text stringlengths 1 5.46k |
|---|
7.1 Upfront Payment. No later than thirty (30) days following the Effective Date, AbbVie shall pay Parvus a one-time upfront amount equal to Fifteen Million Dollars ($15,000,000) in consideration of the License Option. |
7.2 Option Exercise and Continuation Payments. |
7.2.1 Option Exercise Payment. In the event that AbbVie exercises the License Option and the Exclusive License goes into effect, AbbVie shall pay Parvus a one-time payment of Forty Million Dollars ($40,000,000) (the "License Option Exercise Payment") within thirty (30) days after the License Option Effective Date. |
7.2.2 Option Continuation Payments. Within sixty (60) days after AbbVie provides an Option Continuation Notice following the Completion of Stage 1 Activities or Completion of Stage 2 Activities, as applicable, (a) if AbbVie in its sole discretion pays Parvus the corresponding one-time Payment Amount set forth in the ta... |
7.3 Development and Commercialization Milestones. In partial consideration of the rights granted by Parvus to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to Parvus the following one-time milestone payments, each within sixty (60) days after the corresponding mi... |
7.3.1 For clarity, each milestone payment in this Section 7.3 (Development and Commercialization Milestones) shall be payable only one (1) time, after first achievement of the corresponding milestone event. No amounts shall be due for subsequent or repeated achievements of any milestone event. |
7.4 Sales-Based Milestones. If AbbVie exercises the License Option, in partial consideration of the license rights granted by Parvus to AbbVie hereunder, AbbVie shall pay to Parvus the following one-time milestone payments, each within sixty (60) days after AbbVie first achieves the corresponding milestone event: |
7.4.1 For clarity, each milestone payment in this Section 7.4 (Sales-Based Milestones) shall be payable only one time, after first achievement of the corresponding milestone event. No amounts shall be due for subsequent or repeated achievements of any milestone event. |
7.5 Royalties. Subject to Section 7.5.1 (Reductions and Deductions), on a Licensed Product-by-Licensed Product basis, commencing upon the First Commercial Sale of such Licensed Product in a country in the Territory and until the expiration of the Royalty Term for such Licensed Product in such country, AbbVie shall pay ... |
AbbVie shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product in any country or other jurisdiction after the Royalty Term for such Licensed Product in such country or other jurisdiction has expired. For purposes of calculating royalties, two Licensed Products containing the same L... |
7.5.1 Reductions and Deductions. Notwithstanding anything herein to the contrary in this Section 7.5 (Royalties): |
(a) Valid Claim Expiration. If, and in such case from and after the date on which there is no Valid Claim in such country or other jurisdiction of a Product Patent that claims the composition of matter of the Licensed Compound contained in or comprising a Licensed Product in such country or other jurisdiction, then the... |
(b) Stacking General IP. If AbbVie (i) enters into an agreement with a Third Party after the Effective Date in order to obtain a license or other right under a Patent or Information Controlled by such Third Party, which Patent or Information is necessary or useful to Exploit any Licensed Compound in or comprising a Lic... |
(c) Biosimilar Products. 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, and unit sales of all Biosimilar Products... |
(d) Compulsory Licensing. If AbbVie grants a Compulsory Sublicense, then, for the purposes of calculating the royalties payable with respect to such Licensed Product under this Section 7.5 (Royalties), fifty percent (50%) of Net Sales of such Licensed Product in such country or other jurisdiction by AbbVie, its Affilia... |
(e) 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... |
(f) Ceiling on Reductions and Deductions. In no event shall the reductions and deductions taken under clauses (a)-(d) of this Section 7.5.1 (Reductions and Deductions) reduce any milestone payment or the royalties payable to Parvus on any Licensed Products in any Calendar Quarter by greater than sixty percent (60%) of ... |
7.5.2 Compulsory Sublicensee Royalties. As further consideration for the rights granted to AbbVie hereunder and notwithstanding anything herein to the contrary, AbbVie shall pay to Parvus fifty percent (50%) of the royalties received by AbbVie from a Compulsory Sublicensee for sales of any Licensed Product by such Comp... |
7.6 Royalty Payments and Reports. AbbVie shall calculate royalties payable to Parvus pursuant to Section 7.5 (Royalties) at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 7.8 (Mode of Payments; Offsets). AbbVie shall pay to Parvus the royalty amounts due with r... |
7.7 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 Sections 7.3 (Development and Commercialization Milestones), 7.4 (Sales-Based Milestones) and 7.6 (Royalty Payments and Reports), including amo... |
7.8 Mode of Payment; Offsets. All payments to either Party under this Agreement shall be made by deposit of Dollars in the requisite amount to such bank account as the receiving Party may from time to time designate by notice to the paying Party. For the purpose of calculating any sums due under, or otherwise reimbursa... |
7.9 Withholding Taxes. Where any sum due to be paid to either Party hereunder is or would otherwise be subject to any withholding tax under Applicable Law, the withholding Party shall give the other Party notice of the intention to make such withholding (such notice, which shall include the authority, basis and method ... |
7.10 Tax Action Gross-up. Notwithstanding anything in Section 7.9 (Withholding Taxes), if either Party or its assignee (such Party, the "Acting Party", and the other Party or its assignee, the "Non-Acting Party") redomiciles or assigns any rights or obligations under this Agreement (such action, a "Tax Action") and if,... |
7.11 Indirect Taxes.All payments are exclusive of value added taxes, sales taxes, consumption taxes and other similar taxes (the "Indirect Taxes"). Where any sum due to be paid to either Party hereunder is or would otherwise be subject to any Indirect Tax, the Parties shall cooperate with each other and use their Comme... |
7.12 Financial Records. Each Party shall, and shall cause its Affiliates to, keep complete and accurate books and records pertaining to its activities under this Agreement, including in the case of AbbVie books and records with respect to Net Sales and royalties, in sufficient detail to calculate all amounts payable he... |
7.13 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 ... |
7.14 Audit Dispute. In the event of a dispute with respect to any audit under Section 7.13 (Audit), Parvus and AbbVie shall work in good faith to resolve the disagreement. If the Parties are unable to reach a mutually acceptable resolution of any such dispute within thirty (30) days, the dispute shall be submitted for ... |
7.15 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 10 (Confidentiality and Non-Disclosure) and the Parties shall cause the Audit Arbitrator to enter into a reasonably acceptable ... |
7.16 No Other Compensation. Each Party hereby agrees that the terms of this Agreement fully define all consideration, compensation and benefits, monetary or otherwise, to be paid, granted or delivered by one Party to the other Party in connection with the transactions contemplated herein. Neither Party previously has p... |
7.17 No Limitation. Nothing contained in this Article 7 (Payments and Records) shall in any way limit either Party's right to indemnification under this Agreement or to otherwise recover damages for breach of this Agreement. |
ARTICLE 8 INTELLECTUAL PROPERTY |
8.1 Ownership of Intellectual Property. |
8.1.1 Ownership of Technology Generally. Subject to the license grants and other rights herein, as between the Parties, the determination of whether Patents, inventions and Information are conceived, reduced to practice, discovered, developed, generated, created or otherwise made by or on behalf of either Party under o... |
8.1.2 Ownership of Parvus Platform IP. Notwithstanding Section 8.1.1 (Ownership of Technology Generally), Parvus shall solely own any Arising IP comprising Parvus Platform IP, regardless of inventorship. |
8.1.3 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 and... |
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. Parvus shall not 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, Patent, or other intellectual property right which would rea... |
8.1.6 Ownership of Corporate Names. As between the Parties, Parvus shall retain all right, title and interest in and to its Corporate Names. |
8.2 Prosecution and Maintenance of Patents. |
8.2.1 Patent Roadmap. Notwithstanding anything to the contrary in this Section 8.2 (Prosecution and Maintenance of Patents), prior to the License Option Effective Date, the Parties shall file and submit Patent applications disclosing any Licensed Compound or Licensed Product in accordance with the terms of this Agreeme... |
8.2.2 Prosecution and Maintenance of Parvus Licensed Patents Prior to License Option Effective Date. Prior to the License Option Effective Date, subject to the terms and conditions of this Section 8.2.2 (Prosecution and Maintenance of Parvus Licensed Patents Prior to License Option Effective Date), Parvus shall have th... |
(a) Other Arising Patents. With respect to Parvus Licensed Patents that are Arising Patents and are not Product Patents or Parvus Platform Patents ("Other Arising Patents"), Parvus shall keep AbbVie reasonably informed of all steps with regard to the preparation, filing, prosecution, defense and maintenance of such Ari... |
(b) Product Patents. With respect to Parvus Licensed Patents that are Product Patents (regardless of whether they are Arising Patents), Parvus shall keep AbbVie reasonably informed of all steps with regard to the preparation, filing, prosecution, defense and maintenance of such Product Patents, including by providing A... |
8.2.3 Prosecution and Maintenance of Parvus Licensed Patents On and After License Option Effective Date. On and after the License Option Effective Date, subject to the terms and conditions of this Section 8.2.3 (Prosecution and Maintenance of Parvus Licensed Patents On and After License Option Effective Date), Parvus s... |
(a) Product Patents. With respect to Parvus Licensed Patents that are Product Patents (regardless of whether they are Arising 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 such Product Patents in the Ter... |
(b) Parvus Platform Patents. With respect to Parvus Licensed Patents that are Parvus Platform Patents, Parvus shall keep AbbVie reasonably informed of all material steps with regard to any preparation, filing, prosecution, defense, or maintenance of any such Parvus Platform Patent or activities in connection with such ... |
(c) Other Arising Patents. With respect to Parvus Licensed Patents that are Arising Patents and are not Product Patents or Parvus Platform Patents, Parvus shall retain the first right, but not the obligation, through the use of internal or outside counsel, to prepare, file, prosecute, defend in any oppositions or post-... |
8.2.4 Prosecution and Maintenance of Joint Patents. AbbVie shall have at all times (whether before or after the License Option Effective Date) the first right, but not the obligation, to prepare, file, prosecute, defend in any oppositions or post-grant proceedings, and maintain the Joint Patents, at AbbVie's sole cost ... |
8.2.5 Prosecution and Maintenance of AbbVie Patents. AbbVie shall have at all times (whether before or after the License Option Effective Date) the sole right, but not the obligation, to prepare, file, prosecute, defend in any oppositions or post-grant proceedings, and maintain the AbbVie Patents at AbbVie's sole cost ... |
8.2.6 Cooperation. The Parties agree to cooperate fully in the preparation, filing, prosecution, defense in oppositions or post-grant proceedings, and maintenance of Patents pursuant to this Section 8.2 (Prosecution and Maintenance of Patents). Such 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 8.1.3 (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 limitation to Section 8.2.6(a) (Maintenance and Prosecution of Patents – Cooperation), within thirty (30) days of transfer of Parvus' responsibility for preparation, filing, prosecution, defense and maintenance of Product Patents as provided for upon the License Option Effective Date pursuant to Section 8.2... |
8.2.7 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 ... |
8.2.8 UPC Opt-Out and Opt-In. On and after the License Option Effective Date with respect to any Licensed Compound, Licensed Product or Unique Component, 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 part... |
8.2.9 Patent Listings. On and after the License Option Effective Date with respect to any Licensed Compound, Licensed Product or Unique Component, AbbVie shall have the sole right to make all filings with Regulatory Authorities in the Territory with respect to the Product Patents and Joint Patents, including as require... |
8.3 Enforcement of IP. |
8.3.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement or misappropriation of (i) Product IP ("Product Infringement") or (ii) Arising IP owned by Parvus that does not constitute Product IP or Parvus Platform IP ("Other Arising IP Infringement") by a Third Par... |
8.3.2 Product Infringement and Other Arising IP Infringement Prior to License Option Effective Date. Prior to the License Option Effective Date, Parvus shall have the primary right to prosecute, including by means of any claim, suit or proceeding, any (i) Product Infringement or (ii) Other Arising IP Infringement in th... |
8.3.3 Product Infringement On and 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, including by means of any claim, suit or proceeding, any Product Infringement in the Territ... |
8.3.4 Other Arising IP Infringement On and After License Option Effective Date. On and after the License Option Effective Date, Parvus shall retain the first right to prosecute, including by means of any claim, suit or proceeding, any Other Arising IP Infringement in the Territory at its sole expense and Parvus shall r... |
8.3.5 Other Parvus Technology. Parvus shall have at all times the sole right, but not the obligation, to prosecute any alleged or threatened infringement or misappropriation of (i) Parvus Platform IP and (ii) any other infringement or misappropriation of Parvus Licensed Patents and Parvus Licensed Know-How that is not ... |
8.3.6 Joint IP and AbbVie IP. Notwithstanding any other provision of this Section 8.3 (Enforcement of IP), AbbVie shall have at all times the sole right, but not the obligation, to prosecute any alleged or threatened infringement or misappropriation of Joint IP, AbbVie Patents or AbbVie Know-How in the Territory at its... |
8.3.7 Biosimilar Applicants. |
(a) 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 Biosimilar Products and any proceedings associated therewith, including any invalidity, unpatentability or unenforceability challenges,... |
(b) If permitted pursuant to Applicable Law, upon AbbVie's request, Parvus shall assist AbbVie in identifying and listing any Patents pursuant to Section 351(l)(1)(3)(A) or Section 351(l)(7) of the PHSA, in preparing, pursuant to section 351(l)(3)(C) of the PHSA, a detailed statement regarding the reference product spo... |
8.3.8 Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 8.3 (Enforcement of IP) (including any proceedings or litigation with respect to Biosimilar Products or any application seeking the approval, license, registration, or authorization of any Regulatory Authority th... |
8.3.9 Recovery. Except as otherwise agreed by the Parties, any recovery realized as a result of such prosecution described in this Section 8.3 (Enforcement of IP) (whether by way of settlement or otherwise) shall be first allocated to reimburse the Parties for their costs and expenses in making such recovery (which amo... |
8.4 Infringement Claims by Third Parties. |
8.4.1 Prior to License Option Effective Date. |
(a) Prior to the License Option Effective Date, if (i) the Exploitation of a Licensed Compound or Licensed Product, or (ii) the Development, Manufacture or use of a Unique Component, in each case (i) or (ii), in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a T... |
(b) Subject to Article 12 (Indemnity), Parvus shall have the first right, but not the obligation, to defend and control the defense of any such Third Party Infringement Claim in a manner that would not reasonably be expected to adversely affect the Product Patents at its own expense using counsel of its own choice, and... |
(c) Parvus shall keep AbbVie reasonably informed of all material developments in connection with any Third Party Infringement Claim prior to the License Option Effective Date. |
(d) Any recoveries by a Party of any sanctions awarded to such Party and against a party asserting a claim being defended under this Section 8.4.1 (Infringement Claims by Third Parties: Prior to License Option Effective Date) shall be applied first to reimburse such Party for its reasonable Out-of-Pocket Costs of defen... |
8.4.2 After License Option Effective Date. |
(a) Following the License Option Effective Date, if the Exploitation of a Licensed Compound, Licensed Product or Unique Component 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), includi... |
(b) Subject to Article 12 (Indemnity), AbbVie shall have the primary 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. If Parvus or its Affiliate is a named defendant in ... |
(c) Each Party shall keep the other Party reasonably informed of all material developments in connection with any Third Party Infringement Claim. |
(d) AbbVie shall, in accordance with Section 7.5.1(b) (Stacking General IP), be entitled to deduct fifty percent (50%) of the reasonable Out-of-Pocket Costs borne by AbbVie of defending such Third Party Infringement Claim from any of the First Commercial Sale milestones due to Parvus pursuant to Sections 7.3 (Developme... |
8.5 Invalidity or Unenforceability Defenses or Actions. |
8.5.1 Notice. Each Party shall promptly notify the other Party in writing of any alleged or threatened assertion of invalidity, unpatentability or unenforceability of any of the Product Patents by a Third Party, in each case in the Territory and of which such Party becomes aware. |
8.5.2 Responsibilities. Subject to Section 8.3.7(a) (Biosimilar Applicants), in the event of any alleged or threatened assertion of invalidity, unpatentability or unenforceability of a Patent which arises in the course of: (a) the preparation, filing, prosecution, maintenance or defense of such Patent as contemplated b... |
8.5.3 Costs and Expenses. Notwithstanding anything to the contrary herein, Parvus shall solely bear all costs and expenses incurred in the defense of any claim, suit, or proceeding under this Section 8.5 (Invalidity or Unenforceability Defenses or Actions) arising from or occurring as a result of Parvus' inequitable co... |
8.6 Product Trademarks. |
8.6.1 Ownership and Prosecution of Product Trademarks. AbbVie or its Affiliates shall own all right, title, and interest 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 right,... |
8.6.2 Enforcement of Product Trademarks. AbbVie or its Affiliates shall have the sole right, but not the obligation, to take such action as AbbVie deems necessary, at its expense, against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair... |
8.6.3 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 ... |
8.6.4 Notice and Cooperation. Parvus shall provide to AbbVie prompt written notice of any actual or threatened infringement of the Product Trademarks in the Territory and of any actual or threatened claim that the use of the Product Trademarks in the Territory violates the rights of any Third Party, in each case of whi... |
8.7 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. |
8.8 Common Interest. All information exchanged between the Parties regarding the prosecution, maintenance, enforcement 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 acknowledge and agree that, with reg... |
ARTICLE 9 DATA PRIVACY |
9.1 Data Privacy and Security. |
9.1.1 For all Personal Data collected, Processed, hosted, or transmitted in performance by a Party of this Agreement, such Party shall comply at all times with the Data Security and Privacy Laws in all countries and jurisdictions in the Territory, all applicable privacy related consents and notices that apply to the Li... |
(a) to the extent permitted by Applicable Law, notify AbbVie, as soon as practicable and in any event prior to making the relevant disclosure, if it is obliged to make a disclosure of the Personal Data under Applicable Law; |
(b) make timely notification to, and obtain any necessary authorizations from, any applicable Regulatory Authority where required under applicable Data Security and Privacy Laws of its Processing of Personal Data in order to comply with its obligations under this Agreement; |
(c) ensure that all fair Processing and required notices have been provided and are maintained and are sufficient in scope, that all required informed consents related to research participants have been obtained, and that Parvus has an appropriate legal basis under Data Security and Privacy Laws, to enable Parvus to Pr... |
(d) implement and maintain reasonable administrative, technical, and physical safeguards designed to (i) maintain the security and confidentiality of the Personal Data; (ii) protect against reasonably anticipated threats or hazards to the security or integrity of the Personal Data; and (iii) protect against unauthorize... |
(e) notify AbbVie promptly, and in any event within forty-eight (48) hours of receipt of, (i) any correspondence from a data protection regulator in relation to the Processing of Personal Data related to this Agreement, or (ii) a request or notice from a data subject exercising his rights under the Data Security and Pr... |
(f) provide AbbVie with such assistance as may be reasonably requested to provide information to ensure that Parvus complies with its obligations under applicable Data Security and Privacy Laws to the extent AbbVie does not otherwise have access to such information. |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.