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5.3.1 Subject to Sections 3.13.2 and 5.3.2, AbbVie shall (i) Manufacture (or cause to be Manufactured) a supply of all requirements of the applicable Licensed Compounds, Licensed Products, comparators, co-administered agents and placebo for the performance of Development activities for the applicable Licensed Program, ... |
5.3.2 If AbbVie anticipates that it may need Heptares to Manufacture (or cause to be Manufactured) a supply of the applicable Licensed Compounds, Licensed Products, comparators, co-administered agents and placebo in addition to the requirements set forth in Section 3.13, then the Parties shall discuss in good faith (i)... |
5.4 Regulatory Matters On or After License Option Effective Date. |
5.4.1 From and after the License Option Effective Date, AbbVie shall have the sole right to prepare, obtain, and maintain the Drug Approval Applications (including the setting of the overall regulatory strategy therefor), all other Regulatory Approvals and other submissions, and to conduct communications with the Regul... |
5.4.2 All Regulatory Documentation (including all Trial Master Files, Regulatory Approvals and Product Labeling) relating to any Licensed Compound or Licensed Product with respect to the Territory shall be owned by and shall be the sole property and held in the name of AbbVie or its Affiliate or Sublicensee or its or t... |
5.4.3 On the License Option Effective Date, Heptares hereby assigns to AbbVie all of its rights, title and interests in and to all Regulatory Documentation relating to any Licensed Compound or Licensed Product that is (a) existing prior to the License Option Effective Date, and (b) Controlled by Heptares or its Affilia... |
5.4.4 After the License Option Effective Date, AbbVie shall have the sole right to determine and initiate all recalls, market suspensions or market withdrawals undertaken, and AbbVie (itself or through its Affiliates or Sublicensees or its or their designees) shall be solely responsible for the execution thereof, and H... |
5.5 Booking of Sales; Distribution. AbbVie (itself or through its Affiliates or Sublicensees or its or their designees) shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute Licensed Products in the Territory and to perform or ... |
5.6 Product Trademarks. AbbVie shall have the sole right to determine and AbbVie and its Affiliates and its and their Sublicensees, as applicable, shall own the Product Trademarks to be used with respect to the Exploitation of the Products on a worldwide basis. Heptares shall not, and shall not permit its Affiliates to... |
ARTICLE 6 GRANT OF RIGHTS |
6.1 Grants to AbbVie on the Effective Date. Subject to Section 6.4, Heptares (on behalf of itself and its Affiliates) hereby grants to AbbVie, subject to Section 4.4.4, on the Effective Date and during the applicable Option Period for each Option Program, a non-exclusive, royalty-free license, with the right to sublice... |
6.2 Grants to AbbVie on the License Option Effective Date. Subject to Section 6.4 and Section 6.7.1, Heptares (on behalf of itself and its Affiliates) grants to AbbVie, subject to Section 4.4.4, on the License Option Effective Date for each Licensed Program: |
6.2.1 an exclusive (even as to Heptares and its Affiliates, except as required to conduct any Research Plan Activities) license, with the right to sublicense in accordance with Section 6.4, under the Licensed Technology to Exploit Licensed Compounds and Licensed Products in the Designated Pharmacology in the Field in t... |
6.2.2 an exclusive (including with regard to Heptares and its Affiliates) license and right of reference, with the right to sublicense and grant further rights of reference in accordance with Section 6.4, under all Regulatory Approvals and any other Regulatory Documentation that Heptares or its Affiliates may Control w... |
6.2.3 subject to Section 8.1.6, a non-exclusive license, with the right to grant sublicenses in accordance with the Section 6.4, to use Heptares' Corporate Names solely as required by Applicable Law or as required by any Regulatory Authority and for no other purpose; and |
6.2.4 a non-exclusive, worldwide, perpetual, royalty free, irrevocable, and sublicensable unblocking license to any Arising Heptares Platform Intellectual Property Rights to Exploit any assets Controlled by AbbVie, its Affiliates and sublicensees. |
6.3 Grant to Heptares. AbbVie hereby grants to Heptares, on a Program-by-Program basis, until acceptance of the applicable Option Data Package by AbbVie, a non-exclusive, royalty-free license, without the right to grant sublicenses, under (i) AbbVie's interest in the Joint Intellectual Property Rights and, (ii) other P... |
6.4 Sublicenses. AbbVie shall have the right to grant sublicenses (or further rights of reference), through multiple layers of Sublicensees, under the licenses and rights of reference granted in Section 6.1, to its Affiliates and Third Parties. AbbVie shall provide prompt written notice to Heptares following the grant ... |
6.5 Distributorships. AbbVie shall have the right, in its sole discretion, to appoint its Affiliates, and AbbVie and its Affiliates shall have the right, in their sole discretion, to appoint any other Persons, in the Territory to Commercialize a Licensed Product (with or without packaging rights), in circumstances wher... |
6.6 Co-Promotion Rights. For clarity, AbbVie and its Affiliates shall have the right, in their sole discretion, to co-promote the Products with any other Person(s), or to appoint one (1) or more Third Parties to promote the Products with or without AbbVie in all or any part of the Territory. |
6.7 Retention of Rights. |
6.7.1 Notwithstanding the Exclusive Licenses, Heptares retains the right to practice under the Heptares Patents, the Heptares Know-How, Heptares' interests in the Joint Patents and the Joint Know-How, in each case, solely as necessary to perform its obligations under the Research Plans and under this Agreement. |
6.7.2 Except as expressly provided in this Agreement, Heptares grants no other right or license, including any rights or licenses to the Heptares Patents, the Heptares Know-How, the Regulatory Documentation, the Heptares Corporate Names, or any other Patent or intellectual property rights not otherwise expressly grante... |
6.7.3 Except as expressly provided in this Agreement, AbbVie grants no other right or license, including any rights or licenses to AbbVie's interest in the Joint Intellectual Property Rights, Regulatory Documentation, or any other Patent or intellectual property rights not otherwise expressly granted in this Agreement. |
6.8 Confirmatory Patent License. Heptares shall, if requested to do so by AbbVie, immediately enter into confirmatory license agreements in the form or substantially the form reasonably requested by AbbVie for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as A... |
6.9 Exclusivity. |
6.9.1 Heptares Exclusivity. In addition to the restrictions set forth in Sections 3.5 and 3.8, on a Program-by-Program basis, beginning on the Effective Date and ending on the earlier of (i) expiration of the Option Period; provided that AbbVie did not exercise the License Option, (ii) termination of a Licensed Program... |
6.9.2 Change in Control of Heptares. Notwithstanding Section 6.9.1 and in addition to the rights of AbbVie set forth in Section 13.2.2, if, as a result of a Change in Control, Heptares or any of its Affiliates merges or consolidates with, or is acquired by, a Third Party (the "Acquiring Party") that is then engaged in ... |
6.9.3 Acknowledgement. Each Party acknowledges and agrees that (i) this Section 6.9 has been negotiated by the Parties, (ii) the time limitations on activities set forth in this Section 6.9 are reasonable, valid and necessary in light of the Parties' circumstances and necessary for the adequate protection of the activi... |
ARTICLE 7 PAYMENTS AND RECORDS |
7.1 One-Time Payments |
7.1.1 Upfront Payment. No later than ten (10) days following the Effective Date, AbbVie shall pay Heptares a one-time upfront amount equal to Ten Million Dollars ($10,000,000) in consideration of a License Option to the GPR65 Program. |
7.1.2 Reserved Option Program Activation Fee. Within ten (10) days of AbbVie's delivery of a Reserved Option Program Activation Notice, AbbVie shall pay Heptares an amount equal to Ten Million Dollars ($10,000,000) (the "Reserved Option Program Activation Fee") in consideration of a License Option to the applicable Res... |
7.1.3 Additional Option Program Selection Fee. Within sixty (60) days of AbbVie's receipt of Heptares' confirmation pursuant to Section 3.6.1, AbbVie shall pay Heptares a one-time amount equal to Ten Million Dollars ($10,000,000) (the "Additional Option Program Selection Fee") in consideration of the License Option to ... |
7.1.4 Alternate Pharmacology Option Fee. Within sixty (60) days of AbbVie's service of a notice in accordance with Section 3.8.3, AbbVie shall pay Heptares a one-time payment of Ten Million Dollars ($10,000,000) (the "Alternate Pharmacology Option Fee") in consideration of, and in respect of, each Option Target for whi... |
7.1.5 License Option Exercise Fee. In the event that AbbVie exercises a License Option with respect to an Option Program, AbbVie shall pay Heptares a one-time (for each such Option Program) payment of Fifteen Million Dollars ($15,000,000) for such Option Program within sixty (60) days of the applicable License Option E... |
7.2 Research Milestones. In partial consideration of the rights granted by Heptares to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to Heptares, on an Option Program-by-Option Program basis, within sixty (60) days after (i) first achievement of the corresponding... |
No. Milestone Event Milestone Payment |
1 Delivery of a completed Stabilized Receptor which corresponds to the Option Target Two Million Five Hundred Thousand Dollars ($2,500,000) |
2 Initiation of Lead Optimization Activities on an Option Compound or Option Product Ten Million Dollars ($10,000,000) |
3 The first Candidate Selection Ten Million Dollars ($10,000,000) plus, to the extent applicable in accordance with Section 3.9.1, the Incremental Manufacturing Cost Amount |
4 Solely to the extent such right is exercised by AbbVie pursuant to Section 3.9.2, the second Candidate Selection The Second Toxicology Study Cost Amount |
Each milestone payment in this Section 7.2 shall be payable only once per Option Program and, with regard to such Option Program, only after first achievement of the corresponding milestone event and no amounts shall be due for subsequent or repeated achievements of such milestone event within that Option Program wheth... |
7.3 Clinical Development Milestones. If AbbVie exercises a License Option with respect to an Option Program, in partial consideration of the rights granted by Heptares to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to Heptares, on a Licensed Program-by-Licensed... |
No. Milestone Event Milestone Payment |
1 The first patient is dosed with a Licensed Product in a Phase II Clinical Study. Twenty Million Dollars ($20,000,000) |
2 The first patient is dosed with a Licensed Product in a Phase III Clinical Study. Thirty Million Dollars ($30,000,000) |
3 The first patient is dosed with a Licensed Product in a Phase III Clinical Study in a second Indication. Fifteen Million Dollars ($15,000,000) |
Each milestone payment in this Section 7.3 shall be payable only once per Licensed Program and, with regard to such Licensed Program, only after a Licensed Product first achieves the corresponding milestone event and no amounts shall be due for subsequent or repeated achievements of such milestone event whether for the... |
7.4 First Commercial Sale Milestones. If AbbVie exercises a License Option with respect to an Option Program, in partial consideration of the rights granted by Heptares to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, AbbVie shall pay to Heptares, on a Licensed Program-by-License... |
No. Milestone Event Milestone Payment |
1 First Commercial Sale of a Licensed Product in the United States Thirty Million Dollars ($30,000,000) |
2 First Commercial Sale of a Licensed Product in a Major European Market Twenty Million Dollars ($20,000,000) |
3 First Commercial Sale of a Licensed Product in Japan Fifteen Million Dollars ($15,000,000) |
4 First Commercial Sale of a Licensed Product in a second Indication in the United States Fifteen Million Dollars ($15,000,000) |
5 First Commercial Sale of a Licensed Product in a second Indication in a Major European Market Ten Million Dollars ($10,000,000) |
6 First Commercial Sale of a Licensed Product in a second Indication in Japan Seven Million Five Hundred Thousand Dollars ($7,500,000) |
Each milestone payment in this Section 7.4 shall be payable only once per Licensed Program and, with regard to such Licensed Program, only after a Licensed Product first achieves the corresponding milestone event and no amounts shall be due for subsequent or repeated achievements of such milestone whether for the same ... |
7.5 Sales-Based Milestones |
7.5.1 If AbbVie exercises a License Option with respect to an Option Program, in partial consideration of the license rights granted by Heptares to AbbVie hereunder, in the event that, on a Licensed Program-by-Licensed Program basis, the aggregate of all Net Sales of all Licensed Products made by AbbVie or any of its A... |
Annual Net Sales Milestone Threshold Annual Net Sales-Based Milestone Payment |
Five Hundred Million Dollars ($500,000,000) Twenty Million Dollars ($20,000,000) |
One Billion Dollars ($1,000,000,000) Forty Million Dollars ($40,000,000) |
Two Billion Dollars ($2,000,000,000) Sixty Million Dollars ($60,000,000) |
Three Billion Dollars ($3,000,000,000) Eighty Million Dollars ($80,000,000) |
Notwithstanding anything contained in Section 7.5.1, each milestone payment in this Section 7.3 shall be payable on a Licensed Program-by-Licensed Program basis only upon the first achievement of such milestone in a Calendar Year, and no amounts shall be due for subsequent or repeated achievements of such milestone in ... |
7.6 Royalties. |
7.6.1 Royalty Rates. As further consideration for the rights granted to AbbVie hereunder, subject to Section 7.6.4, commencing upon the First Commercial Sale of a Licensed Product in the Territory, AbbVie shall pay to Heptares, on a Licensed Program-by-Licensed Program basis, a royalty on Net Sales of all Licensed Prod... |
Aggregate Net Sales of all Licensed Products in a Licensed Program Royalty Rate |
For that portion of aggregate Net Sales of all Licensed Products in a Licensed Program that are less than Five Hundred Million Dollars ($500,000,000) Six Percent (6%) |
For that portion of aggregate Net Sales of all Licensed Products in a Licensed Program that are equal to or greater than Five Hundred Million ($500,000,000) and less than One Billion Dollars ($1,000,000,000) Seven Percent (7%) |
For that portion of aggregate Net Sales of all Licensed Products in a Licensed Program that are equal to or greater than One Billion Dollars ($1,000,000,000) but less than Three Billion Dollars ($3,000,000,000) Eight Percent (8%) |
For that portion of aggregate Net Sales of all Licensed Products in a Licensed Program that are equal to or greater than Three Billion Dollars ($3,000,000,000) Ten Percent (10%) |
7.6.2 Example Calculations. Examples of the calculations of the royalty payments under Section 7.6.1 are set forth on Schedule 7.6.2. |
7.6.3 Royalty Term. 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. |
7.6.4 Royalty Reductions. Notwithstanding anything herein to the contrary, with respect to royalties under Section 7.6, the following shall apply: |
(a) if in any country or other jurisdiction in the Territory during the Royalty Term for a Licensed Product a Generic Product with respect to such Licensed Product is launched in such country or other jurisdiction and, on a Licensed Product-by-Licensed Product, Calendar Quarter-by-Calendar Quarter and country-by-countr... |
(b) if AbbVie enters into an agreement with a Third Party in order to obtain a license or right under a Patent or intellectual property right owned or Controlled by such Third Party in a particular country or other jurisdiction pursuant to Section 8.6, then for any Licensed Product and country for which a royalty under... |
(c) if a court or a governmental agency of competent jurisdiction requires AbbVie or any of its Affiliates or Sublicensees to grant a compulsory license to a Third Party permitting such Third Party to make and sell a Licensed Product in a country or other jurisdiction in the Territory, then, for the purposes of calcula... |
(d) if, and in such case from and after the date on which, a Licensed Product is Exploited in a country or other jurisdiction and the Royalty Term is in effect but there is no Valid Claim of a Heptares Patent that claims the Licensed Compound contained in such Licensed Product in such country or other jurisdiction and ... |
(e) in no event will the reductions taken under clauses (a) through (d) of this Section 7.6.4 reduce the royalties payable to Heptares on any Licensed Products in any Calendar Quarter by greater than fifty percent (50%) in aggregate of the amounts otherwise payable under Section 7.6.1 (without reduction) for such Licen... |
7.7 In-License Agreements. With respect to In-License Agreements, Heptares is fully responsible for all financial obligations, including any royalties, milestone, and other amounts, due in connection with In-License Agreements, including as may be due as a result of or in respect to the Exploitation of any Licensed Pro... |
7.8 Royalty Payments and Reports. AbbVie shall calculate all amounts payable to Heptares pursuant to Section 7.6 at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 7.10. AbbVie shall pay to Heptares the royalty amounts due with respect to a given Calendar Quarte... |
7.9 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 7.1 through 7.5 and 7.8, including reimbursable amounts pursuant to Section 3.7.4 and 3.12 and amounts reimbursable or otherwise owed p... |
7.10 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 reimburs... |
7.11 Withholding Taxes. The amounts payable pursuant to this Agreement shall not be reduced on account of any taxes unless required by Applicable Law. Where any sum due to be paid to either Party hereunder is subject to any withholding or similar tax, the Parties shall use their commercially reasonable efforts to do al... |
7.12 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 followin... |
7.13 Financial Records. Each Party shall, and shall cause its Affiliates to, keep complete and accurate books and records pertaining to Net Sales of Licensed Products and other sums payable under this Agreement in sufficient detail to calculate all amounts payable hereunder and to verify compliance with its obligations... |
7.14 Audit. At the request of Heptares, AbbVie shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognized standing designated by Heptares and reasonably acceptable to AbbVie, at reasonable times during normal business hours and upon reasonable notice, to audit the bo... |
7.15 Audit Dispute. In the event of a dispute with respect to any audit under Section 7.14, Heptares 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 resolu... |
7.16 Confidentiality. The receiving Party shall treat all information subject to review under this ARTICLE 7 in accordance with the confidentiality provisions of ARTICLE 9 and the Parties shall cause the Audit Arbitrator to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating s... |
7.17 Diagnostic or Veterinary Products. The milestones and royalties in ARTICLE 7 shall not apply to the Exploitation of Licensed Compounds or Licensed Products for diagnostic or veterinary use, or for uses solely for screening patients who have been diagnosed with a disease, state, or condition for eligibility to be t... |
7.18 No Other Compensation. Each Party hereby agrees that the terms of this Agreement fully define all consideration and benefits, monetary or otherwise, to be paid, granted or delivered by one (1) Party to the other Party in connection with the transactions contemplated herein. Neither Party previously has paid or ent... |
7.19 No Limitation. Nothing contained in this ARTICLE 7 shall in any way limit a 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. Subject to Sections 8.1.2 and 8.1.3, as between the Parties, each Party (as used in ARTICLE 8, including its designated Affiliate(s)) shall own and retain all right, title, and interest in and to any and all: (a) Information and inventions that are conceived, reduced to practice, discover... |
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 Intellectual Property Rights. Each Party shall promptly disclose to the other Party in writing, and shall cause its Affiliates, licensees and sublicensees to so disclose, the... |
8.1.3 Ownership of Improvements to Heptares Platform. Subject to Section 6.2.3, Heptares shall own any and all Arising Heptares Platform Intellectual Property Rights howsoever conceived, reduced to practice, discovered, developed or otherwise made by or on behalf of either Party and/or their Affiliates and/or their Sub... |
8.1.4 United States Law. The determination of whether Information and inventions are conceived, reduced to practice, discovered, developed, or made by a Party for the purpose of allocating proprietary rights (including Patent, copyright or other intellectual property rights) therein, shall, for purposes of this Agreeme... |
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