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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... |
8.3.2. Enforcement of Cugene Patents Prior to the License Option Effective Date. The following provisions shall apply with respect to enforcement of the Cugene Patents prior to the License Option Effective Date: |
(a) Other Cugene Patents. Cugene shall have the sole right (except with respect to Mixed Cugene Patents, in which case Cugene shall have the first right), but not the obligation, to prosecute any Product Infringement with respect to Other Cugene Patents in the Territory, including as a defense or counterclaim in connec... |
If Cugene prosecutes any such Product Infringement, AbbVie shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense to the extent such claim, suit, or proceeding relates to Mixed Cugene Patents; provided that Cugene shall retain ... |
To the extent such claim, suit, or proceeding relates to Mixed Cugene Patents, Cugene shall: (a) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantive... |
If such Product Infringement relates to Mixed Cugene Patents and Cugene does not take commercially reasonable steps to prosecute such Product Infringement (i) within 90 days following the first notice provided above with respect to such Product Infringement, or (ii) provided such date occurs after the first such notice... |
(b) Product Patents. Cugene shall have the first right, but not the obligation, to prosecute any Product Infringement with respect to Product Patents in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and Cugene shall retain control of th... |
If Cugene prosecutes any such Product Infringement, AbbVie shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense; provided that Cugene shall retain control of the prosecution of such claim, suit, or proceeding. |
Cugene shall: (a) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantively comment thereon, (b) reasonably consider taking action to incorporate AbbVie... |
If Cugene does not take commercially reasonable steps to prosecute such Product Infringement (i) within 90 days following the first notice provided above with respect to such Product Infringement, or (ii) provided such date occurs after the first such notice of such Product Infringement is provided, ten Business Days b... |
8.3.3. Enforcement of Cugene Patents After the License Option Effective Date. The following provisions shall apply with respect to enforcement of the Cugene Patents on or after the License Option Effective Date: |
(a) Other Cugene Patents. Cugene shall have the sole right (except with respect to Mixed Cugene Patents, in which case Cugene shall have the first right), but not the obligation, to prosecute any Product Infringement with respect to Other Cugene Patents in the Territory, including as a defense or counterclaim in connec... |
If Cugene prosecutes any such Product Infringement, AbbVie shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense to the extent such claim, suit, or proceeding relates to Mixed Cugene Patents; provided that Cugene shall retain ... |
To the extent such claim, suit, or proceeding relates to Mixed Cugene Patents, Cugene shall: (a) provide AbbVie with drafts of all official papers and statements (whether written or oral) prior to their submission in such claim, suit, or proceeding, in sufficient time to allow AbbVie to review, consider and substantive... |
If such Product Infringement relates to Mixed Cugene Patents and Cugene does not take commercially reasonable steps to prosecute such Product Infringement (i) within 90 days following the first notice provided above with respect to such Product Infringement, or (ii) provided such date occurs after the first such notice... |
(b) Product Patents. AbbVie shall have the first right, but not the obligation, to prosecute any Product Infringement with respect to Product Patents in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense (except as may be otherwise agreed to ... |
If AbbVie prosecutes any such Product Infringement, Cugene shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense; provided that AbbVie shall retain control of the prosecution of such claim, suit, or proceeding. |
AbbVie shall: (a) keep Cugene reasonably informed regarding material developments in such claim, suit, or proceeding and (b) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. |
If AbbVie does not take commercially reasonable steps to prosecute a Product Infringement (i) within 90 days following the first notice provided above with respect to the Product Infringement, or (ii) provided such date occurs after the first such notice of the Product Infringement is provided, ten Business Days before... |
8.3.4. Enforcement of Joint Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the Joint Patents by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement based on the development, commercialization, o... |
After the License Option Effective Date, AbbVie shall have the first right, but not the obligation, to prosecute any such infringement in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and AbbVie shall retain control of the prosecution o... |
If AbbVie prosecutes any such infringement, Cugene shall have the right to join as a party to such claim, suit, or proceeding in the Territory and participate with its own counsel at its own expense; provided that AbbVie shall retain control of the prosecution of such claim, suit, or proceeding. |
AbbVie shall: (a) keep Cugene reasonably informed regarding material developments in such claim, suit, or proceeding and (b) not settle any such claim, suit, or proceeding except in a manner that it believes in good faith is in the best interests of the Licensed Therapeutics or Licensed Products. |
If AbbVie does not take commercially reasonable steps to prosecute the alleged or threatened infringement in the Territory with respect to such Joint Patents (a) within 90 days following the first notice provided above with respect to such alleged infringement, or (b) provided such date occurs after the first such noti... |
8.3.5. Enforcement of AbbVie Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement of the AbbVie Patents by a Third Party in the Territory of which such Party becomes aware (including alleged or threatened infringement based on the development, commercialization,... |
AbbVie shall have the sole right, but not the obligation, to prosecute any such infringement in the Territory, including as a defense or counterclaim in connection with any Third Party Infringement Claim, at its sole expense, and AbbVie shall retain control of the prosecution of the applicable claim, suit or proceeding... |
8.3.6. Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 8.3. If a Party brings such an action, the other Party shall, if necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary party to, such action. |
Unless otherwise set forth herein, the Party entitled to bring any patent infringement litigation in accordance with this Section 8.3 shall have the right to settle such claim; provided that neither Party shall have the right to settle any patent infringement litigation under this Section 8.3 in a manner that imposes a... |
The Party commencing the litigation shall provide the other Party with copies of all pleadings and other documents filed with the court and shall consider reasonable input from the other Party during the course of the proceedings. |
8.3.7. Patent Exclusivity Listings. If either Party receives a copy of an application submitted to the FDA under subsection (k) of Section 351 of the PHSA (a "Biosimilar Application") naming a Licensed Product as a reference product or otherwise becomes aware that such a Biosimilar Application has been filed (such as i... |
If either Party receives any equivalent or similar certification or notice in any other jurisdiction in the Territory, such Party shall, within ten Business Days, notify and provide the other Party with copies of such communication. |
Regardless of the Party that is the "reference product sponsor" for purposes of such Biosimilar Application, after the License Option Effective Date (a) AbbVie shall have the sole right to designate pursuant to Section 351(l)(1)(B)(ii) of the PHSA the outside counsel and in-house counsel who shall receive confidential ... |
If required pursuant to Applicable Law, Cugene shall prepare such lists and make such responses at AbbVie's direction. Cugene shall (i) provide to AbbVie, within 15 days of AbbVie's request, all Information in Cugene's control that is necessary or reasonably useful to enable AbbVie to make such lists and communications... |
AbbVie shall (A) reasonably consult with Cugene prior to identifying any Cugene Patents to a Third Party as contemplated by this Section 8.3.7 and shall consider in good faith Cugene's advice and suggestions with respect thereto, and (B) notify Cugene of any such lists or communications promptly after they are made. |
8.3.8. Conduct of Patent Litigation Under the Biologics Price Competition and Innovation Act. Notwithstanding anything to the contrary in Section 8.3, AbbVie shall have the first right to bring an action for infringement of the AbbVie Patents and Joint Patents and, after the License Option Effective Date, Cugene Patent... |
The Parties' rights and obligations with respect to the foregoing legal actions shall be as set forth in Section 8.3.2 through Section 8.3.5; provided that within 15 days of reaching agreement on a list of Patents for litigation under Section 351(l)(4) or exchange of Patent lists pursuant to Section 351(l)(5)(B), AbbVi... |
Either Party shall, within ten Business Days, notify and provide the other Party with copies of any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to Section 351(l)(8)(A) of the PHSA, or any equivalent or similar certification or notice in any other jurisdiction. |
Thereafter, the Party controlling any Patent infringement litigation pursuant to this Section 8.3.8 shall have the first right to seek an injunction against such commercial marketing as permitted pursuant to Section 351(l)(8)(B) of the PHSA. If no such litigation is ongoing at the time of such notice, then AbbVie shall... |
8.3.9. Recovery. Except as otherwise agreed by the Parties in connection with a cost sharing arrangement and except with respect to costs incurred by a Party that joins and participates in such litigation at its sole cost and expense as set forth in this Section 8.3, any recovery realized as a result of such litigation... |
Any remainder after such reimbursement is made shall be retained by the Party that has exercised its right to bring the enforcement action; provided that to the extent that any award or settlement (whether by judgment or otherwise) is attributable to loss of sales or profits with respect to a Licensed Product, the Part... |
8.4. Infringement Claims by Third Parties. |
8.4.1. If the manufacture, sale, or use of a Licensed Therapeutic or Licensed Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging patent infringement by AbbVie (or its Affiliates or Sublicensees) (a "Third Party Infringement Claim"),... |
8.4.2. Notwithstanding Section 11.3.2, following the License Option Effective Date, AbbVie shall have the first right, but not the obligation, to defend and control the defense and settlement of any Third Party Infringement Claim at its own expense (but subject to deduction as provided below), using counsel of its own ... |
Cugene may participate in any such Third Party Infringement Claim with counsel of its choice at its own expense. Without limitation of the foregoing, if AbbVie finds it necessary or desirable to join Cugene as a party to any such Third Party Infringement Claim, Cugene shall execute all papers and perform such acts as s... |
8.4.3. AbbVie shall keep Cugene reasonably informed of all material developments in connection with any Third Party Infringement Claim. AbbVie shall have the right to settle any Third Party Infringement Claim in its reasonable discretion; provided that AbbVie shall not have the right to settle any Third Party Infringem... |
If Cugene is named as a party in a Third Party Infringement Claim, (a) AbbVie agrees to provide Cugene with copies of all pleadings filed in the applicable action and to allow Cugene reasonable opportunity to participate in the defense of the Third Party Infringement Claim and (b) if AbbVie elects (in a written communi... |
8.4.4. AbbVie shall be entitled to deduct 50% of the out-of-pocket costs borne by AbbVie in defending or settling such Third Party Infringement Claim (including pursuant to any adverse judgment in connection therewith) from any royalties payable under Section 7.5.1 in accordance with and subject to the limitations set ... |
Any recoveries by a Party of any sanctions awarded to such Party and against a party asserting a claim being defended under this Section 8.4 shall be applied as follows: such recovery shall be applied first to (a) reimburse AbbVie for its out-of-pocket costs of defending such Third Party Infringement Claim to the exten... |
The balance of any such recoveries shall be retained by or provided to AbbVie and, to the extent that such recoveries are attributable to loss of sales or profits with respect to a Licensed Product, included in calculation of Net Sales for the relevant Licensed Product. |
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