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6.11 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... |
6.12 Taxes. |
6.12.1 Withholding Taxes. Each Party shall be responsible for its own taxes, duties, levies, imposts, assessments, deductions, fees, withholdings or similar charges imposed on or measured by net income or overall gross income (including branch profits), gross receipts, capital, ability or right to do business, property... |
6.12.2 Indirect Taxes. Notwithstanding anything to the contrary herein, this Section 6.12.2 (Indirect Taxes) shall apply with respect to any value added tax, ad valorem, goods and services or similar tax chargeable on the supply or deemed supply of goods or services, sales and use taxes, transaction taxes, consumption ... |
6.12.3 Allocation of Payment. The Parties hereby agree that for all tax purposes, the payment in Section 6.1 (Upfront Fee) is allocated as follows: Thirteen Million Nine Hundred and Ninety-Nine Thousand Nine Hundred Dollars ($13,999,900.00) is allocated to the rights granted in Section 4.1 (Grant of Exclusive Rights to... |
6.13 Late Payments. In the event that any payment due under this Agreement is not paid when due in accordance with the applicable provisions of this Agreement, the payment shall accrue interest at a monthly interest rate equal to the U.S. prime interest rate, as reported by The Wall Street Journal (New York edition) fo... |
6.14 Financial Obligations under In-License Agreements. CollPlant shall be responsible for all payments owed to Third Parties under the In-License Agreements unless otherwise agreed by the Parties. |
ARTICLE 7 - INTELLECTUAL PROPERTY RIGHTS |
7.1 Ownership of Intellectual Property; Disclosure. |
7.1.1 Ownership. |
(a) CollPlant Inventions. Subject to the rights herein, as between the Parties, all right, title and interest in and to all inventions conceived, discovered, developed or otherwise made by or on behalf of either Party (or its respective Affiliates), including those inventions made by subcontractors on behalf of either ... |
(b) AbbVie Inventions. Subject to the rights herein, as between the Parties, all right, title and interest in and to all inventions conceived, discovered, developed or otherwise made by or on behalf of either Party (or its respective Affiliates), including those inventions made by subcontractors on behalf of either Par... |
(c) Ownership of Other Intellectual Property. Ownership of other intellectual property not addressed in Section 7.1.1(a) (CollPlant Inventions) or Section 7.1.1(b) (AbbVie Inventions) shall be based on inventorship. The Parties do not plan to conduct any activities that would lead to any jointly-invented intellectual p... |
7.1.2 United States Law. The determination of inventorship, as well as whether an invention or Know-How is conceived, discovered, developed or otherwise made by or on behalf of a Party or its Affiliates for the purpose of allocating proprietary rights (including patent, copyright or other intellectual property rights) ... |
7.1.3 Disclosure of Inventions. During the Term: |
(a) CollPlant shall, and shall cause its Affiliates and permitted subcontractors to, promptly disclose in writing to AbbVie the development, making, conception or reduction to practice of any CollPlant Know-How and AbbVie Inventions by CollPlant or any of its Affiliates; and |
(b) AbbVie shall, and shall cause its Affiliates to, promptly disclose in writing to CollPlant the development, making, conception or reduction to practice of any CollPlant Inventions by AbbVie or any of its Affiliates. |
7.2 Patent Prosecution and Maintenance. |
7.2.1 General Prosecution Terms. Except as otherwise set forth in this Agreement, as between the Parties, each Party shall have the sole right to prepare, file, prosecute, defend in any opposition or post-grant proceedings, and maintain Patent Rights owned or otherwise Controlled by such Party at such Party's sole cost... |
7.2.2 Exercise of Prosecution Rights. Notwithstanding anything to the contrary in this Agreement, (a) neither CollPlant nor its Affiliates will file any new patent application disclosing or claiming any use of CollPlant Collagen in or as a product that would be an Exclusive Product if Developed by or on behalf of AbbVi... |
7.2.3 UPC Opt-Out and Opt-In. The Parties shall coordinate and agree on any decision regarding whether or not to elect Opt-Out or Opt-In with respect to any CollPlant Patent; provided that the Party that controls the prosecution of a Patent Right shall have final say regarding any such Opt-Out or Opt-In with respect to... |
7.2.4 Patent Term Extension and Supplementary Protection Certificate. With respect to an Exclusive Product, AbbVie shall be responsible for making decisions regarding patent term extensions, including supplementary protection certificates, pediatric exclusivity, and any other extensions that are now or become available... |
7.2.5 Cooperation. The Parties agree to cooperate fully in the preparation, filing, prosecution, defense and maintenance of the CollPlant Patents at their own expense. 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 Section 7.1.1 (Ownership); (ii) enable the other Party to apply for and to prosecute patent applications in the Territor... |
(b) consistent with this Agreement, assisting in any license registration processes with applicable Governmental Authorities that may be available in the Territory for the protection of a Party's interests in this Agreement; and |
(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 Patent Rights arising under this Agreement in the Territory. |
7.3 Enforcement of Patent Rights. |
7.3.1 Enforcement of CollPlant Technology. Each Party shall promptly notify the other Party in writing of any alleged or threatened infringement or misappropriation of the CollPlant Technology by a Third Party in the Territory of which such Party becomes aware based on the Exploitation of, or an application to seek reg... |
7.3.2 Cooperation. The Parties agree to cooperate fully in any infringement action pursuant to this Section 7.3 (Enforcement of Patent Rights). Where a Party brings such an action, the other Party shall, where necessary, furnish a power of attorney solely for such purpose or shall join in, or be named as a necessary pa... |
7.3.3 Enforcement of Other CollPlant Patent Rights. Except as otherwise set forth in Section 7.3 (Enforcement of Patent Rights), AbbVie will not have the right to enforce any CollPlant Technology against any Third Party actions that do not constitute a Competitive Infringement without first obtaining the prior written ... |
7.3.4 Option Products. If CollPlant and APIL enter into a definitive license agreement pursuant to Section 2.3.1 (Injectable Breast Implant Product Option) or Section 2.3.2 (Photocurable Dermal Filler Product Option), such definitive license agreement will provide, unless otherwise mutually agreed by the parties theret... |
7.4 Infringement Claims by Third Parties . If the Exploitation of an Exclusive Product in the Territory pursuant to this Agreement results in, or may result in, any claim, suit, or proceeding by a Third Party alleging patent infringement by a Party (or its Affiliates or Third Party Transferees) (a "Third Party Infringe... |
7.5 Invalidity or Unenforceability Defenses or Actions. |
7.5.1 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 CollPlant Patents by a Third Party, in each case in the Territory and of which such Party becomes aware. |
7.5.2 Responsibility. The Party responsible for prosecuting a Patent Right under Section 7.2 (Patent Prosecution and Maintenance) will have the right to defend and control the defense of the validity, patentability and enforceability of such Patent Right at its own expense in the Territory, provided that if the asserti... |
7.5.3 Cooperation. Each Party shall assist and cooperate with the other Party as such other Party may reasonably request from time to time in connection with its activities set forth in this Section 7.5 (Invalidity or Unenforceability Defenses or Actions), including by providing access to relevant documents and other e... |
7.6 Product Trademarks. |
7.6.1 Ownership of Product Trademarks. As between the Parties, AbbVie shall have the sole right to determine and shall own all right, title and interest in and to the Trademarks that are used in connection with any Exclusive Product anywhere in the world (the "Product Trademarks"). CollPlant shall not and shall cause i... |
7.6.2 Enforcement of Product Trademarks. As between the Parties, AbbVie shall have the sole right to take such action as AbbVie deems necessary against a Third Party based on any alleged, threatened, or actual infringement, dilution, misappropriation, or other violation of, or unfair trade practices or any other like o... |
7.6.3 Third Party Claims. As between the Parties, AbbVie shall have the sole right to defend against (including the right to 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 violate... |
7.6.4 Notice and Cooperation. CollPlant shall, and shall cause its Affiliates and its and their (sub)licensees to, (a) provide 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 Ter... |
7.7 Inventor's Remuneration. Each Party shall be solely responsible for any remuneration that may be due such Party's inventors under any applicable inventor remuneration laws, including without limitation under Section 134 of the Israeli Patent Law-1967. |
7.8 International Nonproprietary Name. As between the Parties and if as to the extent applicable, AbbVie shall have the sole right and responsibility to select the International Nonproprietary Name or other name or identifier for any Exclusive Product. AbbVie shall have the sole right and responsibility to apply for su... |
ARTICLE 8 - CONFIDENTIALITY |
8.1 Product Information. CollPlant recognizes that by reason of AbbVie's rights under this Agreement, AbbVie has an interest in CollPlant's maintaining the confidentiality of certain information of CollPlant. Accordingly, during the Term, CollPlant shall, and shall cause its Affiliates and permitted subcontractors and ... |
8.2 Confidentiality Obligations. At all times during the Term and for a period of ten (10) years following termination or expiration hereof in its entirety, each Party shall, and shall cause its Affiliates, permitted subcontractors, and its and their respective officers, directors, employees and agents to, keep confide... |
8.2.1 has been published by a Third Party or otherwise is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the receiving Party; |
8.2.2 has been in the receiving Party's possession prior to disclosure by the disclosing Party without any obligation of confidentiality with respect to such information; provided that the foregoing exception shall not apply with respect to Regulatory Filings; |
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8.2.3 is subsequently received by the receiving Party from a Third Party without restriction and without breach of any agreement between such Third Party and the disclosing Party; |
8.2.4 that is generally made available to Third Parties by the disclosing Party without restriction on disclosure; or |
8.2.5 has been independently developed by or for the receiving Party without reference to, or use or disclosure of, the disclosing Party's Confidential Information as evidenced by competent records. |
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the receiving Party. Further, any combin... |
8.3 Permitted Disclosures. Each Party may disclose Confidential Information to the extent that such disclosure is: |
8.3.1 in the reasonable opinion of the receiving Party's legal counsel, required to be disclosed pursuant to applicable Law or a valid order of a Governmental Authority of competent jurisdiction, (including by reason of filing with securities regulators or to comply with rules of a securities exchange on which the secu... |
8.3.2 made by or on behalf of the receiving Party to the Regulatory Authorities as required in connection with any filing, application or request for any Regulatory Approval in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such Confiden... |
8.3.3 made by or on behalf of the receiving Party to a patent authority as may be necessary or reasonably useful for purposes of preparing, obtaining, defending or enforcing a Patent Right in accordance with the terms of this Agreement; provided that reasonable measures shall be taken to assure confidential treatment o... |
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8.3.4 made to its or its Affiliates' financial and legal advisors who have a need to know such disclosing Party's Confidential Information and are either under professional codes of conduct giving rise to expectations of confidentiality and non-use or under written agreements of confidentiality and non-use, in each cas... |
8.3.5 made by the receiving Party or its Affiliates to potential or actual investors or acquirers as may be necessary in connection with their evaluation of such potential or actual investment or acquisition; provided that such Persons shall be subject to obligations of confidentiality and non-use with respect to such ... |
8.3.6 made by AbbVie or its Affiliates or Third Party Transferees to its or their advisors, consultants, clinicians, vendors, service providers, contractors, existing or prospective collaboration partners, licensees, Third Party Transferees, or other Third Parties as may be necessary or useful in connection with the Ex... |
8.3.7 made by CollPlant or its Affiliates to its or their advisors, consultants, clinicians, vendors, service providers, contractors, and the like to the extent necessary in assisting with CollPlant's activities contemplated by this Agreement; provided that such Persons shall be subject to obligations of confidentialit... |
8.4 Use of Name. Except as expressly provided herein, neither Party shall mention or otherwise use the name, logo, or Trademark of the other Party or any of its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, marketing and promotional material, or other form of publicity withou... |
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8.5 Public Announcements. Neither Party shall issue any public announcement, press release, or other public disclosure regarding this Agreement or the Supply Agreement or their respective subject matter without the other Party's prior written consent, except for any such disclosure that is, in the opinion of the disclo... |
8.6 Publications. CollPlant shall not publish, present, or otherwise disclose, and shall cause its Affiliates and any permitted subcontractors and its and their respective employees and agents not to disclose any information relating to the Exclusive Products without the prior written consent of AbbVie, except as requi... |
8.7 Return of Confidential Information. Upon the effective date of the termination of this Agreement for any reason, either Party may request in writing, and the other Party shall either, with respect to Confidential Information to which such first Party does not retain rights under the surviving provisions of this Agr... |
8.8 Survival. All Confidential Information shall continue to be subject to the terms of this Agreement for the period set forth in Section 8.2 (Confidentiality Obligations). |
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ARTICLE 9 - REPRESENTATIONS AND WARRANTIES |
9.1 Representations and Warranties of Both Parties. Each Party hereby represents and warrants to the other Party, as of the Effective Date, that: |
9.1.1 such Party is duly organized, validly existing and in good standing (in jurisdictions where the concept of good standing is recognized) under the Laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; |
9.1.2 such Party has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; |
9.1.3 this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof, subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor r... |
9.1.4 the execution, delivery and performance of this Agreement by such Party do not conflict with and do not violate: (a) such Party's charter documents, bylaws or other organizational documents; (b) in any material respect, any agreement or any provision thereof, or any instrument or understanding, oral or written, t... |
9.1.5 it is not under any obligation, contractual or otherwise, to any Person that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the diligent and complete fulfillment of its obligations hereunder; |
9.1.6 no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any applicable Laws currently in effect, is or will be necessary for, or in connection with, t... |
9.1.7 neither Party nor any of its Affiliates has been debarred or is subject to debarment and neither it nor any of its Affiliates will use in any capacity, in connection with the activities to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA or who is the subjec... |
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9.2 Representations, Warranties and Covenants, as applicable, of CollPlant. CollPlant hereby (a) represents and warrants to AbbVie as of the Effective Date, except as set forth in the corresponding section of Schedule 9.2 (CollPlant Disclosure Schedule), and (b) covenants (solely to the extent expressly set forth below... |
9.2.1 CollPlant (a) is entitled to grant the rights specified herein and (b) has the right to use all Regulatory Filings, Know-How and Patent Rights necessary for CollPlant to fulfill its obligations hereunder; |
9.2.2 The Development, Manufacture, Commercialization or Exploitation of the CollPlant Collagen as contemplated herein will not (a) be subject to any license or agreement (other than the IIA Terms) to which CollPlant or any of its Affiliates is a party or (b), to CollPlant's Knowledge, infringe any Patent Rights or oth... |
9.2.3 All CollPlant Patents existing as of such date (the "Existing Patent Rights") are listed on Schedule 1.26 and to CollPlant's Knowledge all Existing Patent Rights are (a) subsisting and are not invalid or unenforceable, in whole or in part, (b) solely and exclusively owned or licensed by CollPlant or one of its Af... |
9.2.4 No contractor, customer, licensee or distributor of CollPlant Collagen is permitted to include CollPlant Collagen (or any altered form thereof developed by or on behalf of such contractor, customer, licensee or distributor) in any Exclusive Product; |
9.2.5 True, complete and correct copies of (a) the file wrappers and other documents and materials relating to the prosecution, defense, maintenance, validity and enforceability of the Existing Patent Rights, (b) all existing Regulatory Filings and (c) all material adverse information with respect to the safety of the ... |
9.2.6 Neither CollPlant nor any of its Affiliates has entered into any In-License Agreement; |
9.2.7 This Agreement is fully consistent with and does not constitute a breach of the IIA Terms; |
9.2.8 The Existing Patent Rights represent all Patent Rights that CollPlant or its Affiliates own, Control or otherwise have rights to relating to the CollPlant Collagen or the Exploitation thereof; |
9.2.9 Neither CollPlant nor any of its Affiliates has entered into any agreement, whether written or oral, (excluding agreements described in Section 9.2 (Representations, Warranties and Covenants, as applicable, of CollPlant) and excluding confidentiality and non-disclosure agreements entered into in the normal course... |
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9.2.10 (a) Except as disclosed in Schedule 9.2.10 (Disputes), no claim or litigation has been brought or asserted (and CollPlant has no Knowledge of any claim, whether or not brought or asserted) by any Person alleging that (i) the Existing Patent Rights, the CollPlant Know-How, CollPlant Inventions or the CollPlant Pa... |
9.2.11 To CollPlant's Knowledge, no Person is infringing or threatening to infringe, or misappropriating or threatening to misappropriate, the Existing Patent Rights, the CollPlant Know-How, the CollPlant Inventions or any Regulatory Filings, and the conception, development, reduction to practice or Exploitation of any... |
9.2.12 Each of the Existing Patent Rights properly identifies each and every inventor of the claims thereof as determined in accordance with the laws of the jurisdiction in which such Existing Patent Right is issued or such application is pending; |
9.2.13 There are no pending or, to CollPlant's Knowledge, alleged or threatened, (a) inter partes reviews, post-grant reviews, interferences, re-examinations or oppositions involving the Existing Patent Rights that are in or before any patent authority (or other Governmental Authority performing similar functions) or (... |
9.2.14 Each Person who has or has had any rights in or to any Existing Patent Rights, any CollPlant Know-How, any CollPlant Inventions, CollPlant Collagen has assigned and has executed an agreement assigning its entire right, title and interest in and to such Existing Patent Rights, CollPlant Know-How, CollPlant Invent... |
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9.2.15 All works of authorship and all other materials subject to copyright protection included in CollPlant Know-How are original and were either created by employees of CollPlant or its Affiliates within the scope of their employment or are otherwise works made for hire, or all right, title, and interest in and to su... |
9.2.16 Except as set forth in Schedule 9.2.16 (Use of Academic Facilities and Personnel): The inventions claimed by the Existing Patent Rights (a) were not conceived, discovered, developed or otherwise made in connection with any research activities funded, in whole or in part, by the federal government of the United S... |
9.2.17 CollPlant has made available to AbbVie (a) all Regulatory Filings with respect to any CollPlant Collagen, and (b) all material CollPlant Know-How, in each case ((a) and (b)), in its possession or Control, and to CollPlant's Knowledge all such Regulatory Filings are true, complete and correct; |
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