-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, LpA+p5NCgyRKLoebOAT3XEpg1i7AGmpvghC8/spMZ433Rl7iAYwnioECDVYO+ef1 K4z4YiwvmBxhgV3Vb6lCEA== /in/edgar/work/20000815/0000071241-00-000025/0000071241-00-000025.txt : 20000922 0000071241-00-000025.hdr.sgml : 20000921 ACCESSION NUMBER: 0000071241-00-000025 CONFORMED SUBMISSION TYPE: 10-Q/A PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19990630 FILED AS OF DATE: 20000814 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NEW BRUNSWICK SCIENTIFIC CO INC CENTRAL INDEX KEY: 0000071241 STANDARD INDUSTRIAL CLASSIFICATION: [3821 ] IRS NUMBER: 221630072 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q/A SEC ACT: SEC FILE NUMBER: 000-06994 FILM NUMBER: 701487 BUSINESS ADDRESS: STREET 1: 44 TALMADGE RD STREET 2: PO BOX 4005 CITY: EDISON STATE: NJ ZIP: 08818-4005 BUSINESS PHONE: 9082871200 MAIL ADDRESS: STREET 1: 44 TALMADGE ROAD STREET 2: PO BOX 4005 CITY: EDISON STATE: NJ ZIP: 08818-4005 10-Q/A 1 0001.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q/A AMENDMENT TO QUARTERLY REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For The Quarter Ended June 30, 1999 Commission File No. 0-6994 ------ NEW BRUNSWICK SCIENTIFIC CO., INC. State of Incorporation - New Jersey E. I. #22-1630072 ----------- 44 Talmadge Road, Edison, N.J. 08818-4005 Registrant's Telephone Number: 732-287-1200 ------------ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15 (d) of the Securities Exchange Act of 1934 during the preceding twelve (12) months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past ninety (90) days. Yes X No --- --- There are 5,325,552 Common shares outstanding as of August 3, 1999. 1 Item 6. Exhibits and Reports on Form 8-K - ------------------------------------------------ The exhibits to this report are listed on the Exhibit Index included elsewhere herein. No reports on Form 8-K have been filed during the quarter ended June 30, 1999. 13 SIGNATURES ---------- Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this amended report to be signed on its behalf by the undersigned thereunto duly authorized. NEW BRUNSWICK SCIENTIFIC CO., INC. -------------------------------------- (Registrant) Date: August 14, 2000 /s/ David Freedman ------------------- David Freedman Chairman (Chief Executive Officer) /s/ Samuel Eichenbaum ----------------------- Samuel Eichenbaum Vice President - Finance (Principal Accounting Officer) 14
NEW BRUNSWICK SCIENTIFIC CO., INC. AND SUBSIDIARIES EXHIBIT INDEX - ----------------- Exhibit No Exhibit Page No. - ---------- ------- -------- Research and Licensing Agreement Between DGI BioTechnologies LLC. And Novo Nordisk A/S dated May 28 1999 [Confidential portions of this document have been omitted and filed separately with the Commission pursuant to a confidential treatment request by Registrant dated August 14, 2000. This document (with additional portions of Section 1.6 omitted) was originally filed as Exhibit 10-18 to Registrant's Form 10-Q for period 10.18 Ending June 30, 1999] 1 Credit Agreement Between New Brunswick Scientific Co., Inc. and First Union National Bank dated 10.19 April 1, 1999 (filed 08/16/99) Financial Data Schedule (Filed- electronically with SEC only 27 (filed 08/16/99)
15 EX-10.18 2 0002.txt "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] RESEARCH AND LICENSE AGREEMENT This License Agreement ("Agreement"), effective as of 28th day of May, 1999 ("Effective Date") is by and between Novo Nordisk A/S, a corporation existing under the laws of Denmark and having a place of business at Novo Alle, DK-2880, Bagsvaerd, Denmark ("Novo Nordisk"), and DGI BioTechnologies, LLC, a company having its principal place of business at 40 Talmadge Road, PO Box 424, Edison, NJ 08818-0424. WITNESSETH WHEREAS, DGI is the owner of certain DGI Technology (as hereinafter defined) and DGI Patent Rights (as hereinafter defined); and WHEREAS, Novo Nordisk desires to obtain from DGI, and DGI desires to grant to Novo Nordisk a license to use and sell products in all countries of the world under such DGI Patent Rights and DGI Technology. NOW THEREFORE, in consideration of the mutual promises and for the other good and valuable consideration, the receipt of which is hereby acknowledged, the Parties agree as follows: 1. DEFINITIONS The following definitions shall control the construction of each of the following items wherever they appear in this Agreement. 1.1 "Affiliate" shall mean any company, joint venture partnership, or other business entity which controls, is controlled by, or is under common control with DGI or Novo Nordisk, as the case may be. A business entity shall be deemed to control another business entity if it possesses, directly or indirectly, the power to order or cause the direction, management and policies of such other business entity, whether through the ownership of voting securities, by contract or otherwise. 1.2 "DGI" shall mean DGI BioTechnologies, LLC and/or any Affiliate which is a party to the arrangements set forth in this Agreement. 1.3 "DGI Patent Rights" shall mean all of DGI's rights possessed at any time during the Term of this Agreement in and to any patents and patent applications, including but not limited to DGI patents listed on Appendix A to this Agreement. Said patents and patent applications shall include but not be limited to selection patents, patent applications, divisionals, continuations, continuations-in-part, reissues, 1 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] re-examinations and extensions. Extensions of patents shall include; (a) extensions under the U.S. Patent Term Restoration Act, (b) extensions of patents under Japanese Patent Law, (c) Supplementary Protection Certificates for members of the European Patent Convention and other countries in the European Economic Area, and (d) similar extensions under any applicable law in the Territory. 1.4 "DGI Technology" shall mean any proprietary know-how owned or controlled by DGI as of the Effective Date and/or developed, acquired or controlled by DGI during the Term, including but not limited to technical data, experimental results, specifications, techniques, inventions, processes, formulas and other materials, all of which are useful in the development, discovery, production or use of Licensed Product. DGI Technology shall not include; (a) know-how which at the time of disclosure is in the public domain, (b) know-how which prior to the disclosure was in Novo Nordisk's possession, and (c ) know-how developed independently by Novo Nordisk without any use of any DGI Technology whatsoever. 1.5 "Diogenesis" shall mean DGI's surrogate ligand-based approach to finding and using site-directed assays to identify drug leads. 1.6 "Field" shall mean a Product useful in treating, preventing or controlling diabetes by direct or indiret [* *], the development or discovery of which utilizes DGI Technology and/or is covered by a DGI Patent Right. 1.7 "First Commercial Sale" shall mean the first sale or other commercial disposal by Novo Nordisk or its sublicensee, after the Effective Date, of a Licensed Product for value, in an arm's length transaction, in any country within the Territory. 1.8 "Improvement" shall mean any modification, alteration, enhancement or improvement to DGI Patent Rights and/or DGI Technology, which relates to the Licensed Product(s). 1.9 "IND" shall mean an Investigational New Drug application submitted to the Food and Drug Administration of the United States, and/or an equivalent application to the equivalent regulatory body in the European Union and/or Japan. 1.10 "Licensed Product" shall mean Products within the Field; (a) the manufacture and/or sale of which are covered by a Valid Claim of DGI Patent Rights, and/or 2 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] (b) which are developed utilizing DGI Technology. 1.11 "Major Market" shall mean the United States, European Union and/or Japan. 1.12 "NDA" shall mean a New Drug Application submitted to the Food and Drug Administration of the United States, and/or an equivalent application to the equivalent regulatory body in the European Union and/or Japan. 1.13 "Net Sales" shall mean Novo Nordisk's and its sublicensee's (s') gross proceeds from sales of Licensed Product invoiced to any independent third party less, i. any direct or indirect credits and allowances or adjustments, including, without limitation, credits and allowances on account of price adjustments or on account of rejection, recall or return of Licensed Product previously sold; ii. any trade and cash discounts; price reductions or rebates, retroactive or otherwise, imposed by government authorities; and third party distributor fees; iii. any sales, excise, turnover, value added, or similar taxes and any duties and other governmental charges imposed upon the production, importation, use or sale of Licensed Product(s); iv. applicable transportation, importation, insurance and other handling charges, and v. the cost of special devices used for administration of Licensed Product. Such special devices shall not include conventional devices (e.g. tablets, standard syringes, suppositories and/or standard transdermal patches). Deductions i, ii, and iv shall not exceed fifteen percent (15%) of gross sales of Licensed Product by Novo Nordisk and its sublicensee(s) during any reporting period. In the event that the Licensed Product is sold as part of a Combination Product the Net Sales of the Licensed Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Combination Product (as defined in the standard Net Sales definition) by the fraction, A/(A + B) where A is the average sale price of the Licensed Product when sold separately in finished form and 3 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] B is the average sale price of the other product(s) sold separately in finished form. In the event that the average sale price of the Licensed Product can be determined but the average sale price of the other product(s) cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Products by the fraction C/(C + D) where C is the selling party's average sales price of the Licensed Product and D is the difference between the average selling price of the Combination Product and the average selling price of the Licensed Product. If the average sale price of the other product(s) can be determined but the average price of the Licensed Product cannot be determined, Net Sales for purposes of determining royalty payment shall be calculated by multiplying the Net Sales of the Combination Products by the following formula: one (1) minus C/(C + D) where C is the average selling price of the other product(s) and D is the difference between the average selling price of the Combination Products and the average selling price of the other product(s). In no event, however, shall the Net Sales of Licensed Products be less than fifty percent (50%) of the Net Sales of the Combination Products. In the event that the average sale price of both the Licensed Product and the other product(s) in the Combination Product cannot be determined, the Net Sales of the Licensed Product shall be deemed to be equal to fifty percent (50%) of the Net Sales of the Combination Product. The Net Sales price for a Combination Product shall be calculated once each calendar year and such price shall be used during all applicable royalty reporting periods for the entire calendar year. When determining the average sale price of a Licensed Product or product(s), the average sale price shall be calculated using data arising from the twelve (12) months preceding the calculation of the Net Sales price for the Combination Product. As used above, the term "Combination Product" means any pharmaceutical product which comprises the Licensed Product and other active compounds and/or ingredients. 1.14 "Novo Nordisk" shall mean Novo Nordisk A/S and/or any Affiliate thereof which is a party to the arrangements set forth in this Agreement. 1.15 "Novo Nordisk Patent Rights" shall mean rights to patent applications and patents filed by or on behalf of Novo Nordisk pursuant to this Agreement. 4 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] 1.16 "Parties" shall mean DGI and Novo Nordisk collectively and the term "Party" shall mean each of DGI and Novo, Nordisk, individually. 1.17 "Phase II" initiation shall mean initiation of clinical trials to demonstrate efficacy and short term safety. 1.18 "Phase III" initiation shall mean initiation of clinical trials to demonstrate efficacy and safety in larger patient groups. 1.19 "PLPc" shall mean Preclinical Lead Profile candidate as defined in the prevailing Novo Nordisk guidelines for management of Novo Nordisk's Health Care Discovery projects. 1.20 "Product" shall mean a molecule discovered and/or developed using DGI Patent Rights and/or DGI Technology. 1.21 [**]. 1.22 "Research Plan" shall mean the research program to be carried out by DGI as described in Section 6.3 and as included as Appendix B to this Agreement. 1.23 "Term" shall mean the last to expire of a DGI or Novo Nordisk Patent Right containing a Valid Claim, covering the making, using or selling of Licensed Product or twenty (20) years, whichever is later. 1.24 "Territory" shall mean all countries in the world. 1.25 [* *] 2. GRANT OF LICENSES 2.1 DGI hereby grants to Novo Nordisk, and Novo Nordisk hereby accepts, an exclusive license within the Field under DGI Patent Rights and DGI Technology, even as to DGI, including the right to sublicense, to use, produce, have produced, import, offer to sell, sell and/or co-promote and/or co-market with one or more third parties, Licensed Products in the Territory subject to Section 2.3. For the purpose of this Agreement, a co-promotor or a co-marketer shall be considered a sublicensee. 5 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] 2.2 DGI hereby grants to Novo Nordisk, and Novo Nordisk hereby accepts, an exclusive license subject to Section 2.3, even as to DGI, to use and develop DGI Patent Rights and DGI Technology within the Field. 2.3 (a) DGI shall retain a royalty free right and license to use DGI Technology, either alone or in combination with others to develop and [* *} povided however such license shall be limited only to the [* *] (b) DGI shall keep Novo Nordisk informed of the progress of its [* *] on a regular basis and particularly if any significant results are observed, provided it is not precluded from doing so by a commitment to a third party. (c) DGI hereby grants to Novo Nordisk, the first right of refusal for an exclusive license to any [* *] DGI shall not offer a license under more favorable terms to a third party unless first offered to Novo Nordisk. 2.4 Any improvements within the Field, made conceived, obtained and/or controlled by DGI during the Term shall be disclosed to Novo Nordisk without further financial obligation subject to Section 2.3. Novo Nordisk may use such DGI improvements in connection with the Licensed Product by Novo Nordisk and/or its sublicensees in the Territory. 3. LICENSING FEES, MILESTONE FEES AND ROYALTIES 3.1 As compensation to DGI for the licenses granted hereunder and furnished to Novo Nordisk, Novo Nordisk agrees to pay to DGI the license fees set forth in Section 3.2, milestone fees set forth in Section 3.3 and royalties set forth in Section 3.4. 3.2 Novo Nordisk shall pay the following license fees to DGI: (a) Six Hundred Thousand U.S. Dollars (US $600,000) within ten (10) business days of signing of this Agreement by both Parties; (b) Five Hundred Thousand U. S. Dollars (US $500,000) within ten (10) business days of the signing of this Agreement by both Parties, and 6 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] (c ) Five Hundred Thousand U.S. Dollars (US $500,000) within ten (10) business days of the one (1) year anniversary of the signing of this Agreement by both Parties. 3.3 Novo Nordisk shall pay the following milestone fees to DGI: (a) [* *]: i. [* .*] ii. [* .*] iii. [* *] iv. [* *] v. [* *] vi. [* *] vii. [* *] (b) [* *] i. [* *] ii. [* *] iii. [* *] iv. [* *] 7 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] v. [* *] vi. [* *] vii. [* *] 3.4. Novo Nordisk shall pay DGI a royalty based upon its and its sublicensee's(s') annual Net Sales of Licensed Products in the Territory, for each year commencing with the First Commercial Sale and terminating [* *] The royalty shall be payable by Novo Nordisk on annual Net Sales within the Territory, according to the following rates: (a) [* *] i. [* *] ii. [* *]; and iii. [* *]. (b) [* *]. 3.5 In the event Novo Nordisk experiences generic competition in excess of twenty percent (20%), in a country of Novo Nordisk and its sublicensee's(s') sales of Licensed Product during any calendar quarter, as reflected in IMS data and/or documented declines in governmental sales, then the rate at which Novo Nordisk pays royalty in that country, shall be reduced by the same reduction of market share as the generic competition. 3.6 One-half of the milestone fee payments, set forth in Section 3.3, shall be credited against the royalty payments under Section 3.4. However, in each year referred to in Section 3.4, Novo Nordisk shall not deduct 8 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] more than fifty percent (50%) of the royalties due under Section 3.4. Novo Nordisk shall continue to take a credit against royalty payments until the sum of the milestone fees has been fully credited. 3.7 Novo Nordisk shall pay only one royalty under Section 3.4 on Net Sales of Licensed Product, notwithstanding the number of patents within DGI Patent Rights and/or the nature and/or amount of DGI Technology. Once Novo Nordisk has made one or more milestone payments for a molecule, such milestone payments already paid need not be paid for another molecule selected for development in place of the first mentioned molecule, unless such molecule is to be taken independently to the market. 3.8 Sales of Licensed Product between Novo Nordisk, its Affiliates and its sublicensees shall not be subject to any royalty obligation. In such cases, the royalty shall be calculated upon Novo Nordisk's or its Affiliate's or its sublicensee's Net Sales to an independent third party. 3.9 (a) If Novo Nordisk grants a sublicense, all of the terms and conditions of this Agreement shall apply to the sublicensee to the same extent as they apply to Novo Nordisk for all purposes of this Agreement. Novo Nordisk assumes responsibility for the performance of all obligations so imposed on such sublicensee and will itself pay and account to DGI for all royalties due under this Agreement by reason of the operations of any such sublicensee. (b) Novo Nordisk may extend to any of its Affiliates the benefit of this Agreement, but Novo Nordisk shall remain responsible to DGI for all of the obligations placed upon Novo Nordisk by this Agreement. 4. PAID UP LICENSE 4.1 Novo Nordisk's obligations to pay royalties, under section 3.4 shall expire on a country-by-country basis upon the later of ten (10) years after the First Commercial Sale of Licensed Product and expiration of the DGI Patent Rights. 4.2 Upon the expiration of Novo Nordisk's obligation to pay royalties, Novo Nordisk shall have a fully paid-up license to use, produce, offer to sell, sell and/or co-promote and/or co-market with one or more third parties under DGI Patent Rights and DGI Technology. 5. REMITTANCES AND AUDITS 5.1 Novo Nordisk shall make all payments to DGI under this Agreement, according to its terms. If any payments made by Novo Nordisk under 9 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] this Agreement is subject to withholding tax, such withholding tax shall be borne by DGI and shall be deducted from the payments made by Novo Nordisk. As long as DGI provides Novo Nordisk with all the necessary documentation (i.e., special Danish Tax Form, IRS Form 1001, and relevant equivalents), Novo Nordisk shall, with respect to applicable laws support DGI in its efforts of minimizing the withholding taxes. In the event that Novo Nordisk does deduct or withhold any such taxes, as soon as practical, Novo Nordisk shall submit to DGI proper documentation confirming Novo Nordisk's payment of any such taxes for DGI's account. 5.2 All royalty payments under this Agreement shall be due and payable within sixty (60) days after the last day of each calendar quarter, beginning with the calendar quarter in which the First Commercial Sale occurred. 5.3 Novo Nordisk shall, within (60) days after the last day of each calendar quarter, beginning with the quarter in which the First Commercial Sale occurred, provide DGI a written statement, showing all Net Sales by country in the Territory. In case no royalty is due for any such period, Novo Nordisk shall so report. 5.4 All payments of royalties shall be made in United States Dollars and such payments shall be made via wire transfer to one or more bank accounts to be designated in writing, prior to the First Commercial Sale, by DGI to Novo Nordisk. In the event that any Net Sale is made in a foreign currency, the amount of such Net Sale shall be converted to United States dollars at the exchange rate set forth in the Wall Street Journal (Eastern Edition). This conversion shall be made using an average quarterly exchange rate determined as the average of the exchange rates set forth in the Wall Street Journal (Eastern Edition) published during the applicable reporting calendar quarter, if available, and otherwise using rates as announced by the central bank of the subject country of the Territory. 5.5 For the Term and for two (2) years thereafter, Novo Nordisk shall keep, and shall cause its sublicensee(s) selling Licensed Product in the Territory to keep, complete and accurate records of Net Sales of Licensed Product. Records shall be kept in sufficient detail to enable the determination of royalties due, under Section 3.4 hereof. 5.6 During the Term and for two (2) years thereafter, Novo Nordisk shall give access to a nationally-recognized independent certified public accountant ("DGI Accountant"), appointed and paid by DGI, to which/whom Novo Nordisk has no reasonable objection, to such 10 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] records of Novo Nordisk as described in Section 5.5, within two (2) years of the royalty period to which the records apply, in order to permit the DGI Accountant to verify the accuracy of any royalty payments made or payable under this Agreement. Such access shall be granted no more than once in any calendar year, at DGI's request, during regular business hours and with ten (10) business-days' notice. The DGI Accountant shall be under a confidentiality obligation to Novo Nordisk to disclose to DGI, in such Accountant's report, only the amount and accuracy of royalty payments made or payable under this Agreement. In the event the amount payable under this Agreement is more than that actually paid to DGI by Novo Nordisk (except for amounts not yet due on Net Sales for the immediately-past calendar quarter), Novo Nordisk shall pay such difference to DGI within thirty (30) days of such DGI Accountant's report. 5.7 If in any country, the transfer of royalties provided for herein is prohibited by law or regulation, Novo Nordisk shall remit the royalty in local currency to an interest bearing account in the name of DGI with banks or other financial institutions located in such country as designated by DGI. 6. DEVELOPMENT AND REGISTRATON 6.1 [* *] Novo Nordisk shall conduct, at its expense, any pre-clinical and clinical trials necessary to receive and maintain registrations to sell any Licensed Products(s) in the Territory. 6.2 Novo Nordisk shall obtain and maintain, at its sole cost and expense, all permits, licenses, authorizations and registrations for any country, sovereignty, state, country, parish, municipality, or other local governmental entity in the Territory which are necessary for Novo Nordisk to import, distribute and sell Licensed Product. 6.3 DGI shall allocate the equivalent of one full time employee to conduct further research on behalf of Novo Nordisk. Such research shall commence upon both Parties mutually agreeing upon the research to 11 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] be conducted, as outlined in the Research Program in Appendix B of this Agreement. Such research shall be performed at a cost of One Hundred Eighty Five Thousand U.S. Dollars (US $185,000). Such payment shall be made to DGI on a quarterly basis. During the Research Program; (i) an exchange of information shall occur on an ad hoc basis between scientists, and (ii) at the conclusion of the Research Program, DGI shall submit a report to Novo Nordisk stating all results of the Research Program. Upon the completion of said research, the Parties shall mutually decide whether further work is necessary. 6.4 (a) A Steering Committee shall be established. Novo Nordisk and DGI shall each appoint their members (one, maximum two) to the Steering Committee. However, each Party may bring as many representatives of its organization to a meeting of the Steering Committee as it chooses. (b) The Steering Committee shall be responsible for the following: i. overseeing execution of the Research Plan to be performed referred to in Section 6.3 of this Agreement; ii. review and report all DGI Technology being transferred to Novo Nordisk; iii. review and comment on all patent applications to be filed by either Party which are related to the Field; iv. perform such other duties as the Parties mutually agree upon; and v. determining which new technologies, know-how, inventions identified by each Party, will become part of Appendix C of this Agreement. (c) The Steering Committee shall make decisions by making a resolution, such resolution being passed unanimously. All decisions, resolutions and matters discussed at the Steering Committee shall be stated in minutes approved by both Parties. Should the Steering Committee not be able to make a unanimous decision, the matter shall be referred to the Corporate Vice President of Health Care Discovery at Novo Nordisk and to the President of DGI. (d) The Steering Committee shall determine all matters of a procedural nature for the conduct of its meetings, including but 12 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] not limited to, place, frequency and form. The first meeting ofthe Steering Committee shall take place no later than thirty (30) days after the execution date of this Agreement. 7. TECHNICAL INFORMATION AND KNOW-HOW During the Term, DGI shall disclose and furnish to Novo Nordisk all DGI Technology developed with the use of the [* *] and controlled by DGI during the Term subject to Section 2.3. 8. MARKETING AND PROMOTION Novo Nordisk shall employ resources in developing, registering, promoting, marketing and selling Licensed Products in the Territory that are consistent with its activities with respect to its other products of similar commercial potential and product profile, and it shall be solely responsible for developing and implementing a marketing plan for the Licensed Products. All costs and expenses in connection with the marketing, advertising and promoting of Licensed Products in the Territory shall be borne by Novo Nordisk. 9. PATENTS 9.1 DGI Patent Rights shall be maintained and prosecuted by DGI. The Parties shall mutually agree on patent counsel [* *]. The fees and expenses including, without limitation, filing, prosecution and maintenance fees and the fees and expenses of such patent counsel shall be paid by [* *]. Any additional countries which [* *] filing, shall be approved by both Parties. [* .*] 9.2 At least every six months and prior to filing of any DGI Patent Rights, DGI shall provide to Novo Nordisk an update on the status and progress of the filing, prosecution and maintenance of all patents and patent applications within DGI Patent Rights. DGI agrees to provide copies of all documents received from the relevant patent offices in relation to all DGI Patent Rights and further agrees to provide Novo 13 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] Nordisk with advance copies of any papers to be filed in a patent office relating to DGI Patent Rights with sufficient time for Novo Nordisk to provide its comments to DGI before the filing of said papers. 9.3 Novo Nordisk shall have the right to file patents based upon DGI Patent Rights, DGI Technology and/or the Licensed Product resulting from Novo Nordisk's research and development. Such patents shall be known as Novo Nordisk Patent Rights which are to be maintained, prosecuted and paid for by Novo Nordisk. 9.4 Without limiting the forgoing, each Party will have all rights of a joint owner under any joint patents or other inventions made jointly by both Parties ("Joint Patent Rights"). DGI agrees that Novo Nordisk shall be granted an exclusive license, even as to DGI, including the right to sublicense, to use Joint Patent Rights within the Field. The use of Joint Patent Rights outside the Field shall be mutually agreed by both Parties. Inventorship shall be determined according to US law. Joint Patent Rights shall be maintained, prosecuted and paid for by Novo Nordisk. 9.5 Except as otherwise explicitly licensed as provided herein each Party will, as between it and the other Party hereto, retain ownership of its own inventions, copyrights, trade secrets, patent rights and other technology. 9.6 All trademark and service mark rights and all goodwill associated with any trademarks and service marks used by Novo Nordisk and its Affiliates and sublicensees in connection with Licensed Products shall belong solely to Novo Nordisk. 9.7 The Parties shall furnish to the other Party copies of any proposed publication and/or presentation of results relating to the Field in advance of the submission of such proposed publication and/or presentation to a journal, editor or other third party. The receiving Party shall have two (2) months after receipt of said copies to object to such proposed presentation and/or proposed publication because there is patentable subject matter or other confidential information which needs protection. In the event, that the receiving Party objects, the other Party shall refrain from making such publication and/or presentation for a maximum of six (6) months from date of receipt of such objection. In no event, shall either Party be allowed to publish and/or present the peptide sequences and motifs and the other Parties' confidential or proprietary information without prior written approval. 14 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] 10. INFRINGEMENT OF DGI PATENT RIGHTS 10.1 Each Party shall advise the other promptly upon becoming aware of any infringement by a third party of DGI Patent Rights. 10.2 Novo Nordisk shall at Novo Nordisk's sole discretion, but including discussion with DGI, take such legal action as is required to restrain such infringement. DGI shall cooperate fully with Novo Nordisk, at Novo Nordisk's request, in Novo Nordisk's effort to restrain such infringement. DGI may be represented by counsel of its own selection at its own expense in any suit or proceeding brought to restrain such infringement but Novo Nordisk shall have the right to control the suit or proceeding. Any recovery obtained by Novo Nordisk as a result of such suit or proceeding whether by judgment, award, decree or settlement shall be first used to reimburse Novo Nordisk for its costs and expenses pursuing such suit or proceeding, and the remaining balance shall be split in the following manner: [* *]. 10.3 If Novo Nordisk elects not to initiate an infringement action within sixty (60) days of the mutual agreement of the Parties as to the existence of infringement of DGI Patent Rights, DGI shall have the right, in its sole discretion, to institute such action, at DGI's own expense. In such event, Novo Nordisk shall fully cooperate with DGI. Any recovery received by DGI as a result of such suit or proceeding whether by judgment, award, decree or settlement shall first be used to reimburse DGI for it's costs and expenses pursuing such suit or proceeding, and the remaining balance shall be [* *]. 11. WARRANTIES AND REPRESENTATIONS 11.1 DGI warrants and represents that it owns all rights, title and interest in and to the DGI Patent Rights and DGI Technology, exclusively licensed hereunder to Novo Nordisk for the Territory, and that it has the full right and authority to license the rights granted to Novo Nordisk hereunder. DGI further warrants and represents that, to the best of its knowledge, each patent within DGI Patent Rights is valid and enforceable, and that each patent resulting from a patent application therein shall be valid and enforceable. 11.2 Each party hereby represents, warrants and further covenants to the other that: (a) It has full authority to enter this Agreement in accordance with the terms of this Agreement; 15 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] (b)This Agreement is not in conflict with any other agreements to which it is party or by which it may be bound; (c) This Agreement when executed shall become the legal valid and binding obligation of it, enforceable against it, in accordance with its terms, except as enforceability may be limited by bankruptcy, insolvency, reorganization or other similar laws relating to the rights of creditors generally; and (d) It shall negotiate in good faith the execution of such other documents or agreements as may be necessary or desirable for the implementation of this Agreement and the effective execution of the transactions contemplated hereby. 12. INDEMNIFICATION 12.1 Each Party shall defend, indemnify and hold the other Party and its shareholders, directors, officers, employees and agents harmless from and against any and all claims, judgments, causes of action, costs, awards, expenses (including attorneys' fees and (other) expenses of litigation), arising out of the indemnifying Party's activities under this Agreement, including, as applicable, the manufacture, importation, use, promotion, marketing and/or sale of Licensed Product, unless such liability results from a breach of the indemnified Party's negligence or willful misrepresentations or other misconduct or a breach of the indemnified Party's warranties set forth in Section 11. 12.2 One Party shall promptly notify the other Party of any claims or suits for which said one Party may assert indemnification from said other Party hereunder and said one Party shall permit said other Party, or its insurer, at said other Party's expense, to assume or participate in the defense of any such claims or suits and said one Party shall cooperate with said other Party or its insurer in such defense when reasonably requested to do so. No settlement or compromise shall be binding on a Party hereto without its prior written consent. 13. CONFIDENTIALITY AND NON-DISCLOSURE 13.1 During the Term, DGI and Novo Nordisk may receive or have access to information that is confidential and proprietary to the other Party (as to either party, its "Information"), the maintenance of the secrecy and confidentiality of which is acknowledged by each Party to be important. For the purpose of this Section, "Recipient" refers to the Party receiving the Information from Discloser and "Discloser" refers to the Party disclosing the Information to Recipient. Information includes proprietary and confidential matters concerning certain know-how, 16 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] data and/or other matters related to the Discloser's current and/or proposed product(s), including but not limited to research, products, clinical data, insulin receptor, developments, inventions, processes, technology, security controls, marketing, finances and pricing. Confidential Information shall not include information which: (i) is known to the Recipient or is independently generated by or for Recipient without benefit of the Discloser's Confidential Information; (ii) is disclosed to the Recipient, without restriction, by an independent third party having a legal right to make such disclosure; (iii) is or becomes part of the public domain through no breach of this Agreement by Recipient; or (iv) the Recipient is required to disclose to relevant authorities in connection with its development or commercialization of a PLPc or Licensed Product pursuant to this Agreement. 13.2 During the Term and for five (5) years thereafter, Recipient (i) shall not, without the Discloser's prior written consent, disclose, use or permit to be used the other Party's Information in any manner except as expressly authorized by this Agreement (ii) shall treat such Information with at least the same degree of care that it treats its own confidential information, but in no event with less than a reasonable degree of care, and (iii) shall use its reasonable best efforts to prevent disclosure of Information to unauthorized parties. Recipient shall ensure that only its employees, authorized agents, or subcontractors or vendors who need to know the other Party's Information will receive such Information from Discloser and that such persons shall be bound to Recipient to the extent that Recipient can honor its obligations under the provisions of this Section 13. Upon demand, or upon the termination of this Agreement, the Parties shall comply with each other's instructions regarding the disposition or return of each other's Information in its possession or control. 13.3 Unless otherwise required by law, neither Party shall use the name, trademark or logo of the other Party in any marketing, advertisement or other publication, shall not make any public statement relating to the other Party, and will not release or disclose any information concerning the terms and conditions of this Agreement to any third party, without the prior written consent of the other Party, or as required to register, promote or sell Licensed Product. 14. COMPLIANCE WITH LAWS Each Party hereto agrees that it shall comply with all applicable international, country and local laws, ordinances and codes in performing its obligations hereunder, including the procurement of sublicenses, permits, certificates, 17 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] registrations and any other requirements necessary to comply with this Agreement. If at any time during the Term, a Party is informed, or information comes to its attention, that it is or may be in violation of any law, ordinance, regulation or code with respect to its activities hereunder, that Party shall immediately take all appropriate steps to attempt to remedy such violation and comply with such law, regulation, ordinance or code in all respects. Further, each Party shall establish and maintain all proper records required by any law or code of practice applicable to it from time to time. 15. NOTICES 15.1 Any notice required to be given pursuant to this Agreement shall be made in writing and shall be deemed to have been duly given if delivered by a recognized commercial courier service with receipt acknowledged, telefaxed with receipt acknowledged (and with a confirmation copy sent by registered mail, return receipt requested), or mailed by registered or certified mail, return receipt requested, postage prepaid, as follows: If to Novo Nordisk Novo Nordisk A/S Novo Alle 2880 Bagsvaerd Denmark Attention: Corporate Vice President of Health Care Fax: 011-45-4442-7280 With copy to: Novo Nordisk A/S Novo Alle 2880 Bagsvaerd Denmark Attention: Legal Department General Counsel Fax: 011-45-4498-0670 If to DGI DGI BioTechnologies, LLC 40 Talmadge Road P.O. Box 424 Edison, NJ 08818 Attention: Dr. Arthur J. Blume, President Fax: 732-287-1486 With copy to: Gibbons, Del Deo, Dolan, Griffinger & Vecchione One River Front Plaza 18 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] Newark, NJ 07102 Attention: Bernard S. Leon, Esq. Fax: 973-639-6461 16. GOVERNING LAW This Agreement shall be deemed to be a contract made under and construed in accordance with the laws of the State of New York, without regard to its conflicts of laws principles. The Parties agree that all disputes will be adjudicated in Federal Court with both Parties agreeing to waive trial by jury. 17. DISPUTE RESOLUTION 17.1 In the event of any dispute or disagreement between the Parties with respect to the interpretation of any provision of this Agreement or with respect to the performance by DGI or by Novo Nordisk of its duties hereunder, each of the Parties shall appoint a designated employee to meet for the purpose of endeavoring to resolve such dispute or to negotiate for an adjustment to such provision. 17.2 In the event, an amicable resolution is not possible the Parties will mutually agree to non-binding mediation. 17.3 Formal proceedings in Federal Court may only commence after the Parties have made a good faith attempt to resolve their dispute during a non-binding mediation proceeding. 18. TERM This Agreement shall become effective as of the Effective Date and shall continue through the Term, unless sooner terminated as provided in this Agreement. 19. TERMINATION 19.1 This Agreement may be terminated with the written approval of both Parties or upon default as provided in Section 19.2 of this Agreement. In the event such termination occurs prior to the payment of the license fees in Section 3.2 of this Agreement, Novo Nordisk will be required to make payment of such license fees to DGI on the notice of such termination. 19.2 If either Party at any time materially defaults (i) in making the payment of any money due hereunder, or (ii) in fulfilling any of the other obligations or conditions hereunder, the other Party may in its sole discretion waive the default; if not electing to waive the default, the 19 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] other Party shall notify the defaulting Party in writing of the default and allow the defaulting Party ninety (90) days from such notification to initiate reasonable steps to cure such default. Notwithstanding this section 19.2, if the defaulting Party disputes the existence, nature or extent of any default set forth above, the Parties shall use good faith efforts to resolve the dispute pursuant to Article 17. This Agreement shall continue until a final decision is reached pursuant to Article 17. 19.3 Either Party may terminate this Agreement by written notice to the other Party in the event the other Party: (a) become insolvent or bankrupt; (b) make an assignment for the benefit of its creditors; (c) appoint a trustee or receiver for itself for all or a substantial part of its property; (d) have any case of proceeding commenced or other action taken by or against itself in bankruptcy that is not dismissed within sixty (60) days of filing; or (e) seeks reorganization, liquidation, dissolution, a winding-up arrangement, composition or readjustment of its debts or other relief under any bankruptcy, insolvency, reorganization or other similar act or law or any jurisdiction, now or hereafter in effect. 19.4 Upon any termination of this Agreement, other than the expiration of the Term, if Novo Nordisk terminates in accordance with Section 19.3 or DGI is considered to be the defaulting Party pursuant to Articles 17 and 19, [* *] and DGI shall reconvey to Novo Nordisk all Novo Nordisk's confidential and proprietary information. In the event, Novo Nordisk is considered to be the defaulting Party pursuant to Article 17 and 19[* *] In addition, DGI and Novo Nordisk shall negotiate in good faith a license for Novo Nordisk's Patent Rights, confidential and proprietary information within the Field. 20. ASSIGNMENT 20.1 DGI shall notify Novo Nordisk with thirty (30) days prior written notice, in the event of a sale, assignment or transfer of its rights, title and interest in, to and under this Agreement to any parent, subsidiary, 20 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] affiliate or controlled corporation of corporations not within its current structure or to any successor by consolidation, merger or the corporate action or to a corporation or other business entity to which it may sell all or a percentage of it's assets. 20.2 In addition, all Novo Nordisk Information shall be returned to Novo Nordisk prior to such assignment. The assignee shall have no access to or rights in any Novo Nordisk Information and/or Novo Nordisk Patent Rights. It is expressly understood and agreed, that any assignee of any rights hereunder shall remain bound by the obligations hereof. 20.3 Neither Party may assign this Agreement except to a party acquiring all or substantially all of the assigning Party's business to which this Agreement relates without the prior written consent of the other Party, which consent shall not be unreasonably withheld. Notwithstanding this Section 20.3, Novo Nordisk may assign this Agreement without receiving prior written consent of DGI, to any of its Affiliates. Notwithstanding Section 20.1 and this Section 20.3, DGI shall not assign, sell and/or transfer in whole or in part this Agreement to Eli Lilly Co., Pfizer and Hoechst and/or their affiliates or divisions, without the prior written consent of Novo Nordisk. 21. SUCCESSORS This Agreement binds the heirs, executors, administrators, successors and assigns of the respective parties with respect to all covenants herein, and cannot be changed except by written agreement signed by both Parties. 22. SEVERABILITY Any provision of this agreement which is prohibited, unenforceable or not authorized in any jurisdiction shall, as to such jurisdiction, be ineffective to extent of such prohibition, unenforceability or non-authorization without invalidating the remaining provisions hereof or affecting the validity enforceability or legality of such provision in any other jurisdiction. 23. FORCE MAJEURE Neither of the Parties hereto shall be liable in any manner for failure or delay in fulfillment of all or part of this Agreement, directly owing to acts of God, governmental orders or restrictions, war, war-like conditions, revolution, riot, looting, strike, lockout, fire, flood or other causes or circumstances beyond the Parties' control. 21 "Omitted Information filed separately with SEC-Confidential Treatment Requested by New Brunswick Scientific Co., Inc." and indicated as [* *] 24. ARTICLE HEADINGS AND SECTION REFERENCES The Article headings contained herein are for reference only and shall not be considered a part of this Agreement, nor shall they in any way affect the interpretation thereof. Unless otherwise specified herein, all references in this Agreement to sections are to Sections of this Agreement. 24. COMPLETE AGREEMENT This Agreement supersedes any and all agreements, contracts or negotiations relating to the Licensed Product in the Territory. This Agreement is entire in itself and cannot be changed or terminated orally. No modifications of this Agreement shall be binding unless signed by the Party against whom it is sought to be enforced. This Agreement, together with the appendices shall be the entire agreement and express the complete, exclusive and final understanding of the Parties with respect to subject written approval herein and shall not be altered, amended or modified except in a writing incorporated hereto, and signed by the Parties. IN WITNESS WHEREOF, Novo Nordisk and DGI have caused this Agreement to be executed by their duly authorized officers. NOVO NORDISK A/S DGI BIOTECHNOLOGIES, LLC. BY:_____________________ BY:_____________________ MADS KROGSGAARD THOMSEN TITLE: CORPORATE VICE PRESIDENT TITLE:____________________ OF HEALTH CARE DISCOVERY DATE:___________________ DATE:____________________ 22 -----END PRIVACY-ENHANCED MESSAGE-----