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(a) Exclusivity Expiration. If, and in such case from and after the date on which, a Licensed Product is Exploited in a country or other jurisdiction but there is no Valid Claim that in such country or other jurisdiction, of a HotSpot Patent (or any Joint Patent, if applicable) that claims the composition of matter of ... |
(b) Stacking for Patents. If (1) AbbVie enters into an agreement with a Third Party in order to obtain a license or other right under a Patent or Information Controlled by such Third Party to such Third Party's (i) Patents that are necessary or reasonably useful to Exploit any Licensed Compound or Licensed Product, or ... |
(c) Stacking for Information. If (1) AbbVie enters into an agreement with a Third Party in order to obtain a license or right under Information Controlled by such Third Party that is necessary to Exploit any Licensed Compound or Licensed Product or necessary to expedite the Development of any Licensed Compound or Licen... |
(d) Generic Competition. If in any country or other jurisdiction in the Territory during the Royalty Term for a Licensed Product there is Generic Competition in such country or other jurisdiction, then for each such country or other jurisdiction, the royalties payable to HotSpot for the Net Sales of such Licensed Produ... |
(e) Compulsory Licensing. If AbbVie grants a Compulsory Sublicense, then, for the purposes of calculating the royalties payable with respect to such Licensed Product under Section 7.6.1 (Royalty Rates), fifty percent (50%) of Net Sales of such Licensed Product in such country or other jurisdiction shall be disregarded. |
(f) Inflation Reduction Act Deductions. If, 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 a maximum fair price that will apply to sales of such Licensed Prod... |
(g) Other Deductions. AbbVie shall have the right to deduct costs and expenses from any royalty under Section 7.6.1 (Royalty Rates) in accordance with Section 5.3.6 (HotSpot Cost-Sharing Option), Section 8.5.1 (Prior to License Option Effective Date), and Section 8.5.2 (After License Option Effective Date). |
(h) Ceiling on Deductions. In no event shall the reductions taken under this Section 7.6.3 (Royalty Reductions) reduce the royalties payable to HotSpot on any Licensed Products in any Calendar Quarter by greater than fifty percent (50%) of the amounts otherwise payable under Section 7.6.1 (Royalty Rates) (without reduc... |
7.6.4. Compulsory or Settlement Sublicensee Royalties. As further consideration for the rights granted to AbbVie hereunder and notwithstanding anything herein to the contrary, during the Royalty Term, AbbVie shall pay to HotSpot fifty percent (50%) of the royalties received by AbbVie from a Compulsory Sublicensee or a ... |
7.7. Royalty Payments and Reports. AbbVie shall calculate all amounts payable to HotSpot pursuant to Section 7.6 (Royalties) at the end of each Calendar Quarter, which amounts shall be converted to Dollars in accordance with Section 7.12 (Mode of Payment; Offsets). Subject to Section 5.3.6 (HotSpot Cost-Sharing Option)... |
7.8. FTE Costs. AbbVie and HotSpot shall record and account for its FTE hours with respect to each Licensed Compound and Licensed Product to the extent that such FTE hours are (a) Shared Development Costs of AbbVie that are, or may be in the future, Shared Development Costs, or (b) FTE Costs of HotSpot for which AbbVie... |
7.9. Supplemental Development Payments. If (a) the Parties mutually agree to amend the Development Plan and Budget in accordance with Section 3.5.4 (Information Reports and Final Data Package) to include a first Phase Ib Study or a first Phase II Study of the first Licensed Product in the first Indication, (b) AbbVie p... |
7.10. Other Invoiced Amounts. If either Party (the "Invoicing Party") is owed amounts by the other Party (the "Invoiced Party") pursuant to this Agreement, other than pursuant to Section 7.8 (FTE Costs), including reimbursable amounts pursuant to Section 5.5 (Manufacturing Supplies Transfer) and amounts reimbursable or... |
7.11. 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 the Interest Rate. |
7.12. 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 reimbur... |
7.13. 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 ... |
7.14. 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 at the applicable rate in respect of such payments followi... |
7.15. Financial Records. Each Party shall, and shall cause its Affiliates to, keep complete and accurate books and records pertaining to reimbursable Shared Development Costs and Net Sales of Licensed Products, including books and records of actual expenditures with respect to the budgets set forth in the Development P... |
7.16. Audit. At the request of either Party, the other Party shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognized standing designated by the auditing Party and reasonably acceptable to the audited Party, at reasonable times during normal business hours and upon... |
7.17. Audit Dispute. In the event of a dispute with respect to any audit under Section 7.16 (Audit), HotSpot 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 fo... |
7.18. Confidentiality. The receiving Party shall treat all information subject to review under this Article 7 (Payments and Records) in accordance with the confidentiality provisions of Article 9 (Confidentiality and Non-Disclosure) and the Parties shall cause the Audit Arbitrator to enter into a reasonably acceptable ... |
7.19. 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 ... |
7.20. No Limitation. Nothing contained in this Article 7 (Payments and Records) shall in any way limit AbbVie's right to indemnification under this Agreement or to otherwise recover damages for breach of this Agreement. |
7.21. No Refunds. Except as expressly provided in this Agreement and, for clarity, subject to Section 7.12 (Mode of Payment; Offsets), Section 7.20 (No Limitation) and Article 11 (Indemnity), all payments from AbbVie to HotSpot under this Agreement will be non-refundable and non-creditable (in each case, absent manifes... |
ARTICLE 8 INTELLECTUAL PROPERTY |
8.1. Ownership of Intellectual Property. |
8.1.1. Ownership of Technology. Subject to the license grants and other rights herein, as between the Parties, (a) AbbVie or its Affiliates shall own and retain all right, title, and interest in and to any and all (i) AbbVie Know-How and AbbVie Patents, and (ii) other Information, inventions, Patents, and other intelle... |
8.1.2. Ownership of Joint Patents and Joint Know-How. As between the Parties, the Parties shall each own an equal, undivided interest in the Joint Patents and the Joint Know-How (collectively, the "Joint IP"). Each Party shall promptly disclose to the other Party in writing, and shall cause its Affiliates, licensees an... |
8.1.3. United States Law. The determination of whether Information and inventions are conceived, reduced to practice, 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, f... |
8.1.4. Assignment Obligation. 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 to negotiate such assignment, be under an obligation to assign; and... |
8.1.5. Control of Intellectual Property. Neither Party shall 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 Compound, Product, Information, invention, Patent, or other intellec... |
8.1.6. Ownership of Corporate Names. As between the Parties, HotSpot shall retain all right, title and interest in and to its Corporate Names. |
8.2. HotSpot Screening Obligation. During the period commencing on the Effective Date and ending five (5) years after the Completion of Stage 4 Activities under and in accordance with the Development Plan and Budget, prior to filing any application for any Patent in any jurisdiction disclosing compounds that antagonize... |
8.3. Maintenance and Prosecution of Patents. |
8.3.1. Patent Roadmap. Notwithstanding anything to the contrary in this Section 8.3 (Maintenance and Prosecution of Patents), prior to the License Option Effective Date, the Parties shall file and submit Patent applications disclosing any Compound or Product in accordance with the terms of this Agreement and the patent... |
8.3.2. Prosecution and Maintenance of Patents Prior to License Option Effective Date. The following provisions shall apply with respect to Patent prosecution and maintenance prior to the License Option Effective Date: |
(a) Prosecution and Maintenance of HotSpot Patents. Subject to Section 8.3.2(c) (Prosecution and Maintenance of HotSpot Platform Patents and HotSpot Product Patents), HotSpot shall have the sole right, but not the obligation, through the use of internal or outside counsel, to prepare, file, prosecute, defend in any opp... |
(b) Prosecution and Maintenance of AbbVie Patents and Joint Patents. AbbVie shall have the sole right, but not the obligation, to prepare, file, prosecute, defend in any oppositions or post-grant proceedings, and maintain the AbbVie Patents, and the first right, but not the obligation, to prepare, file, prosecute, defe... |
(c) Patent Prosecution and Maintenance of HotSpot Platform Patents and HotSpot Product Patents. HotSpot shall have the sole right, but not the obligation, to prepare, file, prosecute, defend in any oppositions or post-grant proceedings, and maintain (i) any HotSpot Patent that claims an aspect of HotSpot Platform Techn... |
8.3.3. Prosecution and Maintenance of Patents on or After License Option Effective Date. The following provisions shall apply with respect to Patent prosecution and maintenance on and after the License Option Effective Date: |
(a) Prosecution and Maintenance of Licensed Product Patents, AbbVie Patents and Joint Patents. AbbVie shall have the sole right, but not the obligation, to prepare, file, prosecute, defend in any oppositions or post-grant proceedings, and maintain the Licensed Product Patents, AbbVie Patents, and Joint Patents worldwid... |
(b) Prosecution and Maintenance of HotSpot Platform Patents and HotSpot Product Patents. HotSpot shall have the sole right, but not the obligation, through the use of internal or outside counsel, to prepare, file, prosecute, defend in any oppositions or post-grant proceedings, and maintain any HotSpot Platform Patents ... |
8.3.4. Prosecution and Maintenance of Overlap Patents. The Parties shall use Commercially Reasonable Efforts and mutually agreed outside patent counsel during the Term to minimize the existence of HotSpot Patents or Joint Patents that disclose both (i) Compounds or Products and (ii) HotSpot Compounds or Products ("Over... |
8.3.5. Prosecution of Patents Claiming Overlap Compounds. Until the fifth (5th) anniversary of the Completion of Stage 4 Activities under the Development Plan and Budget, prior to filing any application for any Patent in any jurisdiction disclosing any Overlap Compound, HotSpot will notify AbbVie through its patent cou... |
8.3.6. Cooperation. The Parties agree to cooperate fully in the preparation, filing, prosecution, defense in oppositions or post-grant proceedings, and maintenance of the Licensed Product Patents and the Overlap Patents in the Territory under this Agreement. Cooperation shall include: |
(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 Sections 8.1.1 (Ownership of Technology) and 8.1.2 (Ownership of Joint Patents and Joint Know-How); (ii) enable the othe... |
(b) 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; |
(c) 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; and |
(d) without limiting Section 8.3.6(a) (Cooperation), within thirty (30) days of transfer of a Party's responsibility for preparation, filing, prosecution, defense and maintenance of a Patent as provided for upon the License Option Effective Date pursuant to Section 8.3.3 (Prosecution and Maintenance of Patents on or Af... |
8.3.7. Patent Term Extension and Supplementary Protection Certificate. With respect to any Licensed Compound or Licensed Product, AbbVie shall have the sole right to make decisions regarding patent term extensions, including supplementary protection certificates, pediatric exclusivity, and any other extensions that are... |
8.3.8. UPC Opt-Out and Opt-In. On and after the License Option Effective Date with respect to any Licensed Compound or Licensed Product, AbbVie shall have the sole 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 Member ... |
8.3.9. Patent Listings. On and after the License Option Effective Date with respect to any Licensed Compound or Licensed Product, AbbVie shall have the sole right to make all filings with Regulatory Authorities in the Territory with respect to Licensed Product Patents, including as required or allowed in (a) the United... |
8.4. Enforcement of IP. |
8.4.1. Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement or misappropriation of the HotSpot Patents, HotSpot Know-How, or Joint IP by a Third Party in the Territory of which such Party becomes aware based on the Exploitation of, or an application to register o... |
8.4.2. Prior to License Option Effective Date. Prior to the License Option Effective Date, HotSpot (including its designated Affiliates) shall have the first right, but not the obligation, to prosecute any Product Infringement in the Territory in a manner that would not adversely affect the Licensed Product Patents at ... |
8.4.3. After License Option Effective Date. On and after the License Option Effective Date, AbbVie (including its designated Affiliates) shall have the sole right, but not the obligation, to prosecute any Product Infringement in the Territory at its sole expense and AbbVie shall retain control of the prosecution of suc... |
8.4.4. HotSpot Platform Patents and HotSpot Product Patents. HotSpot shall have the sole right, but not the obligation, to prosecute any alleged or threatened infringement or misappropriation of HotSpot Platform Patents and HotSpot Product Patents (or any other infringement or misappropriation of HotSpot Patents and Ho... |
8.4.5. AbbVie Patents. AbbVie shall have the sole right, but not the obligation, to prosecute any alleged or threatened infringement or misappropriation of AbbVie Patents and AbbVie Know-How in the Territory at its sole expense and AbbVie shall retain control of the prosecution and settlement of such claim, suit or pro... |
8.4.6. Overlap Patents. If the mutually agreed outside patent counsel is unable to divide claims of any Overlap Patents such that they become either Licensed Product Patents or HotSpot Product Patents, then such counsel shall be responsible for controlling the prosecution of any alleged or threatened infringement of su... |
8.4.7. Generic Competition. Notwithstanding anything to the contrary in this Agreement, AbbVie shall have the sole right, but not the obligation, to prosecute, manage and settle any litigation with respect to Generic Products or any application seeking the approval, license, registration or authorization of any Regulat... |
8.4.8. Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 8.4 (Enforcement of IP) (including any proceedings or litigation with respect to Generic Products or any application seeking the approval, license, registration, or authorization of any Regulatory Authority ther... |
8.4.9. Recovery. Except as otherwise agreed by the Parties, any recovery realized as a result of such litigation described in Section 8.4.2 (Prior to License Option Effective Date), Section 8.4.3 (After License Option Effective Date), Section 8.4.6 (Overlap Patents), and Section 8.4.7 (Generic Competition) (whether by ... |
8.5. Infringement Claims by Third Parties. |
8.5.1. Prior to License Option Effective Date. |
(a) Prior to the License Option Effective Date, if the Exploitation of a Compound or 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 either Party (or its Affiliates or Sublicensees) (a "Third-Party Infringe... |
(b) Subject to Article 11 (Indemnity), HotSpot shall have the first right, but not the obligation, to defend and control the defense of any Third-Party Infringement Claim in a manner that would not adversely affect the Licensed Product Patents and at its own expense (but subject to deduction as provided below) using co... |
(c) Each Party shall keep the other Party reasonably informed of all material developments in connection with any Third-Party Infringement Claim. AbbVie shall be entitled to deduct the reasonable Out-of-Pocket Costs borne by AbbVie of defending such Third-Party Infringement Claim (including pursuant to any adverse judg... |
8.5.2. After License Option Effective Date. |
(a) Following the License Option Effective Date, if the Exploitation of a Licensed Compound or Licensed Product in the Territory pursuant to this Agreement results in, or may result in, a Third-Party Infringement Claim alleging patent infringement by AbbVie (or its Affiliates or Sublicensees), including any defense or ... |
(b) Subject to Article 11 (Indemnity), AbbVie shall have the first right, but not the obligation, to defend and control the defense of any Third-Party Infringement Claim at its own expense (but subject to deduction as provided below) using counsel of its own choice. HotSpot may participate in any such Third-Party Infri... |
(c) AbbVie shall keep HotSpot reasonably informed of all material developments in connection with any Third-Party Infringement Claim. AbbVie shall be entitled to treat any of the reasonable Out-of-Pocket Costs borne by AbbVie of defending such Third-Party Infringement Claim (including pursuant to any adverse judgment i... |
8.6. Invalidity or Unenforceability Defenses or Actions. |
8.6.1. 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 Licensed Product Patents by a Third Party, in each case in the Territory, of which such Party becomes aware. |
8.6.2. HotSpot Patents prior to License Option Effective Date. Subject to the other terms and conditions of this Agreement, prior to the License Option Effective Date, HotSpot shall have the first right, but not the obligation, to defend and control the defense of the validity, patentability, and enforceability of the ... |
8.6.3. AbbVie Patents prior to License Option Effective Date. Subject to the other terms and conditions of this Agreement, prior to the License Option Effective Date, AbbVie shall have the sole right, but not the obligation, to defend and control the defense of the validity, patentability, and enforceability of the Abb... |
8.6.4. Joint Patents prior to License Option Effective Date. Prior to the License Option Effective Date, 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. HotSpot may ... |
8.6.5. Licensed Product Patents, AbbVie Patents, and Joint Patents on or After License Option Effective Date. Subject to the other terms and conditions of this Agreement, on and after the License Option Effective Date, AbbVie shall have the sole right, but not the obligation, to defend and control the defense of the va... |
8.6.6. Overlap Patents. If the mutually agreed outside patent counsel is unable to divide claims of any Overlap Patents such that they become either Licensed Product Patents or HotSpot Product Patents, then such counsel shall be responsible for controlling the defense of the validity, patentability, and enforceability ... |
8.6.7. 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 8.6 (Invalidity or Unenforceability Defenses or Actions), including by being joined as a party plaintiff in the applicab... |
8.6.8. Costs and Expenses. |
(a) Each Party shall bear its own costs and expenses of defending any claim, suit, or proceeding under this Section 8.6 (Invalidity or Unenforceability Defenses or Actions) in respect of Joint Patents. |
(b) AbbVie shall be entitled to deduct twenty percent (20%) of the reasonable Out-of-Pocket Costs of defending any claim, suit, or proceeding under this Section 8.6 (Invalidity or Unenforceability Defenses or Actions) in respect of HotSpot Patents, or thirty percent (30%) of such Out-of-Pocket Costs if HotSpot has exer... |
(c) Notwithstanding anything to the contrary herein, HotSpot shall solely bear all costs and expenses incurred in the defense of any claim, suit, or proceeding under this Section 8.6 (Invalidity or Unenforceability Defenses or Actions) arising from or occurring as a result of HotSpot's inequitable conduct and AbbVie sh... |
8.7. Product Trademarks. |
8.7.1. Ownership and Prosecution of Product Trademarks. AbbVie or its Affiliates shall own all rights, title, and interests to the Product Trademarks in the Territory, and shall have the sole right, but not the obligation, to conduct the registration, prosecution, and maintenance thereof. AbbVie shall have the sole rig... |
8.7.2. Enforcement of Product Trademarks. AbbVie or its Affiliates shall have the sole right, but not the obligation, to take such action as AbbVie, after consultation with HotSpot, deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other viola... |
8.7.3. Third-Party Claims. AbbVie or its Affiliates shall have the sole right, but not the obligation, to defend against and settle any alleged, threatened, or actual claim by a Third Party that the use or registration of the Product Trademarks in the Territory infringes, dilutes, misappropriates, or otherwise violates... |
8.7.4. Notice and Cooperation. HotSpot shall provide to AbbVie prompt written notice of any actual or threatened infringement of the Product Trademarks in the Territory of which HotSpot becomes aware and of any actual or threatened claim that the use of the Product Trademarks in the Territory violates the rights of any... |
8.8. Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due to such Party's employees or agents that are inventors under any applicable inventor remuneration laws. |
8.9. Common Interest. All information exchanged between the Parties regarding the prosecution, maintenance, enforcement, validity, enforceability, and defense of Patents under this Article 8 (Intellectual Property) shall be deemed to be Confidential Information of the disclosing Party. In addition, the Parties acknowle... |
ARTICLE 9 CONFIDENTIALITY AND NON-DISCLOSURE |
9.1. Product Information. HotSpot recognizes that by reason of, inter alia, AbbVie's status as an exclusive licensee pursuant to the grants under Section 6.3 (Grants to AbbVie on the License Option Effective Date), AbbVie has an interest in HotSpot's maintaining the confidentiality of certain Information of HotSpot. Ac... |
9.2. Confidentiality Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration hereof in its entirety, each Party shall, and shall cause its officers, directors, employees and agents to, keep confidential and not publish or otherwise disclose to a Third Party and n... |
9.2.1. has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault, or negligence on the part of the receiving Party; |
9.2.2. has been in the receiving Party's possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; |
9.2.3. is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
9.2.4. that is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or |
9.2.5. has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party's Confidential Information. |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combin... |
9.3. Permitted Disclosures. Each Party may disclose Confidential Information, or, in the case of HotSpot, Product Information, to the extent that such disclosure is: |
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