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6.2. General Provisions Applicable to the JGC. |
6.2.1. Composition. The JGC shall consist of three representatives from each Party, each with the requisite experience and seniority to enable such representative to make decisions on behalf of the applicable Party with respect to the issues falling within the jurisdiction of the JGC. From time to time, each Party may ... |
6.2.2. Meetings and Minutes. The JGC shall meet monthly or as otherwise agreed to by the Parties until the initiation of the first Phase Ib Clinical Trial for a Licensed Product conducted in accordance with the Initial Development Plan and Budget. Thereafter, the JGC shall meet quarterly or as otherwise agreed to by th... |
6.2.3. Procedural Rules. The JGC shall have the right to adopt such standing rules as shall be necessary for its work, which shall be consistent with this Agreement. A quorum of the JGC shall exist whenever there is present at a meeting at least one representative appointed by each Party. Representatives of the Parties... |
6.2.4. Decision-Making. If the JGC cannot, or does not, reach consensus on an issue at a meeting or within a period of ten Business Days thereafter, or such other period as the Parties may agree, including any dispute arising in a Working Group, then the dispute shall first be referred to the Senior Officers of the Par... |
(a) Cugene shall have final decision-making authority with respect to conduct of activities performed pursuant to the Initial Development Plan and Budget, including termination of a Clinical Study due to a Safety Event; provided that (i) any conduct that would materially adversely affect the information AbbVie would re... |
(b) neither Party shall have final decision-making authority with respect to (i) approval of any amendment to IND, study protocol or other regulatory submission (excluding any administrative or scheduling communications or interactions) to be filed by Cugene pursuant to Section 2.3.2, (ii) approval of the GLP Toxicolog... |
(c) all such decisions must be consistent with the terms of this Agreement and Applicable Law; and |
(d) Disputes arising between the Parties in connection with or relating to this Agreement or any document or instrument delivered in connection herewith, and that are outside of the jurisdiction of the JGC or described in Section 6.1.2(k), shall be resolved pursuant to Section 13.5. For clarity, with respect to the mat... |
6.2.5. Limitations on Authority. Each Party shall retain the rights, powers, and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JGC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expre... |
6.2.6. Discontinuation; Disbandment. The JGC shall continue to exist until the first to occur of: (a) the Parties mutually agreeing to disband the JGC, (b) the License Option Effective Date (provided that, if Cugene is required to perform any Unfinished Initial Development Activities after the License Option Effective ... |
6.3. Working Groups. From time to time, the 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. Each such Working Group shall be constituted and shall operate as the JGC determines; provided that each... |
6.4. Alliance Managers. Each Party shall appoint an individual who shall oversee contact between the Parties for all matters between meetings of the JGC, shall be the primary contacts between the Parties after disbandment of the JGC, and shall have such other responsibilities as the Parties may agree in writing after t... |
ARTICLE 7 PAYMENTS AND RECORDS |
7.1. Upfront Payment. Subject to the terms and conditions of this Agreement, no later than 30 days after the Effective Date, AbbVie shall pay Cugene a non-refundable, non-creditable upfront amount equal to $48,500,000. |
7.2. License Option Exercise Payment. If AbbVie delivers Cugene an Exercise Notice pursuant to Section 3.2.1, AbbVie shall pay to Cugene a one-time non-refundable, non-creditable payment of $40,000,000 (the "License Option Exercise Payment") within 30 days after the License Option Effective Date. |
7.3. Development Milestone Events. Subject to the terms and conditions of this Agreement, with respect to each milestone event set forth in the table immediately below (each, a "Development Milestone Event"), AbbVie shall pay Cugene the corresponding non-refundable, non-creditable milestone payment set forth in such ta... |
Development Milestone Event |
1. Initiation of the first Phase Ib Clinical Trial for a Licensed Product containing CUG252, as set forth the Initial Development Plan and Budget for such Licensed Product following Successful Completion of the Phase Ia Clinical Trial |
1.1. Initiation of the first Phase II Clinical Trial sponsored by AbbVie or any of its Affiliates or Sublicensees for a Different Licensed Product |
2. Initiation of the first Registrational Trial sponsored by AbbVie or any of its Affiliates or Sublicensees for a Licensed Product |
3. Initiation of the first Registrational Trial sponsored by AbbVie or any of its Affiliates or Sublicensees for a Licensed Product for an Indication other than the Indication for the Registrational Trial that achieved Development Milestone Event #2 |
4. Acceptance of a BLA for a Licensed Product by the FDA |
5. First Commercial Sale of a Licensed Product in the United States |
6. First Commercial Sale of a Licensed Product in any Major European Market |
Except as follows, each Development Milestone Event in this Section 7.3 shall be payable once. If, after the First Commercial Sale of a Licensed Product that contains CUG252 in the United States, any Development Milestone Event (other than the Development Milestone Events #1 and #1.1) is achieved for the second time by... |
Development Milestone Events are determined as of the Initiation of a Clinical Study; provided that if a Clinical Study does not meet the criteria for a Phase Ib (or II, as applicable) Clinical Trial or Registrational Trial, as applicable, at the time such Clinical Study is Initiated, but is later modified based on int... |
7.4. Sales Milestone Events. Subject to the terms and conditions of this Agreement, with respect to each milestone event set forth set forth in the table immediately below (each, a "Sales Milestone Event"), AbbVie shall pay Cugene the corresponding non-refundable, non-creditable milestone payment set forth in such tabl... |
Sales Milestone Event |
1. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $500,000,000 |
2. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $1,000,000,000 |
3. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $2,000,000,000 |
4. The first Calendar Year in which aggregate Net Sales of such Licensed Product in the Territory exceed $3,000,000,000 |
Each Sales Milestone Payment in this Section 7.4 shall be payable only upon the first achievement of the applicable Sales Milestone Event and not for any other subsequent achievement by the same or another Licensed Product. For clarity, the Sales Milestone Payments shall be additive such that if multiple Sales Mileston... |
7.5. Royalties. |
7.5.1. Royalty Rates. Subject to Section 7.5.3 and Section 7.5.4, commencing on the beginning of the Royalty Term with respect to a Licensed Product in the Territory, on a Licensed Product-by-Licensed Product basis, AbbVie shall pay Cugene a non-refundable, non-creditable royalty on Net Sales of such Licensed Product i... |
Aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year |
For that portion of aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year that is less than $1,000,000,000 |
For that portion of aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year that is greater than or equal to $1,000,000,000 but less than $3,000,000,000 |
For that portion of aggregate Net Sales of such Licensed Product in the Territory in a Calendar Year that is equal to or greater than $3,000,000,000 |
7.5.2. Royalty Term. AbbVie's obligation to pay Cugene royalties with respect to a Licensed Product, on a Licensed Product-by-Licensed Product and country-by-country basis (or jurisdiction-by-jurisdiction basis), shall commence on the beginning of the Royalty Term with respect to such Licensed Product in such country o... |
7.5.3. Royalty Rate Reductions. Notwithstanding Section 7.5.1, but subject to Section 7.5.2 and Section 7.5.5, if: |
(a) from and after the date on which a Licensed Product is sold in a country or other jurisdiction in the Territory and is not Covered by a Royalty Claim in such country or other jurisdiction during the Royalty Term for such Licensed Product in such country or other jurisdiction, the royalty rate for such Licensed Prod... |
(b) if in any country or other jurisdiction in the Territory during the Royalty Term in such country or other jurisdiction for a Licensed Product a Biosimilar Product with respect to such Licensed Product is launched in such country or other jurisdiction, then, for so long as the Net Sales of such Licensed Product in s... |
7.5.4. Third Party Payments. Subject to Section 7.5.5(b), if (a) AbbVie enters into an agreement with a Third Party in order to obtain a license or right under a Patent or Information owned or controlled by such Third Party that, absent a license thereunder, would be infringed by the sale, use, or Manufacture of a Lice... |
7.5.5. Mechanics of Royalty Adjustments. |
(a) Any reductions set forth in Section 7.5.3 shall be applied to the royalty rates payable to Cugene under Section 7.5.1 in the order in which the event triggering such reduction occurs. For purposes of Section 7.5.3, the portion of Net Sales of the applicable Licensed Product in each country or other jurisdiction sub... |
(b) In no event shall the royalties payable to Cugene under Section 7.5.1, as applicable, for Net Sales of a particular Licensed Product in a country or jurisdiction in a Calendar Quarter be reduced by more than 50% of what would otherwise be payable for such Licensed Product in such country or jurisdiction in such Cal... |
7.6. Estimated Sales Levels. Cugene acknowledges and agrees that the sales levels set forth in Section 7.4 and Section 7.5.1 shall not be construed as representing an estimate or projection of anticipated sales of the Licensed Products, or implying any level of diligence or Commercially Reasonable Efforts, in the Terri... |
7.7. Royalty Payments and Reports. AbbVie shall calculate all amounts payable to Cugene pursuant to Section 7.5 at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 7.8. AbbVie shall pay to Cugene the royalty amounts due with respect to a given Calendar Quarter wi... |
7.8. 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 payee Party may from time to time designate by notice to the payor Party. For the purpose of calculating any amounts due under, or otherwise reimbursable pursua... |
7.9. Taxes. |
7.9.1. Income Taxes. Each Party shall be solely responsible for the payment of all taxes imposed on its share of income arising directly or indirectly from the activities of the Parties under this Agreement. |
7.9.2. Withholding Taxes. If 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 to... |
7.9.3. Indirect Taxes. All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the "Indirect Taxes") which shall be borne by the paying Party. If any Indirect Taxes are chargeable in respect of any payments, the paying Party shall pay such Indirect Taxes at the applicabl... |
7.9.4. Taxes Resulting from a Paying Party's Action. Notwithstanding anything to the contrary, if, following the Effective Date of this Agreement, the payee Party (a) changes the Person making payments, (b) re-domiciles to a jurisdiction other than the jurisdiction of such Party's domicile as of the Effective Date, or ... |
7.10. Interest on Late Payments. If any payment due to either Party under this Agreement is not paid when due, then the payor Party shall pay interest thereon (before and after any judgment) at an annual rate (but with interest accruing on a daily basis) of 100 basis points above SOFR, such interest to run from the dat... |
7.11. Financial Records. AbbVie shall, and shall cause its Affiliates and its and their Sublicensees to, keep complete and accurate financial books and records pertaining to Net Sales to the extent required to calculate and verify all amounts payable hereunder. AbbVie shall, and shall cause its Affiliates and its and t... |
7.12. Audit. |
7.12.1. Procedures. At the request of Cugene, AbbVie shall, and shall cause its Affiliates and its and their Sublicensees to, permit an independent auditor designated by Cugene and reasonably acceptable to AbbVie, at reasonable times and upon reasonable notice, to audit the books and records maintained pursuant to Sect... |
7.12.2. Audit Dispute. If there is a dispute with respect to any audit under Section 7.12, Cugene and AbbVie shall work in good faith to resolve the dispute. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within 30 days after one Party notifies the other Party of such dispute, t... |
7.12.3. Confidentiality. Cugene shall treat all information subject to review under this ARTICLE 7 in accordance with the confidentiality provisions of ARTICLE 9. AbbVie shall not be obligated to provide any information to the independent auditor pursuant to Section 7.12.1 or the Auditor pursuant to Section 7.12.2, unt... |
7.13. Right to Offset. Each Party shall have the right to offset any amount owed by the other Party to such first Party under or in connection with this Agreement against any payments owed by such first Party to such other Party under this Agreement. Such offsets shall be in addition to any other rights or remedies ava... |
7.14. Diagnostic and Veterinary Products. The milestones and royalties in this ARTICLE 7 shall not apply to the Development and Commercialization of Licensed Products for diagnostic, veterinary or any other non-human use or for uses solely for screening patients who have been diagnosed with a disease, state or conditio... |
7.15. No Other Compensation. Neither Party previously has paid or entered into any other commitment to pay, whether orally or in writing, any of the other Party's employees, directly or indirectly, any consideration, compensation, or benefits, monetary or otherwise, in connection with the transaction contemplated herei... |
7.16. No Limitation. Nothing contained in this ARTICLE 7 shall in any way limit AbbVie's or Cugene's right to indemnification under this Agreement or to otherwise recover damages for breach of this Agreement. |
7.17. Financial Obligations Under WuXi Agreements. All financial obligations, including royalties, due from Cugene to Third Parties for or in respect of a Licensed Therapeutic or a Licensed Product arising under the WuXi Agreement or any Included In-License Agreement are the responsibility of Cugene. |
ARTICLE 8 INTELLECTUAL PROPERTY |
8.1. Ownership of Intellectual Property. |
8.1.1. Ownership of IP. Subject to the license grants and other rights herein as between the Parties, 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 Affil... |
8.1.2. Ownership of Joint IP. As between the Parties, each Party shall each own an equal, undivided interest in any and all: (a) (i) Information and inventions that are conceived, discovered, developed or otherwise made under or in connection with this Agreement or the MTA jointly by or on behalf of Cugene or its Affil... |
8.1.3. United States Law. The determination of whether Information and inventions are conceived, discovered, developed or otherwise made by or on behalf of a Party for the purpose of allocating proprietary rights (including Patent, copyright, or other intellectual property rights) therein, shall, for purposes of this A... |
8.1.4. Assignment Obligation. Each Party shall cause all Persons who perform Development activities, Manufacturing activities or regulatory activities for such Party under this Agreement to be under an obligation to assign (or, if such Party is unable to cause such Person to agree to such assignment obligation despite ... |
8.1.5. Control of Intellectual Property. Neither Party shall, and each Party shall cause its Affiliates not to, enter into or amend any agreement with a Third Party, or include in any such agreement or amendment any restrictive provisions, with an intent to limit its Control of, or to not Control, any Information, inve... |
8.2. Prosecution and Maintenance of Patents. |
8.2.1. Cugene Patents Prior to the License Option Effective Date. The following provisions shall apply with respect to Cugene Patent prosecution and maintenance prior to the License Option Effective Date: |
(a) Other Cugene Patents. Cugene shall have the sole right, except with respect to any Mixed Cugene Patents in which case Cugene shall have the first right, but, in each case, but not the obligation, through the use of outside counsel reasonably acceptable to AbbVie, to prepare, file, prosecute, and maintain the Other ... |
(b) Product Patents. In consultation with AbbVie, Cugene shall have the first right, but not the obligation, through the use of outside counsel reasonably acceptable to AbbVie, to prepare, file, prosecute, and maintain the Product Patents worldwide and to conduct any Defense Proceeding relating thereto (except that in ... |
(c) Cugene shall keep AbbVie fully informed of all material steps with regard to the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding relating to, the Product Patents or Mixed Cugene Patents, including by providing AbbVie with a copy of material filings and communications to and from any... |
8.2.2. Cugene Patents After the License Option Effective Date. The following provisions shall apply with respect to Cugene Patent prosecution and maintenance after the License Option Effective Date: |
(a) Other Cugene Patents. Cugene shall have the sole right, except with respect to any Mixed Cugene Patents in which case Cugene shall have the first right, but, in each case, not the obligation, through the use of outside counsel reasonably acceptable to AbbVie, to prepare, file, prosecute, and maintain the Other Cuge... |
(b) Product Patents. AbbVie shall have the first right, but not the obligation, through the use of internal or outside counsel reasonably acceptable to Cugene, to prepare, file, prosecute, and maintain the Product Patents worldwide and to conduct any Defense Proceeding relating thereto (except that in connection with a... |
(c) The Party with the first right to prosecute and maintain a Cugene Patent (or claims thereof), and to conduct any Defense Proceeding relating thereto, shall keep the other Party fully informed of all material steps with regard to the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding re... |
8.2.3. AbbVie Patents and Joint Patents. AbbVie shall have (a) the first right, but not the obligation, through the use of internal or outside counsel reasonably acceptable to Cugene, to prepare, file, prosecute, and maintain the Joint Patents, and to conduct any Defense Proceeding relating thereto (except that in conn... |
AbbVie shall keep Cugene reasonably informed of all steps with regard to the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding relating to, Joint Patents, including by providing Cugene with a copy of material filings and communications to and from any patent authority in the United States... |
If AbbVie decides not to prepare, file, prosecute, or maintain, or not to initiate or continue any Defense Proceeding relating to, a Joint Patent in a country or other jurisdiction in the Territory, AbbVie shall provide reasonable prior written notice to Cugene of such intention (which notice shall, in any event, be gi... |
AbbVie's consent shall not be deemed unreasonably withheld, conditioned, or delayed if either (i) AbbVie decides not to file a continuing, divisional or child Joint Patent application when the parent Patent application is pending or has been granted or (ii) AbbVie decides not to prepare, file, prosecute or maintain suc... |
8.2.4. Cooperation. The Parties agree to cooperate fully in the preparation, filing, prosecution, and maintenance of, and any Defense Proceeding relating to, the Product Patents, Mixed Cugene Patents, Joint Patents and, at the request of AbbVie, the AbbVie Patents in the Territory under this Agreement. Cooperation shal... |
(a) 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 Section 8.1.1 and Section 8.1.2; (ii) enable the other Party to apply for and to prosecute Patent applications in the Te... |
(b) consistent with this Agreement, assisting in any license 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 |
(c) promptly informing the other Party of any matters coming to such Party's attention that may materially affect the preparation, filing, prosecution, or maintenance of, or any Defense Proceeding relating to, any such Patents in the Territory. |
8.2.5. Patent Term Extension and Supplementary Protection Certificate. After the License Option Effective Date, AbbVie shall be responsible for making decisions regarding patent term extensions, including supplementary protection certificates and any other extensions that are now or become available in the future, wher... |
AbbVie shall have the responsibility for applying for any extension or supplementary protection certificate with respect to such Patents in the Territory. AbbVie shall keep Cugene fully informed of its efforts to obtain such extension or supplementary protection certificate. Cugene shall, at AbbVie's cost, provide prom... |
8.2.6. CREATE Act. Notwithstanding anything to the contrary in this ARTICLE 8, neither Party shall have the right to make an election under the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. 103(c)(2)-(c)(3) (the "CREATE Act") when exercising its rights under this ARTICLE 8 without the prior wri... |
8.2.7. Patent Listings. After the License Option Effective Date, AbbVie shall have the sole right to make all filings with Regulatory Authorities in the Territory with respect to Mixed Cugene Patents, Product Patents, AbbVie Patents, and Joint Patents, and to the extent required by Applicable Law, any other Other Cugen... |
Cugene shall (a) provide to AbbVie all Information in Cugene's control that is necessary or reasonably useful to enable AbbVie to make such filings with Regulatory Authorities in the Territory with respect to such Patents, including a correct and complete list of Cugene Patents Covering any Licensed Product, and (b) co... |
8.2.8. UPC Opt-Out and Opt-In. AbbVie shall have the sole right to make any decision regarding whether or not to elect Opt-Out or Opt-In with respect to any Mixed Cugene Patent, Product Patent and Joint Patent; provided that AbbVie shall consider in good faith Cugene's comments with respect thereto. |
8.2.9. Notice of Assignments. Cugene shall promptly notify AbbVie of any assignment (including to its Affiliates) of any Cugene Patent. |
8.3. Enforcement of Patents. |
8.3.1. Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Product Patents or Mixed Cugene Patents, in each case, by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement (x) of any Mixed Cugene Pat... |
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