During the student years, every single student is facing at least once with this task as a term paper. But if you still have not encountered such a task, or do not know how to perform it, then you have come to the right place.
In order to perform your term paper perfectly, you will need a lot of effort. You will need skills in planning, writing and time management. No less important will be the availability of free time for this task. Do not postpone it at the last minute and then you will succeed. There is always an occupation that will be much more interesting than writing a term paper. However, you should not succumb to temptation. If you do not rush to accomplish this task, then your chances of success will be quite high.
Let's see what kind of task this is like a term paper. So, this type of task is usually asked students as a research task. Such a task covers most of the teaching material during the academic term (semester or academic year). This type of assignment allows the professors to assess the knowledge and skills associated with the course. However, this kind of task may not be a large-scale, but as small research. This is lead on your professor.
The absence of grammatical errors and relevant vocabulary.
Processing a large amount of only relevant information.
A lot of spare time for work.
Be sure to clarify all the nuances and requirements for work with your professor. Do not postpone it to the very end.
Let some time to adjust and complement the work.
Unfortunately, many students do not take such a step as creating the skeleton of their work. Not enough time, desire, many other academic assignments and so on. And when it comes to writing a term paper, the student becomes a bewildered, where to start, especially when there is very little time left.
Hence, you must start with the creation of the so-called "skeleton" of our work! Having spent time on this stage, you will take your time in all subsequent stages of writing the term paper. Moreover, on the Internet, you can find many ready-made examples of term paper outline for your topic. Use them as a sample for your work. Do not copy the ready-made template, because in this case you run the risk of performing work not qualitatively.
The template will be your reference point and will guide you to the search for the information you need, thereby you protect yourself from spent hours on unnecessary information. Don't forget to pay your attention to the standard outline format which you have to use in your work.
What About the Term Paper Examples?
Nowadays, many ready-made works for college students are available on the Internet. However, on the part of the student, it will not be entirely sensible to give out a ready-made job from the Internet for its own. Since there are various risks: the risk of not high-quality work, uniqueness, relevance and so on.
However, nobody forbids students to use ready-made examples of a term paper, if this is used only as an example. We want to provide you with a step-by-step plan for an example of writing a term paper, relying on which you will be much easier to fulfill your task.
Whatever one may say, the first step is the choice of the topic. The topic can be chosen as a student, or be appointedas a professor. Perhaps the simplest step, as it seems at first glance. However, if you are allowed to choose a topic on your own, you should give it time. Choose a topic that will really interest you and then it will be easier for you to cope with the work. Also, see if there is enough information on your topic.
Then we begin to search for relevant information in libraries, books, articles, reviews, websites and so on. Try to understand as much as possible what information you need to select, so as not to be burdened by reading absolutely unnecessary information to you.
Actually,the second step is the understanding and reading of the material found. Therefore, it is not advisable to implement the recommendation from point two. This item will take the longest time. Since it is important not only to read everything that you have found but also to select and understand the material. Take notes. Do not forget that the facts and figures are important in your work. Also, remember that they must be held in the specified format.
Then follows the most ignored by the student's step. Create a template for your work on notes, so that you clearly understand the steps and sequence of your work.
After creating the contour, create a solid contour.
The most important and difficult step is to compose the introduction. Remember that in it you must write a good statement of the thesis.
Well, the last stages will be reading, editing and of course checking your work.
So, today we considered the structure of term paper. The template for your work will make it much easier to write terminology work. However, this does not eliminate all the rest of the hard work but helps you quickly organize the writing process. If you follow the steps outlined here, then you will undoubtedly create an excellent term paper!


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Meets the Secretary of the Interior's Professional Qualifications Standards for Architectural History.
Lesleigh has been at MASON since 2009.
Lesleigh's main goals in life are to one day have a pet squirrel and a greyhound (please don't tell her that those two aspirations are mutually exclusive). Her time in the U.S. Air Force took her to Turkey, allowing her to get up close and personal with some of the world's oldest built heritage. It also provided her with the GI bill to augment her B.A. in history with a newfound focus on Historic Preservation and Architectural History. She aspires to learn all of the history about almost all of the things, just because.
Her work at Mason consists mainly of gathering all the informational acorns available, producing unparalleled historic contexts and building descriptions, and then editing and formatting the heck out of them in MS Word. She also putters with GIS, creating interesting, useful maps.
Lesleigh is an active member of Docomomo Hawaii. She *will* travel for food.


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Martin Dale
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My Cd collection pt. 1
by Martin Dale
in Music blogs, reviews
I've finally moved to a permanent address, which means that I've finally unpacked my CD collection which has been in storage for about 7 years. Having set them up on shelves in the studio I've started playing through them in alphebetic order. So far I've got through:
The Adventure Babies: Laugh
The last album released on Factory Records and recorded at Mad Hat Studios in Wolverhampton. I was going out with an engineer from Mad Hat while it was being made and knew some members of the band and the engineer Mark Stuart. I met Steve Lilywhite, who produced the album (with Mark) at the Newhampton Pub one evening. I always liked TAB's catchy tunes and clever, unorthodox lyrics, and it's a good quirky, feelgood album
Aerosmith: Big Ones
I never consider myself a fan, but listening to this, it's astounding how many great songs they crammed onto this. And you really can't question the musicianship. Brilliant stuff and full of deserved hits.
AfroCelt Soundsystem: Vol 1 Sound Magic
The first Afro Celts album is still the best I think and it's great to hear it again. Whirl-y-reel was briefly included in Rumpus and The Rhythm Maniacs set when we had Matt playing Bass, whistle and Sax. Still as good as ever, and – having recently seen the new Emerson fronted line up – it's got the visual element of a record by a band I've seen live (although most of this line up wasn't there). Great and ground breaking record.
All About Eve: best of
I'm not a big fan of "best of" albums, but this has nearly the whole first album on it – which is what I really wanted, but this was on offer for a fiver! Martha's Harbour, Every Angel must die, Gypsy dance…amazing stuff. Shame they didn't keep the magic going longer.
Alphabeat: This is
An Ok album if you can ignore the terrible lyrics, and the out of place cover of Public Image. You can hear why they made such an impact when they came out, but in retospect, you can also hear that they didn't have enough substance to back it up with a second bearable album. Brainless fun for a party.
Altan: Best of
I know…another best of. Great band and this is one of my most played CD's (it never made storage in the cellar and has been with me the whole way through!) Concentrates mostly on the early years and is thus more whistle dominated than later stuff. Which is no bad thing.
Tori Amos: Tales from a Librarian
Terrific songs from a terrific artist. Crucify should zap straight on to my Spotify "Greatest Songs Ever Written" playlist
Anthony and The Johnsons: I am a bird now
I bought this on impulse after hearing Anthony do one song on a tribute show (I can't remember what show). I rather like his bizarre voice, the music is atmospheric and the theme of gender identity interesting…but a whole album is a lot to take at one time
Atomic Swing: In their finest hour
A great example of why the Swedish music scene has for years been one of the best. A real band playing real music with real songs about real things. The bass is beautifully abstract – he does exactly what you don't expect all the time. Love this band. Shame they didn't do more – I think this is a compilation of 2 albums. I knew Meat Swap Bossanova, from which many of the songs are taken, and I think they did one more. Weird in retrospect to hear Phil Spector singing on "So in need of a change".
B52's – Planet Clare
Early stuff from the great B52's – most of this is from 1979, and is the same material by and large they played when we saw them 2 years ago. Good live band, and that live vibe is captured perfectly on record. You can't help but love em!
I'll keep you posted as I continue…
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Sep 25, 2018 11:50
Black Foxxes release VADA studios version of 'Oh, It Had to Be You'
By Yasmin Brown
September 25, 2018 by Yasmin Brown
Just a few weeks after releasing their take on The Cure's 'Lovesong', Black Foxxes have now treated us to a stunning and emotional live studio version of 'Oh, It Had to Be You', a fan favourite from the band's second album, reiði.
The song is one that resonated with fans immediately after the album's release, something that was quickly picked up on by the band, and this version of the beloved track feels like a thank you to those fans, with Black Foxxes tweeting:
"I remember the moment we wrote this track feeling like it was a huge jump for us sonically, we just didn't think it would connect with you as quickly as it did. Oh, it had to be you".
Watch the VADA studios version below.
Yasmin Brown
Cider lover and baby animal enthusiast. Yasmin can usually be found front and centre at music venues across Cambridge and London - probably with tears of joy streaming down her face.
Follow @yasnimnicole


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In past years, we've organized fire sales inviting friends and some industry folk to drive over to our studio and fill their cars and vans with treasure. But with the current administration cutting funding to the Arts, we decided to donate LMD's unwanted inventory to Materials for the Arts. It was my colleague Rebecca who found the organization and donating to MFTA was the best thing we could have done with our supplies and hard goods.
Materials for the Arts collects unneeded items from businesses and individuals, and make these donations available for free to its recipients: nonprofit organizations with arts programming, government agencies, and public schools. It felt good to purge and declutter but my team and I had no idea that the do-good feeling was only just about to begin.
When someone donates to MFTA, you receive thank you letters from every organization that has taken your wares. It was very rewarding for the LMD staff and I to read about where our things landed and how the items were used. We received letters from The Lowell School, a not for profit coed special education school that has a visual arts and theater program, The Church of Saint Luke in the Fields conducts a Saturday evening performance art class for LGBTQA homeless teenagers, and Housing Works thanked us on behalf of their Adult Day Healthcare facility, serving clients who have HIV/AIDS. There were many other letters, varying from charter schools focused on special needs children to Senior programs in under resourced communities but the one thing they all have in common is a shoe string budget for Arts programming. If you are able to donate to this amazing organization, I encourage you to do so, the timing couldn't be more right.
The MFTA warehouse is operated by the New York City Department of Cultural Affairs with additional support from the City's Departments of Sanitation and of Education.


Earlier this week, Judge Richard G. Andrews, U.S. District Court Judge for the District of Delaware decided a veritable plethora of post-trial motions (by both parties) in Amgen Inc. v. Hospira, Inc. (he denied them all). These included Hospira's Rule 50(a) Motion for Judgment as a Matter of Law on the Issues of Safe Harbor, Noninfringement, Invalidity, and Damages and related briefing, Hospira's Motion for Judgment as a Matter of Law Under Rule 50(b) and, in the Alternative, For Remittitur or New Trial Under Rule 59 and related briefing, Hospira's Motion to Seal Confidential Exhibits Admitted at Trial and related briefing, Amgen's Renewed Motion for Judgment as a Matter of Law of Infringement of the '349 Patent or, in the Alternative, for a New Trial and related briefing, and Amgen's Motion for Prejudgment and Post-judgment Interest and related briefing. Of note is the basis for the Court's denial of Hospira's safe harbor motion under the provisions of the Biologics Price Competition and Innovation Act (BPCIA).
24. A method of preparing erythropoietin molecules having a predetermined number of sialic acids per molecule said number selected from the group consisting of 1-14, comprising applying material containing erythropoietin to an ion exchange column and selectively eluting said molecules from the column.
27. A method for obtaining an erythropoietin composition having a predetermined in vivo specific activity comprising preparing a mixture of two or more erythropoietin isoforms of claim 1.
1. An isolated biologically active erythropoietin isoform having a single isoelectric point and having a specific number of sialic acids per molecule, said number selected from the group consisting of 1-14, and said isoform being the product of the expression of an exogenous DNA sequence in a non-human eucaryotic host cell.
1. Vertebrate cells which can be propagated in vitro and which are capable upon growth in culture of producing erythropoietin in the medium of their growth in excess of 100 U of erythropoietin per 106 cells in 48 hours as determined by radioimmunoassay, said cells comprising non-human DNA sequences which control transcription of DNA encoding human erythropoietin.
2. Vertebrate cells according to claim 1 capable of producing in excess of 500 U erythropoietin per 106 cells in 48 hours.
3. Vertebrate cells according to claim 1 capable of producing in excess of 1000 U erythropoietin per 106 cells in 48 hours.
4. Vertebrate cells which can be propagated in vitro which comprise transcription control DNA sequences, other than human erythropoietin transcription control sequences, for production of human erythropoietin, and which upon growth in culture are capable of producing in the medium of their growth in excess of 100 U of erythropoietin per 106 cells in 48 hours as determined by radioimmunoassay.
5. Vertebrate cells according to claim 4 capable of producing in excess of 500 U erythropoietin per 106 cells in 48 hours.
6. Vertebrate cells according to claim 4 capable of producing in excess of 1000 U erythropoietin per 106 cells in 48 hours.
7. A process for producing erythropoietin comprising the step of culturing, under suitable nutrient conditions, vertebrate cells according to claim 1, 2, 3, 4, 5 or 6.
The Court also assessed damages in the amount of $70 million, inclusive of pre- and post-judgment interest.
Hospira contended that the jury instructions were "legally erroneous and prejudicial," inter alia, because "ulterior motives and intent are irrelevant to [entitlement to] the Safe Harbor." Specifically, Hospira argued that the instructions did not clarify the use of the terms "use" and "make" as relevant to whether an activity was entitled to the safe harbor provisions of the statute. ("We would urge the broader standard for uses, but focus on the instruction should be on the uses and not the motives or purposes in making [a] batch. The statutory exemption is premised on the use aspect.") According to Hospira, the jury was asked to determine whether "manufacture" of the accused infringing article (biosimilar erythropoietin, bEPO) fell under the safe harbor when the only burden Hospira rightfully was obliged to meet was whether "use" of the allegedly infringing bEPO was "reasonably related to obtaining FDA approval." The Court disagreed, stating that "Hospira's potentially infringing 'use' of Amgen' s patented invention is Hospira's manufacture of the EPO drug substance referred to in its BLA (i.e., Hospira's performance of the steps of Amgen's method claims), not Hospira's subsequent use of the EPO drug substance (i.e., Hospira's subsequent use of the product obtained by practicing Amgen's method claims)." Thus, the safe harbor is available to Hospira only if manufacture of its bEPO was "reasonably related to obtaining FDA approval." Hospira's subsequent use of the bEPO is "probative in determining whether Hospira's manufacture of its EPO drug substance was reasonably related to obtaining FDA approval, [but] it is the manufacture itself (not Hospira's subsequent uses of EPO drug substance) that is the potentially infringing act which must be evaluated for safe harbor protection."
[A]dopting Hospira's interpretation of the safe harbor defense would expand the defense beyond recognition and create a loophole that would make it virtually impossible to prove infringement in cases involving products regulated by the FDA. Since Hospira's interpretation requires ignoring intent in deciding whether the safe harbor applies, a party could manufacture 200 drug substance batches and earmark them for future use as commercial inventory without infringing, so long as the party used each of those batches for at least one test to generate data of the type used by the FDA in determining whether to approve the drug. In that scenario, each batch would be tested to generate data that could conceivably be used to respond to inquiries from the FDA, making each batch reasonably related to obtaining FDA approval. Essentially, Hospira's interpretation allows a single "token" submission of information derived from a potential infringing act to exempt that act from infringement, without regard to the realities surrounding the potentially infringing act. It seems to me that Hospira's interpretation reads the words "solely" and "reasonably" out of the statute, and that a party's stated intent may be considered as part of whether the manufacture or use of a patented drug was "solely for uses reasonably related to" obtaining FDA approval. I think that the jury instructions properly recited the role of intent in the safe harbor analysis.
The hypothetical nicely illustrates the practical considerations behind the scope of the safe harbor, and how these considerations influence how courts evaluate the safe harbor's proper scope.
The high cost of biologic drugs was one of the (if not the) most compelling motivations for Congress to adopt a biosimilar pathway as part of the Affordable Care Act in 2010 (aka "Obamacare"). Passage of the Biologic Price Control and Innovation Act (BPCIA, codified at 42 U.S.C. § 262(k)) created for the first time a pathway for FDA approval of biosimilar drugs in the U.S. But from the beginning there have been grumblings, particularly regarding the term of the data exclusivity period (see "Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term"; "President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements"; "Senators Send Letter on Biosimilars to FDA"; "Senators Back 12-Year Data Exclusivity Period for Biosimilars and President Obama (Once Again) Does Not"; and "President's Latest Budget Proposal Seeks Decrease of Data Exclusivity Period and Elimination of Pay-for-Delay Agreements"). As biosimilar applicants have utilized the FDA's implementation of the abbreviated biologics license application (aBLA) pathway, and parties and the courts have begun to work out the litigation provisions of the Act (42 U.S.C. § 262(l)), the question of settlement of such litigation has arisen. As mentioned in a recent roundup of the biosimilar landscape (see "Status of U.S. Biosimilar Approvals and Pending Applications"), there have been several biosimilar patent litigations that have settled or been avoided by licenses between branded biologic drug makers (termed "reference product sponsors" under the law) and biosimilars applicants. For example, Genentech entered a global licensing agreement on March 31, 2017 with Mylan/Biocon over their Herceptin® biosimilar, Ogivri (trastuzumab-dkst) (although this biosimilar is not yet on the market), and Amgen/Samsung-Bioepsis's Amjetiva® (adalimumab-atto) is scheduled to enter the market in competition with AbbVie's Humira® in January 2023 as the result of a settlement agreement between the parties (see "HUMIRA® Biosimilar Update -- Settlement in AbbVie v. Amgen Case Announced and AbbVie v. Boehringer Ingelheim Litigation Begins").
Settlement agreements between conventional branded and generic drug makers were the source of a long dispute between pharmaceutical companies and the Federal Trade Commission, culminating in the Supreme Court's decision in FTC v. Actavis in 2013. Before that decision, Congress implemented a protocol requiring any such "reverse payment" settlement agreements (called "pay-for-delay" by the FTC and those opposed to the practice) to be vetted by the Commission, wherein ones deserving of suspicion as being anticompetitive would come to the FTC's attention (and presumably corrective action).
No such regime has been put in place for biosimilar drugs, and two Senators, Charles Grassley (R-IA) and Claire Klobucher (D-MN), think the FTC should commence review of the Humira® settlement. Part of their angst on the issue is a disparity of biosimilar entry dates between the U.S. (2023) and Europe (October 2018). Part is their innate inclinations: Senators Grassley and Klobucher have carried the branded company abuse torch for a while (see "The CREATES Act of 2016: Senate Listens to Generics Industry"). And of course perhaps the biggest factor is the high cost of Humira®, which is and has been the top-selling biologic drug for several years, and the price of which cannot but help to be reduced when biosimilar competitors enter the marketplace. It must be noted in passing, however, that the size of such a reduction is unlikely to be as great as has been the case for conventional generic small molecule drugs. In a fashion predicted by an FTC White Paper prepared before enactment of the BPCIA (see "No One Seems Happy with Follow-on Biologics According to the FTC"), the few biosimilar providers on the market have priced their drugs at only 15% less than the reference product sponsor (Sandoz's Zarxio® (filgrastim-sndz) (in competition with Amgen's Neupogen®); Pfizer's Inflectra® (infliximab-dyyb) (in competition with J&J/Janssen's Remicade®), although Merck-Samsung-Bioepsis's Renflexis® (infliximab-abda) (another Remicade® competitor) launched at risk (i.e., while patent litigation was on-going) at a 35% discount). While this is a significant savings in aggregate (say, for example, insurers and the Federal government), it is not the windfall for consumers that some (including perhaps these Senators) seem to think it will be.
As yet the Commission has not responded publicly.
Last month, in Celltrion, Inc. v. Genentech, Inc., District Judge Jeffrey S. White of the U.S. District Court for the Northern District of California granted two motions to dismiss filed by Defendants Genentech, Inc.; Hoffman La-Roche, Inc.; and City of Hope ("Genentech"), which sought to dismiss the first amended complaint filed by Plaintiffs Celltrion, Inc.; Celltrion Healthcare, Co. Ltd.; Teva Pharmaceuticals International GMGH; and Teva Pharmaceuticals USA, Inc. ("Celltrion"). Celltrion had initiated the dispute between the parties by filing complaints for declaratory judgment with respect to patents related to Genentech's Herceptin and Rituxan biologic drugs.
Both of the cases involve the Biologics Price Competition and Innovation Act of 2009 ("BPCIA"), which provides a regulatory approval pathway for biosimilar drugs. Under the BPCIA, a biologic licensed by the U.S. Food and Drug Administration is known as a reference product, and the entity that manufactures the reference product is known as the reference product sponsor ("RPS"). An entity that wishes to manufacture a biosimilar drug -- the biosimilar applicant (BA) -- may apply to the FDA for approval, and upon a showing that there are no "clinically meaningful differences" between the biosimilar drug and the biologic drug, can procure FDA approval for the biosimilar drug.
The two cases between Celltrion and Genentech relating to Herceptin and Rituxan involved §§ 262(l)(5)(A) and 262(l)(5)(B)(i), which specify the steps in the patent dance that take place after the biosimilar applicant and reference product sponsor engage in "good faith negotiations" to reach an agreement identifying the patents that will be the subject of patent infringement litigation (pursuant to § 262(l)(4)(A)). If the biosimilar applicant and reference product sponsor cannot agree on a list of patents to be litigated, the parties must simultaneously exchange lists of patents that each believes should be immediately litigated ("5(B) Lists"), and before that exchange takes place, the biosimilar applicant must identify the number of patents that it will identify on its own 5(B) List ("5(A) Number"). Pursuant to § 262(l)(9)(B), if a biosimilar applicant fails to serve its 5(A) Number or 5(B) List (or comply with several other steps), the applicant may not bring an action for declaratory judgment.
With respect to Herceptin, Celltrion had applied for FDA approval to market a biosimilar of that biologic drug called "Herzuma," and received notice that its application had been accepted by the FDA for review. When it came time for the parties to conduct good faith negotiations, Genentech proposed that the parties agree to litigate a discrete number (fewer than all) of the patents under discussion, and Celltrion responded by indicating that it wished to litigate a larger number of patents than Genentech's opening offer. Without providing its 5(A) Number or 5(B) List, Celltrion served a notice of commercial marketing on Genentech and then filed a declaratory judgment action against Genentech regarding the Herceptin patents it wished to litigate.
With respect to Rituxan, Celltrion had applied for FDA approval to market a biosimilar of that biologic drug called "Truxima," and received notice that its application had been accepted by the FDA for review. During good faith negotiations, Celltrion indicated that it wished to litigate all forty of the patents Genentech had placed on its § 262(l)(3)(A) List. As with Herceptin, Celltrion served a notice of commercial marketing on Genentech without providing its 5(A) Number or 5(B) List, and then filed a declaratory judgment action against Genentech regarding the Rituxan patents Celltrion wished to litigate.
Genentech responded to the declaratory judgment actions by filing motions to dismiss both suits for lack of subject matter jurisdiction, or alternatively, failure to state a claim. With respect to subject matter jurisdiction, the District Court noted that "Genentech has cited no 'clear statement' by Congress suggesting that Congress intended the BPCIA's requirements to be jurisdictional prerequisites," and therefore treated Genentech's motions as seeking dismissal for failure to state a claim under Federal Rule of Civil Procedure 12(b)(6).
In arguing against those motions, Celltrion contended that it may streamline its obligations under the BPCIA and satisfy several steps of the patent dance at once. In particular, Celltrion argued that it was absolved of the responsibility to comply with § 262(l)(5) because it told Genentech it "wished" to litigate all of the patents on Genentech's § 262(l)(3)(A) Disclosure, and that this statement both fulfilled its obligations to engage in "good faith negotiations" under § 262(l)(4) and made the exchange of the 5(A) Number and 5(B) Lists "redundant." The District Court, however, countered that "[t]his argument . . . improperly conflates Sections (l)(4) and (l)(5)," pointing out that "[t]he parties' obligations under Section (l)(5) only arise if the parties are unable to agree, after fifteen days of good faith negotiations, on a final and complete list of patents to litigate in Phase I." The Court concluded that "[g]iven the plain language of this provision, and the relationship between Sections (l)(4) and (l)(5) more generally[,] . . . no single statement or gesture can satisfy the requirements of both sections simultaneously."
With respect to the Rituxan complaint, Celltrion argued that that it was not obligated to offer its 5(A) Number or exchange 5(B) Lists because it filed its lawsuit nine days before the expiration of the fifteen-day period provided under § 262(l)(4) for good faith negotiation. The Court found this argument to be unpersuasive, noting that "[b]y this argument, Celltrion suggests that the filing of this declaratory judgment action was permissible because it skipped required statutory steps, where the non-occurrence of those statutory steps explicitly bars Celltrion from filing this action—an unpersuasive legal Catch-22." The Court stated that "Celltrion was obligated to complete all required procedures before filing this lawsuit, and it did not."
Celltrion's final argument was that the notices of commercial marketing it served for Herzuma and Truxima enabled it to file the declaratory judgment actions regardless of its compliance with other portions of the BPCIA. In particular, Celltrion contended that because a notice of commercial marketing lifts the ban on declaratory judgment actions described in § 262(l)(9)(A), a notice of commercial marketing should also lift §§ 262(l)(9)(B) and (C)'s prohibitions. The District Court, however, pointed out that the Central District of California had recently considered and rejected a similar argument in Amgen v. Genentech, Inc., 17-cv-7349-GHW, 2018 WL 910198 (C.D. Cal. Jan. 11, 2018). The Court reiterated that "a notice of commercial marketing only opens the door for an applicant to file a declaratory judgment action if the applicant complies with the rest of the statute."
"Because Celltrion did not complete its obligations under Section (l)(5)," the District Court determined that "Celltrion may not file actions for declaratory judgment with respect to the patents at issue," and therefore granted both of Genentech's motions to dismiss, while affording Celltrion leave to amend its complaints.
Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2017) -- One Last Dance . . .
Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the Court held that the 180-day notice-of-commercial-marketing provision of the statute may be provided either before or after receiving FDA approval. In addition, with respect to the so-called "Patent Dance," the Supreme Court held that a reference product sponsor ("RPS") cannot seek enforcement of the aBLA disclosure provision in 42 U.S.C. § 262(l)(2)(A) by injunction under federal law. This ruling all but made the Patent Dance optional for biosimilar applicants. Nevertheless, the Court left open a tiny ray of hope for patent owners by reversing and remanding the question whether the disclosure provision of the BPCIA was enforceable under state law. In a decision that came out earlier today, the Federal Circuit extinguished any hope. First, the Federal Circuit reasoned that it has discretion to address the preemption issue, and that it should exercise that discretion, notwithstanding the fact that the issue had not yet been addressed on the merits. Second, it held that the BPCIA's comprehensive framework demonstrates the intent of Congress that federal law would exclusively occupy the field of biosimilar patent litigation. And finally, the Federal Circuit held that any remedy provided for under state law would conflict with the careful balance struck by Congress in establishing the BPCIA. As a result, the Court affirmed the District Court's initial dismissal of Amgen's state law claims.
We provide this background possibly for the last time -- this case stemmed from the aBLA filing by Sandoz pursuant to the BPCIA to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic drug product. In the interim, the FDA approved the biosimilar known as ZarxioTM in March of 2015, and Sandoz (a Novartis company) has been selling the drug in the U.S. since September 3, 2015. However, despite availing itself of the BPCIA-abbreviated pathway for FDA approval, Sandoz refused to participate in the patent resolution component (the disclosure and information exchange provisions, also known affectionately as the "patent dance"), alleging that it was not a mandatory component. Amgen responded by filing suit in the Northern District of California, requesting in part a preliminary injunction to prevent Sandoz from entering the market. United States District Judge Seeborg of the Northern District of California denied Amgen's motion, the Federal Circuit (in a seriously fractured decision) essentially affirmed, and the case was taken up by the Supreme Court. In ruling as indicated above, the Supreme Court noted that the previous Federal Circuit decision that interpreted California's unfair competition law to not provide a remedy was based on an incorrect interpretation of federal law. With regard to whether Sandoz's failure to disclose its application and manufacturing information was "unlawful" under California's unfair competition law, the Supreme Court declined to resolve that dispute because it was not a question of federal law. The Federal Circuit, therefore, erred in attempting to answer the state-law question by referring to the BPCIA alone (according to the Supreme Court). Therefore, the Federal Circuit was charged with determining "whether California law would treat noncompliance with §262(l)(2)(A) as 'unlawful.'"
If the answer is yes, then the court should proceed to determine whether the BPCIA pre-empts any additional remedy available under state law for an applicant's failure to comply with §262(l)(2)(A) (and whether Sandoz has forfeited any pre-emption defense, see 794 F. 3d, at 1360, n. 5). The court is also of course free to address the pre-emption question first by assuming that a remedy under state law exists.
Sandoz Inc. v. Amgen Inc. (2017).
The Court first addressed the question whether Sandoz had waived the preemption defense. Sandoz has raised preemption as a defense in its answer, although it had not yet been addressed by the District Court or the Federal Circuit. As "'a general rule . . . a federal appellate court does not consider an issue not passed upon below.'" Amgen Inc. v. Sandoz Inc. (citing Singleton v. Wulff, 428 U.S. 106, 120 (1976)). Nevertheless, the Federal Circuit had previously articulated reasons to exercise discretion to address issues anyway. Relevant to this case is when the issue presents significant questions of general impact or of great public concern, specifically here "whether state law claims may play a role in enforcing compliance with § 262(l)(2)(A)." Moreover, because Sandoz had preserved its ability to assert preemption by including it as a defense in its answer, it could have raised it on remand, thereby lessening (or eliminating) any prejudice to Amgen. Finally, the preemption issue had been fully briefed. Of course, it didn't hurt the analysis that the Supreme Court had also directed the Federal Circuit to consider the issue on remand.
The Supremacy Clause of the Constitution (U.S. Const. art. VI, cl. 2), provides that federal law "shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby . . . ." Preemption can either be by express preemption, field preemption, or conflict preemption." The BPCIA did not expressly preempt state law, so the Federal Circuit addressed the other two forms.
Field preemption occurs when Congress intended the Federal Government to exclusively occupy a particular field. There is, however, a presumption against preemption in a field in which states have historically legislated. The Federal Circuit easily found no presumption against preemption for biosimilar patent litigation. The Court then noted that patents are 'inherently federal in character' and that the FDA has exclusive authority to license biosimilars. Moreover, the Court noted that the BPCIA is "comprehensive" and "'provide[s] a full set of standards governing' the exchange of information in biosimilar patent litigation, 'including the punishment for noncompliance.'" Amgen Inc. v. Sandoz Inc. (citing Arizona v. United States, 567 U.S. 387, 401 (2012)). Such a comprehensive and calibrated scheme makes the inference that Congress left no room for the States reasonable. Finally, the Court noted that the relief Amgen was seeking from California law was not provided for by the BPCIA. For example, Amgen was seeking an injunction that the Supreme Court made clear was unavailable under Federal law. "This conflict in available remedies between federal and state law 'underscore[s] the reason for field preemption.'" Id.
If state law conflicts with federal law, it can also be preempted. This "occurs 'where it is impossible for a private party to comply with both state and federal requirements, or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Amgen Inc. v. Sandoz Inc. (citing Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947)). The Federal Circuit found that Amgen's state law claims "clash" with the BPCIA, and that the differences in available and sought-after remedies supports the conclusion that the state law claims are preempted. The Court reasoned that Congress acted intentionally when it did not provide for injunctive relief, and that if Amgen were able to seek such a remedy under state law, it "'would interfere with the careful balance struck by Congress.'" Amgen Inc. v. Sandoz Inc. (citing Arizona, 567 U.S. at 405-06). As the Court ultimately concluded on the issue: "the preemption analysis here demonstrates that Amgen's state law claims conflict with the BPCIA and intrude upon a field, biosimilar patent litigation, that Congress reserved for the federal government."
So will this be the last "Amgen v. Sandoz" case in this family? The Federal Circuit affirmed the dismissal of Amgen's unfair competition and conversion claims because they were preempted on both field and conflict grounds. Correspondingly, the case was not remanded back to the District Court. Therefore, unless a petition for either panel rehearing or rehearing en banc is granted, or the Supreme Court grants another petition for cert., it is very possible that we have just seen the last dance of Amgen v. Sandoz.
Earlier today, both parties to the AbbVie v. Amgen litigation announced a settlement that resolves all intellectual property-related litigation over Amgen's FDA-approved adalimumab biosimilar AMGEVITA™/AMJEVITA™ (see AbbVie press release & Amgen press release). While the financial terms of the agreement were not disclosed, it was reported that AbbVie will grant non-exclusive patent licenses worldwide, on a country-by-country basis, for the use and sale of Amgen's biosimilar product. AMGEVITA is expected to launch in most countries of the European Union on October 16, 2018, and AMJEVITA (adalimumab-atto) in the U.S. on January 31, 2023. AbbVie reported that all related pending litigation will be dismissed, and that "Amgen has acknowledged the validity of AbbVie's intellectual property related to HUMIRA." The prices of both companies' stock were up at the end of the day, although on a percentage basis, AbbVie's was up higher. This could be due to the certainty in the delay of competition that AbbVie will face from Amgen in the United States. However, HUMIRA could face competition from Boehringer Ingelheim's biosimilar Cyltezo (adalimumab-adbm), which was approved by the FDA in late August (see "FDA Approves First Cancer-Treatment Biosimilar -- Amgen's Mvasi").
As we reported at the time, AbbVie filed suit against Amgen in the United States District Court for the District of Delaware on August 4, 2016, pursuant to the BPCIA and 35 U.S.C. 271(e)(2)(C). In its Counterclaims and Answer, Amgen reported that it had certified to AbbVie that it would not begin commercial marketing of its biosimilar before at least one of the patents identified by AbbVie had expired on December 31, 2016. Obviously, Amgen did not launch-at-risk after that date. Moreover, Amgen had stated that it intended to fully comply with the 180-day Notice of Commercial Marketing provision of the BPCIA (at least as it understood it before the Supreme Court's Sandoz v. Amgen case), which would have prevented them from launching until at least March, 2017. However, the present litigation only encompassed 10 of the 61 patents identified by AbbVie and Amgen during the so-called patent dance. Because AbbVie would have certainly filed the second-phase litigation if Amgen had provided commercial-marketing notice, it is reasonable to assume that such notice was not yet given.
The AbbVie v. Boehringer Ingelheim litigation, on the other hand, is just getting started. On August 2, 2016, almost a year after the Amgen case, AbbVie sued Boehringer pursuant to the BPCIA and 35 U.S.C. 271(e)(2)(C) because Boehringer submitted its application to the FDA to market its HUMIRA® biosimilar. Boehringer answered the Complaint on September 11, 2017. AbbVie alleged that there are more than 100 patents concerning the HUMIRA product, and that it identified 74 of which that were (or would be) infringed. Nevertheless, because Boehringer, as the Biosimilar application, had the ability to cap the number of patents in the suit, the initial phase litigation only concerns eight patents. Boehringer had selected the number of patents each side could identify for litigation as five, but the litigation only concerns eight patents because two appeared on both lists. The second wave can only occur after Boehringer provides its 180-day commercial-marketing notice.
Boehringer also identified AbbVie's '041 patent asserted in the Amgen case, and listed the '666 patent, which Amgen had similarly listed. For those interested, the entire list of 74 patents can be found on pages 15-19 of the complaint. Boehringer asserted, though, that at least four of these patents were improperly listed, as they had either expired or had been determined by the PTAB to be unpatentable. This case is at the very early stages, and there have been no reports of its settlement. As always, we will continue to monitor this case and provide updates as warranted.
In the third installment of the "Amgen v." trilogy of BPCIA Federal Circuit cases, the Court in Amgen Inc. v. Hospira, Inc. answered a question that had been lingering since the very first case -- can a reference product sponsor use discovery to obtain information from a biosimilar applicant if it does not receive a copy of the aBLA or other information about the manufacturing process as required by the BPCIA? In Amgen v. Sandoz, the first case in this series, the Federal Circuit found that an aBLA applicant was not required to disclose its application and related information, but noted that such information could be accessed through discovery after an infringement suit is filed. In the second installment, Amgen v. Apotex, the plot centered on the Notice-of-Commercial-Marketing provision, and did not focus significantly on the provisions of 42 U.S.C. § 262(l)(2)(A). In this most recent case, the Court appears to have closed the discovery loophole it created, at least with respect to cases in which the requested information is not relevant to the asserted patents. More importantly, reference product sponsors suffered another blow when the Court suggested that if a patent was not included in its paragraph (l)(3)(A) list, even if there was no reason to suspect that it might be relevant to the present case, the BLA holder could be precluded under 35 U.S.C. § 271(e)(6)(C) from ever asserting that patent (depending on what "under this section" turns out to mean). Of course, this could lead to the unintended (or maybe intended) consequence of overly long patent lists containing every conceivable patent that could be related to the manufacture of biologics in situations when inadequate information has been provided.
This case stems from Hospira's subsection (k) biosimilar application seeking approval to market a version of Amgen's EPOGEN® drug product. BLA 125545 was submitted in December 2014, and shortly thereafter Hospira provided its application to Amgen. Nevertheless, it did not otherwise provide any additional manufacturing information. On March 31, 2015, Amgen alerted Hospira that it had failed to comply with paragraph (l)(2)(A) of the BPCIA. Hospira responded that the application contained sufficient information about both the product and the process of its manufacture. Notwithstanding, the parties conducted the patent dance. However, Amgen did not include any cell-culture patents on its paragraph (l)(3)(A) patent list because it alleged it could not "assess the reasonableness of asserting claims for infringement" without the requested information.
Amgen ultimately filed suit on two patents in the U.S. District Court for the District of Delaware, U.S. Patent Nos. 5,756,349 and 5,856,298. Relying on the Amgen v. Sandoz statement referenced above, Amgen sought discovery of the withheld information, including the composition of Hospira's cell-culture medium. After Hospira refused to produce the information, the Court denied a motion to compel discovery filed by Amgen because the information sought had "essentially no relevance to the patents that are asserted." Amgen sought interlocutory appeal and in the alternative mandamus under the All Writs Act.
With regard to whether the Federal Circuit had jurisdiction, the Court looked to the collateral order doctrine to see if the appeal could be heard regardless of the fact that the judgement was not yet final. The test, established by the Supreme Court, is that "the order must conclusively determine the disputed question, resolve an important issue completely separate from the merits of the action, and be effectively unreviewable on appeal from a final judgment." Coopers & Lybrand v. Livesay, 437 U.S. 463, 468 (1978). After acknowledging that the first two conditions were met, the Court concluded that the lower Court's order was not "effectively unreviewable." In general, discovery rulings fall outside the collateral order doctrine because they are reviewable upon final judgement. Moreover, this was not a case analogous to an order to unseal confidential information or deny a claim of immunity. In essence, this was found to be a "run-of-the-mill discovery dispute," and therefore the Court determined it lacked jurisdiction.
With regard to the request for mandamus, the Court noted that such a writ is a "drastic remedy reserved for the most 'extraordinary causes,'" citing Cheney v. U.S. Dist. Court for D.C., 542 U.S. 367, 380 (2004). Amgen's right to the issuance of a writ, according to Supreme Court precedent, centered on whether there was a "clear and indisputable" right to that relief. The Court identified five potential avenues based on the BPCIA, but immediately shot down two or three of them. The first -- an injunction under federal law compelling the disclosures -- was foreclosed in the Supreme Court's Sandoz v. Amgen decision. The second -- an injunction under state law compelling the disclosures -- was left open by the Supreme Court, but Amgen had not sought a state law remedy in the Hospira case. Third -- suing the biosimilar applicant under the BPCIA and 35 U.S.C. § 271(e)(2) for failure to comply with the information disclosure provision -- was also foreclosed by the Supreme Court. The Court had explained in Sandoz that it was the act of submitting the aBLA to the FDA that gave rise to the artificial infringement, not the failure to comply with the provisions of the BPCIA.
The final two potential avenues arise from the ability of the reference product sponsor to bring an infringement suit: either pursuant to the list of patents created under paragraph (l)(3)(A) (avenue 4), or patents that "could" be identified in the case the aBLA is not disclosed (avenue 5). The Court did not address avenue 5. Rather, it noted that Amgen provided a patent list, and sued Hospira on two of the patents on that list. However, neither of those patents related to cell-culture media. The Federal Circuit back-peddled from its previous statement in Amgen v. Sandoz (that discovery would always be available) by claiming it had never intended to alter the Federal Rules of Civil Procedure.
Importantly, the Court addressed a question that Practitioners have been wondering ever since the original Amgen v. Sandoz decision: whether a reference product sponsor could assert a patent in the BPCIA context if it did not receive sufficient information from the biosimilar applicant about that patent. For example, would Amgen have faced Rule 11 sanctions for asserting the cell-culture patent, considering it did not know if Hospira was indeed practicing the invention claimed therein? The solution, according the Federal Circuit, is for a patent owner to include every patent that it could conceivably assert on its (l)(3)(A) list. After all, the statute does not provide for sanctions if a patent is unreasonably listed. In fact, it is the response from the biosimilar applicant in its "detailed statement" that could give rise to the reasonable basis for asserting the patent in litigation. Moreover, Rule 11 only requires that a filing be "to the best of the person's knowledge, information, and belief, formed after an inquiry reasonable under the circumstances." That belief could be based on an inquiry limited to the withholding of information. As such, the Court concluded, "the reasonableness requirement of paragraph (l)(3)(A) does not preclude a sponsor from listing as patent for which an applicant has not provided information under paragraph (l)(2)(A)." Ultimately, therefore, the Court concluded that the denial of discovery did not undermine the BPCIA and that denial of the motion to compel was proper.
Of course, this creates a chicken-and-the-egg situation. If the biosimilar applicant does not disclose its relevant information, the reference product sponsor will not know what patents cover the non-disclosed material. But if the sponsor will be unable to assert such a non-listed patent, it will be motivated to include every conceivable patent when it does create its list. This has the potential of escalating the amount of paperwork needed to be exchanged during the patent dance. Maybe the specter of responding to countless irrelevant patents will ultimately sway some biosimilar applicants to disclosure the information in the first place. Or maybe the question will be resolved in the next installment of the "Amgen v." series of BPCIA cases.
Before we leave this case, there is an update on the FDA approval process for the aBLA underlying this case. We had reported in June that the FDA's Oncologic Drug Advisory Committee recommended approval of Hospira's aBLA (see "Biosimilars Update -- Pfizer's Proposed Epogen®/Procrit® Biosimilar Recommended for Approval"). However, on June 22, 2017, Pfizer announced that it had received another Complete Response Letter (CRL) from the FDA. And even though this CRL did not relate specifically to the manufacture of epoetin alfa, it will likely result in a delay of drug approval. This is the second CRL that Pfizer received for this drug product application, thereby causing this application to be the longest between submission and approval (if it is, in fact, ultimately approved). We will continue to monitor the situation and provide updates as warranted.
Earlier today, the Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. The Court described the statute as "a carefully calibrated scheme for preparing to adjudicate, and then adjudicating, claims of infringement" related to biosimilar applications. This process begins with the disclosure by the biosimilar applicant of the aBLA and related information in order to "enable the sponsor to evaluate the biosimilar for possible infringement of patents it holds on the reference product . . . ." Nevertheless, the Court held that the reference product sponsor ("RPS") cannot seek enforcement of the disclosure provision in 42 U.S.C. § 262(l)(2)(A) by injunction under federal law. This was essentially the result reached by Federal Circuit. However, the Supreme Court reversed and remanded the question whether the disclosure provision was enforceable under state law, or whether the BPCIA pre-empted any state law claim. With regard to the 180-day notice-of-commercial-marketing provision of the statute, the Court reversed the Federal Circuit and held that the notice may be provided "either before or after receiving FDA approval."
As background, for those who have not being paying close attention for the past three years, in 2014, Sandoz became the first company to file a BLA pursuant to the BPCIA's abbreviated pathway found at 42 U.S.C. § 262(k). This application was for approval to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic drug product. NEUPOGEN® is a 175 amino acid recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF), and is often prescribed for cancer patients on chemotherapy at times when they are at most risk of infection because their white blood cell count is low. However, despite availing itself of this pathway for FDA approval, Sandoz refused to participate in the patent resolution component (the disclosure and information exchange provisions, also known affectionately as the "patent dance"), alleging that it was not a mandatory component. Amgen responded by filing suit on October 24, 2014, requesting in part a preliminary injunction to prevent Sandoz from entering the market before the issues can be resolved by the Court. United States District Judge Seeborg of the Northern District of California denied Amgen's motion, ruling that the disclosure and notice provisions of the BPCIA were not mandatory. And, in a seriously fractured decision, the Federal Circuit agreed (see "Federal Circuit Decides Amgen v. Sandoz (in an opinion that will make neither party happy)").
Is an Applicant required by 42 U.S.C. § 262(l)(2)(A) to provide the Sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the Applicant "shall provide," and, where an Applicant fails to provide that required information, is the Sponsor's sole recourse to commence a declaratory-judgment action under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii)?
However, the Court essentially sidestepped the question of whether "shall" means "shall" and instead held that an RPS cannot seek enforcement of this section by injunction under federal law. The Supreme Court essentially agreed with the Federal Circuit that the BPCIA provides the exclusive federal remedy for failure to disclose the required information by authorizing an RPS to bring an immediate declaratory-judgement action.
if the purpose of such submission is to obtain approval under such Act to engage in the commercial manufacture, use, or sale of a drug, veterinary biological product, or biological product claimed in a patent or the use of which is claimed in a patent before the expiration of such patent.
35 U.S.C. § 271 (e)(2)(c). As the Court put it: "The flaw in the Federal Circuit's reasoning is that Sandoz's failure to disclose its application and manufacturing information was not an act of artificial infringement, and thus was not remediable under § 271(e)(4)." Instead, the artificial infringement is the act of submitting the application. The language in the statute regarding noncompliance with § 262(l)(2)(A) is not an element of infringement, but rather "merely assists in identifying which patents will be the subject of the artificial infringement suit." As a result, the exclusive remedies outlined in § 271(e)(4) for this artificial infringement do not apply. Instead, the Supreme Court remanded this issue back to the Federal Circuit to determine whether an injunction is available under state law to enforce § 262(l)(2)(A), or whether state law enforcement is preempted by BPCIA. If the Federal Circuit does determine that state-law remedies are pre-empted, biosimilar applicants will be able to continue withholding information required by the BPCIA without threat of enforcement of that provision.
The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k) [emphasis in opinion].
Sandoz had provided this notice prior to obtaining FDA approval, and the District Court agreed with Sandoz that this notice was effective. Sandoz's biosimilar, under the brand name Zarxio®, obtained FDA approval on March 5, 2015 and under the District Court's interpretation of the statute Sandoz was free to enter the market (an outcome prevented by an injunction granted by the Federal Circuit pending its decision on appeal). The Federal Circuit had agreed with Amgen that notice could only effectively be given after the biosimilar product has been approved by the FDA. According to the Federal Circuit, while in other portions of the statute the biosimilar product is referred to as "the biological product that is the subject of the application," in subsection (l)(8)(A) the statute reads "the biological product licensed under subsection (k)." The change in language indicated to the Federal Circuit that "[i]f Congress intended paragraph (l)(8)(A) to permit effective notice before the product is licensed, it would have used the 'subject of' language." The appellate court appreciated that Congress made this distinction at least in part because it is only after licensure that "the product, its therapeutic uses, and its manufacturing processes are fixed," something that even the biosimilar applicant does not know with certainty when it applies for FDA approval. In addition, "[g]iving notice after FDA licensure, once the scope of the approved license is known and the marketing of the proposed biosimilar product is imminent, allows the RPS to effectively determine whether, and on which patents, to seek a preliminary injunction from the court." This permits "a fully crystallized controversy" between the parties to have arisen when suit is filed, and "provides a defined statutory window during which the court and the parties can fairly assess the parties' rights prior to the launch of the biosimilar product." Interpreting the statute as advanced by Sandoz would, on the contrary, result in a situation where "the RPS would be left to guess the scope of the approved license and when commercial marketing would actually begin."
Whether notice of commercial marketing given before FDA approval can be effective and whether, in any event, treating Section 262(l)(8)(A) as a stand-alone requirement and creating an injunctive remedy that delays all biosimilars by 180 days after approval is improper.
The Supreme Court reversed. The Court's analysis regarding the 180-day notice provisions of the statute was straightforward. The Court held that the Federal Circuit had misinterpreted the statutory language by imposing a requirement for FDA approval before proper notice could be given. According to the opinion, the reference in the statute to a licensed biosimilar product was to the term "commercial marketing" not "notice," and thus just imposed the requirement that a product be licensed before it is marketed. With this interpretation the notice was not tied to a product having been licensed before notice was given, as the Federal Circuit had held, but to the unremarkable reality that the product had to be licensed before it was sold. The Supreme Court found only one timing requirement in the statute, that notice must be provided 180 days prior to marketing the biosimilar product. The opinion recognized the Federal Circuit opinion to contain a second timing requirement, that FDA had approved the biosimilar. This second requirement was not in the statute according to the Court and hence requiring approval was a misinterpretation of the statutory language by the Federal Circuit. This conclusion was supported for the Court by the structure of subsection §262(l)(8)(B) ("After receiving notice under subparagraph (A) and before such date of the first commercial marketing of such biological product, the reference product sponsor may seek a preliminary injunction" (emphasis added)). According to the opinion, Congress would have used this structure in its language for §262(l)(8)(A) if it intended the provision to have the interpretation applied by the Federal Circuit.
Outside this question of statutory interpretation, the Court identified the policy arguments raised by the parties and the government, and refused to be persuaded by the plausible contentions set forth therein. Rather, the Court recommended that Congress is the appropriate body for making these policy distinctions and advised the parties to go there to effect a change in the law.
Justice Breyer filed a brief concurring opinion, directed to his concerns (voiced during oral argument) that Congress had delegated to FDA responsibility for interpreting the statute, based in part on its greater expertise. The Justice thus invited the agency to "depart from, or to modify, today's interpretation" under the appropriate circumstance, citing National Cable & Telecommunications Assn. v. Brand X Internet Services, 545 U. S. 967, 982–984 (2005), to support his interpretation of the agency's authority in this regard.


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Orientalism: Good or Bad
Posted by michelinewalker in Napoléon Bonaparte, Orientalism, The Middle East, The Ottoman Empire
Edward Said, Egyptology, l'Institut d'Égype, Napoléon Bonaparte, Orientalism, The Middle East
Head of an Arab Man by Jean-Horace Vernet (pen, brown ink, brown wash) (Stephen Ongpin Fine Art, London)
Entering the Mosque by Edwin Lord Weeks, 1885 (Photo credit: thephora.net)
"Orientalism is the exaggeration of difference, the presumption of Western superiority, and the application of clichéd analytical models for perceiving the Oriental world."
(Edward Said, Orientalism, Wikipedia)
At first sight, the post that published itself on 1 September 2016 and was returned to the status of "draft," seemed to indicate opposition to Edward Said's Orientalism, which I took to be the art of Jean-Léon Gérôme (11 May 1824 – 10 January 1904), Alexandre-Gabriel Decamps (March 3, 1803 – August 22, 1860), Émile Jean-Horace Vernet (30 June 1789 – 17 January 1863), the Baron Antoine-Jean Gros (16 March 171- 25 June 1835), Eugène Delacroix (26 April 1798 – 13 August 1863) and others. There is a difference between my view and his, but it is not opposition.
According to Dr Said, colonialism and imperialism rested on a sense of superiority on the part of colonialists. Edward Said studied "the cultural representations that are the bases of Orientalism, the West's patronizing perceptions and fictional depictions of 'The East.'" Orientalism, Wikipedia.)
There can be no doubt that the Sykes-Picot Agreement of 1916 epitomizes what is now referred to as Eurocentrism, the postulate governing both colonialism and imperialism. Colonialists viewed themselves as superior to the inhabitants of the countries they had discovered and/ or conquered.
It is within the nature of Empires to rise and fall. It could be therefore that, in 1916, the Ottoman Empire was about to collapse. However, it was not for Mark Sykes, from Britain, and for François Georges-Picot, from France, to partition the Ottoman Empire and to do so before it had fallen. The Sykes-Picot Agreement violated what we now consider a right: the right of nations to determine their future, a right which, in 1916, may not have been perceived as a right.
Nativism is also Eurocentric and, in 2016, Eurocentrism should be a thing of the past. However, it has resurfaced as a result of the European Migrant Crisis. Where will Marine Le Pen send the Muslim migrants who are now entering France? She could be elected to the presidency of France in 2017. More ominous is the possible election, three months from now, of Donald Trump to the presidency of the United States. If Mr Trump is elected, there will be no asylum for migrant Muslims in the United States. It is Mr Trump's view that Muslims are terrorists.
Who would have imagined, a year ago, that British Jews would exercise their right of return to Germany because of the degree of racism that seemed to underpin the unexpected Brexit leave vote? There are consequences to colonialism and to imperialism. If a nation has colonized a nation, the identity of the colonized people may reflect the identity of the citizens who rule it. During the period its territory is considered home to another nation, inhabitants of the colony are educated in the schools of the colonist. All a society needs to ask of its inhabitants, whatever their origin, is that they be law-abiding citizens. "Je suis Charlie" and "Je suis Raïf."
For that matter, "I am Dr Said." One does not partition a country to make room for a people who claim as theirs a land they have not inhabited for two thousand years or more. Notions such as the concepts of "promised land" and that of "chosen" people are not literal. The Balfour Declaration of 1917 supported the creation of a homeland for the Jewish people, but the Jewish homeland Britain supported was in Palestine. That is all Britain could promise. If it is the right of nations to determine their own future, the matter should have been negotiated by the people concerned: the Jews and the Palestinians.
Hitler's persecution of the Jews
the United States and World War II
the partition of Palestine
the creation of Israel 1948
History took a wrong turn. Adolf Hitler and his Nazis rose to power in the 1930s and in 1939, they started invading European countries. They also built concentration camps and killed 6 million Jews, most of them in gas chambers. Intervention was needed, so Winston Churchill approached US President Franklin Delano Roosevelt (30 January 1882 – 12 April 1945), a truly great American.
American intervention was required both to liberate occupied Europe and to save the Jews who had survived Hitler's concentration camps. American help was also needed to rebuild Europe. Europe had been crushed. The United States is a powerful country, but seldom was it so powerful than after World War II. The State of Israel was created and the United States, under President Harry S Truman, was the first country to recognize it as a state. Israel would enlarge its borders in 1967, during the Six-Day War. In fact, nearly 50 years later, Israel has yet to return the occupied territories it conquered during the Six-Day War. We may still have autocrats, but colonialism is over.
http://www.telegraph.co.uk/news/uknews/1442478/De-Gaulle-feared-Six-Day-War-might-start-global-conflict.html
In the meantime, Dr Said, a musician, and pianist Daniel Barenboim were promoting harmony and counterpoint. Dr Said and Mr Barenboim co-founded the West–Eastern Divan Orchestra, based in Seville, and whose members are Israeli, Arab and Jewish musicians. (See Edward Said, Wikipedia.)
I can understand why Mr Said finds fault with Orientalism. Although it has produced masterpieces, Orientalism conveys a view of the Orient that is conditioned by artists whose Orient is a borrowed Orient. It is not Islamic art and it may be purely of an ornamental value. By and large, the West does not learn the East. Lawrence of Arabia was an exception.
Jean-Horace Vernet's Head of an Arab Man, featured at the top of this post, is quite an achievement, by artistic standards. However, it is not Islamic art. It is Orientalism, a movement that followed Napoleon Bonaparte's expedition to Egypt and Syria. Which takes us to Egyptology.
Napoleon at the Battle of the Pyramids, Baron Antoine-Jean Gros
Bonaparte visiting the Plague-Stricken at Jaffa by Antoine-Jean Gros, 1799 (Art Renewal Centre)
Visit the Louvre: http://www.louvre.fr/en/oeuvre-notices/napoleon-bonaparte-visiting-plague-stricken-jaffa
The Battle of the Pyramids (Wikipedia.)
"An unusual aspect of the Egyptian expedition was the inclusion of an enormous contingent of scientists and scholars ("savants") assigned to the invading French force, 167 in total. This deployment of intellectual resources is considered as an indication of Napoleon's devotion to the principles of the Enlightenment, and by others as a masterstroke of propaganda obfuscating the true motives of the invasion; the increase of Bonaparte's power. (See French campaign in Egypt and Syria, Wikipedia.)
L'Institut d'Égypte
I realize fully that Napoleon's campaign in Egypt and Syria was motivated by his wish to hinder British trade with a more distant Orient and that France, under Napoleon wanted to annex Egypt. It wanted to enlarge its Empire. Nevertheless, although the French campaign in Egypt was mostly self-serving, I rather admire Napoleon' caveat to his troops as they approached Alexandria. They would meet Muslims and had to be tolerant of their culture. His caveat is quoted in my last post: A Mameluke & the Napoleonic Code.
Interestingly, Napoleon took 167 scientists and scholars to the Near East and even if the discovery of the Rosetta Stone were their only finding, it was an important discovery and the stone's ancient Egyptian hieroglyphs were deciphered by Jean-François Champollion, who was a linguist whose research interest was ancient languages and whose linguistic research would lead to more research.[1]
Copies were made of the inscriptions of the Rosetta Stone were sent to various countries and a discipline was born: Egyptology. The scientists and scholars who travelled with Napoleon's troops made several findings and, on 24 August 1798, 48 of Napoleon's scholars met and founded l'Institut d'Égypte. As early as 22 November 1799, they decided to publish their Description de l'Égypte. The Institut d'Égypte was closed on 21 March 1801, when Napoleon returned to France.
At the time, an artefact such as the Rosetta Stone could be considered part of the spoils of wars. It was established that Napoleon had been defeated by Britain at the Battle of the Nile, fought from 1 to 3 August 1798. Therefore, under the terms of the Capitulation of Alexandria (1801), the Rosetta Stone was transported to England aboard l'Égyptienne, a frigate captured from the French. It was housed in the British Museum where it is still exhibited.
Ironically, General Jacques-François Menou, baron de Boussay, who had converted to Islam and married a Muslim, was the person who handed the Rosetta Stone over to Britain. The precious rock stele had been found under Menou's command.
In Egypt, Napoleon had recruited an élite corps of soldiers whom he called the Mamelukes of the Imperial Guard. They joined his Armée d'Orient and followed Napoleon back to France. One Mamluk, Roustam Raza, a slave of Armenian descent, would be Napoleon's bodyguard for 15 years. He had settled in France and would not follow Napoleon to Elba, where the Emperor was first exiled.
Taha Hussein
The Institut d'Égypte resumed its activities in 1836. Its scholars were English, French, German, Egyptians… Scholars from every nationality may choose Egyptology as a field of expertise. But l'Institut égyptien's major figure would be Egyptian scholar Taha Hussein (15 November 1889 – 28 October 1973) whose accomplishments include a book on Ibn Khaldūn (27 May 1332 – 19 March 1406). The Institut was severely damaged by a fire during the Egyptian Revolution of 2011 (The Arab Spring). It is being rebuilt but some, if not many, of the documents it housed are forever lost. There may not be another copy.
http://www.historytoday.com/jonathan-downs/calamity-cairo
Orientalism in Art and Literature
Gérôme, Vernet, Gros, Ingres, etc.
in Literature: Flaubert's Salammbô
As for Orientalism as subject matter or theme, the French campaign in Egypt and Syria (Wikipedia) did inspire artists, such as Jean-Léon Gérôme (11 May 1824 – 10 January 1904) and Horace Vernet (MMA, NY). Jean-Auguste-Dominique Ingres (29 August 1780 – 14 January 1867), painted the famous Grande Odalisque (Louvre). Earlier in history an oda (Turkish for room) had been a chambermaid, but Ingres' Grande Odalisque was a concubine, almost a secret, but she was the first of many. She may be elongated, but that is poetic licence. Among Orientalists, most had travelled to the Near East, but Ingres had not. His Grande Odalisque was the product of the imagination or Orientalisme. It was not Islamic Art.
The French campaign in Egypt and Syria also inspired musical compositions and literature. However, neither Victor Hugo's "Les Djinns," nor Gustave Flaubert (12 December 1821 – 8 May 1880) Salammbô, a 1862 historical novel, are Islamic literature. Gustave Flaubert, the author of Madame Bovary (1856), did visit Istanbul, in modern day Turkey, and Beirut, Lebanon, before he wrote Salammbô. At the time Salammbô was in progress, Flaubert also went to Carthage to research his historical novel. He needed information and couleur locale.
Like Ingres, Victor Hugo (26 February 1802 – 22 May 1885) did not travel to the Orient. "Les Djinns," one of the poems included in Hugo's Orientales (1829), is the product of a brilliant imagination. However, Hugo was inspired by the Greek War of Independence, 1821 – 1832, as was Eugène Delacroix. During the course of his career, Delacroix also illustrated William Shakespeare, the Scottish author Walter Scott and the German author Johann Wolfgang von Goethe. (See Eugène Delacroix, Wikipedia.)
Interculturalism
Quebec has a policy of interculturalism. It is based on the work of Martha Nussbaum and emphasizes humanity. Interculturalism involves "the recognition of common human needs across cultures and of dissonance and critical dialogue within cultures" Cultivating Humanity).[2] Humanism is precisely what Dr Said believes should be emphasized. We are all the same and it is this sameness we should recognized. Palestinians are not second-class citizens no more than Muslims in Algeria.
As works of art, musical compositions and literature, which is what I have shown, would not be criticized by Dr Said, not individually and not as paintings, musical compositions, and literature. All express an interest in the East. That interest can lead to a wish to understand and to accept what differs from the rest of us but only superficially. Works of art can be inspirational, including a depiction of the orient by an outsider. It may lead to an appreciation of Islamic art, which is where peace may begin.
What Dr Said bemoans is a human tragedy. Palestinians have been trivialized and they have been dispossessed. They are still, to this day, being relocated, like pawns. The exodus of Palestinians started in 1948 and, in 2003, United States President George W. Bush entered Iraq at British Prime Minister Tony Blair's instigation. Entering a sovereign nation is illegal, but it is also disrespectful, a human value.
Mr Said's book, entitled Orientalism, has to do, first and foremost, with the humiliation Palestinians were subjected to when their country was partitioned and its citizens marginalized. But the more significant starting-point was the Sykes-Picot Agreement of 1916, the partitioning of the Ottoman Empire by Britain and France. Sykes and Georges-Picot divided the spoils of war so their "spheres of influence" were protected. Countries were like pawns and the promise of a Greater Syria, made to Arabs through Lawrence of Arabia, was not reflected in the new map. As for the Balfour Declaration of 1917, it went no further than a decision to support the creation of a Jewish homeland, in Palestine.
Whatever its starting-point, l'Institut égyptien would have survived in its pristine condition as an Egyptian establishment which it had become, had rioters not thrown a Molotov cocktail through a window during the Egyptian Revolution of 2011. We now have suicide bombers.
I have included two videos. One is difficult to understand and the other, too long for a post. They feature Dr Said. Dr Said may at first be difficult to understand. However he seems to be saying that ornaments, however beautiful, fall short of an understanding of the East.
I apologize for a lengthy absence. I've been unwell: anemia.
Love to everyone. ♥
A Mameluke & the Napoleonic Code (1 September 2016)
More Orientalism by Gérôme (17 August 1916)
Orientalisme: Mostly Gérôme (15 August 1916
The Sykes-Picot Agreement of 1916 (11 August 1916)
The Remains of the Past (9 August 2016)
The Algerian War: the Aftermath (25 July 2016)
France in North Africa (21 July 2016)
Algeria: second-class citizens (20 July 2016)
The Last Crusades: the Ottoman Empire (12 February 2015)
Beyond Bilingualism and Biculturalism (2 May 2015)
Quebec group pushes interculturalism in place of multiculturalism (Globe and Mail, 23 August 2012)
A Clarification of Terms: Canadian Multiculturalism and Quebec Interculturalism (Centre for Human Rights and Legal Pluralism, McGill University, August 2012)
[1] Jean Lacouture, Champollion, une Vie de lumières (Paris: Éditions Grasset & Fasquelle, 1988).
[2] Quoted in Beyond Bilingualism and Biculturalism (see RELATED ARTICLES)
Napoleon Bonaparte, aged 23, by Henri-Félix-Emmanuel Philippoteaux (Photo credit: Wikipedia)


Is This Kid Going To Wear Me Out?
It is a thought I have had a few times. It is the age gap. It doesn't worry me but I would be lying if I said it didn't cross my mind from time to time. While he is getting faster, stronger and more energetic as he grows, I am obviously slowing down. It will not get any better and over the next few years that age difference will become more apparent.
Last night I hardly had enough energy to take a shower. After bathing Dani I thought it was a good idea to lie down for a few minutes first. Twenty minutes later I woke up.
Had it been such a long and busy day? Or did I just need a little more sleep?
In the morning we took the metro into the city centre to see a traditional Easter parade with lots of drums. Very loud. Dani had to cover his ears at one point. Then we went for a stroll taking in a small tapas route. Only 3 bars; well it's not all about doing kids things at the weekend. We decided to take a bus home because a bus or car ride works wonders when it comes to making Dani sleep. We still had to walk a fair bit to catch the bus but it stopped close enough to the house so that carrying him would not be an issue.
On the bus he fell asleep as planned. Not much later his mum was also taking a siesta. His old dad rarely needs a siesta and today seemed no different.
After Dani's siesta we woke him for his snack (merienda). There was just enough time before the start of a puppet show at the local community library/theatre/cultural centre. It was a story about pirate's treasure. Some of the kids got very animated and noisy. Dani as much as any. I was surrounded by the loudest kids in the theatre. I was tired but there was no chance of dozing off. Not the best kids show we have been to but it was free and it was fun for the little ones.
The pirate looked uncannily like the big bad wolf with an eye patch. Still, he did the job for the little ones. Then there were the crocodiles. Two. A traditional green one and, oddly, a blue one. Again it worked. The kids – particularly those surrounding me – went nuts whenever the crocs appeared.
On the way home I had to run most of the way. It was a race apparently. Then I had to play superheroes. Super villains in my case to be precise. Then it was bath time. Not a particularly exhausting day I admit but it did for me. That is when I went to relax for a couple of minutes.
I think I need to get to the gym more often and get as fit as I possibly can. That kind of thing is a double-edged sword. Training to get (and stay) fit tires you out – that's kind of the idea. Overall however it gives you more energy. I am trying and will continue to make the effort.
The question remains though: How long can I keep up with this growing bundle of energy?
Next > Can You Dig It?


The new Project One high rise in Greenville is nearing completion and several companies already located in the city's center will relocate to the new site. That means that about 250,000 square feet of office space will be vacant in the next 12 months and although vacancy rates will rise initially, City officials are excited about the level of interest from businesses considering a move downtown. Downtown Greenville is seen as the regional hotspot and many suburban tenants are eying the possibility acquiring more space downtown that was previously unavailable and where the number may have not worked before.
The City's grown has been pushing away from the North end of Main Street toward the West End over the past few years, but Project One and the re-branded Hyatt Hotel as part of the NOMA (North Main) Tower have pushed the attention back up to North Main. The city also hopes to expand westward out toward Heritage Green and the main library, but that will probably be a few years out.
Jim Costelo of Americas Research CBRE predicts that growth in Greenville will exceed larger metro markets such as Atlanta and Charlotte, partially due to the manufacturing base in the Upstate. The Upstate has more industrial retail space than Columbia and Charleston combined, with about 60% of that being used for actual manufacturing rather than distribution. To assist the local manufacturing community, the South Carolina Ports Authority is establishing an "inland port" in Greer, which is scheduled to open later this year near GSP International Airport. Its purpose is to speed up delivery of goods by creating a contain transfer station between rail and trucks 200 miles inland from a congested port. It has major implications for goods being shipped around the entire Southeast region, especially as ports receive increased traffic when the Panama Canal expands.
Spring is here! After unseasonable sunny highs in the mid to high 70s this past weekend and scattered thunderstorms Monday night, we are expecting mostly sunny conditions with highs in the 60s the next few days. A chance of rain on Friday will bring a drop in temperature for the upcoming weekend.
Thanks for the very interesting post, i really enjoyed it. yes i agree that spring season in Grenville is really beautiful, its a good place to spend holidays here.
Wow, that is a good job. I like this.


Bengaluru based embedded systems company Mistral Solutions launched Smart Mobility Architecture (SMARC) module powered by Renesas' RZ/G1E that incorporates dual ARM Cortex-A7 CPU cores operating at up to 1.0 GHz. The smart and compact module is suggested as an ideal building block for any embedded system. The SMARC (Smart Mobility Architecture) Module consists of the Renesas' core CPU and supporting circuits including memories and power supplies.
Module supports dual cameras, dual display ports, dual Ethernet and most of the interfaces of SMARC 1.0 standard. The RZ/G1E-based SMARC module is designed in a compact 82mm x 50mm with 1.2mm PCB thickness. It is compatible with any design that follows SMARC architecture and can be plugged in to provide enhanced performance and functionality.
As a development support, Mistral offers a carrier board with Display, Video, Audio, Wireless, USB, Connectivity and other interfaces through its SMARC Dev Kit. Based on requirements, application-specific interfaces can also be brought on to a custom carrier board and used along with the SMARC module.
SMARC Module from Mistral is suggested for applications such as Industrial HMI, Intelligent Cameras, IoT gateway, Embedded Vision, Industrial Controllers and V2X Infrastructure.


We live in an unprecedented "age of information," but we use very little of it. Dieters prefer not to look at the calories in their tasty dessert, people at high risk for disease avoid screenings and people choose the news source that aligns with their political ideology.
Feel down about getting older? Wish your life was better? Worried about all the problems that come with age?
A new survey suggests you need only wait: Many pessimistic feelings held by people earlier in life take an optimistic turn as they move toward old age. Even hallmark concerns of old age — about declining health, lack of independence and memory loss — lessen as Americans age. "The younger generation is less optimistic," said Dr. Zia Agha, chief medical officer at West Health, a nonprofit focused on aging issues whose related research institute released the poll Wednesday with the independent research organization NORC at the University of Chicago.
Whether we're talking about a great novelist like John Irving or an era-defining entrepreneur like Jeff Bezos, it's natural to conclude that the mega-successful owe their achievements to an almost magical quality that you're either born with or you're not: talent.
Columbia University Medical Center (CUMC) researchers have discovered a common genetic variant that greatly impacts normal brain aging, starting at around age 65, and may modify the risk for neurodegenerative diseases. The findings could point toward a novel biomarker for the evaluation of anti-aging interventions and highlight potential new targets for the prevention or treatment of age-associated brain disorders such as Alzheimer's disease.
Can humans outsmart aging? Here's what the science says.
We've talked about how important location is when choosing a gym, but not how much travel distance can affect motivation. The sweet spot, it turns out, is around 4 miles. People who traveled only 3.7 miles to their gym went five or more times every month. People who traveled around five miles or more only hit the gym about once a month. Distance was less of a factor, however, for individuals that sprung for more expensive gym experiences. Establishments like Equinox, The Barre Code, and SoulCycle warranted trips almost twice as far as cheaper competitors. Better amenities, more class offerings, and cleanliness can be a big draw for some. Basically, a mediocre gym five miles away is the worst option you could pick.
People in superstar mode want a world they can change. Those in rock star mode seek a world they can stabilize. You'll need both.
The Startup Idea Matrix helps founders brainstorm new startup ideas. The matrix outlines various consumer markets and tactics a company can take to bring a unique product to the market. Chris Dixon first showed me this format a few years ago, and since then I've found that browsing rows and columns of matrixes like this can help inspire new ideas. This is the B2B edition.
According to neuroscientists, several figures from the tech sector are currently scouring labs across the U.S. for technology that might fuse human and artificial intelligence. In addition to Johnson, Elon Musk has been teasing a project called "neural lace," which he said at a 2016 conference will lead to "symbiosis with machines." And Mark Zuckerberg declared in a 2015 Q&A that people will one day be able to share "full sensory and emotional experiences," not just photos. Facebook has been hiring neuroscientists for an undisclosed project at Building 8, its secretive hardware division.


text:
キバ (牙)
The more or less leader of the quotpackquot Kiba follows his instincts towards Paradise. When he was young his pack and family were slaughtered when the forest where he lived was burned to the ground by Jagara039s troops. He was then raised by a native who told him that he had a purpose explaining why the forest spared his life. This native told him that he would have a great journey ahead of him and that journey was to find paradise. Kiba begins his quest for paradise in the hope that there he will finally find peace. He tends to be distrustful of humans and in the early episodes is reluctant to take a human form even when it039s more convenient. He also has a 039love039 for Cheza which may only be due to the fact that she can lead them to paradise. Kiba seems to be an arctic wolf in the series. Source: Wikipedia Kiba039s name means quotfangquot in Japanese.


There are many reputed undergraduate colleges in Purba Bardhaman district and all the colleges located in this district are under Burdwan University. St. Xaviers' College, Burdwan is one of the famous colleges in Purba Bardhaman district under University of Burdwan. This college offers UG courses in B.A., B.Com and B.Sc – both pass and honours. This page provides complete information related to online submission of application form, last date of submission, honours subjects offered, eligibility criteria, merit lists, merit list publication etc of the college for the in the academic year 2019-20.


Tips with two easy steps to remove MICROSOFT.BUILD.NUGETSDKRESOLVER.DLL file.
In this article I will give you tips with two easy steps to turn off microsoft.build.nugetsdkresolver.dll process, and then I will show you how to block microsoft.build.nugetsdkresolver.dll from running in your computer.
First thing let us find out what is microsoft.build.nugetsdkresolver.dll file?
microsoft.build.nugetsdkresolver.dll file from Microsoft Corporation is part of NuGet. microsoft.build.nugetsdkresolver.dll located in C:/program files/mono/lib/mono/msbuild/15.0/bin/ with file size 40080 byte, file version 4.8.0-preview1.5196, MD5 signature b98b4de069ff50e2e876a18b45eb2d27.
First Tip How to Stop microsoft.build.nugetsdkresolver.dll process.
Then from main window select "Process Manager" item. wait for few seconds, then after the process list appears scroll down to find microsoft.build.nugetsdkresolver.dll file you want to delete or stop.
click the microsoft.build.nugetsdkresolver.dll process file then click the right mouse button then from the list select "Add to the block list".
Second tip How to remove microsoft.build.nugetsdkresolver.dll from windows startup.
From startup manager main window find microsoft.build.nugetsdkresolver.dll process you want to delete or disable by clicking it then click right mouse button then select "Delete selected item" to permanently delete it or select "Disable selected item".
Do you think microsoft.build.nugetsdkresolver.dll Safe or NOT?
(microsoft.build.nugetsdkresolver.dll) has encountered a problem and needs to close. We are sorry for the inconvenience.
Fix microsoft.build.nugetsdkresolver.dll has stopped working error.
microsoft.build.nugetsdkresolver.dll. This program is not responding.
(microsoft.build.nugetsdkresolver.dll) - Application Error: the instruction at 0xXXXXXX referenced memory error, the memory could not be read. Click OK to terminate the program.
(microsoft.build.nugetsdkresolver.dll) is not a valid windows 32 application error.
(microsoft.build.nugetsdkresolver.dll) missing or not found.
Description: microsoft.build.nugetsdkresolver.dll file from Microsoft Corporation is part of NuGet. microsoft.build.nugetsdkresolver.dll located in C:/program files/mono/lib/mono/msbuild/15.0/bin/ with file size 40080 byte, file version 4.8.0-preview1.5196, MD5 signature b98b4de069ff50e2e876a18b45eb2d27.
Recommended: * To help you analyze the microsoft.build.nugetsdkresolver.dll process on your computer, "Asmwsoft PC optimizer" program have proven to be helpful.