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5.3.2 During the Cost-Sharing Option Period, Plexium shall have a one-time right to elect to share, based on the Pro Rata Percentage, in the Development Costs of one (1) Licensed Product, in exchange for the Cost-Sharing Royalty, by delivering a Cost-Sharing Option Exercise Notice to AbbVie before expiration of the app... |
5.3.3 During the Cost-Sharing Period, (a) Plexium and AbbVie shall each bear its Pro Rata Percentage of all Development Costs for the Cost-Sharing Product (such Development Costs, the "Shared Costs"), and (b) Plexium shall, subject to the terms and conditions of this Section 5.3, be entitled to receive the Cost-Sharing... |
5.3.4 If Plexium exercises the Cost-Sharing Option, within forty-five (45) days after the end of each Calendar Quarter thereafter, AbbVie shall provide to Plexium (a) a summary report of the Shared Costs incurred by AbbVie during such Calendar Quarter (or, with respect to the first such report, since the License Option... |
5.3.5 Without limiting its obligation to deliver an updated Non-Binding Budget in accordance with Section 5.3.4, AbbVie may update any Non-Binding Budget from time to time; provided that, to the extent that such update is an increase, in the aggregate as compared to the last Non-Binding Budget provided to Plexium by Ab... |
5.3.6 Plexium may, in its sole discretion, elect to defer payment of its Pro Rata Percentage of any Shared Costs for the Cost-Sharing Product that exceed one hundred twenty percent (120%) of the initial Non-Binding Budget (the "Excess Shared Costs") by providing written notice of such election (a "Deferral Notice") to ... |
5.3.7 If Plexium provides AbbVie a Deferral Notice pursuant to Section 5.3.6, then (a) Plexium shall no longer be obligated to reimburse AbbVie for its Pro Rata Percentage of the Excess Shared Costs (including any such Excess Shared Costs for the Calendar Quarter immediately prior to the date Plexium provides such Defe... |
5.3.8 Plexium, may opt out of its obligation to pay its Pro Rata Percentage of the Shared Costs (a "Shared Cost Opt-Out") by providing written notice to AbbVie (a "Shared Cost Opt-Out Notice"), which shall be effective on (a) January 1st of the following Calendar Year if such Cost Opt-Out Notice is received by AbbVie o... |
5.4 Regulatory Matters. |
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 a Licensed Compound or Licensed Product (including the Cost-Sharing 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 A... |
5.4.3 On the License Option Effective Date, Plexium hereby assigns to AbbVie, and shall cause its Affiliates to assign to AbbVie, all of its and their right, title, and interest in and to all Regulatory Documentation relating exclusively to the applicable Licensed Compound or Licensed Product that is existing prior to ... |
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 with respect to the Licensed Compounds and Licensed Products (including Cost-Sharing Product), and AbbVie (itself or through its Affiliates or Sublic... |
5.5 Booking of Sales; Distribution. AbbVie (itself or through its Affiliates or Sublicensees) shall have the sole right to invoice and book sales, establish all terms of sale (including pricing and discounts) and warehousing, and distribute the Licensed Products in the Territory and to perform or cause to be performed ... |
5.6 Product Trademarks. AbbVie (itself or through its Affiliates or Sublicensees or its or their designee(s)) shall have the sole right to determine and AbbVie (itself or through its Affiliates or Sublicensees or its or their designee(s)) shall own the Product Trademarks to be used with respect to the Exploitation of t... |
ARTICLE 6 GRANT OF RIGHTS |
6.1 Grants to AbbVie on the Effective Date. Subject to Section 6.4 and Section 6.7, Plexium (on behalf of itself and its Affiliates) hereby grants to AbbVie and its Affiliates, on the Effective Date and during the applicable Option Period for each Research Program, a non-exclusive, non-transferable, royalty-free licens... |
6.2 Grants to AbbVie on the License Option Effective Date. Subject to Section 6.4 and Section 6.7, Plexium (on behalf of itself and its Affiliates) grants to AbbVie and its Affiliates, subject to Section 4.4.4, on the License Option Effective Date for each Licensed Program: |
6.2.1 an exclusive (even as to Plexium and its Affiliates, except as required to conduct any Research Plan Activities allocated to Plexium) license, with the right to sublicense in accordance with Section 6.4, under the Licensed IP as necessary or reasonably useful for the sole purpose of Exploiting the Licensed Compou... |
6.2.2 an exclusive (even as to Plexium and its Affiliates, except as required to perform Research Plan Activities allocated to Plexium) 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 Regulato... |
6.3 Grant to Plexium. AbbVie hereby grants to Plexium a non-exclusive, non-transferable, non-sublicenseable, royalty-free license under the AbbVie Background Technology and AbbVie Agreement IP solely as necessary or reasonably useful to perform the Research Plan Activities allocated to Plexium. |
6.4 Sublicenses. AbbVie shall have the right to grant sublicenses (or further rights of reference), through multiple tiers of Sublicensees, under the licenses and rights of reference and granted in Sections 6.1 and 6.2, to its Affiliates and other Persons. |
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 Licensed Products with any other Person(s), or to appoint one (1) or more Third Parties to promote the Licensed Products with or without AbbVie in all or any part of the Territory. |
6.7 Retention of Rights. |
6.7.1 Notwithstanding the Exclusive License, Plexium retains the right to practice under the Licensed IP (a) as necessary or reasonably useful to perform its obligations under the Research Plans, and (b) for the purpose of clarity, for any purpose other than the Exploitation of the Licensed Compounds and Licensed Produ... |
6.7.2 Except as expressly provided in this Agreement, Plexium grants no other right or license, including any rights or licenses to the Plexium Background Technology, Licensed IP, Regulatory Documentation or any other Patent or intellectual property rights not otherwise expressly granted in this Agreement. For the purp... |
6.7.3 Except as expressly provided in this Agreement, AbbVie grants no other right or license, including any rights or licenses to the AbbVie Background Technology, AbbVie's interest in the Joint IP, the Regulatory Documentation, or any other Patent or intellectual property rights not otherwise expressly granted in thi... |
6.8 Confirmatory Patent License. Plexium shall, if requested to do so by AbbVie, immediately enter into confirmatory license agreements in the form mutually and reasonably agreed upon by the Parties for purposes of recording the licenses granted under this Agreement with such patent offices in the Territory as AbbVie r... |
6.9 Exclusivity. |
6.9.1 Plexium Exclusivity. On a Program-by-Program basis, Plexium shall not, itself or with or through any Affiliate or Third Party, directly or indirectly, Exploit, or license, authorize, appoint or otherwise intentionally enable any Third Party to Exploit (a) any Licensed Compound or Licensed Product for any purpose ... |
6.9.2 Change in Control of Plexium. 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, Plexium or any of its Affiliates merges or consolidates with, or is acquired by, a Third Party (the "Acquiring Party") that is then engaged in ac... |
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 Upfront Payment. No later than fifteen (15) days following the Effective Date, AbbVie shall pay Plexium a one-time upfront amount equal to Thirty-Five Million Dollars ($35,000,000). |
7.2 Substitute Research Program Fee. In the event that a Substitute Research Program Fee is owed by AbbVie to Plexium in accordance with Section 3.4.1, AbbVie shall pay Plexium a payment equal to the applicable Substitute Research Program Fee within thirty (30) days of the date on which, subject to Section 3.4.1, the P... |
7.3 Option Payment. In the event that AbbVie exercises a License Option with respect to a third (3rd), fourth (4th), or fifth (5th) Research Program, AbbVie shall pay Plexium a one-time payment of Ten Million Dollars ($10,000,000) with respect to each such Research Program within thirty (30) days of the License Option ... |
7.4 Development Milestones. In partial consideration of the rights granted by Plexium to AbbVie hereunder and subject to the terms and conditions set forth in this Agreement, subject to the remainder of this Section 7.4, AbbVie shall pay to Plexium the following non-creditable, nonrefundable milestone payments, on a Li... |
No. Milestone Event Milestone Payment |
Third subject receives first dose in a Phase I Clinical Study in the Territory with a Licensed Product. Ten Million Dollars ($10,000,000) |
First subject receives first dose in a Phase II Clinical Study in the Territory with a Licensed Product. Fifteen Million Dollars ($15,000,000) |
First subject receives first dose in a Phase III Clinical Study in the Territory with a Licensed Product Twenty-Five Million Dollars ($25,000,000) 80 | No later than ten (10) Business Days following the occurrence of each milestone event, AbbVie shall provide Plexium with written notice thereof. Each milestone payment ... |
First Commercial Sale of a Licensed Compound in the United States Thirty-Five Million Dollars ($35,000,000) |
First Commercial Sale of a Licensed Compound in three (3) of the European Major Markets Fifteen Million Dollars ($15,000,000) 83 | No later than ten (10) Business Days following the occurrence of each milestone event, AbbVie shall provide Plexium with written notice thereof. Each milestone payment in this Section 7.5 s... |
No later than ten (10) Business Days following the occurrence of each milestone event, AbbVie shall provide Plexium with written notice thereof. Each milestone payment in this Section 7.4 shall be payable only upon the first achievement of the corresponding milestone event for the applicable Licensed Program by the fir... |
No later than ten (10) Business Days following the occurrence of each milestone event, AbbVie shall provide Plexium with written notice thereof. Each milestone payment in this Section 7.5 shall be payable only upon the first achievement of the corresponding milestone event for the first Licensed Product for each Licens... |
In the event that in a given Calendar Year more than one (1) Annual Net Sales Milestone Threshold is exceeded, AbbVie shall pay to Plexium a separate milestone payment with respect to each Annual Net Sales Milestone Threshold that is exceeded in such Calendar Year. Each such milestone payment shall be due within sixty ... |
Each milestone payment in this Section 7.6 shall be payable only upon the first achievement of the corresponding milestone event for the first Licensed Product from each applicable Licensed Program. After achievement of such milestone by the first Licensed Product from an applicable Licensed Program, no amounts shall b... |
As further consideration for the rights granted to AbbVie hereunder, subject to the terms and conditions of this Section 7.7.1 and Section 7.7.4, commencing upon the First Commercial Sale of a Licensed Product in the Territory during the Royalty Term, AbbVie shall pay to Plexium, on a Licensed Product-by-Licensed Produ... |
As further consideration for the rights granted to AbbVie hereunder, subject to Sections 5.3 and 7.7.4, commencing upon the First Commercial Sale of the Cost-Sharing Product in the Territory during the Royalty Term, each of the royalty rates payable pursuant to Section 7.7.1(a) in respect to the Cost-Sharing Product sh... |
As further consideration for the rights granted to AbbVie hereunder, subject to Sections 5.3 and 7.7.4, commencing upon the First Commercial Sale of an Opt-Out Product in the Territory during the Royalty Term, the royalties payable pursuant to Section 7.7.1(a) in respect to such Opt-Out Product shall be increased by (a... |
With respect to each Licensed Product in each country or other jurisdiction in the Territory, from and after the expiration of the Royalty Term for such Licensed Product in such country or other jurisdiction, Net Sales of such Licensed Product in such country or other jurisdiction shall be excluded for purposes of calc... |
Examples of the calculations of the royalty payments under Section 7.7.1 are set forth on Schedule 7.7.1. |
AbbVie shall have no obligation to pay any royalty with respect to Net Sales of any Licensed Product (including the Cost-Sharing Product) in any country or other jurisdiction after the Royalty Term for such Licensed Product in such country or other jurisdiction has expired. |
Notwithstanding anything herein to the contrary, with respect to royalty rates under Section 7.7.1, 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 commercially available in ... |
(b) if AbbVie (i) enters into an agreement with a Third Party in order to obtain a license or right under a Patent or intellectual property right Controlled by such Third Party that is necessary for Exploiting any Licensed Product in the Field in a particular country or other jurisdiction pursuant to Section 8.6, or (i... |
(c) if a Licensed Product is Exploited in a country or other jurisdiction and the Royalty Term is in effect, but both (i) such Licensed Product is not covered by Regulatory Exclusivity in such country or other jurisdiction, and (ii) there is no Valid Claim of any Product Patent or Joint Patent that claims the Licensed ... |
(d) AbbVie shall have the right to deduct costs and expenses from any royalty under Section 7.7.1 in accordance with Section 3.7(a)(ii) and 5.3; and |
(e) in no event will the reductions taken under clauses (a) through (c) of this Section 7.7.4 reduce the royalties payable to Plexium on any Licensed Product in any Calendar Quarter by greater than fifty percent (50%) of the amounts otherwise payable under Section 7.7.1 (without reduction) for such Licensed Product; pr... |
AbbVie shall calculate all amounts payable to Plexium pursuant to Section 7.7 at the end of each Calendar Quarter, which amounts shall be converted to Dollars, in accordance with Section 7.10. Subject to Sections 5.3.7 and 7.7.4(c), AbbVie shall pay to Plexium the royalty amounts due with respect to a given Calendar Qu... |
If either Party (the "Invoicing Party") is owed amounts by the other Party (the "Invoiced Party") pursuant to this Agreement, other than pursuant to this ARTICLE 7, including amounts reimbursable or otherwise owed pursuant to Section 5.3 and ARTICLE 8, the Invoicing Party shall have the right to invoice the Invoiced Pa... |
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 reimbursable pursuant to, this Agreemen... |
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 all such acts and things and to sign all such documents as will enable them to take advantage of any applicable double taxation agreement or treaty. In t... |
In the event that a government authority retroactively determines that a payment made by a Party to the other pursuant to this Agreement should have been subject to withholding or similar (or to additional withholding or similar) Taxes, and such Party (the "Withholding Party") remits such withholding or similar Taxes t... |
All payments are exclusive of value added Taxes, sales Taxes, consumption Taxes and other similar Taxes (the "Indirect Taxes"). The Parties will cooperate in accordance with Applicable Laws to minimize Indirect Taxes in connection with payments to be made under this Agreement. If any Indirect Taxes are chargeable in re... |
The Parties shall issue invoices for all amounts payable under this Agreement consistent with Indirect Tax requirements and irrespective of whether the sums may be netted for settlement purposes. If the Indirect Taxes originally paid or otherwise borne by the paying Party are in whole or in part subsequently determined... |
AbbVie shall, and shall cause its Affiliates to, keep complete and accurate books and records pertaining to Net Sales of Licensed Products in sufficient detail to (a) calculate all amounts payable hereunder, and (b) verify compliance with its obligations under this Agreement. Such books and records shall be retained by... |
At the request of Plexium, AbbVie shall, and shall cause its Affiliates to, permit an independent public accounting firm of nationally recognized standing designated by Plexium and reasonably acceptable to AbbVie, at reasonable times during normal business hours and upon reasonable notice, to audit the books and record... |
The accounting firm shall disclose only whether the reports are correct or not, and any identified breach of AbbVie's obligations under this Agreement, and the specific details concerning any discrepancies and/or breaches. No other information shall be shared. Except as provided below, the cost of this audit shall be b... |
In the event of a dispute with respect to any audit under Section 7.14, Plexium 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 resolution to a certified p... |
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 such firm to retain all... |
The milestones and royalties in Sections 7.3, 7.4, 7.5 and 7.6 shall not apply to 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 treated for such disease... |
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 (1) Party to the other Party in connection with the transactions contemplated herein. Neither Party previously has paid or entered into any ... |
Nothing contained in this ARTICLE 7 shall in any way limit AbbVie's right to indemnification under this Agreement or to otherwise recover damages for breach of this Agreement. |
Subject to Section 8.1.2, as between the Parties, each Party (as used in this ARTICLE 8, including its designated Affiliate(s)) shall own and retain all right, title, and interest in and to any and all Information and inventions that are conceived, reduced to practice, discovered, developed or otherwise made by or on b... |
As between the Parties, the Parties shall each own an equal, undivided interest in the Joint IP. Each Party shall promptly disclose to the other Party in writing, and shall cause its Affiliates, licensees and sublicensees to so disclose, the conception, reduction to practice, discovery, development or other making of a... |
Subject to the other terms and conditions of this ARTICLE 8, the determination of inventorship as well as 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, copyrig... |
Each Party shall cause all Persons who perform Research or other activities for or on behalf of 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;... |
As between the Parties, each Party shall retain all right, title and interest in and to its own corporate names. |
The following provisions shall apply with respect to Patent prosecution and maintenance during the Option Period: Subject to the provisions of Section 8.2.1(b), Plexium shall have the sole and exclusive right, but not the obligation, through the use of internal or outside counsel, to prepare, file, prosecute, defend in... |
Plexium shall consult with and keep AbbVie reasonably informed of all material steps with regard to the preparation, filing, prosecution, defense and maintenance of such Plexium Product Patents, including by providing AbbVie with a copy of material communications to and from any patent authority in the Territory regard... |
Plexium shall consider in good faith the requests and suggestions of AbbVie with respect to such Plexium drafts and with respect to strategies for filing, defending and prosecuting the Plexium Product Patents in the Territory. Without limiting the foregoing, Plexium shall promptly inform AbbVie of any adversarial paten... |
The Parties shall thereafter consult and cooperate to determine a course of action with respect to any such proceeding in the Territory and Plexium shall consider in good faith all comments, requests and suggestions provided by AbbVie; provided, however, that Plexium shall have decision-making authority. |
Unless otherwise agreed to by Plexium and AbbVie in writing, neither Party shall file a Patent that covers any Option Compound or Option Product during the Option Period. |
AbbVie shall have 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-grant proceedings, and maintain the Joint Patents, at AbbVie's sole cost and expense. AbbVie shall consult with and keep Plexium reasonably informed o... |
AbbVie shall consider in good faith the requests and suggestions of Plexium with respect to such AbbVie drafts and with respect to strategies for filing, defending and prosecuting any such Joint Patents. Without limiting the foregoing, AbbVie shall promptly inform Plexium of any adversarial patent office proceeding or ... |
The Parties shall thereafter consult and cooperate to determine a course of action with respect to any such proceeding and AbbVie shall consider in good faith all comments, requests and suggestions provided by Plexium; provided, however, that AbbVie shall have decision-making authority. If AbbVie decides not to prepare... |
Plexium shall thereupon have the right, but not the obligation, to assume the control and direction of the preparation, filing, prosecution, defense and maintenance of such Joint Patent at Plexium's expense in such country or other jurisdiction. AbbVie shall reasonably cooperate with Plexium, at Plexium's expense, in s... |
In the event that AbbVie exercises the License Option with respect to a particular Research Program, the following provisions shall apply with respect to prosecution and maintenance of any Patents arising or relating to such Licensed Program on or after the applicable License Option Effective Date: AbbVie shall have th... |
AbbVie shall consult with and keep Plexium reasonably informed of all material steps with regard to the preparation, filing, prosecution, defense, and maintenance of any Plexium Product Patents and/or Joint Patents, including by providing Plexium with a copy of material communications to and from any patent authority r... |
AbbVie shall consider in good faith the requests and suggestions of Plexium with respect to such AbbVie drafts and with respect to strategies for filing, defending and prosecuting any such Plexium Product Patents and/or Joint Patents. Without limiting the foregoing, AbbVie shall promptly inform Plexium of any adversari... |
The Parties shall thereafter consult and cooperate to determine a course of action with respect to any such proceeding and AbbVie shall consider in good faith all comments, requests and suggestions provided by Plexium; provided, however, that AbbVie shall have decision-making authority. If AbbVie decides not to prepare... |
Plexium shall thereupon have the right, but not the obligation, to assume the control and direction of the preparation, filing, prosecution, defense and maintenance of such Plexium Product Patent and/or Joint Patent at Plexium's expense in such country or other jurisdiction. AbbVie shall reasonably cooperate with Plexi... |
Subject to the provisions of Section 8.2.1(b), AbbVie shall, at all times, have the sole and exclusive 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, at AbbVie's sole cost and expense, all Abb... |
Plexium shall, at all times, have the sole and exclusive 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, at Plexium's sole cost and expense, the following: (a) all Plexium Platform Patents, and... |
Subject to the other terms and conditions of this Section 8.2, the Parties agree to cooperate fully with the other Party in the preparation, filing, prosecution, defense in oppositions or post-grant proceedings, and maintenance of the Plexium Product Patents and Joint Patents in the Territory in accordance with Section... |
(ii) consistent with this Agreement, assisting in any license registration processes with applicable governmental authorities that may be available in the Territory and reasonably necessary for the protection of a Party's interests in this Agreement; and (iii) promptly informing the other Party of any matters coming to... |
Within thirty (30) days of transfer of a Party's responsibility for preparation, filing, prosecution, defense and maintenance of a Patent in accordance with this Section 8.2, the then-current prosecuting Party shall promptly deliver to the other Party or its designee copies of all necessary files related to such Patent... |
With respect to any Licensed Compound or Licensed Product, AbbVie shall have the right to make decisions regarding patent term extensions, including supplementary protection certificates, pediatric exclusivity, and any other extensions that are now or become available in the future, wherever applicable, for the Plexium... |
AbbVie shall keep Plexium reasonably informed of its efforts to obtain such extension. Plexium shall provide prompt and reasonable assistance, as requested by AbbVie, including by taking such action as patent holder as is required under any Applicable Law to obtain any such extension. AbbVie shall pay all expenses in r... |
AbbVie shall have the first 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 States of the European Union (2013/C 175/01), with respect to any Plexium Product Patents and Joint Patents, and pay all fees associated... |
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