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ARTICLE 3 DEVELOPMENT AND REGULATORY |
3.1 Transition and Development Activities. |
3.1.1 Transition. |
(a) Promptly following the Effective Date, OSE shall, subject to Section 3.1.2(b), transition to AbbVie (or cause to be transitioned to AbbVie, as applicable) or its designee all materials and supporting data packages (including complete toxicology packages and reports by OSE) related to the Transition Activities in ac... |
(b) transfer to AbbVie of any and all regulatory filings, it being understood that there are no regulatory filings as of the Execution Date; |
(c) delivery to AbbVie of all preclinical and IND-enabling data, reports and materials to support regulatory submissions; |
(d) cause and facilitate the technology transfer to AbbVie or its designee of manufacturing and supply capabilities detailed in and in accordance with Section 3.4.1; and |
(e) conduct (and cause to be conducted, as applicable) any remaining Transition Activities in accordance with the Transition Development Plan. |
3.1.2 Development Activities. |
(a) OSE shall perform or cause to be performed, if applicable, the Transition Activities, in good scientific manner and in compliance with all Applicable Law. |
(b) The Parties acknowledge and agree that the Development activities pursuant to the Transition Development Plan are experimental by nature and OSE does not guarantee that it will be able to generate results achieving the objectives of the Parties. Failure to achieve those objectives shall not be a breach of this Agre... |
3.2 Development Activities and Costs. Following the Effective Date, AbbVie shall control the Development of all Licensed Antibodies and Licensed Products. Subject to OSE completing, at its cost (subject to Section 3.1.2(b) and Section 3.4), the Transition Activities, AbbVie shall be responsible for all Development and ... |
3.3 Subcontracting. Except as specifically set forth in the Transition Development Plan, OSE shall not subcontract any of its Transition Activities to a Third Party (a "Third Party Provider") without AbbVie's prior written consent. AbbVie's consent, to be granted at AbbVie's discretion, shall be conditioned on the foll... |
3.4 Supply, Manufacture and Cost of Licensed Antibodies or Licensed Products. Following the Effective Date, AbbVie shall have the right, at its expense, to Manufacture (or have Manufactured) and supply the Licensed Antibodies and Licensed Products for Development and Commercialization by AbbVie and its Affiliates and S... |
3.4.1 Manufacturing Technology Transfer. Upon the Effective Date, OSE shall initiate the facilitation of full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer, and which Third Party manufacturer may be a backup manufacturer or a second manufacturer of Licensed Antibod... |
(a) OSE shall make available, and shall use commercially reasonable efforts to cause its Third Party manufacturers to make available, to AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) from time to time as AbbVie may request: (i) all Manufacturing-related Know-How, Information, and mater... |
(b) OSE shall cause all appropriate employees and representatives of OSE 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, employees or representatives of AbbVie (or its Affiliate or design... |
(c) Without limiting the generality of Section 3.4.1(b), OSE shall cause all appropriate analytical and quality control laboratory employees and representatives of OSE and its Affiliates to meet with, and shall use commercially reasonable efforts to cause all appropriate analytical and quality control employees and rep... |
(d) OSE shall take such steps, and OSE shall use commercially reasonable efforts to cause its Third Party manufacturers to take such steps, as are reasonably necessary or useful to assist in reasonable respects AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) in obtaining any necessary li... |
(e) OSE shall provide, and shall use commercially reasonable efforts to cause its Third Party manufacturers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party manufacture... |
In this Section 3.4.1, wherever OSE is required to use commercially reasonable efforts to cause its Third Party manufacturers to take an action or otherwise assist, such obligation shall include using commercially reasonable efforts to negotiate contractual obligations for such Third Party manufacturers to do so under ... |
3.5 Records. |
3.5.1 OSE shall and shall ensure that its Third Party Providers, if applicable, 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 all work done and res... |
3.5.2 AbbVie shall have the right, during normal business hours and upon reasonable notice, to inspect and copy all records of OSE or its Third Party Provider maintained pursuant to Section 3.5. AbbVie shall maintain such records and the information disclosed therein in confidence in accordance with Article 9. |
3.6 Regulatory Matters. |
3.6.1 Regulatory Activities. |
(a) AbbVie shall have the sole right to prepare, obtain, and maintain the IND and Drug Approval Applications (including the setting of the overall regulatory strategy therefor), all other Regulatory Approvals and other submissions, and to conduct communications with the Regulatory Authorities, for Licensed Antibodies o... |
(b) All Regulatory Documentation (including all IND, Regulatory Approvals and Product Labeling) relating to the Licensed Antibodies or Licensed Products with respect to the Territory shall be owned by, and shall be the sole property and held in the name of, AbbVie or its designated Affiliate, Sublicensee or designee. O... |
3.7 AbbVie Diligence Obligations. |
3.7.1 AbbVie shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for a Licensed Product for any Indication in the United States and three countries in the European Major Market; provided that such obligation is expressly conditioned upon continuing absence of any adverse condition as det... |
3.7.2 Progress Reporting. At least sixty (60) days prior to the start of each Calendar Year until receipt of the first two Regulatory Approvals for which milestone payments are due pursuant to Section 6.3, AbbVie shall provide to OSE a written summary of ongoing and planned material Development activities for any Licen... |
ARTICLE 4 COMMERCIALIZATION |
4.1 In General. AbbVie (itself or through its Affiliates or Sublicensees) shall have the sole right to Commercialize Licensed Antibodies and Licensed Products in the Field in the Territory at its own cost and expense (except as otherwise expressly set forth herein). |
4.2 Statements and Compliance with Applicable Law. AbbVie shall, and shall cause its Affiliates to, comply in all material respects with all Applicable Law with respect to the Commercialization of Licensed Products. |
4.3 Booking of Sales; Distribution. AbbVie (or its designee(s)) 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 Territory and to perform or cause to be performed all related services. AbbVie s... |
ARTICLE 5 GRANT OF RIGHTS |
5.1 Grants to AbbVie. OSE (on behalf of itself and its Affiliates) hereby grants to AbbVie an exclusive (including with regard to OSE and its Affiliates) license, with the right to grant sublicenses through multiple tiers of sublicensees to its Affiliates and other Persons (subject to Section 5.2), under the Licensed I... |
5.2 Sublicenses. AbbVie shall have the right to grant sublicenses through multiple tiers of sublicensees, under the license granted to AbbVie in Section 5.1, to its Affiliates and other Persons, provided that any sublicenses shall be consistent with the terms and conditions of this Agreement. Promptly after execution o... |
5.3 Distributorships. 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 Territory or in any country or other jurisdiction of the Territory, to distribute, market, and sell the... |
5.4 No Other Rights. Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party or Third Party, as a result of this Agreement, obtain any ownership interest, license right or other right in any Know-How, Patent rights or other intellectual property rights of the other Party or any of... |
5.5 OSE Proposed Future In-License Agreements. During the Term, neither OSE nor any of its Affiliates shall, without AbbVie's prior written consent, enter into any agreement with a Third Party related to OSE Patents, OSE Know-How (which includes Regulatory Documentation, if any) or other intellectual property rights di... |
ARTICLE 6 PAYMENTS AND RECORDS |
6.1 Upfront Payment. No later than fifteen (15) days following the Effective Date, AbbVie shall pay OSE an upfront amount equal to Forty-Eight Million Dollars (US $48,000,000). Such payment shall be non-creditable against any other payments due hereunder. |
6.2 Development Milestones. In partial consideration of the rights granted by OSE to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement (including Section 6.5.3 and Section 12.10.1), AbbVie shall, within ten (10) Business Days after the occurrence of a Development Milestone, notify OSE... |
Milestone Event |
1. First IND filing in the United States |
2. Third patient dosed in the first Phase 2 Study that is designed to seek approval in the United States |
3. First patient dosed in the first Phase 3 Study that is designed to seek approval for the first Indication in the United States |
4. First patient dosed in the first Phase 3 Study that is designed to seek approval for a second Indication in the United States |
Each milestone payment in this Section 6.2 shall be payable only upon the first achievement of such milestone and no amounts shall be due for subsequent or repeated achievements of such milestone, whether for the same or a different Licensed Antibody or Licensed Product. The maximum aggregate amount payable by AbbVie p... |
6.3 Regulatory Milestones. In partial consideration of the rights granted by OSE to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement (including Section 6.5.3 and Section 12.10.1), AbbVie shall pay to OSE a milestone payment within sixty (60) days after the achievement of each of the ... |
Milestone Event |
1. Regulatory Approval granted by the FDA (i.e., BLA approval) of a first Indication |
2. Regulatory Approval granted by the EMA of a first Indication such that AbbVie is able to launch in at least three European Major Markets |
3. Regulatory Approval granted by the FDA (i.e., BLA approval or supplemental BLA) of a second Indication |
4. Regulatory Approval granted by the EMA of a second Indication such that AbbVie is able to launch in at least three European Major Markets |
Each milestone payment in this Section 6.3 shall be payable only upon the first achievement of such milestone and no amounts shall be due for subsequent or repeated achievements of such milestone, whether for the same or a different Licensed Antibody or Licensed Product. The maximum aggregate amount payable by AbbVie p... |
6.4 Sales-Based Milestones. In partial consideration of the license rights granted by OSE to AbbVie hereunder, subject to Section 6.4.1, Section 6.5.3 and Section 12.10.1, in the event that the aggregate Net Sales by the first Licensed Product made by AbbVie or any of its Affiliates or Sublicensees in a given Calendar ... |
Annual Net Sales Milestone Threshold |
1. Greater than One Billion Dollars (US$1,000,000,000) |
2. Greater than Two Billion Dollars (US$2,000,000,000) |
3. Greater than Three Billion Dollars (US$3,000,000,000) |
4. Greater than Five Billion Dollars (US$5,000,000,000) |
6.4.1 Notwithstanding anything contained in Section 6.4, each milestone payment in this Section 6.4 shall be payable only upon the first achievement of such milestone in a Calendar Year, and no amounts shall be due for subsequent or repeated achievements of such milestone in subsequent Calendar Years. The maximum aggre... |
6.4.2 With respect to each Licensed Product in each country or other jurisdiction in the Territory, from and after the expiration of the Royalty Term for such Licensed Product in such country or other jurisdiction, Net Sales of such Licensed Product in such country or other jurisdiction shall be excluded for purposes o... |
6.5 Royalties. |
6.5.1 Royalty Rates. As further consideration for the rights granted to AbbVie hereunder, subject to Section 6.5.3, Section 6.6 and Section 6.7, commencing upon the First Commercial Sale of a Licensed Product in the Territory, on a Licensed Product-by-Licensed Product basis, AbbVie shall pay to OSE a tiered royalty on ... |
Annual Net Sales of Licensed Product |
For that portion of annual Net Sales less than One Billion Dollars (US$1,000,000,000) |
For that portion of annual Net Sales greater than or equal to One Billion Dollars (US$1,000,000,000) but less than Two Billion Dollars (US$2,000,000,000) |
For that portion of annual Net Sales greater than or equal to Two Billion Dollars (US$2,000,000,000) but less than Three Billion Dollars (US$3,000,000,000) |
For that portion of annual Net Sales greater than or equal to Three Billion Dollars (US$3,000,000,000) |
6.5.2 Sublicensee Income. Sublicensee Income shall be included in the calculation of Net Sales for the relevant period for the relevant Product. |
6.5.3 Royalty Obligations. AbbVie shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country or other jurisdiction after the Royalty Term for such Licensed Product in such country or other jurisdiction has expired. With respect to each Licensed Product in each country o... |
6.6 Reductions. |
6.6.1 Notwithstanding Section 6.3, Section 6.4 and Section 6.5: |
(a) in the event that in any country or other jurisdiction in the Territory during the Royalty Term for a Licensed Product sales of all Biosimilar Products in such country or other jurisdiction in a Calendar Quarter exceed fifty percent (50%) of the sales of such Licensed Product and all Biosimilar Products in such cou... |
(b) in the event that, and in such case from and after the date on which, a Licensed Product is Exploited in a country or other jurisdiction and is not covered by a Valid Claim of a OSE Patent that claims the Licensed Antibody as a composition of matter contained in such Licensed Product in such country, then (x) the m... |
(c) in the event that a court or a governmental agency of competent jurisdiction requires AbbVie or any of its Affiliates or Sublicensees to grant a compulsory license to a Third Party permitting such Third Party to make and sell a Licensed Product in a country or other jurisdiction in the Territory, then, for the purp... |
(d) in the event that during the Royalty Term for a Licensed Product, such Licensed Product is designated as a Selected Drug by the Secretary of the U.S. Department of Health and Human Services, and AbbVie is required to negotiate, and is ultimately subject to, a Maximum Fair Price that will apply to sales of such Lice... |
6.6.2 Mechanics of Adjustments. Any reductions set forth in Section 6.6 shall be applied to the milestone payments set forth in Section 6.3 and Section 6.4 and royalty rate payable to OSE under Section 6.5.1, as applicable, in the order in which the event triggering such reduction occurs. Any adjustments pursuant to Se... |
6.7 Third Party Payments; Patent Costs. |
6.7.1 In the event that (a) AbbVie enters into an agreement with a Third Party in order to obtain a license or right under a Patent or intellectual property right owned or Controlled by such Third Party pursuant to Section 7.6 or (b) AbbVie incurs any reasonable Out-of-Pocket Costs in defending or settling any Third Pa... |
6.7.2 AbbVie shall have the right to deduct costs in accordance with Section 7.4.4 and Section 7.5.6. |
6.8 Minimum Payment. Notwithstanding the application of any reductions contemplated in Section 6.6, Section 6.7, Section 7.4.4, or Section 7.5.6, in no event shall any single payment payable to OSE with respect to the sale of any Licensed Product in any country during the applicable Royalty Term or a milestone be reduc... |
6.9 Royalty Payments and Reports. AbbVie shall calculate all amounts payable to OSE pursuant to Section 6.5 at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 6.10. AbbVie shall pay to OSE the royalty amounts due with respect to a given Calendar Quarter within n... |
6.10 Mode of Payment. All payments to either Party under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party. For the purpose of calculating any sums due under, or otherwise reimbursable purs... |
6.11 Interest on Late Payments. If any payment due to either Party under this Agreement is not paid when due, then such paying Party shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of one hundred (100) basis points above the U.S. effective feder... |
6.12 Withholding Taxes. Where any sum due to be paid to either Party hereunder is or would otherwise be subject to any withholding or similar tax, the Parties shall cooperate with each other and use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them t... |
6.13 Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes, and other similar taxes (the "Indirect Taxes"). If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes in addition to the amounts due hereunder at the applicable... |
6.14 Financial Records. AbbVie shall, and shall cause its Affiliates and Sublicensees to, keep complete and accurate books and records pertaining to Net Sales of Licensed Products, as applicable, including books and records of actual expenditures in sufficient detail to calculate all amounts payable hereunder and to ve... |
6.15 Audit. At the request of OSE, AbbVie shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognized standing designated by OSE and reasonably acceptable to AbbVie, at reasonable times during normal business hours and upon reasonable notice, to audit the books and re... |
6.16 Audit Dispute. In the event of a dispute with respect to any audit under Section 6.15, OSE and AbbVie shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be submitted for resolution ... |
6.17 Confidentiality. The receiving Party shall treat all information subject to review under this Article 6 in accordance with the confidentiality provisions of Article 9, and the Parties shall cause the Audit Arbitrator to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating ... |
6.18 No Other Compensation. Each Party hereby agrees that the terms of this Agreement fully define all consideration, compensation, and benefits, monetary or otherwise, to be paid, granted, or delivered by one (1) Party to the other Party in connection with the transactions contemplated herein. Neither Party previously... |
6.19 No Limitation. Nothing contained in this Article 6 shall in any way limit either Party's right to indemnification under this Agreement or to otherwise recover damages for breach of this Agreement. |
ARTICLE 7 INTELLECTUAL PROPERTY |
7.1 Ownership of Intellectual Property. |
7.1.1 Ownership of Technology. Subject to Section 3.6.1(b), Section 5.1, and Section 7.1.2, each Party shall own and retain all right, title, and interest in and to any and all: (a) Information and inventions that are conceived, discovered, developed, or otherwise made by or on behalf of such Party (or its Affiliates o... |
7.1.2 Ownership of Joint Patents and Joint Know-How. Subject to Section 3.6.1(b), as between the Parties, the Parties shall each own an equal, undivided interest in any and all (a) Information and inventions that are conceived, discovered, developed, or otherwise made by or on behalf of either Party or its Affiliates o... |
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