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(c) The grants set forth in this Section 5.1.2 will automatically come into full force and effect on the License Option Exercise Closing Date without any further action required by either Party under this Agreement. |
5.2 Sublicenses. 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 Sections 5.1.1 and 5.1.2, to its Affiliates and other Persons; provided that any such sublicenses shall be consistent with the... |
5.3 Distributorships. Subject to the terms of this Agreement, 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 Territ... |
5.4 Co-Promotion Rights. For purposes of clarity, subject to the terms of this Agreement, AbbVie and its Affiliates shall have the right, in their sole discretion, to co-promote the Licensed Products with any other Person(s), or to appoint one (1) or more Third Parties to promote the Licensed Products without AbbVie in... |
5.5 Retention of Rights. |
5.5.1 No Implied Licenses. Notwithstanding the exclusive licenses granted to AbbVie pursuant to Section 5.1.2, Licensor retains the right to practice under the Licensor Patents, the Licensor Know-How, Licensor's interests in the Joint Patents and the Joint Know-How, Regulatory Approvals and any other Regulatory Documen... |
5.6 Confirmatory Patent License. Licensor shall if requested to do so by AbbVie and at AbbVie's cost and expense, immediately enter into confirmatory license agreements consistent with this Agreement in the form or substantially the form reasonably requested by AbbVie for purposes of recording the licenses granted unde... |
5.7 Exclusivity with Respect to the Territory. |
5.7.1 Exclusivity Covenant. Subject to Section 5.7.2, Licensor shall not, and shall cause its Affiliates not to (a) directly or indirectly, Develop, commercialize, manufacture or otherwise Exploit any Competing Product in any country or other jurisdiction in the Territory, or (b) license, authorize, appoint, or otherwi... |
5.7.2 Exception. Notwithstanding the provisions of Section 5.7.1, if, during the Term, Licensor undergoes a Change in Control and the relevant acquirer is either then commercializing a Competing Product, or has in development any Competing Product, such Change in Control, and the commercialization (or development and s... |
5.8 In-License Agreements. |
5.8.1 Restriction. During the Term, neither Licensor nor any of its Affiliates shall, without AbbVie's prior written consent, enter into any agreement with a Third Party with respect to any Regulatory Documentation, Patents, or other intellectual property rights directed primarily to the Licensed Antibody or Licensed P... |
5.8.2 AbbVie Right. Following the License Option Exercise Closing Date, if in the reasonable opinion of AbbVie a Patent or other intellectual property right owned or controlled by a Third Party in a particular country or jurisdiction is necessary or reasonably useful to Exploit a Licensed Antibody or Licensed Product, ... |
5.8.3 Licensor Right; Inclusion of New IP. If Licensor or any of its Affiliates, after the Effective Date, become a party to a license, sublicense or other agreement for additional intellectual property rights, with the right to sublicense, that are relevant to the Exploitation of the Licensed Antibodies or Licensed Pr... |
ARTICLE 6 PAYMENTS AND RECORDS |
6.1 Upfront Payment. No later than ten (10) days following the Effective Date, AbbVie shall pay Licensor an upfront, non-refundable, non-creditable amount equal to Twenty-Five Million Dollars ($25,000,000). |
6.2 License Option Exercise. No later than thirty (30) days following the License Option Exercise Closing Date: (a) $45,000,000 if AbbVie paid the Biomarker Milestone prior to the License Option Exercise Closing Date, or (b) $50,000,000 if AbbVie does not pay the Biomarker Milestone prior to License Option Exercise Clo... |
6.3 Development and Regulatory Milestones. In partial consideration of the rights granted by Licensor to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, and subject to Section 3.3, AbbVie shall pay to Licensor a non-refundable milestone payment within sixty (60) days after the achi... |
6.3.1 Third subject dosed in the single ascending dose segment of a Phase I/IA Trial meeting the clinical protocols described on Schedule 6.3.1 and Licensor otherwise meeting the requirements in Section V.A of the Initial Development Plan and Budget (the "Phase I/IA Milestone"), Twenty Million Dollars ($20,000,000); |
6.3.2 Biomarker proof-of-target engagement in the Phase I/IA Trial with the criteria described on Schedule 6.3.2 (the "Biomarker Milestone"), Ten Million Dollars ($10,000,000); |
6.3.3 First subject dosed in a Phase I/IB Trial meeting the clinical protocols described on Schedule 6.3.3 and Licensor otherwise meeting the requirements in items 1 through 4 of Section V.B of the Initial Development Plan and Budget (the "Phase I/IB Milestone"), Sixteen Million Dollars ($16,000,000); |
6.3.4 First subject dosed in a Phase III Trial (the "Phase III Milestone"), Thirty Million Dollars ($30,000,000); |
6.3.5 upon the first Acceptance by the FDA of a BLA in the U.S. for a Licensed Product and the first Indication, (the "First BLA Milestone"), Thirty-Five Million Dollars ($35,000,000); |
6.3.6 upon the first Acceptance by the FDA of a supplemental or new BLA in the U.S. for a Licensed Product and the second Indication (i.e. a different Indication than the Indication achieved for the milestone in Section 6.3.5), Twenty Million Dollars ($20,000,000); and |
6.3.7 upon the first Acceptance by the FDA of a supplemental or new BLA in the U.S. for a Licensed Product and the third Indication (i.e. a different Indication than the Indications achieved for the milestones in Sections 6.3.5 and 6.3.6), Fifteen Million Dollars ($15,000,000). |
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. If AbbVie pays the Phase I/IB Milestone but has ... |
6.4 First Commercial Sales Milestones. In partial consideration of the rights granted by Licensor to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to Licensor the following non-refundable milestone payments due within sixty (60) days after the achievement of each... |
6.4.1 upon the First Commercial Sale in the United States for a Licensed Product, Forty Million Dollars ($40,000,000); |
6.4.2 upon the First Commercial Sale in at least two (2) Major European Markets for a Licensed Product, Twenty Million Dollars ($20,000,000); and |
6.4.3 upon the First Commercial Sale in Japan for a Licensed Product, Ten Million Dollars ($10,000,000). |
Each milestone payment in this Section 6.4 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... |
6.5 Sales-Based Milestones. In partial consideration of the rights granted by Licensor to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to Licensor the following non-refundable milestone payments due within ninety (90) days after the end of the Calendar Quarter f... |
6.5.1 upon the Net Sales in the Territory of a Licensed Product made by AbbVie or any of its Affiliates or Sublicensees in a given Calendar Year exceeding One Billion Dollars ($1,000,000,000) but less than or equal to Two Billion Dollars ($2,000,000,000), Forty Million Dollars ($40,000,000); and |
6.5.2 upon the Net Sales in the Territory of a Licensed Product made by AbbVie or any of its Affiliates or Sublicensees in a given Calendar Year exceeding Two Billion Dollars ($2,000,000,000), Sixty Million Dollars ($60,000,000). |
Each milestone payment in this Section 6.5 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, whether for the same or a different Licensed Antibody or Licensed Product.... |
6.6 Royalties. |
6.6.1 Royalty Rates. As further consideration for the rights granted to AbbVie hereunder, subject to Section 6.6.3, 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 Licensor a royalty on Net Sales of each Licensed Prod... |
Net Sales in the Territory of each Licensed Product in a Calendar Year |
For that portion of aggregate Net Sales of each Licensed Product in the Territory during a Calendar Year less than One Billion Dollars ($1,000,000,000) |
For that portion of aggregate Net Sales of each Licensed Product in the Territory during a Calendar Year greater than or equal to One Billion ($1,000,000,000) but less Two Billion Dollars ($2,000,000,000) |
For that portion of aggregate Net Sales of each Licensed Product in the Territory during a Calendar Year greater than or equal to Two Billion Dollars ($2,000,000,000) |
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 of calc... |
6.6.2 Royalty Term. 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. |
6.6.3 Reductions. Notwithstanding the foregoing: |
(a) Subject to Section 6.6.3(d), in the event that in any country or other jurisdiction in the Territory during the Royalty Term for a Licensed Product there is Biosimilar Competition in such country or other jurisdiction, then for each such country or other jurisdiction, the royalties payable to Licensor for the Net S... |
(b) in the event that 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 that is necessary or reasonably useful to Manufacture or Commercialize a Licensed Antibody or Licensed Product in a particu... |
(c) Subject to Section 6.6.3(d) in the event that, during a given Calendar Quarter during the Royalty Term for a given Licensed Product in given a country or other jurisdiction, (i) no Licensor Patent or Joint Patent exists that includes a Valid Claim that (1) claims as a composition of matter the Licensed Antibody con... |
(d) In no event will the cumulative reductions under (i) the foregoing Sections 6.6.3(b) through 6.6.3(c) reduce the royalties payable to Licensor on any Licensed Product in any Calendar Quarter by more than fifty percent (50%) of the amounts otherwise payable under Section 6.6.1 for such Licensed Product, and (ii) the... |
6.7 Royalty Payments and Reports. AbbVie shall calculate all amounts payable to Licensor pursuant to Section 6.6 at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 6.8. AbbVie shall pay to Licensor the royalty amounts due with respect to a given Calendar Quarter... |
6.8 Mode of Payment; Offsets. 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 reimbursa... |
6.9 Withholding Taxes. Where any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, the Parties shall use their commercially reasonable efforts to do all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation ag... |
6.10 Indirect Taxes. All payments due under this Agreement 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 at the applicable rate in respect ... |
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 LIBOR, such interest to ... |
6.12 Financial Records. Licensor shall, and shall cause its Affiliates to, and shall use commercially reasonable efforts to cause its Sublicensees to, keep complete and accurate books and records pertaining to the Initial Development Activities, including books and records of actual expenditures with respect to the bud... |
6.13 Audit. AbbVie shall, shall cause its Affiliates to, and shall use commercially reasonable efforts to cause its Sublicensees to, keep complete and accurate books and records pertaining to Net Sales of Licensed Products, in sufficient detail to calculate all amounts payable hereunder. At the request of Licensor, Abb... |
Except as provided below, the cost of this audit shall be borne by Licensor, unless the audit reveals a variance of more than the greater of five percent (5%) from the reported amounts or Two Hundred Fifty Thousand Dollars ($250,000), in which case AbbVie shall bear the cost of the audit. |
6.14 Audit Dispute. In the event of a dispute with respect to any audit under Section 6.13, Licensor 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 resolu... |
6.15 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 AbbVie obligating such firm to... |
6.16 Diagnostic or Veterinary Products. The development and regulatory milestone payments, first commercial sales milestone payments, sales-based milestone payments and royalties in Sections 6.3, 6.4 6.5, and 6.6 shall not apply to Development and Commercialization of Licensed Antibodies or Licensed Products indicated ... |
6.17 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 Party to the other Party in connection with the transactions contemplated herein. Neither Party previously has p... |
ARTICLE 7 INTELLECTUAL PROPERTY RIGHTS |
7.1 Ownership of Intellectual Property. |
7.1.1 Ownership of Technology. Subject to Section 3.7.2(c) and Section 7.1.2, as between the Parties, each Party, or their respective Affiliates, shall own and retain all right, title, and interest in and to any and all: (a) Information and inventions that are conceived, reduced to practice, discovered, developed, or m... |
7.1.2 Ownership of Joint Patents and Joint Know-How. Subject to Section 3.7.2(c), as between the Parties, each Party, or their respective Affiliates, shall own an equal, undivided interest in any and all (a) Information and inventions that are conceived, reduced to practice, discovered, developed or made jointly by or ... |
7.1.3 United States Law. The determination of inventorship and whether Information and inventions are conceived, reduced to practice, discovered, developed, or made by a Party for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property rights) therein, shall, for purpose... |
7.1.4 Assignment Obligation. |
(a) Each Party shall cause all Persons who perform activities for such Party under this Agreement to assign (or, if such Party is unable to cause such Person to assign despite such Party's using commercially reasonable efforts, then be under an obligation to assign; and if still unable to cause such Person to agree to ... |
(b) Each Party will promptly disclose to the other Party in writing, the conception, reduction to practice, discovery, development or making of any Joint Know-How or Joint Patents by Persons who perform activities for it under this Agreement. Each Party will execute and record assignments and other necessary documents ... |
7.2 Maintenance and Prosecution of Patents. |
7.2.1 Patent Prosecution and Maintenance of Licensor Patents. |
(a) Subject to Section 7.2.1(b), Licensor shall have the right, but not the obligation, through the use of internal or outside counsel reasonably acceptable to AbbVie, to prepare, file, prosecute, defend in any oppositions or post-grant proceedings, and maintain the Licensor Patents worldwide, at Licensor's sole cost a... |
(b) On and after the License Option Exercise Closing Date, as between the Parties, AbbVie shall have the responsibility for and control over the preparation, filing, prosecution, defend in any oppositions or post-grant proceedings, and maintenance of all Licensor Patents (other than the University Patent Rights, unless... |
7.2.2 Patent Prosecution and Maintenance of Joint Patents. As between the Parties, AbbVie shall have the right, but not the obligation, to prepare, file, prosecute, defend in any opposition or post-grant proceedings, and maintain the Joint Patents worldwide, at AbbVie's sole cost and expense. AbbVie shall keep Licensor... |
7.2.3 Cooperation. The Parties agree to cooperate fully in the preparation, filing, prosecution, defense in oppositions or post-grant proceedings, and maintenance of the Licensor Patents and Joint Patents in the Territory under this Agreement. Cooperation shall include: |
(a) without limiting any other rights and obligations of the Parties under this Agreement, cooperating with respect to the timing, scope and filing of such Patents to preserve and enhance the patent protection for Licensed Antibodies and Licensed Products, including the manufacture and use thereof; |
(b) executing all papers and instruments, or requiring its employees or contractors to execute such papers and instruments, so as to (i) effectuate the ownership of intellectual property set forth in Sections 7.1.1 and 7.1.2; (ii) enable the other Party to apply for and to prosecute Patent applications in the Territory... |
(c) consistent with this Agreement, assisting in any license, transfer or assignment registration processes with applicable governmental authorities that may be available in the Territory for the protection of a Party's interests in this Agreement; and |
(d) promptly informing the other Party of any matters coming to such Party's attention that may materially affect the preparation, filing, prosecution, defense or maintenance of any such Patents in the Territory. |
7.2.4 Patent Term Extension and Supplementary Protection Certificate. On and after the License Option Exercise Closing Date, AbbVie shall be responsible for making decisions regarding patent term extensions, supplementary protection certificates, pediatric exclusivity and any other extensions that are now or become ava... |
7.2.5 UPC Opt-Out and Opt-In. On and after the License Option Exercise Closing Date, with respect to a Licensed Antibody or Licensed Product, AbbVie shall have the first right to make decisions regarding the Opt-Out or Opt-In under the Article 83(4) of the Agreement on a Unified Patent Court between the participating M... |
7.2.6 Patent Listings. With respect to each Licensed Product, on and after the License Option Exercise Closing Date, AbbVie will have the sole right to list Joint Patents and Licensor Patents with Regulatory Authorities or other agencies, including as required or allowed under Applicable Law. AbbVie shall notify Licens... |
7.3 Enforcement of Patents. |
7.3.1 Notice; Enforcement of Licensor Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Licensor Patents or Joint Patents by a Third Party in the Territory of which such Party becomes aware based on the Exploitation of, or an application to register or... |
7.3.2 Enforcement of Joint Patents. As between the Parties, AbbVie shall have the first right, but not the obligation, to prosecute any Patent infringement of Joint Patents in the Territory at its sole expense and AbbVie shall retain control of the prosecution and settlement of such claim, suit or proceeding. In the ev... |
7.3.3 Conduct of Biosimilar Patent Litigation Including Under the Biologics Price Competition and Innovation Act. Notwithstanding anything to the contrary in this Agreement, on and after the License Option Exercise Closing Date, AbbVie shall the first right, but not the obligation, to prosecute, manage and settle any l... |
7.3.4 Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 7.3. Where a Party brings such an action in accordance with this Agreement, the other Party, shall, where necessary, join in, or be named as a necessary party to, such action or furnish a power of attorney solely... |
7.3.5 Recovery. Any recovery realized as a result of such litigation described in Section 7.3.1, 7.3.2, or 7.3.4 (whether by way of settlement or otherwise) shall be first, allocated to reimburse the Parties for their costs and expenses in making such recovery (which amounts shall be allocated pro rata if insufficient ... |
7.4 Infringement Claims by Third Parties. If, following the License Option Exercise Closing Date, the manufacture, sale, or use of a Licensed Antibody or Licensed Product in the Territory pursuant to this Agreement by AbbVie (or its Affiliates or Sublicensees) results in, or may result in, any claim, suit, or proceedin... |
7.5 Invalidity or Unenforceability Defenses or Actions. |
7.5.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity, unpatentability or unenforceability of any of the Licensor Patents, or Joint Patents by a Third Party, in each case in the Territory and of which such Party becomes aware. |
7.5.2 Licensor Patents. |
(a) Subject to Section 7.5.2(b) and other terms and conditions of this Agreement, Licensor shall have the first right, but not the obligation, to defend and control the defence of the validity, patentability and enforceability of the Licensor Patents at its own expense in the Territory. AbbVie may participate in any su... |
(b) On and after the License Option Exercise Closing Date, AbbVie shall have the responsibility for and control over the defense of the validity, patentability and enforceability of Licensor Product Patents at AbbVie's sole cost and expense. Licensor may participate in any such claim, suit, or proceeding in the Territo... |
7.5.3 Joint Patents. |
(a) AbbVie shall have the first right, but not the obligation, to defend and control the defense of the validity, patentability and enforceability of the Joint Patents at its own expense in the Territory. Licensor may participate in any such claim, suit, or proceeding in the Territory related to the Joint Patents with ... |
7.5.4 Cooperation. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in this Section 7.5, including by being joined as a necessary party in such claim, suit or proceeding, providing access to relevant docum... |
7.5.5 Relationship to Enforcement of Patents. Notwithstanding anything herein to the contrary, the defense to any challenge of validity, enforceability or patentability of any of the Licensor Patents or Joint Patents that is raised in connection with or in response to an infringement action or a biosimilar litigation s... |
7.6 Product Trademarks. As between the Parties, AbbVie shall own all right, title, and interest to the Product Trademarks in the Territory, and shall be responsible for the registration, prosecution, maintenance and enforcement thereof. All costs and expenses of registering, prosecuting, maintaining and enforcing the P... |
7.7 International Nonproprietary Name. As between the Parties, AbbVie shall have the sole right and responsibility to select the International Nonproprietary Name or other name or identifier for any Licensed Antibody or Licensed Product. AbbVie shall have the sole right and responsibility to apply for submission to the... |
7.8 Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Party's inventors under any applicable inventor remuneration laws. |
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