as provided in Section 8.6.1), ... |
8.3 Sublicenses. Each Party shall have the right to grant sublicenses (or further rights of reference), through multiple tiers of Sublicensees to the extent specified in Section 8.1 or Section 8.2, as applicable, under the licenses and rights of reference granted in Section 8.1 or Section 8.2, as applicable, to its Aff... |
8.4 In-License Agreements. |
8.4.1 Existing In-License Agreements. |
(a) Without limiting the representations, warranties and covenants set forth in Article 12, AbbVie acknowledges and agrees that the sublicenses granted by Capsida to AbbVie in this Agreement are subject to the terms of the Existing In-License Agreements, the scope of the licenses granted to Capsida or the applicable Af... |
(b) The Parties shall cooperate with each other in good faith to support each other in complying with Capsida's obligations under each Existing In-License Agreement. Without limitation to the foregoing, (i) the Parties shall, from time to time, upon the reasonable request of either Party, discuss the terms of an Existi... |
8.4.2 Future In-License Agreements. |
(a) Subject to Section 10.6, prior to Capsida or any of its Affiliates entering into a license or other agreement with a Third Party pursuant to which Capsida or any of its Affiliates would acquire, license or obtain any right or interest in any invention, material or Know-How (or any Third Party Rights) that may be ne... |
(i) With respect to any Subject Technology that is necessary for the Program Activities, Capsida may enter into a Subject Technology Agreement that is consistent with the terms and conditions of this Agreement in all material respects and does not in any way limit AbbVie's rights and interests or increase its obligatio... |
(b) With respect to any Subject Technology that is not necessary for the Program Activities, (A) Capsida may enter into such Subject Technology Agreement on such terms and conditions as it determines, provided that the terms and conditions applicable to the Program Activities are no less favorable than the terms and co... |
8.4.3 Payments under In-License Agreements. Capsida shall be solely responsible for any license fees, milestones, royalties or other payments owed to Third Parties under or in connection with (a) the Existing In-License Agreement (whether or not any such Existing In-License Agreement is disclosed to AbbVie prior to the... |
8.4.4 Amendments; Breaches; Terminations. After the Effective Date, (a) Capsida shall not enter into any subsequent agreement or understanding with any Third Party to an In-License Agreement that modifies, amends or terminates any such In-License Agreement, or waives any right or obligation thereunder, in any way that ... |
8.5 Section intentionally left blank. |
8.6 Retention of Rights. |
8.6.1 Notwithstanding the exclusive licenses granted to Capsida pursuant to Section 8.2.4, AbbVie retains the right under the Reversion IP to Exploit products, including gene therapy products, directed to TDP-43 and the ALS Cargo (other than the ALS Reversion Product). |
8.6.2 Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party, as a result of this Agreement, obtain any ownership interest, license right or other right in any Know-How, Patent or other intellectual property rights of the other Party or any of its Affiliates, including items owne... |
8.7 Confirmatory Patent License. Capsida shall if requested to do so by AbbVie immediately enter into confirmatory license agreements in such form as may be reasonably requested by AbbVie for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as AbbVie considers ap... |
8.8 Exclusivity. |
8.8.1 Research Program and Licensed Capsid Products and Ophthalmology Research Program and Licensed Ophthalmology Products. |
(a) Without limiting Capsida's obligations with respect to General Capsid Libraries, Target-specific Capsid Libraries and Reserved Capsids pursuant to Section 2.3, during the period commencing on the Effective Date and ending on the expiration of the Capsid Program Option Period, Capsida shall not, and, subject to Sect... |
(b) If AbbVie exercises any Capsid Program Option, then during the period commencing on the applicable Option Exercise Date and ending on the expiration of the last Royalty Term for a Licensed Capsid Product for the applicable Target, Capsida shall not, and shall cause its Affiliates not to, directly or indirectly (exc... |
(c) If AbbVie exercises any Ophthalmology Program Option, then during the period commencing on the applicable Option Exercise Date and ending on the expiration of the last Royalty Term for the last Licensed Ophthalmology Product directed to a Final Selected Ophthalmology Target, Capsida shall not, and shall cause its A... |
(d) Without limiting Capsida's obligations with respect to General Ophthalmology Capsid Libraries and Reserved Ophthalmology Capsids pursuant to Section 2.13, Capsida shall not, and, subject to Section 15.4, shall cause its Affiliates not to, directly or indirectly (except with respect to activities conducted under and... |
(i) during the period commencing on the Effective Date and ending on the earlier of the date that is (a) twenty-four (24) months from the end of the first Ophthalmology Program Option Period, which period may be extended on a month-by-month basis until delivery of the first Ophthalmology Program Option Exercise Notice ... |
(ii) all Ophthalmology Targets on the Target List (except for any Ophthalmology Target removed from the Target List by AbbVie; provided that AbbVie may not re-select any Ophthalmology Target with respect to which Capsida has, consistent with its other exclusivity obligations, entered into a third-party agreement or oth... |
(iii) all Reserved Ophthalmology Capsids until such time as AbbVie may no longer designate any Reserved Ophthalmology Capsid as a Selected Ophthalmology Capsid for a Route of Administration under the terms of this Agreement, after which time the exclusivity restriction shall be limited to Selected Ophthalmology Capsids... |
For clarity, AbbVie shall retain the right to use all AbbVie Ophthalmology Cargo, including AbbVie Ophthalmology Cargo used in Licensed Ophthalmology Products, for any and all purposes, including in connection with other gene therapy platforms and delivery approaches. |
8.8.2 Collaboration Research Program and ALS Products. |
(a) Without limiting Capsida's obligations with respect to General Capsid Libraries, Target-specific Capsid libraries and Reserved Capsids pursuant to Section 2.3, during the period commencing on the Effective Date and ending on the expiration of the Collaboration Program Option Period, Capsida shall not, and shall cau... |
(b) If AbbVie exercises the Collaboration Program Option, then during the period commencing on such option exercise and ending on the expiration of the last Profit Share Term or Royalty Term for an ALS Product, Capsida shall not, and shall cause its Affiliates not to, directly or indirectly (except with respect to acti... |
8.8.3 Licensed Capsids. Without limiting Capsida's obligations with respect to General Capsid Libraries, Target-specific Capsid Libraries and Reserved Capsids pursuant to Section 2.3, Section 8.8.1 or Section 8.8.2, Capsida shall not, and shall cause its Affiliates not to, directly or indirectly (except with respect to... |
8.8.4 AbbVie Cargo. Except as expressly set forth in this Section 8.8.4, AbbVie shall retain the right to use all AbbVie Cargo outside of this Agreement for any and all purposes, including in connection with other gene therapy platforms and delivery approaches. Unless and until AbbVie fails to exercise the Collaboratio... |
8.8.5 Acknowledgement. The Parties acknowledge and agree that (a) this Section 8.8 has been negotiated by the Parties, (b) the geographical and time limitations on activities set forth in this Section 8.8 are reasonable, valid and necessary in light of the Parties' circumstances and necessary for the adequate protectio... |
ARTICLE 9 PAYMENTS AND RECORDS |
9.1 Upfront Payment and First Final Ophthalmology Data Package Payment. |
9.1.1 Original Neurology Rights. The Parties acknowledge and agree that the payment that was required by Section 9.1 of the Original Agreement was paid in full and no further upfront payment is due hereunder with respect to the Original Neurology Rights. |
9.1.2 Ophthalmology Rights. In partial consideration of the Ophthalmology Rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than ten (10) days following the Effective Date, AbbVie shall pay Capsida a one-time upfront payment equal to Sixty Million Dollars... |
9.1.3 Additional Ophthalmology Research Program Payment. In partial consideration of the rights granted by Capsida to AbbVie hereunder, and subject to the terms and conditions of this Agreement, no later than ten (10) days after the delivery by Capsida to AbbVie of the first Final Ophthalmology Data Package, AbbVie sha... |
9.2 Equity Investment. |
The Parties acknowledge and agree that the purchase of convertible notes of Capsida required by Section 9.2 of the Original Agreement was completed in full and no equity payment is due hereunder with respect to the Original Neurology Rights. |
In partial consideration of the Ophthalmology Rights granted by Capsida to AbbVie hereunder, AbbVie or an Affiliate shall purchase Ten Million Dollars (US$10,000,000) of convertible notes of Capsida that would convert to Capsida preferred stock on terms to be set forth in the convertible notes. |
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