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3.10.4. No Harmful Actions. Subject to this Section 3.10.4, each Party shall not, and shall use commercially reasonable efforts to cause its Affiliates, Sublicensees, and subcontractors not to, take any action with respect to the Licensed Compound or a Licensed Product that could reasonably be expected to have a materi... |
3.10.5. Recalls. Each Party shall make every reasonable effort to notify the other Party promptly following its determination that any event, incident, or circumstance has occurred that may result in the need for a recall, market suspension, or market withdrawal of a Licensed Product anywhere in the Territory, and shal... |
3.10.6. Regulatory Data. Each Party shall promptly provide to the other Party copies of or access to all non-clinical data and Clinical Data, and other Information, results, and analyses with respect to any Party Development Activities that are Controlled by such Party or any of its Affiliates (collectively, "Regulator... |
3.10.7. Compliance. Each Party shall perform or cause to be performed, any and all of its Party Development Activities, including Discovery Program Activities, IND-Enabling Activities and Clinical Development Activities, and its Development Manufacturing Activities in good scientific manner and in compliance with all A... |
3.10.8. Records. Each of Richter and AbbVie shall, and shall ensure that its Third Party Providers, maintain records in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, and in compliance with Applicable Law, which shall be complete and accurate and shall properly reflect a... |
ARTICLE 4 COMMERCIALIZATION |
4.1 In General. |
4.1.1. Global Commercialization Plan. No later than one (1) year prior to the anticipated First Commercial Sale of a Licensed Product in the Territory, the Parties will prepare and submit to the JSC, an initial high-level global commercialization plan for such Licensed Product in the Territory (each a, "Global Commerci... |
4.1.2. AbbVie Territory. AbbVie (itself or through its Affiliates or Sublicensees) shall have the sole right, control over and decision-making authority with respect to Commercializing Licensed Compounds and Licensed Products in the Field in the AbbVie Territory at its own cost and expense (except as otherwise expressl... |
4.1.3. Richter Territory. Richter (itself or through its Affiliates or Sublicensees) shall have the sole right, control over and decision-making authority with respect to Commercializing Licensed Compounds and Licensed Products in the Field in the Richter Territory at its own cost and expense (except as otherwise expre... |
4.2 Diligence. On a Discovery Program-by-Discovery Program basis, AbbVie shall use Commercially Reasonable Efforts to Commercialize an initial Licensed Product for the Discovery Program for the first Indication in the United States following receipt of Regulatory Approval therefor in the United States. Richter acknowle... |
4.3 Booking of Sales; Distribution. |
4.3.1. AbbVie Territory. AbbVie shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Licensed Products in the AbbVie Territory and to perform or cause to be performed all related services. AbbVie shall handle all returns, ... |
4.3.2. Richter Territory. Richter shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Licensed Products in the Richter Territory and to perform or cause to be performed all related services. Richter shall handle all retur... |
4.4 Coordination of Commercialization Activities. The Parties recognize that each Party may benefit from the coordination of certain Commercialization activities for the Licensed Products between the AbbVie Territory and Richter Territory. Accordingly, the Parties will coordinate such activities through the JSC where a... |
4.5 Pricing; Reimbursement Approvals. Each Party will have the right to determine the price of the Licensed Products sold in its Applicable Territory and neither Party will have the right to direct, control, or approve the pricing of the Licensed Products in the other Party's Applicable Territory. Each Party will keep ... |
4.6 Diversion. Subject to Applicable Law, each Party hereby covenants and agrees that (a) it and its Affiliates will not, and it will contractually obligate its licensees, Sublicensees and contractors not to, directly or indirectly, actively promote, market, distribute, import, sell or have sold any Licensed Product, i... |
4.7 Product Trademarks. AbbVie shall have the sole right to determine and own the AbbVie Product Trademarks to be used with respect to the Exploitation of the Licensed Products in the AbbVie Territory and will be solely responsible for all costs and expense of registration and maintenance of the AbbVie Product Trademar... |
4.8 Markings. |
4.8.1. To the extent required by Applicable Law in a country or other jurisdiction, each Party will have the right to include the Corporate Name of the other Party and the logo and corporate name of the manufacturer on the packaging and Product Labeling used by such Party and its Affiliates in connection with the Licen... |
4.8.2. Richter agrees that it will not use any of AbbVie's Corporate Name, names, trademarks or logos in any way that could demean, defame, embarrass, diminish or cause any harm to AbbVie or any of its affiliates, or subsidiaries. Richter hereby acknowledges that any and all use of AbbVie's Corporate Names will inure t... |
4.8.3. AbbVie agrees that it will not use any of Richter's Corporate Name, names, trademarks or logos in any way that could demean, defame, embarrass, diminish or cause any harm to Richter or any of its affiliates, or subsidiaries. AbbVie hereby acknowledges that any and all use of Richter's Corporate Names will inure ... |
4.9 Manufacturing. |
4.9.1. Commercial Supply of Licensed Compounds. Subject to this Section 4.9.1 and the Richter Supply Agreement, Richter will have responsibility for, and decision-making authority with respect to, all Manufacturing activities and associated costs and expenses for the Manufacture of the Licensed Compounds for the Territ... |
(a) No later than one (1) year prior to the anticipated First Commercial Sale of a Licensed Product in the Territory, AbbVie and Richter shall enter into (a) a supply agreement pursuant to which Richter shall supply to AbbVie the Licensed Compounds (the "Richter Supply Agreement") in such quantities as AbbVie may order... |
(b) At AbbVie's written request, and at a time sufficiently in advance to allow such transfer to occur in a reasonable manner and time prior to submission of the first NDA for a Licensed Product in the AbbVie Territory, Richter will conduct a Manufacturing Technology Transfer pursuant to Section 4.9.3 to allow AbbVie t... |
(c) If AbbVie can at any time reasonably demonstrate that it will be able to Manufacture the Licensed Compound for a savings of twenty (20%) or more as compared with the supply price under the Richter Supply Agreement, then AbbVie will thereafter have the right to Manufacture up to twenty-five percent (25%) of the tota... |
4.9.2. Commercial Supply of Licensed Products. Subject to this Section 4.9.2 and the AbbVie Supply Agreement, AbbVie will have responsibility for, and decision-making authority with respect to, all Manufacturing activities and associated costs and expenses for the Manufacture of the Licensed Products for the Territory. |
(a) No later than one (1) year prior to the anticipated First Commercial Sale of a Licensed Product in the Richter Territory, AbbVie and Richter shall enter into (a) a supply agreement pursuant to which AbbVie shall supply to Richter the Licensed Products in bulk containers suitable for product stability (the "AbbVie S... |
(b) At Richter's request, in sufficient time prior to submission of the first NDA for a Licensed Product in the Richter Territory, AbbVie will conduct a Manufacturing Technology Transfer pursuant to Section 4.9.3 to allow Richter to preemptively qualify either its own facility or its designee's facility (which designee... |
4.9.3. Manufacturing Technology Transfer. |
(a) AbbVie's Right to Request a Manufacturing Technology Transfer. AbbVie shall have the right, in sufficient time prior to submission of the first NDA for a Licensed Product in the AbbVie Territory to allow AbbVie or its designee to be included as a manufacturer of the Licensed Compound in such NDA and from time to ti... |
(b) Richter's Right to Request a Manufacturing Technology Transfer. Richter shall have the right, in sufficient time prior to submission of the first NDA in the Richter Territory for a Licensed Product to allow Richter or its designee to be included as a manufacturer of the Licensed Compound in such NDA and from time t... |
(c) Protection of Proprietary Information. If the AbbVie Formulation Manufacturing Process involves any proprietary Information Controlled by AbbVie ("AbbVie Proprietary Manufacturing Information") or if the Richter Manufacturing Process involves any proprietary Information Controlled by Richter ("Richter Proprietary M... |
(d) Manufacturing Technology Transfer. If AbbVie requests a Richter Manufacturing Technology Transfer pursuant to Section 4.9.3(a) or if Richter requests an AbbVie Formulation Manufacturing Technology Transfer pursuant to Section 4.9.3(b), then Richter, in the case of a Richter Manufacturing Technology Transfer, or Abb... |
(i) The Transferor Party shall make available, and shall use commercially reasonable efforts to cause its Third Party manufacturers to make available (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into followi... |
(ii) The Transferor Party shall cause all appropriate employees and representatives of the Transferor Party and its Affiliates to meet with, and shall use commercially reasonable efforts to cause all appropriate employees and representatives of its Third Party manufacturers to meet with (including by using commercially... |
(iii) Without limiting the generality of clause (ii) above, the Transferor Party shall cause all appropriate analytical and quality control laboratory employees and representatives of the Transferor Party and its Affiliates to meet with, and shall use commercially reasonable efforts to cause all appropriate analytical ... |
(iv) The Transferor Party shall take such steps, and shall use commercially reasonable efforts to cause its Third Party manufacturers to take such steps (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into foll... |
(v) The Transferor Party shall provide, and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide (including by using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under agreements entered into following the Executi... |
(vi) The Transferor Party will provide, at its sole cost and expense, three hundred (300) hours of support for the Manufacturing Technology Transfer of such Licensed Compound or Licensed Product. Any assistance in excess of such three hundred (300) hours for a Licensed Compound or Licensed Product will be at the Transf... |
4.10 Compliance. Each Party shall perform or cause to be performed, any and all of its Commercialization and Manufacturing activities in good scientific manner and in compliance with all Applicable Law. |
ARTICLE 5 GRANT OF RIGHTS |
5.1 Grants to AbbVie. Subject, in each case, to the terms and conditions of this Agreement (including Section 5.3.1), Richter (on behalf of itself and its Affiliates) hereby grants to AbbVie: |
5.1.1. an exclusive (including with regard to Richter and its Affiliates, except as set forth in Section 5.2) license (or sublicense), with the right to grant sublicenses in accordance with Section 5.3.1, under the Richter Patents, the Richter Know-How, and Richter's interests in the Joint Patents and the Joint Know-Ho... |
5.1.2. an exclusive (including with regard to Richter and its Affiliates, except as set forth in Section 5.2) license and right of reference, with the right to grant sublicenses and further rights of reference in accordance with Section 5.3.1, under all Regulatory Approval and any other Regulatory Documentation that Ri... |
5.1.3. subject to Section 4.8, a non-exclusive license, with the right to grant sublicenses in accordance with Section 5.3, to use Richter's Corporate Names solely (a) as required by a Regulatory Authority under Applicable Law in a country or other jurisdiction in the AbbVie Territory to be included in the packaging or... |
5.2 Grants to Richter. Subject to the terms and conditions of this Agreement (including Section 5.3.2), AbbVie hereby grants to Richter: |
5.2.1. under the rights granted to AbbVie pursuant to Section 5.1.1 and Section 5.1.2, the AbbVie Patents, the AbbVie Know-How, and AbbVie's interests in the Joint Patents and the Joint Know-How: |
(a) a non-exclusive, royalty-free license, with the right to grant sublicenses and further rights of reference in accordance with Section 5.3.2 to Develop the Licensed Compounds or Licensed Products in the Territory solely for purposes of performing under each applicable Discovery Program Plan, each applicable IND-Enab... |
(b) a non-exclusive, royalty-free license, with the right to grant sublicenses and further rights of reference in accordance with Section 5.3.2 to Manufacture the Licensed Compounds in the Territory solely (i) for purposes of performing under the Development Manufacturing Plan and the Richter Supply Agreement or (ii) a... |
(c) an exclusive, royalty-free license, with the right to grant sublicenses and further rights of reference in accordance with Section 5.3.2 to Commercialize the Licensed Compounds or Licensed Products in the Richter Territory solely in compliance with the terms of this Agreement; |
5.2.2. a non-exclusive, royalty-free license and right of reference, with the right to grant sublicenses and further rights of reference in accordance with Section 5.3.2, under the rights to Regulatory Approvals and other Regulatory Documentation granted to AbbVie pursuant to Section 5.1.1 and Section 5.1.2 and all Reg... |
5.2.3. subject to Section 4.8, a non-exclusive license, with the right to grant sublicenses in accordance with Section 5.3, to use AbbVie's Corporate Names solely (a) as required by a Regulatory Authority under Applicable Law in a country or other jurisdiction in the Richter Territory to be included in the packaging or... |
5.3 Sublicenses. |
5.3.1. Sublicenses by AbbVie. Subject to this Section 5.3.1, AbbVie shall have the right to grant sublicenses (or further rights of reference), through multiple tiers of sublicensees, under the licenses and rights of reference granted in Section 5.1, to its Affiliates and other Persons; provided that any such sublicens... |
5.3.2. Sublicenses by Richter. Richter shall have the right to grant sublicenses (or further rights of reference), through multiple tiers of sublicensees, under the licenses and rights of reference granted in Section 5.2, to its Affiliates; provided that any such sublicenses shall be consistent with the terms and condi... |
5.4 Distributorships. |
5.4.1. AbbVie shall have the right, in its sole discretion, to appoint its Affiliates, and AbbVie and its Affiliates shall have the right, in their sole discretion, to appoint any other Persons, in the AbbVie Territory, to distribute, market, and sell the Licensed Products (with or without packaging rights), in circums... |
5.4.2. Richter shall have the right, in its sole discretion, to appoint its Affiliates, and Richter and its Affiliates shall have the right, in their sole discretion, to appoint any other Persons, in the Richter Territory, to distribute, market, and sell the Licensed Products (with or without packaging rights), in circ... |
5.5 Retention of Rights. |
5.5.1. Except as expressly provided herein, Richter grants no other right or license, including any rights or licenses to the Richter Patents, the Richter Know-How, the Regulatory Documentation, its Corporate Names, or any other Patent or intellectual property rights not otherwise expressly granted herein. |
5.5.2. Except as expressly provided herein, AbbVie grants no other right or license, including any rights or licenses to the AbbVie Patents, the AbbVie Know-How, the Regulatory Documentation, or any other Patent or intellectual property rights not otherwise expressly granted herein. |
5.6 Confirmatory Patent License. If requested by one Party, the other Party shall promptly enter into confirmatory license agreements in the form or substantially the form reasonably requested for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as considered app... |
5.7 Richter Activities in the Territory. During the Term, neither Richter nor any of its Affiliates shall, directly or indirectly, conduct any Development activity with respect to the Licensed Compounds or Licensed Products in the Territory other than as set forth in the Discovery Program Plan, the IND-Enabling Studies... |
5.8 Exclusivity. |
5.8.1. Richter Exclusivity Obligations. |
(a) D3 Receptor Modulator Competing Product. |
(i) Richter shall not, and shall cause its Affiliates not to (i) directly or indirectly, research or develop any D3 Receptor Modulator Competing Product, or (ii) license, authorize, appoint, or otherwise enable any Third Party to directly or indirectly, research or develop any D3 Receptor Modulator Competing Product in... |
(ii) Richter shall not, and shall cause its Affiliates not to (i) directly or indirectly, commercialize, manufacture or otherwise exploit any D3 Receptor Competing Product, or (ii) license, authorize, appoint, or otherwise enable any Third Party to directly or indirectly, commercialize, manufacture or otherwise exploit... |
(b) Pro-Metabolite Competing Product. |
(i) Richter shall not, and shall cause its Affiliates not to (i) directly or indirectly, research or develop any Pro-Metabolite Competing Product, or (ii) license, authorize, appoint, or otherwise enable any Third Party to directly or indirectly, research or develop any Pro-Metabolite Competing Product in any country o... |
(ii) Richter shall not, and shall cause its Affiliates not to (i) directly or indirectly, commercialize, manufacture or otherwise exploit any Pro-Metabolite Competing Product, or (ii) license, authorize, appoint, or otherwise enable any Third Party to directly or indirectly, commercialize, manufacture or otherwise expl... |
5.8.2. Exception for Generic Products. Notwithstanding anything to the contrary in Section 5.8.1, Section 5.8.1 will not prohibit Richter, on a Competing Product-by-Competing Product and country-by-country basis in the Richter Territory, from acquiring, developing, commercializing, manufacturing or otherwise exploiting... |
5.8.3. Exception for a Change in Control. Notwithstanding the provisions of Section 5.8.1 and without limiting Section 13.2.1, if Richter undergoes a Change in Control during the Term and, as of immediately prior to the closing of such Change in Control, any Person that becomes an Affiliate of Richter upon such Change ... |
(a) notify AbbVie in writing that Richter and the Richter Acquirer, as applicable, and their Affiliates will Divest their respective rights to such Competing Product, in which case, within one (1) year (or such longer period as may be required by Applicable Law or agreed by Richter or the Richter Acquirer, as applicabl... |
(b) notify AbbVie in writing that it is ceasing all such research, development and commercialization activities with respect to the Competing Product, in which case, within one hundred and twenty (120) days (or such longer period as may be agreed by Richter or the Richter Acquirer, as applicable, and AbbVie) after AbbV... |
(c) promptly notify AbbVie in writing that it will not Divest nor cease all research, development and commercialization activities with respect to the Competing Product, and in such case Richter and the Richter Acquirer, as applicable, will transfer, at Richter's sole cost and expense, all rights, title and interest in... |
(d) Prior to the time of Divestiture pursuant to Section 5.8.3(a) or prior to the termination of activities pursuant to Section 5.8.3(b), or prior to the time of transfer pursuant to Section 5.8.3(c), as applicable, Richter and the Richter Acquirer, as applicable, and their Affiliates will segregate all research, devel... |
5.8.4. Exception for Affiliate Acquisition. Notwithstanding the provisions of Section 5.8.1, if Richter acquires a Third Party (whether such acquisition occurs by way of a purchase of assets, merger, consolidation, change of control, or otherwise) (the "Richter Acquiree") that, as of immediately prior to the consummati... |
(a) notify AbbVie in writing that Richter and its Affiliates will Divest their respective rights to such Competing Product, in which case, within one (1) year (or such longer period as may be required by Applicable Law or agreed by Richter and AbbVie) after the closing of the acquisition, Richter and its Affiliates wil... |
(b) notify AbbVie in writing that it is ceasing all such research, development and commercialization activities with respect to the Competing Product, in which case, within one hundred and twenty (120) days (or such longer period as may be agreed by Richter and AbbVie) after AbbVie's receipt of such notice, Richter and... |
(c) promptly notify AbbVie in writing that it will not Divest nor cease all research, development and commercialization activities with respect to the Competing Product, and in such case Richter will transfer, at Richter's sole cost and expense, all rights, title and interest in and to the Licensed Compounds, Licensed ... |
(d) Prior to the time of Divestiture pursuant to Section 5.8.4(a), prior to the termination of activities pursuant to Section 5.8.4(b), or prior to the time of transfer pursuant to Section 5.8.4(c), as applicable, Richter and its Affiliates will segregate all research, development or commercialization activities relati... |
5.9 In-License Agreements. |
5.9.1. Necessary Third Party Licenses. |
(a) If in the reasonable opinion of either Party, the Development, Manufacture, or Commercialization of any Licensed Compound or Licensed Product by AbbVie or Richter, any of their Affiliates, or any of their Sublicensees potentially infringes or misappropriates any Patent, trade secret, or other intellectual property ... |
(b) Prior to executing any Necessary Third Party License that would be applicable to the Richter Territory, AbbVie will (i) provide Richter an opportunity to review and comment on the terms of such proposed Necessary Third Party License that are applicable to the Richter Territory, (ii) consider Richter's comments in g... |
(c) If AbbVie elects not to obtain a license to any Necessary Third Party IP pursuant to Section 5.9.1(a) and such Necessary Third Party IP applies to the Richter Territory, then Richter may notify AbbVie if it wishes to obtain a license to such Necessary Third Party IP and the Parties will promptly meet to discuss. Ri... |
5.9.2. New In-License Agreements. |
(a) If Richter or its Affiliate is planning to enter into an agreement during the Term with a Third Party to obtain a license or rights to Information, Regulatory Documentation, material, Patents, or other intellectual other property rights reasonably useful for the Exploitation of the Licensed Compounds or Licensed Pr... |
(b) Subject to Section 5.9.2(a), if Richter or any of its Affiliates enter into a license, sublicense or other agreement for additional rights to Information, Regulatory Documentation, material, Patents, or other intellectual other property rights reasonably useful for the Exploitation of the Licensed Compounds or Lice... |
5.9.3. Payment Obligations for Existing In-License Agreements. With respect to In-License Agreements entered into prior to the Effective Date, Richter is responsible for all financial obligations, including any royalties, due in connection with such In-License Agreements. |
5.10 Existing Collaboration Agreement. To the extent that a compound is both a D3 Receptor Compound or a Pro-metabolite Compound under this Agreement and a D2/D3 Compound or a Compound (as each such term is defined in the Existing Collaboration Agreement) under the Existing Collaboration Agreement, such compound will b... |
ARTICLE 6 PAYMENTS AND RECORDS |
6.1 Upfront Payment. No later than thirty (30) days following the Effective Date, AbbVie shall pay Richter an upfront amount equal to Twenty Million Dollars ($20,000,000). Such payment shall be noncreditable against any other payments due hereunder. |
6.2 Development and Regulatory Milestones. In partial consideration of the rights granted by Richter to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to Richter the applicable milestone payment within sixty (60) days after the achievement of each of the following... |
Development Milestone Payments |
Milestone Event D3 Receptor Product Pro-metabolite Product |
For a first Indication |
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