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4.6 In-License Agreements. On a Target Program Slot-by-Target Program Slot basis, if at any time during the applicable In-License Agreement Notification Period Anima or any of its Affiliates enters into an agreement with a Third Party pursuant to which Anima or its Affiliate in-licenses or otherwise acquires rights tha... |
4.7 Rights in Bankruptcy. |
4.7.1 Section 365(n) of the Bankruptcy Code. All rights and licenses granted under or pursuant to this Agreement by Anima to AbbVie, including those set forth in Section 4.1 (Licenses to AbbVie) (collectively, the "Bankruptcy Code Intellectual Property") are and shall otherwise be deemed to be, for purposes of Section ... |
4.7.2 Rights of Non-Debtor Party in Bankruptcy. If a bankruptcy proceeding is commenced by or against Anima under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, then AbbVie shall be entitled to a complete duplicate of (or complete access to, as appropriate) any Bankruptcy Cod... |
ARTICLE 5 POST-LICENSE OPTION EXERCISE ACTIVITIES |
5.1 Anima Transition Obligation Upon License Option Exercise. On a Target Program Slot-by-Target Program Slot basis, upon AbbVie's request following the exercise of a License Option by AbbVie with respect to a Target Program Slot, without additional consideration to Anima: |
5.1.1 within thirty (30) days after the applicable License Option Effective Date, Anima shall transfer to AbbVie: (a) copies of all data, reports, records, materials, and other information within the Licensed IP and (b) the file wrappers and other documents and materials relating to the prosecution, defense, maintenanc... |
5.1.2 without limiting Section 5.1.1(b), Anima shall assist and cooperate with AbbVie, as AbbVie may reasonably request, in the transition of the prosecution, maintenance, enforcement, and defense of the applicable Anima Collaboration Patents; and |
5.1.3 Anima shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall do and cause to be done such acts and things, including the filing of such assignments, agreements, documents, and instruments, as may be necessary under or as AbbVie may reasonably request in connection wi... |
5.2 AbbVie Development and Commercialization. On a Target Program Slot-by-Target Program Slot basis, following the applicable License Option Effective Date with respect to such Target Program Slot, other than any remaining activities allocated to Anima under the applicable Collaboration Plan or any applicable Post-Lice... |
5.3 AbbVie Diligence Obligation. Following initiation of IND-Enabling Studies for the first Royalty-Bearing Product under this Agreement, AbbVie shall use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for such first Royalty-Bearing Product in the Field in the United States and three (3) Majo... |
ARTICLE 6 GENERAL PROVISIONS RELATING TO ACTIVITIES |
6.1 Compliance. All activities to be conducted by a Party under this Agreement shall be conducted in compliance with applicable Laws, including all applicable good laboratory practice requirements and good clinical practice requirements. |
6.2 Regulatory Activities. |
6.2.1 From and after the exercise by AbbVie of a License Option, AbbVie shall, as between the Parties, have the sole right to prepare, obtain, and maintain all INDs, Regulatory Approval Applications (including the setting of the overall regulatory strategy therefor), other Regulatory Approvals, and other submissions fo... |
6.2.2 From and after the exercise by AbbVie of a License Option, all Regulatory Filings (including all Regulatory Approvals) in the Territory relating to the applicable Royalty-Bearing Products shall be owned by, and shall be the sole property and held in the name of, AbbVie or its designated Affiliate, Sublicensee, or... |
6.3 Performance by Affiliates and Sublicensees. Notwithstanding any provision to the contrary set forth in this Agreement, AbbVie shall have the right to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any Affiliate or Sublicensee (subject to Section 4.2 (Sublice... |
6.4 Subcontracting. |
6.4.1 AbbVie shall have the right to engage Third Party subcontractors (including by appointing one (1) or more contract sales forces, co-promotion partners, or Distributors) to perform any of its activities under this Agreement. |
6.4.2 Anima and its Affiliates shall have the right to subcontract its activities under this Agreement to any Affiliate or Third Party subcontractor to the extent expressly provided for in a Collaboration Plan or otherwise with the prior written approval of AbbVie, such approval not to be unreasonably withheld; provide... |
6.5 Records and Audits. Each Party shall, and shall require its Affiliates and permitted subcontractors to, maintain materially complete, current, and accurate hard and electronic (as applicable) copies of records of all work conducted pursuant to its Development, Manufacturing, and Commercialization activities under t... |
ARTICLE 7 UPFRONT FEE; MILESTONES AND ROYALTIES; PAYMENTS |
7.1 Upfront Fee. No later than ten (10) days following the Effective Date, AbbVie shall pay Anima a one-time non-refundable, non-creditable upfront payment of Forty-Two Million Dollars ($42,000,000). |
7.2 Additional Target Program Fee. On an Additional Target Program Slot-by-Additional Target Program Slot basis, AbbVie shall pay to Anima a one-time non-refundable, non creditable payment corresponding to the period during which the Additional Target Program Slot Designation Date occurs, as set forth in the table belo... |
Time Period During Which Additional Target Program Slot Designation Date Occurs |
Before or on two- (2-) year anniversary of the Effective Date |
After two- (2-) year anniversary of the Effective Date and before or on three- (3-) year anniversary of the Effective Date |
After three- (3-) year anniversary of the Effective Date and before or on four- (4-) year anniversary of the Effective Date |
After four- (4-) year anniversary of the Effective Date |
7.3 Collaboration Target Substitution Fee. Within thirty (30) days of Anima's receipt of a Collaboration Target Substitution Notice for each Collaboration Target substitution pursuant to Section 2.3 (Collaboration Target Substitution): |
7.3.1 Solely if Anima receives the applicable Collaboration Target Substitution Notice prior to AbbVie's payment of the License Option Period Extension Fee for the replaced Collaboration Target, then AbbVie shall pay to Anima the non-refundable, non-creditable fee corresponding to the period during which such substitut... |
As of the date of the applicable Collaboration Target Substitution Notice, number of Months following (a) for Collaboration Targets Selected as of the Effective Date, the Effective Date, or (b) for any Other Collaboration Target, the Commencement of Activities with respect to such Collaboration Target under the Applica... |
Less than three (3) months |
Three (3) – six (6) months |
Six (6) – nine (9) months |
Nine (9) – twelve (12) months |
Twelve (12) – fifteen (15) months |
More than fifteen (15) months |
7.3.2 Solely if Anima receives the applicable Collaboration Target Substitution Notice after (a) AbbVie had paid a License Option Period Extension Fee for the replaced Collaboration Target and (b) Anima has completed lead generation activities under the applicable Collaboration Plan (as may be amended by the JGC from t... |
As of the date of the applicable Collaboration Target Substitution Notice, number of Months following Completion of Lead Generation Activities under Applicable Collaboration Plan |
Less than three (3) months |
Three (3) – six (6) months |
Six (6) – nine (9) months |
Nine (9) – twelve (12) months |
Twelve (12) – fifteen (15) months |
More than fifteen (15) months |
7.3.3 Any fee payable under the foregoing Section 7.3.1 (Collaboration Target Substitution Fee) or Section 7.3.2 (Collaboration Target Substitution Fee) is a "Collaboration Target Substitution Fee." For clarity, AbbVie will have no obligation to pay a Collaboration Target Substitution Fee or make any other payment unde... |
7.4 License Option Period Extension Fee. On a Target Program Slot-by-Target Program Slot basis, AbbVie may extend the end date of the License Option Period with respect to a Target Program Slot by paying to Anima a non-refundable, non-creditable license option period extension fee of (a) for a Target Program Slot that ... |
Time Period During Which AbbVie Pays the License Option Period Extension Fee |
Before or on two- (2-) year anniversary of the Effective Date |
After two- (2-) year anniversary of the Effective Date and before or on three- (3-) year anniversary of the Effective Date |
After three- (3-) year anniversary of the Effective Date and before or on four- (4-) year anniversary of the Effective Date |
After four- (4-) year anniversary of the Effective Date |
7.5 License Option Exercise Fee. On a Target Program Slot-by-Target Program Slot basis, if AbbVie exercises a License Option with respect to a Target Program Slot, then AbbVie shall pay to Anima a one-time non-refundable, non-creditable payment of Five Million Dollars ($5,000,000) (the "License Option Exercise Fee") wi... |
7.6 Development and Regulatory Milestone Payments. In partial consideration for the rights and licenses granted to AbbVie hereunder, and subject to Section 7.10 (Royalty and Milestone Adjustments), within ninety (90) days after the first achievement of each milestone event set forth in this Section 7.6 (Development and... |
Development Milestone Event |
(1) Initiation of first (1st) IND-Enabling Studies for a Royalty-Bearing Product with respect to a Target Program Slot |
(2) Dosing of third (3rd) patient in the first Phase 1 Clinical Trial of a Royalty-Bearing Product with respect to a Target Program Slot |
(3) Dosing of first (1st) patient in the first Phase 2 Clinical Trial of a Royalty-Bearing Product with respect to a Target Program Slot |
(4) Dosing of first (1st) patient in the first Registrational Clinical Trial of a Royalty-Bearing Product with respect to a Target Program Slot |
(5) Acceptance by the FDA of the first Regulatory Approval Application of a Royalty-Bearing Product with respect to a Target Program Slot |
(6) Acceptance by the EMA of the first Regulatory Approval Application of a Royalty-Bearing Product with respect to a Target Program Slot |
On a Target Program Slot-by-Target Program Slot basis, if for any reason a Development Milestone Event does not occur prior to the occurrence of the next Development Milestone Event listed in the table above, then such prior non-occurring Development Milestone Event shall be deemed to occur concurrently with the occurr... |
7.7 Sales-Based Milestone Payments. In partial consideration for the rights and licenses granted to AbbVie hereunder, and subject to Section 7.10 (Royalty and Milestone Adjustments), in the event that the aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot by AbbVie or any o... |
Annual Net Sales Milestone Threshold |
Aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot greater than or equal to One Billion Dollars ($1,000,000,000) |
Aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot greater than or equal to Two Billion Dollars ($2,000,000,000) |
Aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot greater than or equal to Three Billion Dollars ($3,000,000,000) |
7.8 Royalties. |
7.8.1 Royalty Rates. Subject to the terms and conditions of this Agreement, including Section 7.9 (Royalty Term) and Section 7.10 (Royalty and Milestone Adjustments), commencing upon the First Commercial Sale of a Royalty-Bearing Product in a country in the Territory, on a Target Program Slot-by-Target Program Slot and... |
Aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot |
For that portion of aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot less than or equal to Five Hundred Million Dollars ($500,000,000) |
For that portion of aggregate Annual Net Sales of all Royalty-Bearing Products respect to a Target Program Slot greater than Five Hundred Million Dollars ($500,000,000) and less than or equal to One Billion Dollars ($1,000,000,000) |
For that portion of aggregate Annual Net Sales of all Royalty-Bearing Products with respect to a Target Program Slot greater than One Billion Dollars ($1,000,000,000) and less than or equal to Two Billion Dollars ($2,000,000,000) |
For that portion of aggregate Annual Net Sales of all Royalty-Bearing Products respect to a Target Program Slot greater than Two Billion Dollars ($2,000,000,000) |
With respect to a given Royalty-Bearing Product in a given country in the Territory, from and after the expiration of the Royalty Term for the applicable Royalty-Bearing Product in such country, Net Sales of such Royalty-Bearing Product in such country will be excluded for purposes of calculating the Net Sales threshol... |
7.8.2 Calculation of Royalties. With respect to each Royalty-Bearing Product with respect to a Target Program Slot, royalties on Net Sales of such Royalty-Bearing Product shall be paid at the rate applicable to that portion of aggregate Annual Net Sales of all such Royalty-Bearing Products with respect to such Target P... |
7.9 Royalty Term. On a country-by-country and Royalty-Bearing Product-by-Royalty-Bearing Product basis, royalty payments on Net Sales of each Royalty-Bearing Product in a country in the Territory shall commence upon the First Commercial Sale of such Royalty-Bearing Product in such country and shall terminate on the ten... |
7.10 Royalty and Milestone Adjustments. Notwithstanding Section 7.6 (Development and Regulatory Milestone Payments), Section 7.7 (Sales-Based Milestone Payments) or Section 7.8.1 (Royalty Rates), but subject to Section 7.10.4 (Mechanics of Adjustments to Royalties and Milestones): |
7.10.1 Generic Products. If, in any country in the Territory during the Royalty Term in such country for a Royalty-Bearing Product, a Generic Product with respect to such Royalty-Bearing Product is launched in such country, then (a) Net Sales of such Royalty-Bearing Product in such country shall thereafter be excluded ... |
7.10.2 Stacking. If AbbVie or any of its Affiliates determines in good faith that, in order to avoid infringement or misappropriation of any Third Party Right, it is necessary or reasonably useful to obtain a license from a Third Party in order for AbbVie, its Affiliates, or its Sublicensees to Exploit a Royalty-Bearin... |
7.10.3 Intellectual Property Expense Offsets. AbbVie shall be entitled to deduct from AbbVie's milestone payments under Section 7.6 (Development and Regulatory Milestone Payments) or Section 7.7 (Sales-Based Milestone Payments) or AbbVie's royalty payments under Section 7.8.1 (Royalty Rates): (a) up to fifty percent (5... |
7.10.4 Mechanics of Adjustments to Royalties and Milestones. Any reductions set forth in this Section 7.10 (Royalty and Milestone Adjustments) shall be applied to the milestone payment or royalty rate payable to Anima under Section 7.6 (Development and Regulatory Milestone Payments), Section 7.7 (Sales-Based Milestone ... |
7.10.5 Inflation Reduction Act Royalty Adjustments. In addition to any reductions set forth in Sections 7.10.1 (Generic Products), 7.10.2 (Stacking), and 7.10.3 (Intellectual Property Expense Offsets), if, during the Royalty Term for a Royalty-Bearing Product, such Royalty-Bearing Product is designated as a "selected d... |
7.11 Estimated Sales Levels. Anima acknowledges and agrees that the sales levels set forth in Section 7.7 (Sales-Based Milestone Payments) and Section 7.8.1 (Royalty Rates) shall not be construed as representing an estimate or projection of anticipated sales of the Royalty-Bearing Products, or implying any level of dil... |
7.12 Reports; Payment of Royalty. During the Term, following the First Commercial Sale of any Royalty-Bearing Product in any country in the Territory, AbbVie shall furnish to Anima a written report within sixty (60) days after the end of each Calendar Quarter showing, on a Royalty-Bearing Product-by-Royalty-Bearing Pro... |
7.13 Financial Records. AbbVie shall, and shall cause its Affiliates and its and their Sublicensees (other than Dispute Settlement Sublicensees) to, keep full, clear, and accurate records pertaining to Net Sales for a minimum period of three (3) years after the relevant payment is owed pursuant to this Agreement, in su... |
7.14 Audit; Audit Dispute. |
7.14.1 Audit. At the request of Anima, AbbVie shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognized standing designated by Anima and reasonably acceptable to AbbVie, at reasonable times during normal business hours and upon reasonable notice, to audit the books ... |
7.14.2 Audit Dispute. In the event of a dispute with respect to any audit under Section 7.14.1 (Audit), Anima 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, then the dispute shall be submit... |
7.15 Methods of Payments; 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 reim... |
7.16 Taxes. |
7.16.1 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. |
7.16.2 Withholding Taxes. If any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, then 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 secure any available exemption from, reduction... |
7.16.3 Indirect Taxes. All payments 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 payment under this Agreement, then the paying Party shall pay such Indirect Taxes at the app... |
7.16.4 Tax Domicile. If, following the Effective Date, as a result of AbbVie assigning this Agreement or changing its domicile to a domicile other than the jurisdiction of AbbVie's domicile as of the Effective Date, AbbVie is required by applicable Law to withhold additional taxes with respect to the payments under thi... |
7.17 Late Payments. Any undisputed amount owed by AbbVie to Anima under this Agreement that is not paid on or before the date such payment is due shall bear interest at an annual rate (but with interest accruing on a daily basis) of the lesser of (a) one hundred (100) basis points above the Secured Overnight Financing ... |
7.18 Financial Obligations under In-License Agreements. As between the Parties, Anima shall be solely responsible for any financial obligations, including royalties, due to any Third Party as consideration for obtaining a license or other rights under any Patent Right or Know-How that is owned by a Third Party and is n... |
ARTICLE 8 EXCLUSIVITY; CHANGE OF CONTROL |
8.1 Exclusivity. |
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